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21st Century Cures report proposes priority review for medtech
The FDA is being urged to establish a priority review process for medtech in a report released by the 21st Century Cures ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl on the discussion draft of potential legislative proposals ...Learn More
Covidien wraps up $30M sale of Stellarex balloon to Spectranetics
Spectranetics has completed its purchase of Covidien's Stellarex drug-eluting balloon for $30 million. ...Learn More
Swiss Dx firm gains $1.1M in additional financing
The second closing of a Series B funding round has pulled in $1.1 million for ProteoMedix. ...Learn More
Siemens Healthcare reorganizes top tier
Hermann Requardt has stepped down as CEO at Siemens Healthcare, while Bernd Montag, the German conglomerate's head of ...Learn More
Agilent scanner approved for in vitro Dx use in China
The SureScan Dx microarray scanner from Agilent Technologies has been given the go-ahead by China's Food and Drug ...Learn More
EU approves a-fib algorithm used with AliveCor's Heart Monitor
European regulators have granted the CE mark to AliveCor's atrial fibrillation-detecting algorithm, making it available for ...Learn More
Study underway for Active's meniscus implant
A patient at the Ohio State University Wexner Medical Center has become the first to be implanted with the NUsurface ...Learn More
Decisio software receives FDA approval
Decisio's solution to improve the workflow of staff in intensive care units and emergency departments has been approved by ...Learn More
St. Jude wins FDA nod for FlexAbility ablation catheter
The FDA has granted St. ...Learn More
FDA grants humanitarian exemption to heart pump from Abiomed
Abiomed secured a humanitarian device exemption approval from the FDA for its Impella RP single-access heart pump to support ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Every artist was first an amateur.
Ralph Waldo Emerson, American ...Learn More
Irish High Court OKs $49.9B Medtronic-Covidien merger
Medtronic's proposed merger with Covidien has obtained approval from the Irish High Court, finalizing the largest merger in ...Learn More
Molecular Dx firm boosts IPO target to $74.3M
AltheaDx has increased the amount it hopes to raise in an initial public offering from $69 million to about $74.3 million. ...Learn More
Neurodiagnostics firm acquired by Natus Medical
Global Neuro-Diagnostics, the maker of home electroencephalography tests, has been purchased by Natus Medical for ...Learn More
GE Healthcare posts strong Q4 sales, orders in U.S.
GE Healthcare reported a 7% increase in sales and a 9% rise in orders in the U.S. ...Learn More
Cervical disc-replacement device from Dymicron gets CE mark
The Triadyme-C Cervical Total Disc Replacement, developed by Dymicron, has obtained CE mark approval in Europe. ...Learn More
Patient enrollment for Sorin's sutureless aortic valve completed
Sorin Group, an Italian maker of cardiovascular devices, has finished enrolling 300 patients in a clinical study of its ...Learn More
Knee-replacement device from OrthAlign used in over 25K procedures
The KneeAlign Total Knee Arthroplasty system, developed by OrthAlign, has been used successfully around the globe in more ...Learn More
FDA OKs device from Bioceptive
The FDA has given medtech startup Bioceptive clearance to market its suction-based device that could replace cervical ...Learn More
Top cardiologist appointed to senior post at FDA
The FDA hired top cardiologist and researcher Dr. ...Learn More
Glucose monitoring app receives marketing approval from FDA
The FDA has approved Dexcom's Share Direct Secondary Displays system for the tracking of blood glucose levels by diabetes ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
We delight in the beauty of the butterfly, but rarely admit the changes it has gone through to achieve that beauty.
Maya Angelou, American ...Learn More
FDA grants HDE status to neurostimulation device from Medtronic
Medtronic secured a humanitarian device exemption approval from the FDA for its Enterra II neurostimulation implant to treat ...Learn More
Calif. insulin pump maker sets IPO's midpoint price at $49M
Asante Solutions said it intends to offer 3.5 million shares in its initial public offering at $13 to $15 per share, making ...Learn More
Firm, clinical reference lab agree to products of conception-testing deal
ReproSource, a clinical reference laboratory, has agreed to offer CombiMatrix's products of conception testing, or ...Learn More
New medtech nomenclature framework unveiled in Russia
Russia's medtech industry regulator, Roszdravnadzor, has issued a new nomenclature classification framework as part of a ...Learn More
Metabolomics project obtains $2.4M boost in Canada
Canada has entered into a $2.4 million investment deal with the University of Alberta and Genome Alberta to develop a ...Learn More
ViewRay taps Itochu to offer radiotherapy product in Japan
ViewRay, a maker of image-guided radiotherapy, has struck a distribution deal with Itochu, a Japanese general trading firm, ...Learn More
FDA gives MED-EL nod on cochlear implant that is MRI-safe
MED-EL said Friday its Synchrony cochlear implant has been cleared by the FDA, and the Durham, N.C.-based medtech firm plans ...Learn More
Nevro closer to FDA approval for pain treatment device
The FDA has issued an approvable letter to Nevro for its Senza system, a device that relieves pain by sending electrical ...Learn More
Health systems, groups call for EHR device ID
A number of health systems, patient safety advocates and medical groups have called on HHS to include provisions in its ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Every time I paint a portrait I lose a friend.
John Singer Sargent, Italian-born American ...Learn More
CareFusion-Becton Dickinson merger gets shareholder approval
Shareholders on Thursday approved CareFusion's proposed $12 billion merger with Becton Dickinson, which will close once it ...Learn More
BioFire buy drives 2014 revenue growth for BioMerieux
BioMerieux said its total revenue increased to $1.9 billion for the 12 months ending Dec. 31, which was up 7% from 2013. ...Learn More
Surgical solutions, new offerings drive Q1 profit growth for Covidien
Covidien posted a 28.4% rise in profits to $511 million for the quarter ending Dec. 26 on sales of $2.69 billion. ...Learn More
San Diego-based cancer Dx firm to sell 6.3 million shares in IPO
Biocept filed plans Wednesday with the Securities and Exchange Commission to sell about 6.3 million company shares in an ...Learn More
Molecular Dx firm, Norwegian hospital team up in cancer Dx deal
University Hospital Oslo has entered into a cancer diagnostics deal with New Oncology, a German molecular diagnostic ...Learn More
Report: Worldwide MRI market could be worth over $9.2B by 2020
A GlobalData report predicts the worldwide market for MRI systems could grow from about $4.1 billion in 2013 to over $9.2 ...Learn More
U.S. grants 66 patents to Carestream Health in 2014
The U.S. ...Learn More
FDA OKs collagen bone graft from BioStructures
The FDA has given BioStructures, a Newport Beach, Calif., medtech firm, clearance to market its advanced Silhouette ...Learn More
FDA is committed to U.S. trials of medical devices
The FDA has made the first step in its commitment to give U.S. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Rough diamonds may sometimes be mistaken for worthless pebbles.
Thomas Browne, English ...Learn More
Welch Allyn buys maker of diabetic retinopathy tests
Welch Allyn announced it has purchased Hubble Telemedical, a Knoxville, Tenn.-based maker of remote eye tests for diabetic ...Learn More
Maker of X-ray imaging pill sets IPO's midpoint price at $13.2M
Check-Cap said it is offering 1.2 million shares in its initial public offering at $10 to $12 per share, making the midpoint ...Learn More
Solid sales of surgical devices bolster Blue Belt's performance in 2014
Blue Belt Technologies reported that it sold 33 Navio Surgical System devices globally during its first full year of ...Learn More
Firm, hospital sign deal to study ovarian cancer diagnostic tests
A deal was recently signed by the Belgian company VolitionRx and Singapore General Hospital to start a pilot study that ...Learn More
B. Braun gets exclusive rights to market surgical adhesive in Europe
B. Braun Medical has struck a distribution agreement with Cohera Medical to allow B. ...Learn More
Sygnis taps BioNova to offer product in Spain
Sygnis said it has signed a distribution deal with BioNova Cientifica to help bring its TruePrime Single Cell WGA kit to ...Learn More
An M&A checklist for medical device companies
Medtech companies considering a merger, strategic partnership or investment should consider the following checklist, sourced ...Learn More
Device stimulates nerve to manage Parkinson's symptoms, boost balance
University of Gothenburg scientists in Sweden are testing a device they designed that controls symptoms of Parkinson's ...Learn More
Medtronic launches insulin management system
Medtronic has introduced its MiniMed 640G system meant to bolster insulin management in diabetes patients by suspending and ...Learn More
FDA clears advanced pedicle screw system from K2M
The MESA 2 Deformity Spinal System, a pedicle screw technology designed by K2M for complex spinal pathologies, has obtained ...Learn More
Roche unit pursues FDA OK for lung cancer companion Dx test
An FDA premarket approval application has been filed by Ventana Medical Systems, a unit of Roche, for its ALK (D5F3) CDx ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
The secret of my influence has always been that it remained secret.
Salvador Dali, Spanish ...Learn More
Calif. PAD catheter maker sets IPO's midpoint price at $59.9M
Avinger said it intends to offer just over 4.6 million shares in its initial public offering at $12 to $14 per share, making ...Learn More
Exactech buys French firm in deal that could reach more than $11M
BlueOrtho SAS, a French computer-assisted surgical technology firm, has been acquired by Exactech, a Gainesville, Fla.-based ...Learn More
Mass. imaging firm sets IPO's midpoint price at $59M
Infraredx said it is offering 4 million shares in its initial public offering at $13 to $15 per share, making the midpoint ...Learn More
Funding round brings in $20M for medical monitoring firm
EarlySense has obtained $20 million in a financing round led by the venture arm of Samsung Electronics. ...Learn More
Public offering of warrants, stock filed by Great Basin
A prospectus has been filed by Great Basin Scientific with the U.S. ...Learn More
Report: Small bone orthopedics market poised for steady growth
A report from Research and Markets projects that the U.S. ...Learn More
Report cites 5% growth for global ultrasound market
A Kalorama Information report says the global market for ultrasound devices is growing at a rate of 5% after posting revenue ...Learn More
U.S. release of Hospira infusion pump planned
Hospira said Tuesday its Plum 360 infusion system with Hospira MedNet has been cleared by the FDA, and the company plans to ...Learn More
Diagnostic monitor from NEC wins FDA nod
The FDA has cleared NEC to market its MultiSync MD210C3 monitor, which comes with an LED display, an integrated front sensor ...Learn More
Integra resolves issues at Puerto Rico facility
The FDA has issued a letter officially clearing Integra Life Sciences' facility in Anasco, Puerto Rico, where the company's ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Some people drink from the fountain of knowledge. Others just gargle.
Robert Anthony, American business ...Learn More
Cell capture specialist acquired by DNAe
DNAe, a London-based maker of blood-to-result tests for bloodstream conditions, has purchased nanoMR, an Albuquerque, ...Learn More
Aurora Spine pulls in nearly $566K in financing
A private placement of ordinary shares brought Aurora Spine about $565,875 in new funding. ...Learn More
Orthopedics firm gets new CEO
Nick Deeter has been appointed chairman and CEO of Nextremity Solutions, a maker of devices for the foot and ankle market ...Learn More
Dx firm launches medical lab in China
PerkinElmer has announced the opening of the Suzhou PerkinElmer Medical Laboratory in China. ...Learn More
Visualization software company offers dynamic contrast-enhanced imaging solution
A dynamic contrast-enhanced imaging solution that gives users various DCE processing options was recently unveiled by ...Learn More
Fujifilm enhances Synapse PACS' data sharing capability
An Imaging Object Change Management support feature has been added to Fujifilm Medical Systems' Synapse PACS solution. ...Learn More
Heart failure patient survives with aid of artificial heart
A 68-year-old man who had terminal congestive heart failure is recovering at home after receiving an artificial heart from ...Learn More
New FDA guidance seeks to curb cross-contamination from improper use of GI endoscopes
Draft guidance aimed at reducing cross-contamination caused by the inappropriate use of flexible gastrointestinal endoscopes ...Learn More
FDA official sees big promise in MDSAP pilot
The Medical Device Single Audit Program pilot, designed to align audit processes in the U.S., Japan, Canada, Brazil and ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Conformity is the jailer of freedom and the enemy of growth.
John F. Kennedy, 35th U.S. ...Learn More
Report: Medtech M&As rose 18.5% in 2014
A GlobalData analysis showed that the medtech sector reported 96 mergers and acquisitions in 2014, which is 18.5% more than ...Learn More
Minn. device firm sets IPO's midpoint price at $70M
Entellus Medical said it is offering 4.375 million shares in its initial public offering at $15 to $17 per share, making the ...Learn More
IPO could pull in as much as $69M for Bellerophon Therapeutics
Bellerophon Therapeutics has filed an initial public offering in hopes of obtaining up to $69 million. ...Learn More
EU approves sirolimus-eluting stent from Eurocor
European regulators have granted the CE mark to Eurocor's E-Magic Plus Sirolimus Eluting Coronary Stent System. ...Learn More
Ultra-thin skin patch could eliminate need for glucose finger prick
Researchers at the University of California, San Diego, have created an ultra-thin, flexible skin patch designed to evaluate ...Learn More
Signostics' handheld bladder scanner cleared by FDA
The FDA has given Signostics 510(k) clearance to market the portable SignosRT Bladder scanner. ...Learn More
FDA clears single-use spine system from ECA Medical
The Intelligent Implant Systems Revolution Spinal System, a single-procedure instrument kit developed by ECA Medical ...Learn More
Joint venture to give researchers access to eICU patient data
Medical researchers will have access to data on more than 100,000 patients in Royal Philips' Hospital to Home eICU ...Learn More
Draft guidance addresses FDA's policy on wellness products
Draft guidance from the FDA aims to clarify its policy on distinguishing low-risk general wellness products from medical ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
It is good to have an end to journey towards, but it is the journey that matters, in the end.
Ursula Le Guin, American ...Learn More
Maker of corneal implant sets IPO's midpoint price at $50.4M
Presbia said it is offering 4.2 million shares in its initial public offering at $11 to $13 per share, making the midpoint ...Learn More
Investments in Minn. medtech reached $430M in 2014
A LifeScience Alley report showed that investment in Minnesota's medtech sector reached a six-year high in 2014 on the back ...Learn More
Loan, funding round bring in $30M for Obalon
Obalon Therapeutics, a Carlsbad, Calif.-based firm, has pulled in $30 million to develop the Obalon balloon, an ingestible ...Learn More
St. Jude posts slightly higher Q4 sales amid setbacks
St. ...Learn More
Molecular Dx firm, hospital team up in cancer genomics deal
Foundation Medicine has agreed to work with Avera McKennan Hospital to carry out clinical trials that center on personalized ...Learn More
B. Braun gains exclusive rights to market pain device in U.K.
GenomeDx scores reimbursement win for prostate cancer test
Medicare benefits administrator Palmetto GBA has issued a policy to cover GenomeDx Biosciences' Decipher prostate cancer ...Learn More
Report lists emerging technologies for hospitals in 2015
Artificial pancreas device technologies, anti-obesity devices and 3D printing are among the emerging health technologies ...Learn More
U.S. patent issued to Silver Bullet's antimicrobial metal ion technology
The U.S. ...Learn More
Lawmakers work on bipartisan legislation to accelerate cures
Rep. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Learn the rules like a pro, so you can break them like an artist.
Pablo Picasso, Spanish ...Learn More
EnteroMedics' anti-obesity device gains FDA approval
The FDA has granted EnteroMedics approval for its Maestro Rechargeable System to address severe obesity. ...Learn More
German Dx firm gains rights to MDxHealth's PCR system
Oncgnostics, a Germany-based molecular diagnostics company, has entered into a licensing deal with MDxHealth for undisclosed ...Learn More
2 groups team up on clinical trial services for cardiovascular device firms
The Cardiovascular Research Foundation has agreed to work with Novella Clinical to provide makers of cardiovascular devices ...Learn More
EU, Australia approve biologic bone graft from Cerapedics
A biologic bone graft developed by Cerapedics has obtained Therapeutic Goods Administration listing in Australia and CE mark ...Learn More
Stryker looks to grow through acquisitions, expand European footprint
Stryker has set its focus on bolstering its market share in Europe and is looking to achieve that growth through ...Learn More
Gov. Deval Patrick's life sciences legacy in Massachusetts
MassDevice.com looks at the legacy of former Massachusetts Gov. Deval Patrick when it comes to medical devices and biotech. ...Learn More
Firm gains FDA clearance for spinal fixation device
Valorem Surgical has received FDA clearance for MaxiMIS, a spinal fixation system that is minimally invasive. ...Learn More
ExThera joins team developing sepsis treatment device
ExThera Medical will work with Battelle and NxStage Medical in a project supported by the Pentagon's Defense Advanced ...Learn More
Patient awaiting heart transplant can go home thanks to portable device
Heart transplant candidate Stan Larkin was able to be discharged from the University of Michigan Frankel Cardiovascular ...Learn More
InVivo gets FDA nod to reopen enrollment for spinal injury trial
The FDA has given InVivo Therapeutics the go-ahead to resume enrollment of patients with acute spinal cord injuries in a ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
You must not lose faith in humanity. Humanity is like an ocean; if a few drops of the ocean are dirty, the ocean does not become dirty.
Mahatma Gandhi, Indian independence movement ...Learn More
Hatch files Senate bill to repeal medical device tax
The Medical Device Access & Innovation Protection Act, a bipartisan bill to repeal the 2.3% excise tax on medical devices, ...Learn More
For more:
Read the statement from AdvaMed, the Medical Imaging & Technology Alliance (MITA) and the Medical Device Manufacturers ...Learn More
Medtech firm gains $16.85M in Series B financing
Vascular Dynamics has obtained $16.85 million in a Series B funding round led by HBM Healthcare Investments. ...Learn More
Ultrasound market in U.S. could eclipse $2B by 2020
An iData Research report found that the ultrasound equipment market in the U.S. ...Learn More
CEO: Boston Scientific eyeing higher sales in BRIC markets by 2017
Boston Scientific obtained about 10% of its overall sales for the quarter ending Sept. ...Learn More
Report predicts global angiography market to reach $27.7B
A MarketsandMarkets report found that the global market for angiography devices is poised to hit $27.7 billion at a compound ...Learn More
Oracle partners with Proteus on data collection using ingestible sensors
A partnership between Proteus Digital Health and Oracle will allow researchers to monitor medication adherence of patients ...Learn More
Colorectal cancer NGS panel introduced by Vela
The Sentosa SQ Colorectal Cancer panel, a next-generation sequencing assay approved by European regulators, is being ...Learn More
Medical center, Advanced Biological Labs partner on HIV drug resistance test
Advanced Biological Laboratories is partnering with University Hospitals Case Medical Center to design and support Deepgen ...Learn More
IDE application for BiO2's pulmonary embolism catheter cleared by FDA
The FDA has approved the investigational device exemption application filed by BiO2 Medical, a San Antonio-based medtech ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
No man is a failure who is enjoying life.
William Feather, American ...Learn More
Roche to get majority stake in Foundation Medicine under $1.18B deal
Roche Holding could spend up to $1.18 billion under plans to acquire a majority stake in Foundation Medicine, a molecular ...Learn More
Conclusion of Medtronic-Covidien deal could come as early as Jan. 29
Ireland's High Court is set to meet Jan. 26 for a hearing on the $43 billion Medtronic-Covidien merger deal. ...Learn More
Maker of genetic tests eyes $86M in IPO
Invitae, a San Francisco-based maker of genetic tests, has filed an initial public offering in hopes of obtaining $86 ...Learn More
Biodesix stretches Series E round to $27M
Biodesix has obtained an additional $12 million in Series E financing from existing investors, bringing its total for that ...Learn More
PACS developer signs imaging system deal with radiology group
A five-year contract was recently signed by Zwanger-Pesiri Radiology with Visage Imaging, a developer of PACS and advanced ...Learn More
Diaxonhit, hospital partner to process molecular Dx tests in Europe
A service sublicensing deal has been signed by Diaxonhit, the European distributor of CareDx's AlloMap tests, with ...Learn More
EU approves lung cancer liquid biopsy test from Qiagen
European regulators have given the CE mark to Qiagen's therascreen EGFR RGQ Plasma PCR kit. ...Learn More
Radiation-free breast scanner introduced by TiaLinx
TiaLinx is launching the AR60-A, a non-contact breast tissue screening device that can detect and single out abnormal cell ...Learn More
FDA expands clearance for Intact Medical's breast-lesion procedure
The Intact System, a minimally invasive procedure developed by Framingham, Mass.-based Intact Medical, has obtained 510(k) ...Learn More
FDA clears Tandem's t:flex Insulin Pump
The FDA has cleared Tandem Diabetes Care to market its t:flex Insulin Pump, which has the largest insulin reservoir capacity ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
It is a fine seasoning for joy to think of those we love.
Moliere, French ...Learn More
Fountain Healthcare to invest $127.5M fund in medtech, other health fields
Irish venture capital firm Fountain Healthcare Partners has closed a $127.5 million fund that it plans to invest in medical ...Learn More
Qiagen buys enzymes provider, signs deal with ArcherDX
The enzyme solutions division of Enzymatics has been purchased by Qiagen for an undisclosed sum. ...Learn More
Medtech raises $50M in venture capital for additional programs
Boston-based PureTech, a life science research firm involved in medical devices, digital health and biotech, has received ...Learn More
Firm gets $8M boost to commercialize products, expand portfolio
DiaCarta, a Hayward, Calif-based developer of in vitro diagnostic tests, has obtained $8 million in a Series A funding round ...Learn More
EU approves drug-eluting balloon from Covidien
Covidien's Stellarex drug-eluting balloon has received market clearance from European regulators as a treatment for ...Learn More
Roche gains approval for blood, plasma donation test
Roche has received FDA approval for the new version of its cobas TaqScreen MPX Test. ...Learn More
FDA approves Viztek's Exa PACS
The FDA has given 510(k) clearance to Viztek for its Exa PACS, which is compatible with any operating system or device being ...Learn More
Researchers create monitoring software for status epilepticus
Boston Children's Hospital researchers developed intelligent software to use as an ICU monitoring system for patients with ...Learn More
FDA device center publishes guidance goals for 2015
The FDA's Center for Devices and Radiological Health will focus this year on giving the medical device industry more data on ...Learn More
PorOsteon's metal cervical cage cleared by FDA
The FDA has granted PorOsteon 510(k) clearance for its Phusion Metal Cervical Cage to address cervical disc disease. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
The most important thing in communication is hearing what isn't said.
Peter Drucker, Austrian-American writer and management ...Learn More
Integrity pulls in $1.6M for noninvasive blood glucose monitor
Blood glucose device maker Integrity Applications obtained $1.6 million in additional funding on Dec. ...Learn More
Lung sealant maker acquired by Pulmonx
Pulmonx, a maker of lung valve implants based in Switzerland and California, announced its acquisition of ...Learn More
2 molecular diagnostic firms to partner on lung cancer test
A partnership deal to create a test to diagnose the mutation and expression of the ALK gene, a target for non-small cell ...Learn More
Nephros appoints acting president, CEO, CFO
Paul Mieyal has been appointed acting president, acting CEO and acting chief financial officer of Nephros, a maker of ...Learn More
EU approves BRACAnalysis CDx assay from Myriad
European regulators have granted Myriad Genetics approval for its Tumor BRACAnalysis CDx assay, which is a companion ...Learn More
India plans update of medtech regulations
The Central Drugs Standard Control Organization of India plans to introduce a bill to revise medical device regulations and ...Learn More
Medtronic begins trial for cryoablation balloon in Europe
A European clinical study launched by Medtronic aims to examine the use of its cryoablation balloon, Arctic Front Advance, ...Learn More
St. Jude starts ventricular tachycardia study in U.S.
St. ...Learn More
Researchers develop new prostate cancer imaging protocol
Researchers at the University of California, San Diego, have created a new imaging technique known as restriction spectrum ...Learn More
U.S. lifts ban on imported pumps from Hospira
The FDA has lifted import restrictions on infusion pumps produced by Hospira in Costa Rica. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Peace cannot be kept by force; it can only be achieved by understanding.
Albert Einstein, German-American theoretical ...Learn More
Proposal to repeal medical device tax introduced in the House
A bipartisan bill to repeal the 2.3% excise tax on medical devices was introduced in the U.S. ...Learn More
For more:
Read the press release from AdvaMed outlining its support, along with the MITA and MDMA, for the medical device tax repeal. ...Learn More
CardioFocus pulls in $31.7M in equity funding
A financing round has brought in $31.7 million for CardioFocus, which hopes to bring in $33.2 million overall. ...Learn More
Report predicts global X-ray market to reach $9.8B by 2018
A Transparency Market Research report found that the global X-ray market is poised to hit $9.8 billion by 2018 on the back ...Learn More
Cleveland HeartLab purchases heart disease risk assessment tool
The MIRISK test, which is designed to assess a person's likelihood of suffering a heart attack within five years, was ...Learn More
Chairman of Boston Scientific announces plan to retire in 2017
Peter Nicholas disclosed his plan to step down as chairman of Boston Scientific in 2017. ...Learn More
Shockwave wins approval for PAD device in Europe
A balloon catheter developed by Shockwave Medical for the treatment of peripheral arterial disease has obtained CE mark ...Learn More
ReShape Medical's Duo balloon system looks to curb obesity
A Q&A with ReShape Medical CEO Richard Thompson on the company's cash pay procedure and how it can make a dent in obese ...Learn More
Trial underway for Medtronic's antibacterial cardiac mesh pouch
Medtronic has begun a clinical study of its Tyrx envelope, which releases minocycline and rifampin to reduce infections ...Learn More
Walgreens teams up with Qualcomm to link personal health data to medical devices
Walgreens and Qualcomm Life will partner to wirelessly link medical devices with personal health data. ...Learn More
Wireless fertility sensor wins mHealth competition
Prima Temp's wireless fertility sensor, called the BLOOM ring, won the top prize at the mHealth Summit 2014 Venture+ Forum ...Learn More
Alere's nucleic acid-based flu test gains FDA waiver
Alere received a CLIA waiver from the FDA for the expanded use of its Alere i Influenza A&B flu diagnostic assay. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Things don't have to change the world to be important.
Steve Jobs, American ...Learn More
Medtronic-Covidien merger gets shareholder approval
Shareholders on Tuesday approved Medtronic's proposed $43 billion merger with Covidien, which is set to close by early next ...Learn More
CareFusion, Becton Dickinson reach settlement deal on merger lawsuits
CareFusion and Becton Dickinson have agreed to settle lawsuits that shareholders filed in Delaware and California state ...Learn More
Molecular Dx firm Diagnovus acquired by Tenn.-based toxicology lab
Nashville, Tenn.-based toxicology lab Aegis Sciences has purchased Diagnovus, a molecular diagnostics firm, for an ...Learn More
Series C round pulls in $12M for GlySens' implantable glucose monitor
GlySens has obtained $12 million in a Series C financing round, which the company will use to complete development of its ...Learn More
Spine, bone-healing unit drives sales growth for Biomet in November quarter
Orthopedic device maker Biomet posted higher earnings for the quarter ended Nov. ...Learn More
EU approves portable hemodialysis system from Quanta
European regulators have granted Quanta Fluid Solutions CE mark approval for its SC+ portable, cartridge-based hemodialysis ...Learn More
High accuracy achieved by CAD for virtual CTC images in study
A study by Massachusetts General Hospital found that virtual monochromatic dual-energy CT colonography could be accurately ...Learn More
Bladder scanner from dBMEDx wins FDA nod
The FDA has cleared dBMEDx, an ultrasound technology developer, to market its BBS Revolution bladder scanner. ...Learn More
Cohera closer to FDA approval for surgical adhesive
The FDA has issued an approvable letter to Cohera Medical for its TissuGlu, a surgical sealant for use in abdominoplasty and ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
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Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It may be necessary temporarily to accept a lesser evil, but one must never label a necessary evil as good.
Margaret Mead, American cultural ...Learn More
Medical imaging technology firm acquired by Lexmark in $37M deal
Lexmark International has agreed to pay $37 million to acquire Claron Technology, a maker of image viewing, distribution, ...Learn More
U.S. antitrust waiting period for Tornier-Wright deal extended until Jan. 28
Dutch medical device company Tornier has resubmitted its antitrust registration in the U.S., which extends until Jan. ...Learn More
Canada-based hospital bed maker acquired by Stryker
CHG Hospital Beds of Canada, a manufacturer of low-height beds to cut the risk of patient falls, has been purchased by ...Learn More
Spine surgery systems drive Q4 revenue growth for Mazor Robotics
Mazor Robotics expects to report revenue of $5.7 million for the fourth quarter of 2014 after selling six Renaissance ...Learn More
Rapid point-of-care test measures blood markers of concussion
BioDirection, an Arizona-based startup that recently raised $1.6 million, is developing a point-of-care test that uses a ...Learn More
RF imaging unit for breast cancer introduced by TiaLinx
The portable radiofrequency imaging system AR60-A has been unveiled by TiaLinx, a radiometry sensor developer, to diagnose ...Learn More
Globus Medical signs supply deal with U.K. collagen powder provider
A contract has been signed by Collagen Solutions to supply Globus Medical, a maker of musculoskeletal implants, with fibrous ...Learn More
Medtronic gains FDA approval for drug-eluting balloon
The FDA has given Medtronic approval to market its drug-eluting balloon as a treatment for patients with peripheral artery ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
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Art is either plagiarism or revolution.
Paul Gauguin, French ...Learn More
Shareholder vote on Medtronic-Covidien merger set for Tuesday
Covidien and Medtronic shareholders will vote Tuesday on whether to approve a deal combining the two firms under a single ...Learn More
Medtech raises nearly $350M in venture capital at year's end
The volume and value of venture financing deals in the medical device sector improved in December. ...Learn More
EU OKs acoustic heart-disease detector from Aum Cardiovascular
European regulators have given Aum Cardiovascular the go-ahead to market its CADence System, designed to diagnose blockages ...Learn More
India hopes to attract foreign investment in medtech firms with new rule
American Chamber of Commerce in India Executive Director Ajay Singha said that the government's move to authorize as much as ...Learn More
Study finds lower recall rates using tomo-digital mammography combo
A study in the journal Radiology found that recall rates were lower by 37% when tomosynthesis was added to digital ...Learn More
Pain-relieving device from NeuroMetrix poised for launch
The Quell pain-relieving neurostimulator will be released this week by NeuroMetrix at the 2015 International Consumer ...Learn More
Heart failure patient survives with aid of experimental partition device
Tom Desmond of Buffalo, N.Y., had three heart attacks and was diagnosed with congestive heart failure when he was chosen to ...Learn More
FDA approves Aethlon's Hemopurifier for Ebola trial
The FDA has given Aethlon Medical the green light to test its Hemopurifier, an experimental device designed to reduce Ebola ...Learn More
SCID test for infants gets FDA nod
The EnLite Neonatal TREC Kit was approved by the FDA to screen newborns for severe combined immunodeficiency, a set of ...Learn More
Medtech innovation, industry suffer under medical device tax
Now is the time to end the medical device tax and support rather than stifle innovation, writes Tom Fogarty, founder of the ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
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Let us not look back in anger, nor forward in fear, but around in awareness.
James Thurber, American ...Learn More
Calif. PAD catheter maker targets $69M in IPO
Avinger filed plans this week with the Securities and Exchange Commission for an initial public offering and is hoping to ...Learn More
IPO could bring in up to $60M for HTG Molecular Diagnostics
Tucson, Ariz.-based HTG Molecular Diagnostics is hoping to secure as much as $60 million in an initial public offering. ...Learn More
Report predicts $5B boost in U.S. neurological device market
The U.S. ...Learn More
Avant Diagnostics acquired by American Liberty Petroleum
Avant Diagnostics, an Arizona-based medical diagnostics firm, has been purchased by American Liberty Petroleum. ...Learn More
Israeli medtech firm announces plans for ADR registration
CollPlant Holdings, a medical device firm based in Israel, aims to secure first-level American Depository Receipts. ...Learn More
Survey examines interest in using wearables to monitor health
An A&D Medical survey says a majority of Americans are interested in using wearable systems to track their health and ...Learn More
Medtech devices that made headlines in 2014
In 2014, the medical device sector used cutting-edge technology to produce some breakthrough devices. ...Learn More
NeuroMetrix to launch new pain relief device
NeuroMetrix plans to launch Quell, its noninvasive neurostimulation device for relieving chronic pain, at a consumer ...Learn More
Availability of rapid syphilis test widened by FDA
A waiver was granted by the FDA extending the use of the Syphilis Health Check rapid test to other health care settings ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
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Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
The soul that is within me no man can degrade.
Frederick Douglass, American social reformer and ...Learn More
Warrant reset agreements pump $903K into Pressure BioSciences
Pressure BioSciences has obtained $903,000 after completing a series of warrant reset agreements that repriced the common ...Learn More
Debt, equity funding round pulls in $6M for BiOM
A debt and equity funding round has brought in $6 million for BiOM, a personal bionics developer based in Bedford, Mass., ...Learn More
U.S. Navy approves Carestream imaging, communication systems
Imaging systems maker Carestream Health has won the U.S. ...Learn More
Echo Therapeutics announces new CFO
Alan Schoenbart has been appointed chief financial officer of Echo Therapeutics, maker of the Symphony continuous glucose ...Learn More
Australian molecular Dx firm obtains $211K
Genetic Technologies, a Melbourne, Australia-based molecular diagnostics firm, raised $211,000 through a share purchase ...Learn More
FDA OKs Olympus' endoscopic light imaging system for cystoscopy
Olympus' Narrow Band Imaging technology has been cleared by the FDA for assessing nonmuscle-invasive bladder cancer in ...Learn More
GOP lawmakers to prioritize medical device tax repeal
Repeal of the 2.3% medical device tax will be one of the main priorities of the Republican-led Congress in 2015, said Rep. ...Learn More
IDE application for cytokine absorber submitted by CytoSorbents
An investigational device exemption application has been filed with the FDA by CytoSorbents to begin human trials of the ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
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SmartBrief will not publish Thursday
In observance of New Year's Day, SmartBrief will not publish Thursday. Publication will resume ...Learn More
Flowers grow out of dark moments.
Corita Kent, American nun and ...Learn More
LabCorp revises revolving credit facility, obtains $1B loan
Bank of America, acting as administrative agent for a group of lenders, has agreed to grant the Laboratory Corp. ...Learn More
Alzheimer's Dx startup receives $1M boost
Palo Alto, Calif.-based NeuroTrack Technologies has secured $1 million in debt, a regulatory filing shows. ...Learn More
Response Genetics faces possible Nasdaq delisting
Response Genetics, a molecular diagnostics company operating in Los Angeles, stands to be delisted from the Nasdaq Capital ...Learn More
Covidien reaches settlement deal with shareholders
Covidien has agreed to a memorandum of understanding with some of its shareholders to resolve a combination of three ...Learn More
Smith & Nephew's wound therapy system shows promise in trial
A study presented at the Sixth European Symposium of Aesthetic Surgery of the Breast in Milan, Italy, showed promising ...Learn More
FDA authorizes emergency use of Roche's Ebola test
Roche announced that the FDA has authorized the emergency use of its LightMix Ebola Zaire rRT-PCR Test in certain U.S. ...Learn More
Heart Sync's defibrillator electrode recall labeled Class I by FDA
A recall initiated by Michigan firm Heart Sync on Nov. ...Learn More
Ubl sets record straight on 510(k) process
In a letter to the editor, AdvaMed President Stephen Ubl emphasizes that the FDA's 510(k) process for clearing low- and ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
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I can accept failure; everyone fails at something. But I can't accept not trying.
Michael Jordan, American professional basketball ...Learn More
N.C. company to buy Va. maker of drug monitoring, Dx products
Alternative Energy & Environmental Solutions, headquartered in Chapel Hill, N.C., has signed a letter of intent to purchase ...Learn More
New Era Orthopaedics signs manufacturing deal with Micron Products
Micron Products has struck an exclusive five-year manufacturing contract with New Era Orthopaedics for its designs for ...Learn More
Alpinion Medical Systems launches first South Korean HIFU system
Alpinion Medical Systems has developed the first High Intensity Focused Ultrasound imaging apparatus in South Korea. ...Learn More
Sleep apnea, heart diagnostics maker seeks partners in new markets
Itamar Medical, a Caesarea, Israel-based firm specializing in sleep apnea and heart diagnostics products, is looking for ...Learn More
Study shows promising results for rheumatoid arthritis device
The University of Amsterdam reported promising results after conducting a small-scale study on an implantable medical device ...Learn More
Researchers warn about safety, accuracy of blood pressure management apps
A study in the Journal of the American Society of Hypertension found that only 3% of 107 blood pressure management ...Learn More
Use of customized implants employing 3D technology increases
Conformis, a Massachusetts company that uses 3D technology, created a knee replacement implant that was used in a successful ...Learn More
Experts create, patent device to speed fracture recovery
Two Tulsa, Okla.-based surgeons have developed and patented a device called the Norris Surgical fracture plate, which is ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Sometimes by losing a battle you find a new way to win the war.
Donald Trump, American ...Learn More
IPO could bring in as much as $69M for Entellus
Entellus Medical said it will launch an initial public offering in hopes of obtaining as much as $69 million. ...Learn More
Investors, financing deal pump $10M into Mass. genetic testing company
A private financing round has brought in $5 million for Interleukin Genetics, developer of the PerioPredict genetic test for ...Learn More
Image-guided therapy company gets $3M boost
IMRIS has received an estimated $3 million in a private placement funding round. ...Learn More
Calif. molecular Dx firm drops plans to go public
CardioDx, the Palo Alto, Calif.-based molecular diagnostics firm behind the Corus CAD test, has filed to withdraw its ...Learn More
Machine Solutions boosts business with Steeger USA acquisition
Arizona-based Machine Solutions, a unit of Forsyth Capital Investors, has closed its purchase of Steeger USA under ...Learn More
Reproductive Health Science, Tani Medikal agree to distribution deal
Turkish company Tani Medikal has struck a three-year distribution deal with Reproductive Health Science, a biotech firm ...Learn More
Cerevast Therapeutics enrolling patients for ClotBust ER trial
Redmond, Wash.-based Cerevast Therapeutics continues to enroll patients in its international trial for ClotBust ER, a ...Learn More
Novocure device may stem spread of brain cancer
The Novocure cap, an experimental medical device that emits electronic signals targeting brain cancer cells to prevent ...Learn More
Alternative to 3D printing precisely places microtissues
Researchers in Rhode Island are developing technology that precisely places individual microtissues, an approach that could ...Learn More
India lifts approval requirement for purchase of device companies
The Indian government has removed the approval requirement for foreign companies seeking to fully purchase existing medical ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It's fine to celebrate success, but it is more important to heed the lessons of failure.
Bill Gates, American businessman and ...Learn More
AltheaDx aims to bring in $69M from IPO
AltheaDx, a molecular diagnostics firm in San Diego, plans to launch an initial public offering to raise up to $69 million. ...Learn More
IPO could pull in up to $55M for Infraredx
Infraredx, a Burlington, Mass.-based intravascular imaging firm, looks to obtain $55 million in an initial public offering. ...Learn More
Calif. medical device firm targets $14M in IPO
San Diego-based BeneChill said in a regulatory filing that it plans to launch an initial public offering in hopes of raising ...Learn More
Abbott closes $250M acquisition of Topera
Abbott Laboratories wrapped up its acquisition of Topera, a California-based firm specializing in medical devices for atrial ...Learn More
Siemens Healthcare denies plans to go public
Siemens Healthcare will not be filing to launch an initial public offering, although there are plans for the health care ...Learn More
Positive results reported in study of Medtronic's drug-eluting balloon
Medtronic's In.Pact Admiral drug-eluting balloon demonstrated superior results compared with a standard angioplasty balloon, ...Learn More
Osiris Therapeutics enters partnership with Stryker
Osiris Therapeutics, developer of the OvationOS viable bone matrix tissue form, has struck an exclusive deal with Stryker. ...Learn More
AMIC files de novo submission to reclassify brachytherapy device
Advanced Medical Isotope has filed a de novo submission with the FDA requesting to reclassify its yttrium-90 RadioGel ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
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SmartBrief will not publish Thursday
In observance of Christmas, SmartBrief will not publish Thursday. Publication will resume ...Learn More
You've got to go out on a limb sometimes because that's where the fruit is.
Will Rogers, American performer and ...Learn More
Modular insulin pump maker aims for $45M in IPO
Sunnyvale, Calif.-based Asante Solutions seeks to obtain $45 million in an initial public offering. ...Learn More
Genomic testing services firm gets $16.8M boost
A financing round has brought in $16.8 million for Kew Group, a genomic testing services company in Cambridge, Mass. ...Learn More
Series B round pulls in $12M for ImmusanT
ImmusanT has received $12 million from Vatera Healthcare Partners in a Series B funding round. ...Learn More
Uroplasty reaches merger deal with Vision-Sciences
Uroplasty and Vision-Sciences have agreed to merge in the first half of 2015. ...Learn More
Zoll Medical to purchase circulatory support device maker
Zoll Medical has agreed to pay an undisclosed sum to acquire Roseville, Minn.-based Advanced Circulatory Systems, which ...Learn More
EU approves Cobas CMV assay from Roche
European regulators have granted Roche CE mark approval for its Cobas CMV assay, which keeps track of the viral load in ...Learn More
CAPRI Corpectomy Cage System from K2M debuts in Italy
A doctor at Rizzoli Hospital in Bologna, Italy, has completed the first surgical procedure that used K2M's CAPRI Corpectomy ...Learn More
Overnight use of NxStage's home dialysis system gets FDA approval
NxStage Medical's at-home hemodialysis system has been cleared by the FDA for use at night while patients sleep. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
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In the time we have it is surely our duty to do all the good we can to all the people we can in all the ways we can.
William Barclay, Scottish ...Learn More
Pentagon taps Meridian Medical for $129.5M auto-injector deal
The Department of Defense has awarded Maryland-based Meridian Medical Technologies a contract worth $129.5 million. ...Learn More
Roche purchases Calif. genomic data software firm
Bina Technologies, a Redwood City, Calif.-based informatics company, has been acquired by Roche for undisclosed terms. ...Learn More
Veracyte, Silicon Valley Bank agree on revised loan agreement
Veracyte, which develops gene expression-based diagnostic tests, has revised its loan agreement with Silicon Valley Bank. ...Learn More
Baxter to expand facility in Ark.
Baxter International is adding 25,000 square feet of space to its 550,000-square-foot medtech facility in Mountain Home, ...Learn More
Trauma fixation device market in Asia expected to hit $1.2B by 2018
The Asian trauma fixation device market is poised to hit $1.2 billion by 2018, which represents a 6.5% compound annual ...Learn More
TransEnterix's SurgiBot system completes 4 surgical procedures
TransEnterix reported that surgeons have used SurgiBot, its robotic surgery system, to complete four preclinical surgery ...Learn More
Myriad gets FDA nod for BRACAnalysis CDx diagnostic assay
The FDA has granted Myriad approval to market its BRACAnalysis CDx assay as a companion diagnostic for AstraZeneca's ...Learn More
Bioactive bone scaffolds from Bio2 Technologies win FDA approval
Bio2 Technologies received 510(k) clearance from the FDA to market its CLM high-tech bioactive scaffold wedges. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
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Great things are not done by impulse, but by a series of small things brought together.
Vincent van Gogh, Dutch ...Learn More
Investors pump $35M into Calif. genomic Dx firm
Redwood City, Calif.-based CardioDx has raised $35 million from a funding round that included Alberta Investment Management ...Learn More
Knee implant device startup raises over $7.8M in funding
Cotera, a startup developing knee implant devices for treating osteoarthritis, has secured over $7.8 million through an ...Learn More
Prices of drug-eluting stents dropped 6% in 2014, index shows
The Modern Healthcare/ECRI Institute Technology Price Index reported a 6% decrease in the average price paid by hospitals ...Learn More
Elekta wins clearance for brachytherapy system in China
Chinese regulators have granted Elekta, which develops radiation oncology systems, clearance to market its Flexitron ...Learn More
179-gene panel shows 78% success rate in detecting gene mutation
A study in PLOS ONE shows how effective a next-generation sequencing multiplex assay can be in analyzing and identifying ...Learn More
MolecularMD NGS lab accredited by CAP
The College of American Pathologists has accredited the next-generation sequencing laboratory operated by MolecularMD in ...Learn More
Paramed Medical announces new MROpen scanner applications
Paramed Medical Systems is set to expand its MROpen scanner clinical applications in 2015 by offering applications for ...Learn More
Updated home heart monitor from AliveCor set to launch in January
An upgraded version of AliveCor's home heart monitor is set to launch in January on Amazon.com and through a collaboration ...Learn More
Surgical sealant from Cohera wins FDA priority review status
The FDA has given priority review status to Cohera Medical's Sylys Surgical Sealant. ...Learn More
FDA clears Memo3d ReChord implant from Sorin Group
The Memo3d ReChord, a surgical implant developed by Sorin Group, has obtained 510(k) clearance from the FDA. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Life is a blank canvas, and you need to throw all the paint on it you can.
Danny Kaye, American actor and ...Learn More
Royal Philips to acquire Volcano in $1.2B deal
Royal Philips announced Wednesday it will purchase Volcano and its cardiovascular imaging technology, including its debt, ...Learn More
Varian to purchase German firm MeVis in $37M-plus deal
Varian Medical Systems has agreed to purchase MeVis Medical Solutions for nearly $37.3 million in a deal that is anticipated ...Learn More
Orthopedic device developer secures $12M investment
Sonoma Orthopedic Products has obtained a $12 million boost from private growth-equity investor First Analysis. ...Learn More
FDA, HHS awards joint Dx development contract to Diatherix
Diatherix Laboratories has entered a one-year joint contract with the FDA and HHS. ...Learn More
Firm earns CE mark for PEEK-OPTIMA HA implant
Karmed Saglik Group has obtained the CE mark for its first implant developed using the PEEK-OPTIMA HA Enhanced implantable ...Learn More
DeviceTalks podcast: Masimo CEO Kiani talks patient safety, corporate culture and debunking the "innovators dilemma"
An interview with medtech entrepreneur Joe Kiani, CEO of Masimo Corp. ...Learn More
Trial set to evaluate VolitionRx's lung cancer assay
A clinical trial is set to get underway at the University of Bonn in Germany to evaluate VolitionRx's Nucleosomics platform, ...Learn More
Dutch study validates use of thrombectomy devices for treating stroke
Thrombectomy devices demonstrated positive results in a Dutch trial involving 500 acute ischemic stroke patients. ...Learn More
Integra to debut skin regeneration template for burns, scars
Integra LifeSciences is set to expand its skin repair product line in January with the introduction of its Meshed Dermal ...Learn More
FDA clears surgical system from THINK Surgical
The TSolution One Surgical System developed by THINK Surgical has obtained 510(k) clearance from the FDA. ...Learn More
Cerus' Intercept Blood System wins FDA approval
Cerus has received FDA approval for its Intercept Blood System. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It's the steady, quiet, plodding ones who win in the lifelong race.
Robert Service, British-Canadian ...Learn More
Medtronic-Covidien deal wins all required anti-trust approvals
Medtronic announced that it has gained the necessary approvals from U.S., European Union, Canadian, Chinese and South Korean ...Learn More
Mass. gives $1M for development of hand-held Ebola Dx device
Diagnostics for All has been awarded a $1 million grant from the state of Massachusetts to help fund the development of a ...Learn More
CytoSorbents taps Fresenius Medical Care to offer product in Europe
CytoSorbents has secured a distribution deal with Fresenius Medical Care to help bring its CytoSorb blood purification ...Learn More
In vitro Dx company completes part of funding round
Protagen, a developer of in vitro diagnostic tests for diseases including systemic sclerosis and rheumatoid arthritis, has ...Learn More
U.K. oncology Dx firm to get $19.7M boost
Investment company Syncona Partners will pump $19.7 million in equity financing into U.K.-based 14M Genomics, a developer of ...Learn More
CVRx wins expanded EU approval for Barostim neo
CVRx has earned additional clearance from the European Union for its Barostim neo carotid artery pulse stimulator. ...Learn More
FDA allows InVivo Therapeutics to speed up trial enrollment
InVivo Therapeutics has received the FDA's approval to expedite the patient enrollment in its Neuro-Spinal Scaffold trial. ...Learn More
FDA OKs injection system from VEXIM
The Masterflow Injection System developed by VEXIM has obtained marketing authorization in the U.S. from the FDA. ...Learn More
FDA clears 3 devices from Merit Medical Systems
The AEROmini tracheobronchial stent system, the ReSolve biliary locking drainage catheter and the ONE Snare line of ...Learn More
Stent planning tool from Vital Images gains FDA clearance
The FDA has granted Vital Images 510(k) clearance to market its fenestrated stent planning tool. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
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I dwell in Possibility.
Emily Dickinson, American ...Learn More
Analysis: Medtech M&A activity surges in 2014
A MassDevice.com analysis found that the value of merger and acquisition deals in the medical device sector increased almost ...Learn More
Funding round brings in $59M for InSightec
A round of Series D financing has pulled in $59 million for InSightec, developer of the EU-approved ExAblate MR-guided ...Learn More
Exact Sciences announces public stock sale
Exact Sciences announced Monday that it is selling 4 million shares in a public offering. ...Learn More
Europe expands approval for Roche's Cobas assays
Roche has earned additional approval from European Union regulators for the use of Cobas MPX and Cobas WNV assays to test ...Learn More
U.K. genomic firm signs distribution deal with AutoGen
LGC, which operates in the U.K., has entered into a distribution deal with AutoGen for undisclosed terms. ...Learn More
FDA approves study of Brainsway's device for PTSD
The FDA has granted Brainsway an investigational device exemption to conduct a 166-patient trial to evaluate the efficiency ...Learn More
Medtronic debuts NovaShield injectable gel for sinus surgery
Medtronic has launched its NovaShield Injectable Nasal Packing and Stent, which is designed for use following functional ...Learn More
Firms win most innovative award for needle safety device
The 2014 DeviceMed award for most innovative device was given to German medtech component maker Raumedic AG and the ...Learn More
FDA clears 3D arthroplasty planning software from EOS
The hipEOS 3D hip arthroplasty planning software developed by orthopedic digital X-ray company EOS Imaging has obtained FDA ...Learn More
Blood test to estimate heart disease risk receives FDA approval
A blood test developed by diaDexus that determines coronary heart disease risk in people with no history of heart disease ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Never mistake motion for action.
Ernest Hemingway, American ...Learn More
Wright Therapy receives $4.4M boost from investors
A group of investors has pumped about $4.4 million into Wright Therapy Products, which developed a device for lymphedema ...Learn More
Equity round brings in $3M for ForSight Vision6
ForSight Vision6, based in Menlo Park, Calif., has pulled in $3 million in an equity round with five undisclosed investors, ...Learn More
K2M Group plans to move headquarters to Va.
K2M Group is moving its headquarters and R&D facility to Leesburg, Va. ...Learn More
Orthopedic device company secures $575K
OrthogenRx, an orthopedic device company, has raised $575,000 in financing from Ben Franklin Technology Partners. ...Learn More
German firm Sygnis pulls in $6.2M in financing
Sygnis, the German developer of the TruePrime Single Cell WGA kit, has closed its rights offering and secured a total of ...Learn More
SDRI enters European distribution deal with joimax
California-based joimax has agreed to to bring Synergy Disc Replacement's SYNERGY Cervical Disc to Germany, Austria and ...Learn More
Firm commences trial for staph ID/R test
Great Basin Scientific is beginning a trial for its staph identification/resistance molecular assay. ...Learn More
New trial begins for Stimwave's chronic back pain device
A new randomized, placebo-controlled trial has been launched by Stimwave Technologies to test the use of its wireless ...Learn More
Alere's rapid HIV test gains FDA waiver
Alere obtained a waiver from the FDA for the expanded use of its Determine HIV-1/2 Ag/Ab Combo test. ...Learn More
FDA review may result in removal of devices from high-risk category
Some devices may be bumped off the highest-risk category after the FDA finishes the review of its premarket approval ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Some of us think holding on makes us strong; but sometimes it is letting go.
Hermann Hesse, German-Swiss writer and ...Learn More
Mass. developer of image management tech obtains $8M
Image Stream Medical has pulled in $8 million from a sole anonymous investor in a new equity offering, according to a ...Learn More
Roche strikes deal to purchase AvanSci Bio's MilliSect products
Roche Diagnostics agreed to acquire the entire MilliSect tissue extraction product line from AvanSci Bio. ...Learn More
Claritas Genomics taps NextCode Health for Dx interpretations
Cambridge, Mass.-based Claritas Genomics, a provider of clinical diagnostic tests including the ClariFocus Exome for ...Learn More
Swedish genomic firm gains rights to license ValidPrime technology
Tataa Biocenter, which is based in Goteborg, Sweden, has struck a licensing deal with the French Institute for Health and ...Learn More
Abbott wins CE mark approval for Iridica platform
Abbott has earned the CE mark for its Iridica pathogen detection platform, which can determine even infrequent pathogens. ...Learn More
EU approves St. Jude's Quadra Allure MP pacemaker
European regulators have granted CE mark approval to St. ...Learn More
Transcatheter Technologies announces new transcatheter valve
Transcatheter Technologies, maker of the Trinity transcatheter aortic valve implant, announced the newest version to its ...Learn More
Cianna Medical wins FDA nod for breast tumor device
The FDA has granted clearance for California-based Cianna Medical's Strut-Adjusted Volume Implant SCOUT system, a breast ...Learn More
FDA approves endoprosthesis from Gore Medical
The GORE VIABAHN endoprosthesis, developed by Flagstaff, Ariz.-based Gore Medical, has obtained FDA approval for use in ...Learn More
Defibrillator leads from Medtronic gain premarket approval
The FDA has given premarket approval to Medtronic for new additions to its Attain Performa line of quadripolar cardiac ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
The future cannot be predicted, but futures can be invented.
Dennis Gabor, Hungarian-British electrical engineer and ...Learn More
Medtech sector IPO filings jumped in 2014, analysis shows
An analysis by MassDevice.com found that the medical device sector filed for 25 initial public offerings this year, up from ...Learn More
Minn. lumbar spinal device maker receives $2M boost
An equity-and-options round has pulled in $2 million for Zyga Technology, maker of lumbar spinal surgical devices, including ...Learn More
UTI Dx startup lands investment from BioGenerator
BacterioScan, a startup working on a urinary tract infection diagnostics device, has received an undisclosed investment from ...Learn More
NIH backs development of Ebola rapid detection assay
David Alland, a researcher from Rutgers New Jersey Medical School, has received a $640,000 supplement grant from the NIH to ...Learn More
Synergetics pays $13.5M for U.K. eye surgical tool firm
Synergetics USA announced its $13.5 million acquisition of Sterimedix, a British company specializing in eye surgical tools. ...Learn More
Intrinsic Therapeutics wraps up trial enrollment for anular closure device
Intrinsic Therapeutics has finished enrolling patients for a trial evaluating its Barricaid anular closure device for lumbar ...Learn More
Hunter Medical unveils elbow surgical assist device
The ElbowLOC Arm Positioning System is now available commercially, according to Hunter Medical. ...Learn More
Patient, industry groups weigh in on FDA policies
AdvaMed, the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America joined patient ...Learn More
AmpliVue molecular Dx assay from Quidel wins FDA nod
The AmpliVue Bordetella Assay developed by Quidel has obtained clearance from the FDA. ...Learn More
FDA delays premarket review of VertiFlex spine implant
The FDA has moved an advisory panel meeting for VertiFlex's Superion spine implant to Feb. 20 for undisclosed reasons. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
What concerns should medical device companies focus on in the coming year?
A painting that is well-composed is half-finished.
Pierre Bonnard, French ...Learn More
N.J. ischemia implantable device maker raises over $10.2M in debt offering
Angel Medical Systems has obtained over $10.2 million toward its goal of $20.5 million in a debt offering, according to a ...Learn More
CareFusion plans to vote on Becton Dickinson merger in January
CareFusion has scheduled a shareholders meeting Jan. ...Learn More
Welch Allyn buys assets of Neb. remote patient monitoring firm
Welch Allyn announced it has acquired the assets of HealthInterlink, the Omaha, Neb.-based maker of the Beacon 2.0 remote ...Learn More
French molecular Dx firm gets $3.8M boost
Novocyte has secured $3.8 million in a private equity financing round joined by Alto Invest. ...Learn More
Canada OKs spinal surgery implant from Aurora Spine
Aurora Spine's ZIP MIS Interspinous Fusion System was granted the Health Canada Medical Device License. ...Learn More
Trial enrollment for Biotronik's ProMRI pacemaker completed
Biotronik announced that patient enrollment and planned MRI studies in phase B of its analysis of its ProMRI pacemakers have ...Learn More
Positive results reported in 2 studies of Medtronic's stent graft
Medtronic's Endurant AAA stent graft demonstrated promising results in two long-term studies. ...Learn More
FDA clears retinal imaging system from CenterVue
The FDA has given CenterVue 510(k) clearance to market Eidon, a retinal imaging system. ...Learn More
Siemens seeks FDA clearance for CT lung cancer screening
Siemens Healthcare has submitted an application seeking 510(k) clearance from the FDA to market its Lung Low Dose Protocol ...Learn More
Focus Diagnostics gets additional clearance for flu strain assays
Focus Diagnostics has received additional clearance from the FDA for eight other influenza strains on its Simplexa Flu A/B & ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
What trend in medical device technology had the biggest impact in the past year?
Respect your efforts, respect yourself. Self-respect leads to self-discipline. When you have both firmly under your belt, that's real power.
Clint Eastwood, American actor and ...Learn More
Amedica brings in nearly $13M from IPO
Amedica raised close to $13 million in gross proceeds from its now-closed underwritten public offering that started Nov. 26. ...Learn More
CardioKinetix secures $50M in funding, exclusive acquisition deal
CardioKinetix, a developer of cardiac devices including the Parachute ventricular partitioning device, has received $50 ...Learn More
Orthopedic surgery kit developer gets $2.2M boost
A private stock sale has pulled in $2.2 million for Flower Orthopedics, according to a Securities and Exchange Commission ...Learn More
Symmetry Medical completes spinout of surgical unit
Symmetry Medical has successfully spun off its surgical instrumentation unit, Symmetry Surgical. ...Learn More
European firm purchases Boston Heart Diagnostics
Eurofins Scientific, a Luxembourg-based bioanalytical testing firm, has agreed to acquire Boston Heart Diagnostics for $140 ...Learn More
Victorian Clinical Genetics Services, Illumina collaborate on prenatal assay
A partnership deal to create a noninvasive prenatal test has been reached between Illumina and Victorian Clinical Genetics ...Learn More
EU approves HIV, HCV molecular Dx from Roche
European regulators have granted Roche CE mark approval for its Cobas HIV-1 and HCV assays. ...Learn More
ExThera's blood-filtering device eliminates drug-resistant bacteria in study
ExThera Medical has released data from a study which evaluated its Seraph blood-filtering device. ...Learn More
Siemens introduces updated SOMATOM Definition Edge CT
Siemens has launched an upgraded version of the SOMATOM Definition Edge CT. ...Learn More
Prosigna assay from NanoString receives new FDA labeling
The FDA has issued an update for the labeling of NanoString's Prosigna Breast Cancer Gene Signature Assay, which received ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Which medical device issue do you encounter most often?
Knowing your own darkness is the best method for dealing with the darknesses of other people.
Carl Jung, Swiss ...Learn More
Becton Dickinson looks to offer $6.2B in senior notes
Becton Dickinson announced that it will sell five sets of senior unsecured bonds worth a total of $6.2 billion, which are ...Learn More
Robotic exoskeleton developer obtains nearly $23M in funding
Ekso Bionics, a firm developing an FDA-approved wearable robotic exoskeleton to help paralyzed or movement-impaired patients ...Learn More
Symmetry Medical's merger, business unit sale get shareholders' OK
Shareholders of Symmetry Medical have voted in favor of approving the company's pending merger with TecoStar, Tecomet and ...Learn More
Qiagen, Altona sign distribution deal for Ebola testing kit
Qiagen has agreed to globally distribute Altona Diagnostics' RealStar Ebolavirus RT-PCR Kit 1.0, a testing kit capable of ...Learn More
Report: BRIC diagnostic imaging markets could hit $7.6B by 2018
A MarketsandMarkets report predicts that the diagnostic imaging markets in Brazil, Russia, India and China will reach $7.6 ...Learn More
Roche to purchase U.S. molecular Dx firm
Switzerland-based Roche Holdings agreed to purchase U.S. ...Learn More
German sequencing, Dx firm plans to restructure
GATC Biotech, a sequencing services and diagnostics firm based in Germany, said it plans to reorganize its business into ...Learn More
Study links St. Jude Medical's Optim leads to lower failure rates
St. ...Learn More
Calif. hospital installs Mazor Robotics Renaissance system
Long Beach, Calif.-based Dignity Health St. ...Learn More
Fiagon wins FDA clearance for extended instrument set
The ear, nose and throat extended instrument set developed by Fiagon has obtained 510(k) clearance from the FDA. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
There are dark shadows on the earth, but its lights are stronger in the contrast.
Charles Dickens, British ...Learn More
Mass. cartilage repair device firm lowers IPO target to $57.2M
Massachusetts-based Histogenics is looking to obtain $57.2 million with the launch of its initial public offering Wednesday, ...Learn More
Calif. replacement heart valve firm gets $32M boost
A funding round has brought in $32 million for Santa Rosa, Calif.-based Direct Flow Medical. ...Learn More
Teleflex enters marketing deal with group purchasing organization
Teleflex has agreed to supply Premier's network of hospitals and health care providers with its current and future dialysis ...Learn More
eBioscience strikes distribution agreement with U.K. supplier
Affymetrix unit eBioscience has struck a distribution deal with The Binding Site, a diagnostic tools supplier based in the ...Learn More
Danish Dx firm secures exclusive license for prostate cancer biomarkers
Aarhus University Hospital has given Exiqon, a Denmark-based diagnostics maker, an exclusive license to prostate cancer ...Learn More
Podcast: B. Braun Medical CEO on the medical device tax, health care law and innovation
Caroll Neubauer, the CEO of B. ...Learn More
Trial enrollment for Spinal Modulation's neurostimulator system closed
Spinal Modulation has wrapped up patient enrollment for a clinical trial evaluating its Axium Neurostimulator System, an ...Learn More
Firms partner for cancer immune response biomarker
An agreement between OncoSec Medical, PerkinElmer and the University of California, Los Angeles, will focus on creating ...Learn More
Spineart gains approval from FDA for posterior axial device
The FDA has given Spineart 510(k) clearance to market the ROMEO2 PAD, a posterior axial device with 30 degrees of plate ...Learn More
Paragonix wins additional FDA clearance for organ transport system
Paragonix Technologies, the developer of the Sherpa Pak organ transport systems, has obtained additional FDA clearance to ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Our finest moments are most likely to occur when we are feeling deeply uncomfortable, unhappy or unfulfilled. For it is only in such moments, propelled by our discomfort, that we are likely to step out of our ruts and start searching for different ways...
M. Scott Peck, American ...Learn More
Minn. maker of fracture implant device secures $24M
A round of Series AA financing has pulled in $24 million for Conventus Orthopaedics. ...Learn More
Healthtell receives NIH funding to evaluate brain cancer Dx
The NIH has awarded a $225,000 Small Business Innovation Research grant to Healthtell to finance an effectiveness study on ...Learn More
US Medical Innovations signs distribution deal with CrossLink Surgical
US Medical Innovations has entered into a distribution deal with CrossLink Surgical. ...Learn More
N-of-One partners with cancer genetics Dx firm
N-of-One has entered into an agreement with NeoGenomics for an undisclosed sum to interpret test results generated by the ...Learn More
Swiss medtech firm obtains $34M in Series B financing
Xeltis, whose first product is a replacement pulmonary valve that can stimulate regeneration of new coronary valves and ...Learn More
Integrated DNA Technologies, Ubiquitome collaborate on handheld Ebola assay
Integrated DNA Technologies has agreed to work with Ubiquitome, a New Zealand-based startup, to create a handheld Ebola test ...Learn More
Device provides docs with real-time feedback on radiation exposure
Interventional cardiologists who wore the Bleeper SV radiation monitoring device while in the cath lab were exposed to lower ...Learn More
Spinal fusion system from Benvenue Medical wins FDA nod
The Luna 360 Interbody Fusion System developed by Benvenue Medical has obtained 510(k) clearance from the FDA. ...Learn More
FDA clears injectable pain relief device from Stimwave
The FDA has given Stimwave clearance to market its Freedom Spinal Cord Stimulator System in the U.S. ...Learn More
Delphinus' SoftVue system gains additional FDA clearance
The FDA has granted Delphinus Medical Technologies an additional 510(k) clearance for its SoftVue system, this time for the ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
The one thing all famous authors, world-class athletes, business tycoons, singers, actors, and celebrated achievers in any field have in common is that they all began their journeys when they were none of these things.
Mike Dooley, American ...Learn More
Medtronic raises $17B in seven-part debt offering
Medtronic has secured $17 billion through a seven-tranche debt offering to help fund the company's $42 billion acquisition ...Learn More
Minn. medical device firm gets $7.5M boost
Interrad Medical, a medical device firm based in Plymouth, Minn., has obtained $7.5 million in a financing round led by ...Learn More
Philips gains license rights to RaySafe S1 X-ray dose system
Royal Philips was granted an exclusive license for the RaySafe S1 X-ray dose-managing system developed by Unfors RaySafe, a ...Learn More
23andMe wins CE mark approval for genetic analysis kit
European regulators have granted CE mark approval for 23andMe's Personal Genome Service spit kits, which performs genetic ...Learn More
EU approves Aptima HIV-1 Quant Dx assay from Hologic
Hologic has earned the CE mark for its Aptima HIV-1 Quant Dx assay, an HIV viral load assay that features real-time, ...Learn More
Trial enrollment for Cardiovascular Systems' atherectomy system closed
Cardiovascular Systems has wrapped up patient enrollment in Japan for a clinical study on its second-generation micro-crown ...Learn More
Thoratec wraps up trial enrollment for heart pump
Pleasanton, Calif.-based Thoratec has finished enrolling patients for a clinical trial evaluating its HeartMate III left ...Learn More
J&J unit wins FDA approval for insulin pump system
Animas, a subsidiary of Johnson & Johnson Diabetes Solutions, has obtained FDA approval for its Animas Vibe insulin pump and ...Learn More
FDA OKs in vitro Dx assay from Cepheid
Cepheid has secured FDA clearance to market its Xpert Norovirus assay, which runs on the company's GeneXpert platform. ...Learn More
FDA clears Turnpike catheters from Vascular Solutions
The FDA granted Vascular Solutions 510(k) clearance to market its Turnpike catheter, which features a dual-layer coil inside ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
The bird a nest, the spider a web, man friendship.
William Blake, British painter and ...Learn More
FTC, EU approve $43B Medtronic-Covidien deal
Medtronic received approval from the U.S. ...Learn More
Genomics gets $12.8M boost for genomic sequencing analysis
Genomics has secured $12.8 million in a private financing round that included the IP Group, the University of Oxford and ...Learn More
Brain injury device maker takes in almost $4.2M in debt financing
X2 Biosystems, a brain injury device developer based in Seattle, has brought in about $4.2 million through a debt and ...Learn More
Diagnostics innovation hub launched in Singapore
A Diagnostics Development Hub has been created by the Singapore Agency for Science and Technology Research to speed up the ...Learn More
Neuromod wins approval for tinnitus device in Europe
A multisensory device for treating tinnitus developed by Neuromod Devices has obtained CE mark approval in Europe. ...Learn More
U.S. patent issued to Acertara's probe testing device
The number of U.S. ...Learn More
Centinel Spine's new lumbar interbody fusion device due out in early 2015
Centinel Spine announced that its newest STALIF Family Lumbar Integrated Interbody fusion device, the MIDLINE II, will be ...Learn More
Konica Minolta introduces portable ultrasound system
Sonimage HS1, a handheld ultrasound system featuring an advanced transducer and a broadband linear probe, was launched by ...Learn More
AdvaMed commends Japanese medtech regulations
Japan's adoption of new medical device regulations will make the regulatory process easier for device manufacturers, said ...Learn More
For more:
Read the AdvaMed press release for President and CEO Stephen Ubl's comments about the new medtech regulatory framework in ...Learn More
Enhanced CT imaging system from Philips wins FDA nod
The IQon Spectral CT system developed by Royal Philips has received 510(k) clearance from the FDA. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
Bring ideas in and entertain them royally, for one of them may be the king.
Mark Van Doren, American poet and ...Learn More
B. Braun drops plans to expand headquarters over device tax costs
Series C round pulls in $5M for iHear Medical hearing aids
iHear Medical has obtained $5 million in a Series C financing round. ...Learn More
Thermo, Samsung to work on point-of-care Dx solutions
Thermo Fisher Scientific and Samsung Electronics have partnered to create and commercialize point-of-care diagnostic ...Learn More
ProMedica opens medtech startup incubator in Ohio
ProMedica Health System has begun the ProMedica Innovations incubator for medical device and bioinformatics startups in ...Learn More
InSightec gets Japanese approval for ExAblate system
Japanese regulators have given InSightec clearance to market ExAblate, a magnetic resonance-guided, focused ultrasound ...Learn More
Device could reduce pressure, pain during mammograms
A team of researchers from the Netherlands has come up with a device that could reduce pain experienced during breast ...Learn More
New patent issued to Spineology for spinal fusion system
Spineology has secured a patent for a percutaneous spinal interbody fusion system, covering implants, instrumentation and ...Learn More
FDA clears lumbar spinal device from Interventional Spine
The FDA has granted Interventional Spine clearance for the Lateral Opticage Expandable Intervertebral Body Fusion Device. ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities. ...Learn More
AdvaMed SmartBrief will not publish Thursday and Friday
In observance of Thanksgiving in the U.S., AdvaMed SmartBrief will not publish Thursday and Friday. ...Learn More
Courage is the capacity to confront what can be imagined.
Leo Rosten, Russian-American teacher and ...Learn More
Second Sight earns over $36M from IPO
The initial public offering last week of Second Sight Medical pulled in $36.2 million for the company after the underwriter, ...Learn More
Maker of cloud-based monitoring platform obtains $17M
The second tranche of InfoBionic's Series B funding round has pulled in $17 million, which it will use to advance the U.S. ...Learn More
Kelyniam Global buys implantable device maker
Kelyniam Global, a cranial and facial implant maker based in Canton, Conn., announced its acquisition of Med-Ally for an ...Learn More
Horizon Discovery enters partnership with Adarza Biosystems
Horizon Discovery Group has agreed to a licensing and supply deal with Adarza Biosystems for an undisclosed sum. ...Learn More
German molecular Dx firm obtains $18M in funding extension
Curetis has brought in $18 million in a Series B financing round extension through the investments of Qiagen and the LSP ...Learn More
FDA OKs study of Cerus' plasma treatment system
The FDA has granted Cerus an investigational device exemption for clinical studies of its INTERCEPT Blood System, a ...Learn More
Microfluidic chip reduces amount of blood needed for testing
Scientists at the Indian Institute of Technology-Bombay have designed a microfluidic chip for blood separation that requires ...Learn More
FDA clears balloon catheter from Covidien
The FDA has given Covidien 510(k) clearance to market the Fortrex PTA balloon catheter. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
The secret of business is to know something that nobody else knows.
Aristotle Onassis, Greek shipping ...Learn More
Calif. bioresorbable stent firm gets $25M boost
Reva Medical has secured $25 million to support current operations and advance its products, the San Diego-based firm ...Learn More
Aneurysm device startup obtains $7M in funding
Aortica, a startup developing a patient-specific device to treat abdominal aortic aneurysms, has raised $7 million in a ...Learn More
U.S. antitrust waiting period ends for Becton Dickinson-CareFusion deal
Becton Dickinson now awaits approval from CareFusion shareholders in its bid to buy the company, as well as the OK from ...Learn More
CareDx ends lupus flare test collaboration with LabCorp
CareDx and Laboratory Corp. ...Learn More
EU approves Covidien's Nellcor oxygen monitor
European regulators have granted CE mark approval for Covidien's Nellcor bedside SpO2 patient monitoring device, which ...Learn More
CoorsTek Medical purchases Italian medtech firm
CoorsTek Medical announced its acquisition of Nanosurfaces Industries, the Italian device manufacturing unit of European ...Learn More
Faxitron to introduce high-resolution detector for new systems
Faxitron Bioptics is set to launch a high-resolution, complementary metal-oxide semiconductor digital detector for its ...Learn More
FDA clears BrainScope's brain trauma device
The Ahead 100 device, developed by Bethesda, Md.-based company BrainScope, has received clearance from the FDA. ...Learn More
FDA extends timeline for UDI marking compliance for certain orthopedic implants
Labelers of certain single-use orthopedic implants will have until Sept. ...Learn More
Low-dose portable X-ray system from Kubtec wins FDA OK
Kubtec has gained approval from the FDA to launch its KUB 250, a portable digital X-ray system designed to cut radiation ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
A broken bone can heal, but the wound a word opens can fester forever.
Jessamyn West, American ...Learn More
BioNano Genomics gets $53M boost to advance Irys platform
BioNano Genomics, a San Diego-based developer of genome mapping platforms, has obtained $53 million in a Series C funding ...Learn More
Funding round brings in $7.5M for molecular Dx startup
A round of Series A financing headed by Sherpa Ventures has pulled in $7.5 million for molecular diagnostics startup Cue. ...Learn More
Hospital GPO awards supply contract to Medical Imaging Solutions International
Medical Imaging Solutions International has entered into a supply agreement with Premier, a hospital group purchasing ...Learn More
New Zealand, Australia drop proposal to form joint regulatory body
A plan by New Zealand and Australia to create a single agency to regulate the medical device sector in both countries has ...Learn More
Canada releases guidance for new medtech license applications
Medical device manufacturers are required to submit license applications for Class III and Class IV devices in Canada via ...Learn More
Firms to develop advanced sequencing technology for infection monitoring
Illumina and bioMerieux agreed to collaborate in the development of applications for microbiology sequencing technologies. ...Learn More
Mich. health system to use firm's proton therapy system
The ProteusOne single-room proton therapy device developed by Ion Beam Applications will be installed at the Beaumont Health ...Learn More
SpineDriver to launch battery-powered device for drilling into spine
SpineDriver unveiled its newest battery-powered device to drill and drive pedicle screws into the spine at a spinal care ...Learn More
Accuray reports N.Y. installation of CyberKnife M6 system
Accuray has installed its CyberKnife M6 radiosurgery system at Winthrop-University Hospital's NYCyberKnife Center in ...Learn More
FDA OK sought by Great Basin Scientific for Group B strep test
Great Basin Scientific has submitted a 510(k) clearance application to the FDA for use of its Group B strep test in ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Men stumble over pebbles, never over mountains.
H. Emilie Cady, American ...Learn More
IPO pulls in $31.5M for Second Sight
An initial public offering Wednesday brought in $31.5 million for artificial retina developer Second Sight Medical Products. ...Learn More
Biomarker firm obtains $2.3M in funding for autism study
The Nancy Lurie Marks Family Foundation has given Stemina Biomarker Discovery $2.3 million to finance its study of autism ...Learn More
Company receives NIH funding to improve antibiotic delivery of implants
The NIH has given a $150,000 grant to Oxford Performance Materials to fund a study on treating infections caused by ...Learn More
Brazil seeks feedback on medtech quality inspections proposal
Medical device manufacturers may opt to provide feedback on how their quality management inspections were conducted under ...Learn More
Genetic Technologies wraps up sale of Australian subsidiary
The sale of Genetic Technologies' Australian Genetics unit to Specialist Diagnostics Services for $1.7 million has been ...Learn More
CardioMEMS device from St. Jude reduces 30-day readmissions
Data from St. ...Learn More
Boston Scientific's Synergy stent passes Evolve II trial
Boston Scientific's Synergy stent passed the Evolve II trial, where it was put against drug-eluting stent Promus, the ...Learn More
OrthoGrid launches device for better total hip replacement
HipGrid, an FDA-approved device designed for better positioning and alignment during total hip replacement, has been ...Learn More
Colonoscopy imaging device from Avantis wins FDA OK
The Third Eye Panoramic device, developed by Avantis Medical Systems, has obtained 510(k) clearance from the FDA. ...Learn More
FDA gives green light to IlluminOss' bone fracture device study
The FDA has given IlluminOss Medical conditional clearance to conduct a clinical study to test the use of its photodynamic ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
I think a hero is any person really intent on making this a better place for all people.
Maya Angelou, American ...Learn More
Royal Philips agrees to sale of InnerCool business to Zoll Medical
Zoll Medical will acquire Royal Philips' InnerCool temperature management business, including the FDA-cleared Accutrol ...Learn More
Genetic Signatures aims to bring in $13.1M in IPO
Genetic Signatures, the molecular diagnostics company behind the EasyScreen PCR pathogen detection kits, is looking to ...Learn More
New heart devices boost Medtronic's Q2 revenue
Medtronic saw a 4% increase in its second-quarter revenue to $4.37 billion, driven in part by sales from its new heart ...Learn More
Wis. blood center taps N-of-One for oncology testing services
The BloodCenter of Wisconsin has entered into an oncology testing partnership with N-of-One for undisclosed terms. ...Learn More
Zimmer agrees to longer EU review of Biomet deal
The European Commission has reached an agreement with Zimmer to extend an antitrust review of the company's pending ...Learn More
Partnership aims to investigate arrhythmia in dialysis patients
DaVita Healthcare Partners will work with Medtronic on a pilot effort to use the latter's Reveal LINQ Insertable Cardiac ...Learn More
FDA clears spinal fusion implant from Aurora Spine
The ZIP 51, developed by Aurora Spine and part of the company's Aurora Spine MIS Fusion System, has obtained 510(k) ...Learn More
Toshiba to launch updated CT and new PET/CT systems
Toshiba has announced updates to its Aquilion CT scanners and the release of its Celesteion PET/CT system. ...Learn More
Industry groups call for extension of tax credits
Over 500 businesses and industry groups, including AdvaMed, have signed a letter to Congress asking for the renewal of some ...Learn More
Rapid MRSA detection assay from AdvanDx wins FDA nod
The FDA has given AdvanDx 510(k) clearance to market its mecA XpressFISH assay for detecting methicillin-resistant and ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
It is always our own self that we find at the end of the journey. The sooner we face that self, the better.
Ella Maillart, Swiss travel ...Learn More
Medtronic to hold shareholder vote in January on Covidien buy
Medtronic has scheduled a special shareholder meeting Jan. ...Learn More
Regenerative medicine firm targets $60M in IPO
Waltham, Mass.-based Histogenics is looking to obtain $60 million with its initial public offering. ...Learn More
Valeant to pay up to $20M for Nicox's U.S. ophthalmic Dx unit
Valeant Pharmaceuticals has agreed to acquire Nicox's U.S. ...Learn More
Partnership aims to develop in vitro Dx kit for MRD
Sequenta has agreed to work with Illumina to develop and market an in vitro diagnostic kit that can be used to detect and ...Learn More
Protagen taps Qiagen in long-term companion Dx deal
An agreement reached by Protagen and Qiagen will focus on further developing protein-based companion diagnostic tests to ...Learn More
Bone Therapeutics to develop spinal fusion device with French firm
French firm Kasios will combine its synthetic microgranules bone substitute with Bone Therapeutics' ALLOB allogeneic ...Learn More
Covidien's VenaSeal offers promising treatment for chronic leg vein disorders
A study conducted by Covidien shows that the effectiveness of its new VenaSeal system as a treatment for chronic leg vein ...Learn More
NFL funds further development of concussion detection device
The University of Miami's Miller School of Medicine has secured a $500,000 grant from the National Football League, which it ...Learn More
EKF Diagnostics launches hemoglobin analyzer
EKF Diagnostics has introduced its DiaSpect TM point-of-care hemoglobin analyzer that can deliver results in a second. ...Learn More
Medtech firms express concern over EPA stance on sterilizer
The Environmental Protection Agency's draft assessment concluding that ethylene oxide, which is used to sterilize medical ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
When nothing seems to help, I go look at a stone-cutter hammering away at his rock perhaps a hundred times without as much as a crack showing in it. Yet at the hundred and first blow it will split in two, and I know it was not that blow that did it,...
Jacob Riis, Danish-American social ...Learn More
Heart valve implant maker obtains nearly $11M boost
JenaValve Technology has pulled in almost $11 million in a round of Series C financing, raising a total of $73.4 million in ...Learn More
Boston Scientific scores reimbursement wins for heart device
Boston Scientific has announced that starting Jan. ...Learn More
DermTech files to withdraw IPO proposal
DermTech, a California-based company specializing in tests to diagnose melanoma and other skin conditions, has filed to ...Learn More
Unilife taps Flextronics to expand production capacity
Unilife, which specializes in drug-delivery systems, has entered a global strategic deal with Flextonics for an undisclosed ...Learn More
Beckman Coulter enters molecular Dx deal with Seegene
Seegene, a South Korea-based firm, has agreed to a molecular diagnostics deal with Beckman Coulter to produce reagents ...Learn More
Nico enters partnership with Canadian firm for neurosurgery system
Nico and Synaptive Medical, a Toronto-based 3D visualization company, have struck a deal to work together on a neurosurgery ...Learn More
Study underway for Zyga's lumbar facet pain syndrome device
A patient at the Greater Baltimore Medical Center has become the first to be implanted with the Glyder Facet Restoration ...Learn More
Aethlon's Hemopurifier reduces Ebola viral load, case report suggests
Doctors from Goethe University in Germany reported at the Kidney Week conference that Aethlon's Hemopurifier helped reduce ...Learn More
FDA authorizes emergency use of Altona's Ebola testing kit
Altona Diagnostics announced that the FDA has authorized the emergency use of its RealStar Ebolavirus RT-PCR Kit 1.0, an in ...Learn More
FDA taps medical center to assist in Sentinel drug, device monitoring program
The Vanderbilt University Medical Center was enlisted by the FDA to offer research expertise to the agency's Sentinel System ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Failure will never overtake me if my determination to succeed is strong enough.
Og Mandino, American ...Learn More
U.S., EU regulators OK Endurant IIs stent graft from Medtronic
Medtronic's new Endurant IIs AAA endovascular stent graft, which is used to treat abdominal aortic aneurysms, has received ...Learn More
Monteris obtains $30M for robotic laser surgery platform
The first tranche of a Series B funding round has brought in $30 million for Minnesota-based Monteris Medical. ...Learn More
Medtronic grants natriuretic peptide rights to Capricor
Capricor Therapeutics secured the patent rights for the formulation and delivery of natriuretic peptides from Medtronic for ...Learn More
C. difficile test drives Q3 revenue growth for Great Basin
Utah-based Great Basin Scientific generated $404,390 in revenue during the third quarter, compared with $223,470 in the same ...Learn More
New Oncology signs cancer Dx deal in Singapore
The National Cancer Centre Singapore has entered into a cancer diagnostics partnership with Germany-based New Oncology for ...Learn More
Molecular Dx firm obtains up to $3.3M for Ebola diagnostic test
The Bill & Melinda Gates Foundation and the Paul G. ...Learn More
Roche's Group A strep test scores FDA clearance
The FDA has cleared Roche to market a polymerase chain reaction-based test that can identify the presence of Group A ...Learn More
Integra announces U.S. release of expandable interbody device
Integra LifeSciences said its first expandable interbody device, the FDA-cleared Integra Expandable Interbody System, is now ...Learn More
Lawmaker: Repeal of medical device tax could come with Republican-led Congress
A good way to create jobs and stimulate the economy is to repeal the 2.3% medical device tax, and it's a move that has ...Learn More
Industry exec commends proposed FDA oversight of LDTs
The FDA's proposed risk-based oversight of laboratory-developed tests would guarantee the effectiveness of the tests and ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
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Clarification
A summary in AdvaMed SmartBrief on Wednesday should have said Lantheus Medical Imaging postponed its plans for an initial ...Learn More
In helping others, we shall help ourselves, for whatever good we give out completes the circle and comes back to us.
Flora Edwards, American ...Learn More
Report: Medtech sector saw more but lower-value M&A deals in Q3
A PricewaterhouseCoopers report finds that the medical device sector signed 13 merger and acquisition deals during the third ...Learn More
IPO brings in nearly $145M for Nevro
Nevro, maker of the Senza spinal cord stimulation system, has obtained $144.9 million in an initial public offering. ...Learn More
Debt funding round nets $16M for Spiracur
Spiracur, the company behind the SnaP negative-pressure wound therapy device, has secured $16 million in debt financing from ...Learn More
Precision Therapeutics rebrands, appoints new execs
Cancer diagnostics firm Precision Therapeutics has pulled in $60 million through a financing round and adopted a new ...Learn More
Intarcia signs distribution deal with French firm Servier
Servier, a pharmaceutical company based in France, has struck a multimillion-dollar distribution deal with Intarcia ...Learn More
InGen to offer One Lambda's transplant Dx tests in France
One Lambda has renewed its distribution deal with InGen, an affiliate of Diaxonhit, for undisclosed terms. ...Learn More
Realizing the value of med-tech innovations
Why have med tech innovators been hesitant to bust through conventional device price ceilings and really go after the money ...Learn More
DNA test detects rejection risk in kidney transplant patients
Researchers at the University of California, San Francisco, and the University of Cincinnati have developed a genetic test ...Learn More
FDA clears Titan Spine's Endoskeleton implant line
The FDA has granted Titan Spine 510(k) clearance to market its Endoskeleton implant line, which features the firm's ...Learn More
Republican move to repeal device tax expected
The GOP's Senate majority win during last week's elections means Sen. ...Learn More
Vertebral body replacement device from K2M wins FDA nod
The CAPRI Corpectomy Cage System, developed by K2M, has obtained 510(k) clearance from the FDA. ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 -- San Francisco, Calif. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It is not the mountain we conquer, but ourselves.
Edmund Hillary, New Zealand ...Learn More
Lantheus plans second IPO attempt
Lantheus Medical Imaging, which makes medical imaging isotopes, announced plans to file for an initial public offering, ...Learn More
Qiagen signs companion Dx deal with Novartis
Qiagen has agreed to work with Novartis to create and market companion diagnostics for the latter's current product line, as ...Learn More
IDT gains licensing rights to EliTech's qPCR probes
Integrated DNA Technologies will manufacture and offer EliTech's MGB Eclipse qPCR probes under a licensing deal reached ...Learn More
CytoSorbents enters partnership with global cardiac surgery company
An unnamed global cardiac surgery company has agreed to work with CytoSorbents to study the use of its CytoSorb cytokine ...Learn More
AdvaMed establishes new outpost in Shanghai
AdvaMed held a ceremony in Beijing to officially open its new office in Shanghai. ...Learn More
For more:
Read the AdvaMed press release about the opening of its representative office in Shanghai, ...Learn More
ViewRay's MRI-based radiotherapy device wins approval in Europe
An MRI-guided radiation therapy device developed by ViewRay has obtained CE mark approval in Europe. ...Learn More
Minimally invasive spinal implant market poised for growth in Latin America
The market for minimally invasive spinal implants in Latin America could be worth $60.7 million by 2019, a report from ...Learn More
New blood test checks for beta amyloid buildup
Scientists have created a blood test that assesses beta amyloid burden, and they believe it will aid research into the ...Learn More
FDA OKs spinal osteosynthesis rod from Medicrea
The FDA has given Medicrea Group 510(k) clearance to market its UNiD system, a spinal osteosynthesis rod that can be ...Learn More
Lombard's U.K. cleanroom facility gets FDA clearance
The FDA has cleared Lombard Medical to begin manufacturing Aorfix endovascular stent grafts at the firm's new cleanroom ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Progress lies not in enhancing what is, but in advancing toward what will be.
Kahlil Gibran, Lebanese artist, poet and ...Learn More
Medtronic signs loan package worth $16.3B
Medtronic has secured a loan package worth $16.3 billion, which the company said will be used to support its pending ...Learn More
IPO pulls in $19.1M for brain stimulation device firm
An initial public offering has brought in $19.1 million for Nexstim. ...Learn More
CareDx posts 16% year-over-year revenue increase in Q3
CareDx, which specializes in molecular diagnostics, reported a 16% year-over-year increase in its third-quarter revenues to ...Learn More
Japanese regulator approves MRI-safe ICD from Medtronic
The Japanese Ministry of Health, Labor and Welfare gave its approval to Medtronic's Evera MRI SureScan implantable cardiac ...Learn More
ACD enters partnership for RNAscope test development
Advanced Cell Diagnostics has struck a development deal with MicroMatrices for undisclosed terms. ...Learn More
Orthofix kicks off bone-stimulating device studies
Orthofix has begun its large-scale U.S. ...Learn More
Device sorts circulating tumor cells in the blood to predict spread of tumor
Scientists at the University of Toronto have designed a device that uses nanoparticles to sort circulating tumor cells into ...Learn More
Cervical plate from Zimmer Spine wins FDA nod
The FDA has granted 510(k) clearance for Zimmer Spine's Optio-C Anterior Cervical Plate, which is used in conjunction with ...Learn More
Guidance explaining molecular Dx device regulation issued by FDA
The FDA has issued guidelines governing the approval or clearance of certain molecular diagnostic systems. ...Learn More
ImThera gets FDA OK to launch trial of sleep apnea device
ImThera Medical has received approval from the FDA to conduct clinical trials of its aura6000, designed to treat obstructive ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 -- San Francisco, Calif. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
The excellence of a gift lies in its appropriateness rather than in its value.
Charles Dudley Warner, American ...Learn More
Funding round brings in $15M for OrthAlign
A round of financing headed by Mutual Capital Partners and River Cities Capital Funds has pulled in $15 million for ...Learn More
Report: Small bone orthopedics market could hit $4B by 2020
A report from iData projects that by 2020, the U.S. ...Learn More
Molecular Dx startup obtains $1.1M in financing
Prostate Management Diagnostics, a molecular diagnostics startup founded by the Peter Michael Foundation, has raised almost ...Learn More
CryoVascular signs distribution deal with Vascular Solutions
The PolarCath cryoplasty device, developed by Dr. ...Learn More
J&J, S. Korea collaborate to boost medtech industry
Johnson & Johnson Medical Korea and South Korea's Ministry of Health and Welfare have entered an agreement to invest $25 ...Learn More
German experts develop degradable orthopedic implants
Scientists from the Fraunhofer Institute for Manufacturing Technology and Advanced Materials in Germany have developed ...Learn More
DePuy Synthes launches hybrid arthroscopic anchor
The GRYPHON PROKNOT Anchor is available commercially, according to DePuy Synthes, a unit of Johnson & Johnson. ...Learn More
Aerocrine's device to treat asthma cleared by FDA
The FDA has cleared Aerocrine to market the Niox Vero system, which measures fractional exhaled nitric oxide in about a ...Learn More
FDA OKs SpineFrontier to develop advanced cervical spine implant
The FDA has granted SpineFrontier clearance for the Arena-C HA device, an intervertebral body fusion system intended to ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
It's better to walk alone than with a crowd going in the wrong direction.
Diane Grant, Canadian playwright and ...Learn More
Maker of Argus II bionic eye targets $31.5M in IPO
Sylmar, Calif.-based Second Sight Medical is looking to obtain $31.5 million with its initial public offering. ...Learn More
Nevro boosts IPO target to $126M
Nevro has increased the amount it hopes to raise in an initial public offering from about $100 million to $126 million. ...Learn More
Hypertension device startup announces $9.7M in funding
Vascular Dynamics, based in the San Francisco Bay Area, has obtained $9.7 million in an equity funding round aiming for ...Learn More
Atlas technology drives Q3 revenue growth for Roka Bioscience
Roka Bioscience generated $1.5 million in revenues during the third quarter, up from $556,000 a year ago. ...Learn More
EU seeks input on safety of medical devices containing plasticizers
The European Commission's Scientific Committee on Emerging Newly Identified Health Risks has issued an updated opinion on ...Learn More
PositiveID partners with military on handheld molecular Dx
PositiveID and the U.S. ...Learn More
ACS guidelines support use of Exact Sciences' colorectal cancer test
Updated guidelines from the American Cancer Society include details on the use of Exact Sciences' Cologuard test for ...Learn More
Cook Medical's Zilver PTX stent shows promise for PAD
The Zilver PTX stent looks promising following a five-year study of 479 patients with peripheral artery disease, according ...Learn More
GOP leaders: Axing device tax is a top priority
Republican leaders in Congress are developing their strategy for attacking the Affordable Care Act. ...Learn More
FDA clears artificial pancreas algorithm for Dexcom device
The FDA has approved Dexcom's Software 505 for its G4 Platinum continuous glucometer. ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Each minute we spend worrying about the future and regretting the past is a minute we miss in our appointment with life.
Thich Nhat Hanh, Vietnamese monk and ...Learn More
Cardio3 to acquire CorQuest Medical
Cardio3 BioSciences has agreed to buy CorQuest Medical, which is working on a tool that gives surgeons direct access to the ...Learn More
AstraZeneca boosts oncology business with Definiens buy
AstraZeneca's MedImmune unit agreed to pay $150 million upfront plus milestone fees to purchase Definiens, a provider of ...Learn More
Push could bring in about $8M for InspireMD's stent systems
Massachusetts-based InspireMD is looking to obtain about $8 million in a direct shares offering. ...Learn More
SV Life Sciences gains majority interest in deal with Ximedica
SV Life Sciences has acquired a majority stake in medtech development firm Ximedica. ...Learn More
Prostate cancer test boosts Q3 revenues for MDxHealth
MDxHealth generated $3.5 million in overall revenues during the third quarter, compared with $2 million in the same period a ...Learn More
Roche announces plans for diagnostics plant in eastern China
Roche has announced plans to establish a plant in eastern China that will be used to manufacture clinical chemistry and ...Learn More
NovioSense wins EU patent for tear glucose monitor
Holland-based NovioSense has secured a patent in Europe for a device that uses a tiny wireless sensor placed in the eye to ...Learn More
Sequent Medical CEO Wilder bets on MicroBraids
Sequent Medical CEO Tom Wilder tells MassDevice.com why his company's MicroBraid technology is a key differentiator in its ...Learn More
S.D. startup behind migraine eyeglass technology gets $1M boost
EyeBrain Medical, a startup based in South Dakota, has obtained $1 million for its NeuroLens technology, which involves ...Learn More
NeoCoil introduces MRI coils for Toshiba scanners
NeoCoil has expanded its MRI coil portfolio with the launch of the 16ch Flex Speeder coils. ...Learn More
Report on device tax's effect is flawed, AdvaMed says
A Congressional Research Service report that suggests the 2.3% medical device tax will have a "relatively small" effect on ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
The greatest work that kindness does to others is that it makes them kind themselves.
Amelia Earhart, American ...Learn More
Device-tax repeal will be at the top of new Congress' agenda
Though the Affordable Care Act is unlikely to be entirely repealed by the Republican-controlled Congress, the law's tax on ...Learn More
PDI strikes deal to purchase RedPath Integrated Pathology
PDI has agreed to pay $23 million in a cash and stock deal, with a $12 million payment upfront, to purchase RedPath ...Learn More
Growth forecast for orthobiologics in N. America
An analysis by ReportsNReports predicts that the orthobiologics market is poised for growth in North America, driven in part ...Learn More
Kimberly-Clark spins off device unit
Kimberly-Clark has spun off its former Surgical & Infection Prevention and Medical Devices units, creating Halyard Health. ...Learn More
U.K. regulator names former NICE official as chairman
Michael Rawlins has been tapped to serve as chairman of the U.K.'s Medicines and Healthcare Products Regulatory Agency, ...Learn More
Cardiovascular Systems wins approval for PAD device in Europe
A percutaneous orbital atherectomy device developed by Cardiovascular Systems has obtained CE mark approval in Europe. ...Learn More
CDC taps Accelerate Diagnostics for work on biological threat detection
Accelerate Diagnostics is creating rapid pathogen detection assays, including tools for detection of antibiotic resistance, ...Learn More
Portable device helps visualize blood donors' veins
Australian researchers are testing a portable device that can map blood donors' veins using near-infrared light. ...Learn More
Patient input sought on FDA approvals
A notice published Tuesday by the FDA establishes a channel for the public to weigh in on how the agency can incorporate ...Learn More
FDA OKs Covidien's device to treat peripheral artery disease
The FDA has given Covidien 510(k) clearance to market its HawkOne technology, the newest addition to its directional ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 – San Francisco, Calif. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
People often say that motivation doesn't last. Well, neither does bathing -- that's why we recommend it daily.
Zig Ziglar, American author and motivational ...Learn More
Diagnostics firm LabCorp to acquire Covance for $6.1B
Laboratory Corporation of America, a North Carolina-based company specializing in developing diagnostic tests, announced ...Learn More
Covidien agrees to $30M sale of Stellarex balloon to Spectranetics
Spectranetics will acquire Covidien's Stellarex drug-eluting balloon under a $30 million deal expected to close early next ...Learn More
Spine unit of Integra LifeSciences to become SeaSpine
Integra LifeSciences Holdings, a maker of specialty surgical devices and orthopedic care products, has announced plans to ...Learn More
Maker of bone-graft collection device gets $1M boost
Avitus Orthopaedics has pulled in over $1 million in a funding push that includes a $750,000 grant from the National Science ...Learn More
EU approves Medtronic's advanced drug-eluting stent
European regulators have granted CE Mark approval for Medtronic's Resolute Onyx drug-eluting stent, an advanced version of ...Learn More
Devices will fall under purview of EU's new industry directorate
The European Commission's new industry directorate will assume responsibility for medical device policy in the EU, taking ...Learn More
Hologic scores reimbursement win for 3D mammo device
Procedures using Hologic's 3D mammography technology will receive Medicare coverage under new reimbursement codes released ...Learn More
Advanced ultrasound scanner released by Siemens
The Acuson X600 ultrasound device, designed for cardiology, obstetric and gynecologic diagnostics as well as general ...Learn More
FDA approves AtriCure's DEEP trial for atrial fibrillation
The FDA has given AtriCure an investigational device exemption to conduct a clinical trial for DEEP, which is designed to ...Learn More
Automatic gating tool from Elekta wins FDA nod
The FDA has given Elekta 510(k) clearance to market its Response automatic gating technology for the Clarity 4D prostate ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
The most powerful weapon on earth is the human soul on fire.
Ferdinand Foch, French military ...Learn More
IPO could pull in up to $150M for EndoChoice
Georgia-based EndoChoice is looking to obtain as much as $150 million in an initial public offering. ...Learn More
Maker of surgical blood-loss monitoring tool obtains $1.5M
California-based Gauss Surgical has secured $1.5 million by selling equity. ...Learn More
Joint venture aims to improve genetic diagnostics
Baylor College of Medicine has partnered with Tokyo-based Miraca Holdings, a provider of in vitro diagnostics and other ...Learn More
Globus posts positive Q3 results, announces resignation of CFO
Globus Medical reported a 13.5% increase in its third-quarter profit, which was $23.1 million. ...Learn More
Alphatec Spine reports revenue growth in Q3
Alphatec Spine posted consolidated net revenue of $51 million in the third quarter, a 2% increase from a year ago. ...Learn More
Aurora Spine's interspinous fixation implant debuts in Israel
A doctor at the Herzliya Medical Center has performed Israel's first implantation of the ZIP ULTRA minimally invasive ...Learn More
Aesculap advances knee repair tech trial
Aesculap Biologics said its Novocart 3D system has been implanted in the first human patient of its clinical trial. ...Learn More
Partnership aims to tap 3D printing to expedite medtech production
Stratasys, which specializes in 3D printing, is partnering with design firm Worrell on an initiative to use 3D-printed ...Learn More
Prototype takes 1 minute to spot Ebola antibodies
Canada-based bioLytical Laboratories has created a preclinical prototype diagnostic that the company said can detect ...Learn More
U.S., EU regulators OK latest surgical robot from Hansen
The FDA has given Hansen Medical the go-ahead to market the Sensei X2 system, a third-generation version of its surgical ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. -- 2:00 p.m. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Wherever there is a human being, there is an opportunity for a kindness.
Seneca, Roman ...Learn More
Medtronic announces restructuring plans
Medtronic said it plans to reorganize its business into four major operating segments after its merger with Covidien closes, ...Learn More
Zimmer to rebrand after Biomet acquisition
Zimmer announced plans to change its name to Zimmer Biomet upon closing its acquisition of former competitor Biomet. ...Learn More
Rosetta signs molecular Dx distribution deal with Admera
Rosetta Genomics has entered into a distribution deal with Admera Health, a spinoff of GeneWiz, for undisclosed terms. ...Learn More
Smith & Nephew posts 3% revenue increase in Q3
Smith & Nephew reported a 3% increase in its third-quarter revenue to $1.15 billion and a 14% increase in its earnings per ...Learn More
Report: Global orthobiologics market could hit $5.5B by 2019
The worldwide market for orthobiologic devices will increase from $3.7 billion in 2012 to $5.5 billion by the close of ...Learn More
Spartan Bioscience wins Canadian OK for near-patient DNA test
Spartan Bioscience has received the go-ahead in Canada to market the Spartan RX CYP2C19 System for near-patient use. ...Learn More
HTG, Illumina collaborate on in vitro diagnostic test kits
HTG Molecular Diagnostics and Illumina have entered into an agreement to create sequencing-based, in vitro diagnostic kits. ...Learn More
Agfa gains FDA clearance for CR, DR imaging detectors
The FDA has cleared Agfa Healthcare to market its DXD imaging package, which consists of cesium-based image plates and ...Learn More
FDA, Abiomed agree on indication for flagship heart pump
Abiomed expects to receive FDA pre-market approval for its Impella 2.5 heart pump by February or March, following an ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. -- 2:00 p.m. ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
I work in whatever medium likes me at the moment.
Marc Chagall, Russian-French ...Learn More
Abbott to acquire 2 catheter-based medical device firms
Abbott has struck a deal to acquire Topera, which develops catheter-based electrophysiology diagnostic technologies, for ...Learn More
Prices of popular medical devices dropped 5% in Aug., index shows
The Modern Healthcare/ECRI Institute technology price index reported a 5% decrease in August in the prices of the top 10 ...Learn More
Zoll Medical agrees to purchase respiratory care device maker
Zoll Medical announced that it has entered an agreement to pay an undisclosed amount to acquire Impact Instrumentation, a ...Learn More
EU approves assay for sexually transmitted infections
European regulators have granted Scienion and Genomica the CE-IVD mark for their Clinical Array Technology STIs A&B, a ...Learn More
Japanese drug firm taps Qiagen in companion Dx deal
A deal reached between Qiagen and Japanese firm Astellas Pharma will focus on the development and commercialization of ...Learn More
Masimo's Kiani on "good-enough innovation," Medtronic, Apple and 25 years of pushing the envelope
MassDevice catches up with Masimo CEO Joe Kiani to discuss new challenges facing the company and how medtech can break the ...Learn More
Scientists develop blood test for Alzheimer's disease
Australian researchers have developed a blood test that is 91% accurate in detecting Alzheimer's disease years before ...Learn More
Yale, OPM to collaborate on 3D-printed biomedical devices
Yale University has agreed to work with Oxford Performance Materials on 10 projects to study the application of 3D printing ...Learn More
PENTAX announces U.S., Canadian launch of advanced GI endoscope
PENTAX is making its i10 Series HD+ endoscope, which gives doctors a high-definition view of the upper gastrointestinal ...Learn More
Biological Signal's heart attack Dx device OK'd by FDA
The FDA has granted Biological Signal Processing the green light to market a device that uses an ECG at rest to allow more ...Learn More
FDA grants compassionate use provision for Aethlon's Ebola treatment device
Aethlon Medical has received approval to provide its blood-filtration device, the Hemopurifier, as an Ebola treatment under ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 – San Francisco, Calif. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
The measure of who we are is what we do with what we have.
Vince Lombardi, American football ...Learn More
VC firm to invest $235M in medical device, drug companies
Advent Life Sciences has secured an investment fund worth $235 million, which it will pump into medical device and ...Learn More
Leica Biosystems acquires breast biopsy tech developer
Leica Biosystems, a unit of Danaher, has agreed to pay an undisclosed sum to acquire breast biopsy device firm Devicor ...Learn More
Stock sale could bring in net proceeds of $18.4M for Nanosphere
Nanosphere has completed its public shares offering, which the company said could bring in about $18.4 million in net ...Learn More
Roche unit signs companion Dx deal with ImmunoGen
Ventana Medical Systems, a Roche unit, has agreed to work with ImmunoGen to create an immunohistochemistry-based test that ...Learn More
Recent acquisitions drive Q3 revenue growth for LabCorp
Laboratory Corp. of America reported a 6.1% increase in revenue during the third quarter. ...Learn More
Report: Global bio-implants market could hit $115.8B in 6 years
A report from Allied Market Research predicts that by 2020, the worldwide market for bio-implants could be worth $115.8 ...Learn More
Trial underway for Medtronic's heart valve implant
A patient at a hospital in Ohio has become the first to be implanted with Medtronic's heart valve replacement device as part ...Learn More
Nanoscale device monitors effect of cancer drug in the blood
A new nanoscale device developed by scientists at the University of Montreal can monitor concentrations of methotrexate in ...Learn More
FDA clears shoulder fixation device from Dallen Medical
The FDA has cleared Dallen Medical to market the Tensyn Band, designed to repair the coracoacromial ligament and ...Learn More
Upgraded radiotherapy planning tool from RaySearch wins FDA nod
Version 4.5 of RaySearch Laboratories' RayStation radiotherapy planning technology has obtained 510(k) clearance from the ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
The great geniuses are those who have kept their childlike spirit and have added to it breadth of vision and experience.
Alfred Stieglitz, American ...Learn More
Wright Medical and Tornier to combine in stock-for-stock deal
A merger has been announced between Wright Medical Group and Dutch company Tornier, with each Wright Medical share to be ...Learn More
Globus Medical buys Texas bone allograft maker
Transplant Technologies of Texas, a distributor of bone allografts, biomaterials and soft tissue products, has been acquired ...Learn More
Integra wraps up purchase of Medtronic's ENT instrument lines
Integra LifeSciences' purchase of Medtronic's Xomed and MicroFrance lines of ear, nose, throat and laparoscopic instruments ...Learn More
Hospital GPO awards imaging device contract to Infraredx
HealthTrust Purchasing Group, a hospital group purchasing organization, has awarded a supply contract to Infraredx. ...Learn More
Zyga wins CE mark approval for Glyder Facet Restoration Device
Zyga Technology has earned the CE mark for its Glyder Facet Restoration Device, which offers release from lumbar facet pain. ...Learn More
Cadens Medical enters partnership with Hisense Medical
Cadens Medical Imaging of Canada has struck a multimillion-dollar deal with Hisense Medical, a Chinese multinational ...Learn More
Chembio, IBT to collaborate on point-of-care Ebola tests
Chembio Diagnostics has entered into a partnership with Integrated BioTherapeutics, for an undisclosed amount, to develop ...Learn More
Advanced lung imaging tech introduced by Covidien
An upgraded version of the superDimension electromagnetic navigation bronchoscope, designed for pulmonary imaging ...Learn More
St. Jude wins FDA nod for TactiCath Quartz ablation catheter
The FDA has granted St. Jude Medical approval to market its TactiCath Quartz irrigated ablation catheter. ...Learn More
Covidien unit gains wider FDA OK for peripheral stent
Ev3, a unit of Covidien, has obtained expanded FDA approval for use of its EverFlex peripheral stent in treating patients ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. -- 2:00 p.m. ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
Never, 'for the sake of peace and quiet,' deny your own experience or convictions.
Dag Hammarskjold, Swedish ...Learn More
Device tax, approval delays cause more U.S. firms to go offshore, AdvaMed CEO says
The medical device tax and FDA approval delays remain major factors influencing an increasing number of companies to launch ...Learn More
Medtronic to use $16B in assumed debt to pursue Covidien deal
Medtronic will help finance its purchase of Covidien for $43 billion by assuming U.S. ...Learn More
Aurora Spine signs marketing deal with MedAssets
Aurora Spine has agreed to give MedAssets' network of hospitals and health care providers access to its product line under a ...Learn More
Edwards Lifesciences beats Q3 earnings estimates
Edwards Lifesciences reported a 23% increase in sales and a 14% increase in earnings compared to last year's third quarter. ...Learn More
Maker of GERD device cancels plans to go public
Renaissance Capital said EndoStim has called off its previously announced plans to launch an initial public offering aimed ...Learn More
EU approves Amoy Diagnostics' cancer mutation assays
China-based Amoy Diagnostics has obtained the CE mark for its cancer mutation assays for NRAS, KRAS/NRAS, RET and ERCC1. ...Learn More
Myriad creates European lab to offer tumor diagnostic
Myriad Genetics has set up a laboratory in Munich, Germany, to provide the company's Tumor BRACAnalysis CDx assay across ...Learn More
Rapid test predicts risk of developing severe sepsis
Canadian researchers have created a test that can quickly assess the risk that patients will develop severe sepsis. ...Learn More
U.S., EU regulators OK ambulatory infusion pump from Zyno
The FDA has cleared Zyno Medical to market its Nimbus Ambulatory Infusion Pump, which the company said can be used to ...Learn More
FDA authorizes emergency use of BioFire's Ebola tests
The FDA has authorized emergency use of two new Ebola tests developed by BioFire Defense in U.S. hospitals. ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. -- 2:00 p.m. ...Learn More
The real art of conversation is not only to say the right thing in the right place but to leave unsaid the wrong thing at the tempting moment.
Lady Dorothy Nevill, British ...Learn More
OxySure, Estill Medical sign merger deal
OxySure has entered into a merger deal with Estill Medical Technologies, whose products include the Thermal Angel system ...Learn More
Investors pump $5.5M into hypertension device startup
Sympara Medical has received $5.5 million in funding from a small group of investors, the firm revealed in a regulatory ...Learn More
Calif. blood cancer test startup lands investment from Celgene
Sequenta has received an undisclosed investment from Celgene, which the California-based startup will use to help launch ...Learn More
Quest Diagnostics reports Q3 revenue growth
Quest Diagnostics generated $1.9 billion in revenues during the third quarter, compared with $1.79 billion during the same ...Learn More
Former Mayo Clinic exec named to RTI Surgical's board
Shirley Weis, the president of Weis Associates, has been tapped to serve on the board of directors at RTI Surgical. ...Learn More
Akers Biosciences forms joint venture with Chinese company
Akers Biosciences has formed a joint venture with Hainan Savy Investment Management that will focus on distributing Akers' ...Learn More
Biotech startups, government work on brain stimulus devices
Silicon Valley startups are following the lead of government researchers to determine whether electrical stimulation from ...Learn More
Crossing catheter from ReFlow wins FDA nod
The FDA has cleared ReFlow Medical to market its Wingman35 crossing catheter, which the company said is already available in ...Learn More
Study finds improvements in FDA's device-review programs
The FDA took an average of 297 days to approve high-risk medical devices under the premarket approval application program in ...Learn More
FDA OKs study of Gynesonics' uterine fibroid technology
The FDA has granted Gynesonics an investigational device exemption for a pilot study of its VizAblate technology, which ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Happiness is like a butterfly: the more you chase it, the more it will elude you, but if you turn your attention to other things, it will come and sit softly on your shoulder.
Henry David Thoreau, American writer and ...Learn More
Boston Scientific's spinal surgical leads win U.S., EU approval
European regulators have granted Boston Scientific the CE mark for its CoverEdge 32 and CoverEdge X 32 spinal surgical ...Learn More
Medtronic affirms intent to consummate $43B Covidien deal
Medtronic has affirmed its plans to acquire Covidien for $43 billion, saying the deal could be finalized late this year or ...Learn More
Sorin makes $20M investment in Respicardia
Minnesota-based startup Respicardia, which is working on an implantable system used to treat central sleep apnea, has ...Learn More
Investors pump $13M into Calif. molecular Dx company
California-based InSilixa has obtained $13 million in financing from Morningside and PointGuard Ventures. ...Learn More
Heart device sales boost Q3 revenue, profit for Boston Scientific
Boston Scientific reported a 6% increase in revenue and $43 million in net income during the third quarter. ...Learn More
Enigma moves to bring molecular Dx platform to China
Enigma Diagnostics has entered into a joint venture with Beijing Leadman Biochemistry to offer the Enigma Mini Laboratory ...Learn More
5 factors affecting the future of medtech
These five factors will determine the future of the medical device industry. Read the ...Learn More
Exact Sciences' colorectal cancer test to be offered by MDVIP
MDVIP has agreed to offer Exact Sciences' ColoGuard test to its network of primary care doctors across the U.S. ...Learn More
Breath-based test can rapidly detect hospital-acquired infections
Isomark has designed a new type of breathalyzer that can spot hospital-acquired infections within two hours of onset. ...Learn More
FDA clears bioceramic burr hole plug from OssDesign
The FDA has given 510(k) clearance for Sweden-based OssDesign's Cranioplug, a bioceramic bone implant intended to be used in ...Learn More
New patent issued to Expanding Orthopedics
Expanding Orthopedics has been issued a patent covering vertebral compression fracture technologies and expandable interbody ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 – San Francisco, Calif. ...Learn More
For the past 33 years, I have looked in the mirror every morning and asked myself: 'If today were the last day of my life, would I want to do what I am about to do today?' And whenever the answer has been ...
Steve Jobs, American ...Learn More
TriVascular wins FDA nod for customized aneurysm-sealing tech
The FDA has granted TriVascular Technologies approval to market its CustomSeal Technology, designed to deliver the Ovation ...Learn More
Funding round brings in $32.5M for diabetes tech developer
A round of Series C financing headed by Norwest Venture Partners has pulled in $32.5 million for Telcare. ...Learn More
Maker of flexible endoscope obtains $20M in financing
Massachusetts-based Medrobotics has raised $20 million in its latest financing round. ...Learn More
Ill. molecular Dx firm launches public stock sale
Nanosphere has initiated a public shares offering, with plans to use the proceeds as working capital and to support general ...Learn More
Infectious-disease-product sales boost Q3 revenue for Quidel
California-based Quidel posted $40.9 million in revenues during the third quarter, up from $33.5 million during the same ...Learn More
Clinical Genomics gains license for bowel cancer Dx test
The Commonwealth Scientific and Industrial Research Organisation in Australia has agreed to license its ColoVantage Plasma ...Learn More
Mammography market in the Americas could hit $1.1B in 6 years
A GBI Research report forecasts that the market for mammography devices in the Americas will reach $1.1 billion by 2020. ...Learn More
Hansen's device used in first robotic fibroid embolization in U.S.
A doctor at the Sierra Medical Center in Texas has performed the first robotic fibroid embolization in the U.S. ...Learn More
Medtronic's PTC-based interbody fusion devices make global debut
Medtronic said its pure titanium coating-based interbody fusion systems, designed to help treat patients with spinal ...Learn More
BioMerieux pursues approval of FilmArray test for Ebola screening
BioMerieux will evaluate its FilmArray system to determine whether it can be used to detect the Ebola virus in preparation ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
Minds are like parachutes; they work best when open.
Thomas Dewar, Scottish ...Learn More
Medtech delivers value well in excess of its cost, AdvaMed CEO says
Studies citing medical technology as a major reason for escalating health costs are misguided, writes AdvaMed President and ...Learn More
ZipLine Medical receives $5.7M from Chinese investor
California-based ZipLine Medical, maker of the Zip system designed to close surgical incisions, has obtained $5.7 million ...Learn More
Orthopedics and prosthetics market poised for growth
A ReportsNReports study forecasts that the orthopedic and prosthetic device market will see a compound annual growth rate of ...Learn More
Brainsway strikes marketing deal, wins reimbursement for Deep TMS device
A French company has agreed to sell Brainsway's Deep Transcranial Magnetic Stimulation system, an FDA-approved device used ...Learn More
Report: Asian arthroscopic device market could exceed $700M by 2018
A report from MicroMarket Monitor predicts that by 2018, the Asian market for arthroscopic systems could surpass $700 ...Learn More
Canada OKs Otoharmonics' tinnitus device
Otoharmonics has received the go-ahead in Canada to market its Levo System as a Class 2 medical device. ...Learn More
Trial begins for Ablative Solutions' infusion ablation catheter
A clinical trial launched by Ablative Solutions in Poland aims to investigate the use of its infusion ablation catheter as a ...Learn More
Sensor has potential to detect viruses at very low levels
A new sensor can detect small traces of target molecules, which could lead to earlier diagnoses of illnesses such as Ebola, ...Learn More
DexCom gains FDA approval for wireless glucose monitoring device
The FDA gave pre-market approval for the DexCom Share device, part of its remote glucose monitoring system that transmits ...Learn More
AnthroTronix's cognitive health testing app gets FDA OK
AnthroTronix has received FDA clearance to market the Defense Automated Neurobehavioral Assessment, or DANA, application, ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. -- 2:00 p.m. ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
Nobody can go back and start a new beginning, but anyone can start today and make a new ending.
Maria Robinson, American ...Learn More
Device sector saw rise in VC deals in Q3, report says
A MoneyTree report from the National Venture Capital Association and PricewaterhouseCoopers found that the medical device ...Learn More
Colo. sinusitis device startup obtains $8.3M in financing
A round of financing has pulled in $8.3 million for Sinopsys Surgical. ...Learn More
Abbott agrees to market Carl Zeiss' cataract surgery devices
Abbott will add Carl Zeiss Meditec's cataract surgery devices to its eye surgery offerings under a deal reached between the ...Learn More
Calif. molecular Dx company posts revenue growth in Q3
California-based Cepheid, which specializes in molecular diagnostics, posted $115.2 million in revenues during the third ...Learn More
EU approves MRI-safe pacemaker from Boston Scientific
European regulators have granted Boston Scientific CE mark approval to market its Accolade pacemaker. ...Learn More
Trial underway for Medtronic's predictive low glucose management tech
Medtronic has begun patient enrollment in a clinical study of its Predictive Low Glucose Management system, which combines a ...Learn More
Foundation Medicine scores reimbursement win for cancer genomic tests
Priority Health has become the first U.S. ...Learn More
New PET/CT system from Mediso designed for research use
Mediso Medical Imaging Systems has introduced the MultiScan LFER 150 PET/CT device, created for use in preclinical and ...Learn More
NHD taps Rayence to supply flat-panel digital detectors
Rayence has struck a deal to provide the National Healthcare Distributors' network of sales and service providers with its ...Learn More
Federal judge rules in favor of Covidien in injunction decision
A federal judge ruled in favor of Covidien last week by imposing a preliminary injunction that prohibits Ethicon ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
We have committed the Golden Rule to memory; let us now commit it to life.
Edwin Markham, American ...Learn More
Report: Medtech, biotech and pharma see strong M&A activity
A recent report from Mergermarket found that the medtech, biotech and pharma industries had 869 merger and acquisition deals ...Learn More
Calif. eye surgery device firm receives $51M funding boost
A round of financing headed by Frontline BioVentures and OrbiMed has pulled in $51 million for MID Labs, which develops ...Learn More
Stock sale brings in $5.3M for Epigenomics
Epigenomics, which has developed the Epi proColon test used to diagnose colorectal cancer, has obtained $5.3 million through ...Learn More
Industry veteran joins Spine Wave's marketing management team
Laine Mashburn has been tapped to serve as executive vice president of global marketing and business development at Spine ...Learn More
EU approves Thermo Fisher's Ion PGM Dx tool
European regulators have granted Thermo Fisher Scientific the CE-IVD mark to market its Ion PGM Dx System. ...Learn More
Genetic test identifies patients at risk of atrial fibrillation and stroke
Scientists have developed a test that screens for 12 genetic variants to determine risk of ischemic stroke and atrial ...Learn More
Siemens' advanced cardiovascular ultrasound scanner gets FDA OK
Siemens Healthcare has received FDA clearance for the Acuson SC2000 Prime, the latest version of its ultrasound scanner used ...Learn More
Wireless imaging device from Konica lands FDA clearance
The AeroDR XE wireless digital radiography device, developed by Konica Minolta Medical Imaging, has obtained clearance from ...Learn More
ITraumaCare's bleeding-control device gets expanded approval from FDA
The FDA has granted iTraumaCare expanded approval for its iTClamp Hemorrhage Control System for use in halting severe ...Learn More
FDA clears cervical fusion device from Precision Spine
The FDA has cleared Precision Spine to market its Vault-C Anterior Cervical Interbody Fusion Device, which the company said ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
People are like stained-glass windows. They sparkle and shine when the sun is out, but when the darkness sets in, their true beauty is revealed only if there is a light from within.
Elisabeth Kubler-Ross, American ...Learn More
Swedish maker of thumb-based ECG device eyes $1.7M in IPO
Swedish firm Zenicor Medical Systems has filed for an initial public offering in hopes of obtaining $1.7 million. ...Learn More
N.H. breast-imaging device startup obtains $6.5M
A regulatory filing shows that Gamma Medica has obtained $6.5 million in its latest funding round. ...Learn More
Tenn. genetic testing firm gains $2.23M in additional financing
The second tranche of a Series B funding round has pulled in $2.23 million for NextGxDx, according to a regulatory filing. ...Learn More
Delphinus Medical appoints new engineering VP
Chris Sanders has been tapped to serve as vice president of engineering at Delphinus Medical Technologies. ...Learn More
Forum seeks comments on problematic-device reporting proposal
A document issued by the International Medical Device Regulators Forum outlines the group's proposal to modify its process ...Learn More
Skyline teams up with Sao Paulo researchers to evaluate leukemia test
SkylineDx will conduct a study with researchers at the Ribeirao Preto Medical School at the University of Sao Paulo to ...Learn More
Medical device tax: A hat trick of futility
In just 21 months, the 2.3% levy has achieved a unique hat trick of futility. ...Learn More
InVivo reports first implantation of spinal scaffold
A patient at a hospital in Arizona has become the first to be implanted with InVivo Therapeutics' Neuro-Spinal Scaffold as ...Learn More
CMS to cover BioTheranostics' breast cancer index test
The CMS has agreed to provide Medicare reimbursement coverage for BioTheranostics' Breast Cancer Index assay. ...Learn More
Aethlon's biofiltration device used to treat Ebola patient
Aethlon Medical has announced that its Hemopurifier blood filtration device is being used at Frankfurt University Hospital ...Learn More
FDA clears HPIV test from Quidel
The FDA has given Quidel 510(k) clearance to market its Lyra Parainfluenza Assay. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Every great dream begins with a dreamer.
Harriet Tubman, American ...Learn More
Medtronic wins FDA nod for MRI-safe pacemaker lead
The FDA has granted Medtronic approval for its CapSureFix Novus MRI SureScan 5076 pacemaker lead. ...Learn More
Becton enters next-generation sequencing market with GenCell buy
Becton Dickinson has agreed to pay an undisclosed sum to purchase GenCell Biosystems, an Irish firm specializing in ...Learn More
Maker of total artificial heart advances $15M funding round
A regulatory filing disclosed that Syncardia has obtained $6.4 million in a Series F financing round aiming for $15 million. ...Learn More
Mazor Robotics appoints new CEO
Christopher Prentice has been promoted from senior vice president of America and global marketing to CEO of Mazor Robotics. ...Learn More
EU nod sought by Medtronic for proposed $43B merger with Covidien
The European Commission said Medtronic has sought the approval of antitrust regulators in Europe for its pending acquisition ...Learn More
Device, drug regulatory agencies in Bulgaria, Sweden get new leaders
The Bulgarian Drug Agency has appointed Assena Stoimenova as its new executive director, while the Medical Products Agency ...Learn More
Collaboration aims to develop test for early TB diagnosis
Advanced Biological Laboratories has struck a development deal with two universities in Hong Kong for undisclosed terms. ...Learn More
VisionCare's eye device obtains wider FDA approval
VisionCare Ophthalmic Technologies has received expanded FDA approval for its miniature telescope implant to be used in ...Learn More
Final FDA guidance distinguishes device recalls from market withdrawals
Guidance outlining requirements for differentiating medical device recalls from market withdrawals has been finalized by the ...Learn More
Tool for CT-based bone mineral density measurement gets FDA OK
The FDA has cleared MindwaysCT to market its computed tomography calibration system for use in measuring bone mineral ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Sometimes you have to step outside of the person you've been, and remember the person you were meant to be, the person you wanted to be, the person you are.
H.G. Wells, British ...Learn More
Steris to acquire British sterilization firm in $1.9B deal
Steris has agreed to pay roughly $1.9 billion in cash and company stock to acquire Synergy Health, a British provider of ...Learn More
Funding round brings in $120M for Invitae
A Series F financing round has pulled in $120 million for Invitae, maker of a gene-based test that can be used to detect ...Learn More
Advanced Biologics' bone allograft sold to Bioventus
Advanced Biologics has agreed to sell its OsteoAMP bone allograft product line to Bioventus, which will market the product ...Learn More
Ohio stroke device startup eyes $3.1M in additional financing
A regulatory filing shows that Ischemia Care has obtained $1.9 million in equity financing and hopes to raise $3.1 million ...Learn More
Ophthalmology device market poised for growth, report says
A Markets & Markets report predicts that the market for ophthalmology devices used for diagnostics, monitoring, vision care ...Learn More
Device could aid in early detection of Ebola virus infection
A device developed by Noninvasive Medical Technologies could allow clinicians to pinpoint Ebola patients before symptoms ...Learn More
Medical device coating resists blood clots and bacterial growth
Harvard University researchers have developed a coating for medical devices that blocks the formation of blood clots and ...Learn More
FDA OKs adenovirus molecular Dx test from Quidel
The FDA has given Quidel 510(k) clearance to sell its real-time polymerase chain reaction-based test called the Lyra ...Learn More
Portable patient monitor from Covidien wins FDA nod
The Nellcor Portable SpO2 Patient Monitoring System by Covidien has been cleared by the FDA. ...Learn More
FDA widens clearance for Nanosphere's enteric pathogens test
The FDA has granted Nanosphere expanded 510(k) clearance for its Verigene Enteric Pathogens Nucleic Acid Test to be used in ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
The free soul is rare, but you know it when you see it -- basically because you feel good, very good, when you are near or with them.
Charles Bukowski, German-born American ...Learn More
Bard gains FDA approval for drug-coated balloon catheter
The FDA has given C.R. Bard the green light to market its drug-coated balloon catheter. ...Learn More
Medtronic unveils restructuring plans after Covidien acquisition
Medtronic said Covidien will operate as a separate unit after it acquires the company in a $43 billion transaction. ...Learn More
Great Basin Scientific to sell 1.15 million shares in IPO
Great Basin Scientific said in a regulatory filing that it will sell 1.15 million company shares valued at $7 apiece in an ...Learn More
Funding round brings in $11.6M for esophageal device maker
C2 Therapeutics, a California-based startup that has developed the Coldplay Focal Cryoballoon Ablation System, has obtained ...Learn More
EU approves RPS Diagnostics' respiratory infection test
RPS Diagnostics has obtained the CE mark for its in-office diagnostic test FebriDx. ...Learn More
Biotronik's hybrid drug-eluting stent hits French market
The Orsiro hybrid drug-eluting stent is available commercially in France, according to Biotronik, which developed the ...Learn More
Ind. patient becomes first in U.S. to receive Sorin's heart valve
Sorin's Solo Smart system has been implanted for the first time in the U.S. in a patient in Indiana. ...Learn More
Microfluidics may be better way to identify Ebola
Microfluidics applied to bodily fluids may be the key to quick and early detection of the Ebola virus, says Juan Pablo ...Learn More
Upgraded ultrasound scanner released by Siemens
Version 3.5 of the Acuson Freestyle ultrasound scanner is available commercially, according to Siemens Healthcare, which ...Learn More
FDA OKs Spineart's cervical secured cage technology
The FDA has given Spineart the go-ahead for its cervical secured cage technology known as the SCARLET AC-T. ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. -- 2:00 p.m. ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
If you want to be successful, you must respect one rule: Never lie to yourself.
Paulo Coelho, Brazilian ...Learn More
Mass. knee cartilage device firm targets $65M in IPO
Massachusetts-based Histogenics plans to launch an initial public offering in a quest to obtain as much as $65 million. ...Learn More
AngioDynamics posts profit growth in FY 2015 first quarter
AngioDynamics generated $629,000 in net income during the first quarter of fiscal year 2015, which represents an increase ...Learn More
EOS hits milestone for imaging technology
Royal Children's Hospital in Melbourne, Australia, has installed a unit of EOS imaging's technology, designed for 2D and 3D ...Learn More
Global sales of connected health care devices poised for growth
A Juniper Research report projects that global sales of connected health care devices such as sleep apnea monitors and ...Learn More
EU approves TB molecular Dx test from Abbott
European regulators have granted Abbott the CE mark for its assay that runs on the company's m2000 molecular testing ...Learn More
Ocular Therapeutix proceeds with 2 eye-duct plug studies
Ocular Therapeutix is set to launch two late-stage clinical trials of its OTX-DP technology, an eye-duct plug that ...Learn More
SomaLogic teams up with Colo. hospital for childhood disease biomarker study
SomaLogic is working with Children's Hospital Colorado to advance research on protein biomarkers for managing and diagnosing ...Learn More
Tumor segmentation tool from Varian OK'd by FDA
Varian Medical Systems has received FDA clearance for software that supports lung tumor segmentation in 3D. ...Learn More
Knee replacement device from OrthAlign debuts in U.K.
The KneeAlign system, a single-use device that offers femoral and tibial navigation during knee replacement procedures, was ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
To be yourself in a world that is constantly trying to make you something else is the greatest accomplishment.
Ralph Waldo Emerson, American ...Learn More
IPO could bring in $60M for AutoGenomics
California-based AutoGenomics is looking to obtain $60 million in an initial public offering. ...Learn More
Funding round pulls in $45.3M for TELA Bio
A regulatory filing shows that TELA Bio has obtained $45.3 million in its latest financing round. ...Learn More
U.S. patent issued to aap Implantate's LOQTEQ system
The U.S. ...Learn More
CEO of AxioMed Spine joins Misonix's board
Patrick McBrayer has been tapped to serve on the board of directors at Misonix. ...Learn More
Report: 3D printing poised to see growth in medical applications market
A Transparency Market Research report predicts that by 2019, 3D printing in the global medical applications market could be ...Learn More
Is medtech held to a double standard on innovation? A conversation with B. Braun's Caroll Neubauer
MassDevice.com catches up with B. ...Learn More
Advanced Cell Diagnostics receives $1.4M to validate lymphoma assay
The National Cancer Institute has awarded Advanced Cell Diagnostics a $1.4 million small business innovation research grant ...Learn More
Medtronic's sacral neurostimulation assessment tool gets FDA OK
The FDA has granted Medtronic approval to market its Verify Evaluation System for use in assessing which patients with ...Learn More
Ubl: Industry fears over 2.3% medical device tax bear out
AdvaMed President and CEO Stephen Ubl said concerns over the 2.3% medical device tax are proving to be true almost two years ...Learn More
Boston Scientific gets mixed FDA panel review for heart device
An FDA panel has agreed that Boston Scientific's Watchman system is potentially safe, but it was split on whether the ...Learn More
Clip failure concerns lead SAM Medical to recall Junctional Tourniquet
SAM Medical Products has issued a voluntary recall involving its SAM Junctional Tourniquet over concerns about possible clip ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
It is not the voice that commands the story; it is the ear.
Italo Calvino, Italian journalist and ...Learn More


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In the News
Freedom Driver Allows Man With Artificial Heart to Await Transplant at Home
By: Gizmag | January 2015

Heart failure patients awaiting organ transplants normally find themselves anchored to the hospital bed by a washing machine-sized device that keeps blood pumping through their veins.

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New Medical Device Helps Local Man Survive
By: Brittni Smallwood | January 2015

At one time, Tom Desmond said only 25 percent of his heart worked. He said the left side was dead and the right side was struggling.

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Cutting-Edge Device Could Reverse Damage Caused by Heart Disease
By: James Walsh | November 2013

Sunshine Heart's C-Pulse device, which could reverse heart damage in some patients, has a potential worldwide market of up to $1 billion, an analyst says.

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New Medical Technologies Offer Hope for Sleep Apnea
By: Karen Weintraub | November 2013

Sleep apnea affects an estimated 5% to 10% of Americans and is undiagnosed in most of them. It can also lead to obesity, diabetes, high blood pressure, strokes and heart attacks. 

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