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$50M shelf registration filed by Biocept
A shelf registration has been filed by Biocept, giving it the ability to offer $50 million in stocks or related securities. ...Learn More
OrthoSpace to use "significant" funding for orthopedic balloon system
OrthoSpace has raised an undisclosed funding amount that it called "significant" from a recent financing round participated ...Learn More
Singulex grants EMD Millipore exclusive rights to molecule counting assay
EMD Millipore has agreed to give Singulex an upfront payment, royalties and milestone payments in exchange for exclusive ...Learn More
Blog: Medtech firms should pay attention to value-based purchasing
Medtech companies must be ready to quantify the additional value their products bring to patients, compared with other ...Learn More
CMS drafts coverage of prostate cancer test from Genomic Health
A CMS contractor has released a local coverage determination draft for Genomic Health's Oncotype DX test for prostate ...Learn More
Radiation dose technology company gets U.S. patent
A U.S. patent was granted for the wireless molecular sensor system and process developed by VeriTeQ. ...Learn More
Dassault's Living Heart Project designs 3D human heart simulator
The first 3D human heart simulator will be unveiled by 3D software company Dassault Systemes on May 29. ...Learn More
FDA requests more data on Guided Therapeutics' cervical device
The FDA said it will not grant approval for Guided Therapeutics' July 2014 amendment in its premarket approval bid for the ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
SmartBrief will not publish Monday
SmartBrief will not publish Monday in observance of Memorial Day in the U.S. Publication will resume ...Learn More
Rank does not confer privilege or give power. It imposes responsibility.
Peter Drucker, management consultant and ...Learn More
Ubl: AdvaMed's Innovation Agenda would revive U.S. medtech leadership
Medical technology can save lives and reduce the burden of disease, as well as generate jobs and spur economic growth, but ...Learn More
Vermillion receives $7.5M grant for ovarian cancer test
The Cancer Prevention and Research Institute of Texas has awarded a $7.5 million grant to Austin, Texas-based diagnostics ...Learn More
San Diego-based startup raises $3M for insulin pen
A recently completed Series B financing round led by Eli Lilly & Co. brought in $3 million for Companion Medical. ...Learn More
ProTek Medical acquired by Irish medtech firm
Irish medtech company Molex has purchased ProTek Medical, a Coralville, Iowa, firm that makes vascular delivery and infusion ...Learn More
FDA grants CLIA certification to cancer Dx firm's lab
Resolution Bioscience said it has obtained CLIA certification for its laboratory. ...Learn More
Traumatic brain injury detector lands FDA clearance
BrainScope's Ahead 200 smartphone-based device has received clearance from the FDA. ...Learn More
LabCorp introduces new hepatitis C resistance tests
LabCorp has introduced two diagnostic tests for hepatitis C virus drug resistance. ...Learn More
Weight device from Emmes lands FDA clearance
A device from Emmes that can calculate the weight of a child has received clearance from the FDA. ...Learn More
Canada approves spinal cord stimulator from St. Jude
Health Canada has given St. ...Learn More
Malaysia's medical device filing deadline is June 30
Medical device companies must file with Malaysia's Medical Device Authority by June 30 to continue sales in that country, ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
IDE Submissions Workshop
Oct. ...Learn More
He who wishes to be obeyed must know how to command.
Niccolo Machiavelli, historian and ...Learn More
Boston Scientific takes part in global diabetes initiative
Boston Scientific has joined the $9.9 million DRIVE consortium, an international program supported by the European Union's ...Learn More
Funding round pulls in $40M for Shockwave Medical
A financing round participated in by several investors including Venrock and Sofinnova Partners has brought in $40 million ...Learn More
Intraocular lens maker obtains $14.5M in financing
ClarVista Medical has raised $14.5 million in a recent funding round. ...Learn More
SonaCare Medical secures partnership deal with Invivo
SonaCare Medical, a developer of high-intensity focused ultrasound systems, has sealed a partnership deal with Invivo. ...Learn More
Medtronic reports increased Q4 sales
Medtronic posted a 59.9% increase in sales in the quarter ending April 24, bringing in $7.30 billion. ...Learn More
Hyperthermic laser system from Cynosure gets FDA clearance
A hyperthermic laser system developed by Cynosure for treating patients with noninvasive lipolysis of the flanks has ...Learn More
Visage's mobile image interpretation app obtains FDA clearance
The FDA has cleared Visage Imaging's Visage Ease Pro iOS application for mobile interpretation of diagnostic images other ...Learn More
Transcarotid stent from Silk Road Medical lands FDA approval
The Enroute device, a transcarotid stent from Silk Road Medical, has obtained premarket approval from the FDA. ...Learn More
Additional sizes of Implanet's JAZZ rods get FDA OK
The FDA recently cleared the 3.5-mm, 4-mm, 4.5-mm and 6-mm lengths of Implanet's JAZZ rods. ...Learn More
EU expands approval for Mauna Kea Technologies' endomicroscopy device
European regulators have granted Mauna Kea Technologies expanded CE mark approval for its Cellvizio confocal laser ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
All truths are easy to understand once they are discovered; the point is to discover them.
Galileo Galilei, ...Learn More
Guidance on using adaptive design in medical device studies issued by FDA
The FDA has released a draft guidance that covers how adaptive design can be properly used in the clinical studies of ...Learn More
ConvaTec seeks $1.85B to refinance debts
ConvaTec is raising a revolving credit facility of $200 million and term loan facilities worth $1.65 billion, both of which ...Learn More
Funding round brings in $8M for Abcodia
A recent financing round co-led by Scottish Equity Partners and Cambridge Innovation Capital has brought in about $8 million ...Learn More
Tokyo Future Style enters distribution agreement with KromaTiD
Tokyo Future Style has struck a deal to distribute some of the products of KromaTiD on the Japanese market. ...Learn More
OrbusNeich enrolls U.S. participants in dual therapy stent trial
The first U.S. ...Learn More
Trial shows Medtronic's pacemaker satisfies clinical performance, safety standards
Medtronic's Micra transcatheter pacing system has satisfied clinical performance and safety standards in a 140-patient ...Learn More
New urological products to be released by Olympus
Olympus reported Friday that it will release five urology products at the 2015 meeting of the American Urological ...Learn More
FDA clears bone marrow drills from Biologic Therapies
The FDA has cleared Biologic Therapies' Bio-CORE and Bio-MAC Bone Marrow Biopsy Cannula drills to be used by doctors to ...Learn More
EU approves bioresorbable stent from Arterial Remodeling
The Pure Bioresorbable Scaffold, developed by Arterial Remodeling Technologies, has obtained CE mark approval in Europe to ...Learn More
India unveils program to report, monitor medical device adverse events
The Materiovigilance Programme of India will be launched by the country's health ministry within three months to ensure that ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
There is nothing worse than a sharp image of a fuzzy concept.
Ansel Adams, ...Learn More
Nanosphere seals debt facility with NSPH Funding, raises $4.4M in financing round
A Series A financing round has brought in $4.4 million for Nanosphere. ...Learn More
Smith & Nephew buys S2 Interactive's supply chain management solutions
Smith & Nephew recently bought S2 Interactive's TrayTouch and Virtual Backtable applications. ...Learn More
Circassia to buy asthma device maker for $217M
Circassia Pharmaceuticals will pay about $217 million to purchase Aerocrine, maker of the Niox Mino, designed to detect ...Learn More
Canon U.S. Life Sciences appoints new CEO, president
Canon U.S. Life Sciences has named Akiko Tanaka its president and CEO. ...Learn More
Medtronic reports positive trial results for antibacterial device
A clinical study showed promising results for Medtonic's TYRX antibacterial envelope, which releases antimicrobial agents to ...Learn More
CVRx to launch U.S. trial for Barostim device
The FDA has given CVRx approval to conduct a pivotal trial for its Barostim device, designed for heart failure patients, in ...Learn More
Wound dressing system released by Acelity in EU
The Nanova therapy system, developed by Acelity for dressing wounds, is now available in European markets. ...Learn More
Advisory panel meets to discuss duodenoscope reprocessing concerns
The FDA's Gastroenterology-Urology Devices Panel warned that cleaning and disinfecting duodenoscopes based on reprocessing ...Learn More
Federal government develops reference material for DNA genetic testing
The U.S. ...Learn More
HeartWare's heart-assist device kit recall labeled Class I by FDA
A recall initiated by HeartWare involving its ventricular assist system pump driveline splice kit has been categorized by ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
510(k) Submissions Workshop
Oct. ...Learn More
Don't limit yourself. Many people limit themselves to what they think they can do.
Mary Kay Ash, ...Learn More
Funding round pulls in $38.9M for Intact Vascular
A Series B financing round brought in $38.9 million in venture capital for Intact Vascular. ...Learn More
Financing round boosts Neuronetics' magnetic stimulation device
A Series F funding round has pulled in $34.3 million in equity financing for Neuronetics. ...Learn More
Funding round brings in $6.6M for OncoCyte
A financing round has brought in $6.6 million for OncoCyte, including $3.3 million in cash and a $3.3 million conversion of ...Learn More
Bionic pancreas maker gains $3M from investors
Funding totaling $3 million was obtained by Bigfoot Biomedical from eight investors to support the development of its bionic ...Learn More
CMS drafts coverage of NanoString's breast cancer test
A positive local coverage determination draft was released by the CMS for the Prosigna breast cancer recurrence test ...Learn More
Q1 revenue increases for Veracyte
Veracyte generated $11.2 million in total revenue in the quarter ending March 31, up nearly 50% from $7.5 million posted in ...Learn More
Study shows positive results for Medtronic's MRI-safe ICD
A clinical study of patients with implantable cardioverter defibrillators who underwent full-body MRI scans showed positive ...Learn More
VA finds ScImage's PACS compliant with requirements
The Department of Veterans Affairs has validated the Picom365 enterprise PACS system developed by ScImage to be used at its ...Learn More
EU approves infusion catheter from Ablative Solutions
European regulators have granted Ablative Solutions CE mark approval for its Peregrine System Infusion Catheter designed to ...Learn More
Data on screening issues for higher-risk devices unveiled in Canada
New information on what reviewers commonly see when screening for deficiencies in the license applications for Class III and ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
It is not who is right, but what is right, that is of importance.
Thomas Huxley, ...Learn More
IPO could bring in as much as $86.2M for Glaukos
Laguna Hills, Calif.-based Glaukos has filed for an initial public offering with the goal of securing up to $86.2 million. ...Learn More
GE Healthcare, Abbott team up in atrial fibrillation Dx deal
A deal was reached between Abbott and GE Healthcare to combine two systems intended to map and diagnose atrial fibrillation. ...Learn More
AstraZeneca partners with Abbott to develop asthma companion Dx tests
A partnership between Abbott and AstraZeneca was formed to develop and commercialize companion diagnostic tests that can ...Learn More
Report: Market for internal trauma fixation devices in North America set for growth
A Research and Markets report predicts the North American market for internal trauma fixation devices will reach $3.8 ...Learn More
Q1 revenue increases for Invitae
Invitae generated $1.2 million in revenue in the first quarter, a nearly tenfold rise from $118,000 in the same period a ...Learn More
Cepheid Ebola test approved for WHO procurement
The Xpert Ebola assay, developed by Cepheid, was included by the World Health Organization in its list of diagnostics that ...Learn More
Spinal bracing device controller from Ellipse lands FDA clearance
The advanced external remote controller for Ellipse Technologies' MAGnetic Expansion Control Spinal Bracing and Distraction ...Learn More
Cleveland Clinic aims to boost brain health, research
The Cleveland Clinic Lou Ruvo Center for Brain Health has established the Healthy Brains Initiative, designed to promote ...Learn More
Insulin infusion device from BD Medical scores FDA clearance
BD Medical's insulin infusion set with BD FlowSmart technology has received 510(k) clearance from the FDA. ...Learn More
EU expands approval for St. Jude's cardiac technologies
St. ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
No heirloom of humankind captures the past as do art and language.
Theodore Bikel, ...Learn More
Funding round brings in $38M for Autonomic Technologies
A Series D financing round led by Edmond de Rothschild Investment Partners pulled in $38 million for Autonomic Technologies. ...Learn More
Atia Medical obtains $5M for intraocular lens development
A Series B financing round brought in $5 million for Shifamed's portfolio firm Atia Medical. ...Learn More
Biodesix's lung cancer test scores reimbursement win from UnitedHealthcare
The use of Biodesix's VeriStrat, a blood-based advanced non-small cell lung cancer test, will be covered by ...Learn More
Higher test volume drives Q1 revenue growth for Biocept
Biocept generated $150,000 in revenue in the first quarter, up from $28,000 in the same period a year earlier. ...Learn More
Q1 revenue increases for Calif. molecular Dx firm
CareDx reported a 22% year-over-year revenue increase in the quarter ending March 31. ...Learn More
Lithoplasty catheter from Shockwave Medical shows positive results in trial
A six-month study involving 35 patients who have peripheral artery disease showed promising results for Shockwave Medical's ...Learn More
Use of "liquid biopsies" is becoming more common
Physicians increasingly are employing noninvasive blood tests to identify cancers, guide treatment and monitor responses to ...Learn More
EU, U.S. approve cryoablation device from Medtronic
The Arctic Front Advance ST Cryoablation Catheter, developed by Medtronic, has obtained CE mark approval in Europe to treat ...Learn More
FDA clears new features added to Toshiba's CT systems
The FDA has cleared the software and detector upgrades made by Toshiba America Medical Systems to its Aquilion One CT ...Learn More
Boston Scientific reaches settlement deal in transvaginal mesh case
Boston Scientific agreed to settle with a patient in a case being heard in the U.S. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
The great aim of education is not knowledge but action.
Herbert Spencer, philosopher and ...Learn More
Suture device maker obtains $35M loan
CRG has granted Ceterix Orthopaedics a term loan worth $35 million. ...Learn More
Funding round brings in $8.5M for Cartiva
An oversubscribed Series D financing round led by New Enterprise Associates and supported by new investor Windham Venture ...Learn More
Q1 revenue rises for bioanalytical solutions company
Vermillion generated $951,000 in total revenue in the quarter ending March 31, up from $305,000 posted in the same period ...Learn More
Nanosphere revenue rises in Q1
Nanosphere generated $4.6 million in revenue in the quarter ending March 31, an increase of nearly 40% from $3.3 million ...Learn More
Industry veteran named VP of business development at Bioventus
Thomas Umbel, who has over 30 years of medical diagnostic and device industry executive management experience, was tapped to ...Learn More
2 trial participants implanted with ImThera sleep apnea device
ImThera Medical reported that its aura6000 sleep apnea system has been implanted in its first two U.S. ...Learn More
6 groups win digital health challenge
The Office of the National Coordinator for Health IT has announced the six winners of its Market R&D Pilot Challenge. ...Learn More
Lawmakers ask for vote on medical device tax repeal before Memorial Day
Rep. ...Learn More
FDA OKs Roche's mutation test for colorectal cancer
The FDA approved the cobas KRAS Mutation Test developed by Roche Holding for use in metastatic colorectal cancer patients ...Learn More
Wireless bladder implant by StimGuard gets investigational device exemption
The FDA has granted an investigational device exemption to StimGuard to conduct a clinical study for its overactive bladder ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
Sadly, it's much easier to create a desert than a forest.
James Lovelock, ...Learn More
Yared: Device tax repeal would provide more capital for innovation
Not only does the 2.3% medical device tax stifle growth and threaten jobs, but it has also had an impact on the amount of ...Learn More
Tornier, Wright Medical shareholders to vote on merger
A set of meetings has been scheduled by Tornier and Wright Medical on June 18 for shareholders to vote on whether to approve ...Learn More
Boston Scientific floats $1.85B debt-for-acquisition deal
Boston Scientific is offering senior notes totaling $1.85 billion to fund the company's purchase of the American Medical ...Learn More
Lucigen enters distribution partnership with Sigma-Aldrich unit in India
Sigma-Aldrich's unit in India has struck a deal to exclusively distribute the life science reagents of Lucigen in the Indian ...Learn More
Dehaier signs supply deal with Sonqao Health Checkup Institution
A contract has been signed by Dehaier Medical to supply Chinese physical examination company Sonqao Health Checkup ...Learn More
Roka Bioscience reports revenue growth in Q1
Roka Bioscience generated $1.5 million in revenue in the quarter ending March 31, up 81% from $828,000 posted in the same ...Learn More
Epigenomics: Most patients take blood-based colon cancer test
Epigenomics, a diagnostics firm in Germany, reported that 99.5% of pivotal trial participants complied with the company's ...Learn More
Pneumonia-detecting app tested in Africa
A low-cost mobile health application is being tested by health care workers to diagnose pneumonia in African children. ...Learn More
Medicrea unveils second-generation spinal fixation connector
The LigaPASS 2.0 band, a spinal fixation connector device, was released by The Medicrea Group on the U.S. market. ...Learn More
Nevro lands FDA approval for Senza spinal cord stimulation system
The Senza system, Nevro's device that relieves trunk or limb pain without paresthesia by sending electrical pulses to the ...Learn More
Surefire's infusion system gains CE mark
European regulators have granted Surefire Medical CE mark approval for its Precision system, a device that delivers drugs to ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
MedTech Compliance Boot Camp Workshop
Nov. 4-5 | Washington, D.C. ...Learn More
I stole everything I ever heard, but mostly I stole from the horns.
Ella Fitzgerald, jazz ...Learn More
Welch Allyn seals acquisition deal with Scale-Tronix
Welch Allyn, which specializes in developing diagnostic tools, has agreed to pay an undisclosed sum to buy Scale-Tronix, a ...Learn More
Funding round nets $195M for Adaptive Biotechnologies
A Series F funding round has pulled in $195 million for Adaptive Biotechnologies. ...Learn More
Moximed gets $33M from investors to support knee implant
Hayward, Calif.-based Moximed has obtained $33 million in private equity financing from four returning investors and new ...Learn More
CombiMatrix posts revenue growth in Q1
CombiMatrix generated $2.3 million in revenue in the quarter ending March 31, up 28% from $1.8 million posted in the same ...Learn More
Fluidigm's revenue rises in Q1
Fluidigm posted earnings of $26.7 million in the first quarter, a 4% increase over the same period last year. ...Learn More
Direct Flow Medical names new CEO, CFO
Daniel Lemaitre, former CoreValve CEO, was tapped to succeed Bernard Lyons as CEO and president of Direct Flow Medical. ...Learn More
Positive results achieved for Intact Vascular's PAD device
A first-in-human trial of Intact Vascular's Tack system showed positive results, according to a study published in the ...Learn More
New iPhone device may help doctors treat parasitic disease
Doctors working to treat people infected with the parasitic worm Loa loa can now use a new handheld device that turns the ...Learn More
Medtronic to evaluate in-office approach to implanting heart monitor
A clinical study will be conducted by Medtronic to compare the effectiveness of in-office insertion of Reveal Linq, an ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. ...Learn More
In any project, the important factor is your belief. Without belief, there can be no successful outcome.
William James, philosopher and ...Learn More
IPO could pull in as much as $115M for EndoChoice
An initial public offering has been filed by EndoChoice with the goal of securing as much as $115 million. ...Learn More
Molecular Dx firm looks to raise $44.4M from IPO
HTG Molecular is selling 3.57 million shares in an initial public offering with the goal of securing net proceeds of about ...Learn More
Analysis: Market for internal trauma fixation devices in Asia-Pacific set for growth
A ReportBuyer analysis predicts the Asia-Pacific market for internal trauma fixation devices will see a 6.7% compound annual ...Learn More
Q1 revenue increases for Sequenom
Sequenom generated revenue of $37.8 million during the first quarter, a 2% increase from the $37.1 million in revenue posted ...Learn More
Instruments, consumables drive Q1 revenue growth for NanoString
NanoString Technologies posted $11.6 million in revenue in the quarter ending March 31, a 32% increase from the $8.8 million ...Learn More
Transcend Medical reports positive trial results for glaucoma stent
A two-year study involving over 500 patients who have mild to moderate glaucoma showed promising results for Transcend ...Learn More
Watson gets the job at 14 cancer centers that aim to personalize treatment
Fourteen cancer centers in the U.S. ...Learn More
Older guidance documents withdrawn by FDA
Forty-seven draft guidance documents covering various areas including drugs, diagnostics and medtech products that were ...Learn More
Lawmaker: Bill to repeal medical device tax could be passed soon
A measure to repeal the 2.3% excise tax on medical devices will be passed sometime this year, Rep. ...Learn More
Smith & Nephew gets FDA warning over quality issues at Mass. facility
A warning letter has been issued to Smith & Nephew by the FDA over quality-control problems affecting mechanical ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
PMA Submissions Workshop
Oct. ...Learn More
Great spirits have always encountered violent opposition from mediocre minds.
Albert Einstein, theoretical ...Learn More
Debt financing round pulls in $17M for Labcyte
Silicon Valley Bank and Oxford Finance granted Sunnyvale, Calif.-based Labcyte a credit facility worth $17 million. ...Learn More
Deal to acquire Spinal Modulation completed by St. Jude
The acquisition of Spinal Modulation by St. Jude Medical has been completed. St. ...Learn More
Oncotype DX tests drive Q1 revenue growth for Genomic Health
Genomic Health generated $68.2 million in revenue in the quarter ending March 31, an increase from the $67 million in ...Learn More
Q4 profit increases for Abiomed
Abiomed generated $98.9 million in profits on $67.6 million in sales in the quarter ending March 31. ...Learn More
Japanese firm unveils blood-pressure monitoring system
The HEM-9200T system, a blood-pressure monitor that allows chronically ill patients to track their health from home, was ...Learn More
Inmar unveils digital health competition with Flywheel
A health application development competition has been unveiled by Inmar, a retail technology company, working in partnership ...Learn More
Ubl: Device tax is paid at the cost of life-changing innovation
Depressed job growth and decreased innovation are the true outcomes of the medical device tax, writes AdvaMed President and ...Learn More
FDA to lower risk classification of some medical devices
The FDA's Center for Devices and Radiological Health said it will place a larger emphasis on postmarket information in ...Learn More
Balloon catheter from Medtronic scores FDA clearance
The Euphora, a semicompliant balloon dilation catheter from Medtronic, has received 510(k) clearance from the FDA. ...Learn More
FDA clears cervical plate system from Medtronic
The Zevo, an anterior cervical plate device from Medtronic, has received 510(k) clearance from the FDA. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
IDE Submissions Workshop
Oct. ...Learn More
Hope is like the sun, which, as we journey toward it, casts the shadow of our burdens behind us.
Samuel Smiles, ...Learn More
Development-stage medtech firm targets $23M from IPO
Pavmed, a development-stage medtech company, has filed for an initial public offering with the goal of securing $23 million. ...Learn More
Neuromodulation technology startup gets $17.3M in equity financing
Axonics Modulation Technologies, a startup developing neuromodulation devices for various medical conditions, has secured ...Learn More
Assay sales drive Q1 revenue growth for Luminex
Luminex generated $57.7 million in revenue in the quarter ending March 31, up 2% from the $56.6 million generated in the ...Learn More
Q1 revenue increases for Exact Sciences
Exact Sciences posted revenue of $4.3 million during the first quarter, an increase from the $294,000 in revenue reported ...Learn More
EU approves cardiac monitoring device from Biotronik
European regulators have granted Biotronik CE mark approval for its CardioMessenger Smart system, a device that ...Learn More
Spine alignment technology from NuVasive debuts in U.S.
The Integrated Global Alignment system, a platform developed by NuVasive for spinal column alignment, is being launched this ...Learn More
Extracranial pressure device from Invictus cleared by FDA
The GELShield, a device developed by Invictus Medical to relieve extracranial pressure in newborns, received clearance from ...Learn More
FDA website gives public access to information on devices with unique identifiers
The FDA has unveiled a website on which the public can find information submitted by firms for medtech products with unique ...Learn More
Medtronic gains expanded approval for surgical navigation tool
Medtronic's StealthStation surgical navigation device has been given an expanded indication by the FDA to include pediatric ...Learn More
Spine device from LinkSPINE gets FDA clearance
The FacetLINK, a device developed by LinkSPINE to stabilize the spine after microsurgical or midline decompression, has ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
510(k) Submissions Workshop
Oct. ...Learn More
If we do not plant knowledge when young, it will give us no shade when we are old.
Lord Chesterfield, ...Learn More
Funding round pulls in $24M for maker of prostate cancer ablation device
A private placement led by Cormark Securities and GMP Securities brought in $24 million for Profound Medical. ...Learn More
BioFire enters distribution partnership with LABSCO
LABSCO has struck a deal to exclusively distribute BioFire Diagnostics' FilmArray technology in some U.S. markets. ...Learn More
Spinout of spinal cord stimulation unit considered by Greatbatch
Spinal cord stimulation unit Algostim would become a publicly traded company under a plan being considered by Frisco, ...Learn More
EU orthopedic trauma device market being hurt by public tendering
An iData Research report found that the continued increase in public tendering in most European countries is causing a ...Learn More
Ortho Clinical names new board members
Thomas MacMahon, former chairman and CEO of Laboratory Corp. ...Learn More
ConvaTec promotes interim CEO to post
ConvaTec has appointed Paul Moraviec its CEO. ...Learn More
Agency awards nearly $810,000 to Canadian imaging firm
The Federal Economic Development Agency for Southern Ontario has awarded repayable funding of close to $810,000 to Exact ...Learn More
Nuclear medicine imaging market for SPECT, PET poised for growth, report says
An RnR Market Research report predicts the global nuclear medicine imaging market for SPECT and PET devices will hit $2.2 ...Learn More
EU competent authorities made fewer medtech reports in Q1
The medtech product reports exchanged between competent authorities in the European Union dropped 14% in the first quarter, ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
Life shrinks or expands according to one's courage.
Anais Nin, ...Learn More
Spinal Modulation to be acquired by St. Jude for $175M
St. ...Learn More
Novation enters distribution deal with Vascular Pathways
Novation has struck a deal to distribute Vascular Pathways' AccuCath, a line of intravascular catheters. ...Learn More
Misonix signs supply deal with third-party provider
MedAssets, a third-party supply chain management and procurement services provider, has signed a U.S. ...Learn More
Report: 4 firms accounted for 70% of orthopedic device market revenue in 2014
A Kalorama Information report identified Medtronic, Zimmer, Stryker and DePuy Synthes as the biggest makers of orthopedic ...Learn More
Stent graft from Medtronic shows positive results in study
The Endurant AAA, a stent graft system from Medtronic, demonstrated strong results in patients with abdominal aortic ...Learn More
Trial underway for Medtronic's renal denervation-cardiac ablation combo therapy
A 245-patient, multisite feasibility trial has been launched by Medtronic to assess the use of its Symplicity Spyral renal ...Learn More
U.S. patent issued to Sensory NeuroStimulation's restless legs syndrome device
The U.S. ...Learn More
FDA approves pregnancy blood test from Abbott
The FDA has granted Abbott approval for its i-STAT Total -hCG, a blood test that can determine the pregnancy status of ...Learn More
Spinal cord stimulation device from St. Jude gets FDA clearance
The Protege MRI system, an implantable spinal cord stimulation device from St. ...Learn More
EU approves coronary stent from Stentys
European regulators have granted Stentys CE mark approval for its Xposition S system, a sirolimus-eluting, self-apposing ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
A quarrel between friends, when made up, adds a new tie to friendship.
Francis de Sales, ...Learn More
Lawmakers move on 21st Century Cures bill
A revised draft of the 21st Century Cures bill was released by the Senate Energy and Commerce Committee's leaders on ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl on the revised discussion draft of the 21st Century Cures ...Learn More
Stock offering could bring in $30M for Alliqua
Alliqua Biomedical is hoping to secure $30 million in a public offering of almost 6.9 million shares. ...Learn More
Debt financing pulls in $26M for Lombard
A loan from Oxford Finance worth $26 million has been secured by Lombard Medical Technologies. ...Learn More
OpGen looks to raise $18.7M from IPO
OpGen, a molecular diagnostics firm based in Maryland, has filed plans to sell 2.5 million shares in an initial public ...Learn More
Molecular Dx segment drives Q2 revenue growth for Hologic
Hologic generated $655.5 million in revenue in the quarter ending March 28, compared with $625 million in the same period a ...Learn More
Brainlab, Boston Scientific partner on distribution deal
Boston Scientific and Brainlab have partnered on a distribution deal that will package the Vercise deep brain stimulation ...Learn More
Quadriceps muscle atrophy device from CyMedica debuts in U.S.
The CyMedica QB1 System, a post-operative knee brace and wrap designed to address quadriceps muscle atrophy, was launched in ...Learn More
Reintroduced bill to ease regulatory oversight of HIT tools
The Medical Electronic Data Technology Enhancement for Consumers' Health Act has been reintroduced in the Senate by Sens. ...Learn More
Timeline for FDA approval of bone graft pushed back by Wright Medical
Wright Medical has moved the timeline for the expected regulatory approval of its Augment bone graft from May to the second ...Learn More
Boston Scientific to pay nearly $119M to resolve transvaginal mesh cases
Boston Scientific agreed to pay about $119 million to settle 2,970 cases claiming that the firm's transvaginal mesh for ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
A quarrel between friends, when made up, adds a new tie to friendship.
Francis de Sales, ...Learn More
Intarcia gets $225M boost
An additional $225 million was raised by Intarcia Therapeutics in a debt funding round, bringing its total for the round to ...Learn More
Funding round pulls in $35M for Scanadu
A Series B financing round led by Fosun International brought in $35 million for Scanadu, a Mountain View, Calif., firm that ...Learn More
Bacterin's dermal allograft scores reimbursement win from Medicare contractor
Novitas Solutions, a Medicare Administrative Contractor, announced that it will cover the use of bioengineered skin ...Learn More
Q1 revenue rises for Fla. cancer genetics testing firm
NeoGenomics generated $23 million in revenue in the quarter ending March 31, up from $18.2 million during the same period ...Learn More
Drug-eluting stent from Boston Scientific shows positive results in trial
A 57-patient study showed promising results for Boston Scientific's Eluvia, a drug-eluting stent for treating peripheral ...Learn More
Study: Genetic tests help guide care for critically ill infants
Rapid genetic tests can give physicians diagnoses that help them make treatment decisions for critically ill infants and in ...Learn More
Volpara adds features to breast density solution
Upgraded VolparaDensity software has been released by Volpara Solutions. ...Learn More
Electroceuticals disrupt neuroscience
Small devices that modulate neural signals promise to upend neurologic medicine, panelists at the World Medical Innovation ...Learn More
Canada approves endoscopes from Strauss Surgical
Health Canada has given Florida-based Strauss Surgical approval to market its Optiks HD laser-welded endoscopes. ...Learn More
CryoLife resolves issues at Ga. facility
The FDA has issued a closeout letter clearing CryoLife's Kennesaw, Ga., facility after the agency found that CryoLife had ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Courage is fire, and bullying is smoke.
Benjamin Disraeli, prime minister and ...Learn More
Trial underway for Medtronic's stent graft system
A 140-patient clinical study has been launched by Medtronic to assess the effectiveness and safety of its Endurant Evo AAA, ...Learn More
IPO could pull in as much as $69M for Calif. surgical lighting firm
An initial public offering has been filed by Invuity with the goal of securing as much as $69 million. ...Learn More
Investor funding brings in $5M for Amarantus
Amarantus BioScience Holdings, which specializes in developing tests and treatments for ophthalmologic, psychiatric and ...Learn More
Voden Medical enters distribution partnership with Linkage Biosciences
Voden Medical Instruments has struck a deal to distribute Linkage Biosciences' genetic tests. ...Learn More
Covance acquisition drives Q1 revenue growth for LabCorp
Laboratory Corp. ...Learn More
Shoulder arthropathy device from FH Orthopedics gets FDA clearance
The Arrow, a reverse shoulder long keel glenoid base plate from French medtech firm FH Orthopedics, has received 510(k) ...Learn More
Raiing Medical unveils smartphone-connected thermometer
Raiing Medical has designed an adhesive temperature monitor and smartphone app that could be used by parents to monitor the ...Learn More
EU approves burn treatment tool from Avita Medical
European regulators have granted Avita Medical CE mark approval for its ReCell, a second-generation device intended for burn ...Learn More
Brazil OKs stent embolic protection technology from InspireMD
The MGuard Prime, a stent embolic protection device from InspireMD, has obtained approval from Brazilian regulators. ...Learn More
FDA labels Maquet's cardiac closure device recall as Class I
A recall involving Maquet Cardiovascular's TigerPaw II, a device intended to occlude the left atrial appendage of the heart ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...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
The world breaks everyone and afterward many are strong at the broken places.
Ernest Hemingway, ...Learn More
Senate proposal would expedite breakthrough medtech approval
A bill introduced by Sen. Richard Burr, R-N.C., would establish an FDA fast-track program for novel medical devices. ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl commending Sens. ...Learn More
Calif. firm takes in $3M in debt financing
A debt funding round has pulled in $3 million for Gynesonics. ...Learn More
Natera's blood-based prenatal test available in Canada
Natera has struck a deal with LifeLabs Medical Laboratory Services in which the lab will offer Natera's Panorama blood-based ...Learn More
Sanofi, Ypsomed enter injection system development deal
Ypsomed Group, a Swiss-based firm, has struck a deal to produce components for injection pens to be used in French drugmaker ...Learn More
Study shows positive results for Misonix's chronic wound device
Misonix's SonicOne OR, an ultrasonic debridement device, was associated with 42% less blood loss than standard debridement ...Learn More
Study to assess effectiveness of telerobotic ultrasound imaging technology
A study was launched by the Icahn School of Medicine at Mount Sinai with Rush University Medical Center to assess whether ...Learn More
VuCOMP seeks FDA approval for breast tomosynthesis software
VuCOMP is seeking premarket approval for its breast tomosynthesis computer-aided detection software. ...Learn More
Blood glucose monitor from Nipro Diagnostics gets FDA clearance
The True Metrix Air, a device developed by Nipro Diagnostics to read and evaluate blood glucose levels, has received 510(k) ...Learn More
FDA could approve Edwards Lifesciences' replacement heart valve in 2015
The Sapien 3 implant, a next-generation transcatheter aortic valve from Edwards Lifesciences, could get FDA approval this ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
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May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
The possible's slow fuse is lit by the imagination.
Emily Dickinson, ...Learn More
Senate subcommittee holds hearing on medical device tax
A hearing to consider repealing the 2.3% tax on medical devices was convened Thursday by the Senate Finance Committee's ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl on the Senate subcommittee hearing on possible repeal of the ...Learn More
Funding round brings in $18.5M for Spirox
Spirox has raised $18.5 million in a Series B financing round led by Aisling Capital and Venrock. ...Learn More
Maker of genetic tests enters distribution agreements in Thailand, Israel
Deals have been struck by Courtagen Life Sciences in Thailand and Israel for distribution of its next-generation sequencing ...Learn More
Developer of rapid blood assay receives $2.3M boost
Miroculus has secured $2.3 million in the first tranche of seed financing. ...Learn More
Clinical business drives Q1 revenue growth for Cepheid
Cepheid generated $132.6 million in revenue in the quarter ending March 31, up from $106.9 million generated in the same ...Learn More
Guidance for accepting medtech data from foreign trials unveiled by FDA
The FDA has issued guidelines on the criteria for accepting data from clinical trials conducted overseas for use in medtech ...Learn More
FDA clears digital radiography system from Rayence
The RU-3000, a universal digital radiography system from Rayence, has received 510(k) clearance from the FDA. ...Learn More
FDA OKs tomosynthesis option for Siemens Healthcare's mammography device
A digital breast tomosynthesis add-on to Siemens Healthcare’s Mammomat Inspiration technology has been approved by the ...Learn More
Interbody devices from Meditech Spine cleared by FDA
The next generation of Meditech Spine's Talos line of cervical intervertebral fusion devices has received 510(k) clearance ...Learn More
FDA approves prosthetic penile device from Coloplast
The FDA has granted Coloplast approval for the use of its Titan Inflatable Penile Prosthesis in ectopic reservoir placement. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Only a man who knows what it is like to be defeated can reach down to the bottom of his soul and come up with the extra ounce of power it takes to win when the match is even.
Muhammad Ali, ...Learn More
Some Biomet, Zimmer EU products to be acquired by Lima
A deal has been struck by Lima Corporate to acquire some products by Zimmer and Biomet in certain markets after the two ...Learn More
Collaboration aims to develop assays for immunity detection
Toronto-based molecular diagnostics firm Axela is partnering with Pathology Associates Medical Laboratories to develop ...Learn More
Biodesix's proteomic test scores reimbursement win from CareFirst
An agreement announced Wednesday between CareFirst Blue Cross Blue Shield and Biodesix will make Biodesix's VeriStrat ...Learn More
Q1 sales increase for Stryker
Stryker posted a 3.2% increase in consolidated net sales in the first quarter over the same period last year. ...Learn More
Green resigns CEO, president, board chair roles at Harvard Apparatus
David Green has stepped down as president, CEO and chairman of the board at Harvard Apparatus Regenerative Technology but ...Learn More
Drug-device combo targets prostate cancer
Swedish drugmaker LIDDS is negotiating with a manufacturer to produce a drug-device combination that could be a potential ...Learn More
Epilepsy device from Natus Medical cleared by FDA
The FDA has granted Natus Medical 510(k) clearance for its Quantum, an amplifier designed to monitor epilepsy and seizure. ...Learn More
EU expands approval for Medtronic's deep-brain stimulation tools
European regulators have given expanded approval to Medtronic to allow patients implanted with the company's MRI-safe Activa ...Learn More
Group B strep test from Great Basin Scientific scores FDA clearance
A molecular test developed by Great Basin Scientific for diagnosing group B streptococcus bacteria has received 510(k) ...Learn More
Agilent unit resolves issues at Danish plant
The FDA has issued a closeout letter clearing Dako Denmark, a unit of Agilent Technologies. ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...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
He can who thinks he can, and he can't who thinks he can't. This is an inexorable, indisputable law.
Orison Marden, ...Learn More
Study underway for Medtronic's stent graft technology
A 24-patient feasibility study has been launched by Medtronic to assess the effectiveness and safety of its Valiant Mona, an ...Learn More
Boston firm gains $14M in Series B financing
A Series B funding round has brought in $14 million for Tal Medical. ...Learn More
Metamark's urology Dx tools score reimbursement win from Highmark Blue Shield
An agreement announced Tuesday between Highmark Blue Shield and Metamark will make Metamark's prognostic and diagnostic ...Learn More
Sequencing products drive Q1 revenue growth for Illumina
Illumina generated $538.6 million in revenue in the first quarter, up from the $420.8 million generated in the same period ...Learn More
Vietnamese installation of linear accelerator reported by Varian
Vinmec International Hospital in Vietnam has installed a unit of Varian Medical Systems' Clinac iX, a medical linear ...Learn More
Report: Worldwide orthobiologics market could reach $7.9B by 2019
A MicroMarketMonitor report predicts the worldwide market for orthobiologics will hit $7.9 billion by 2019, with a 6.7% ...Learn More
EU approves 4 Dx tests from Invivoscribe
European regulators have granted Invivoscribe Technologies CE mark approval for its four LymphoTrack Dx next-generation ...Learn More
Alcyone Lifesciences' neuro-ventricular device cleared by FDA
The FDA has granted Alcyone Lifesciences 510(k) clearance for its MEMS Cannula, a neuro-ventricular system designed to treat ...Learn More
FDA clears smaller Diamondback 360 system from Cardiovascular Systems
A smaller version of Cardiovascular Systems' Diamondback 360, a technology designed to treat peripheral artery disease, has ...Learn More
Aneurysm device recommendations released by FDA panel
Recommendations including five years of postmarket monitoring and one year of premarket study have been issued by the FDA's ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Every man must do two things alone: He must do his own believing and his own dying.
Martin Luther, ...Learn More
St. Jude Medical to buy Spinal Modulation for $175M
St. ...Learn More
Baltimore medtech firm takes in over $2.9M in debt financing
A debt funding round involving some 30 investors has pulled in more than $2.9 million for CSA Medical. ...Learn More
Molecular Dx firm enters distribution deals in Middle East, Italy
Curetis, a German molecular diagnostics company, has struck distribution deals in the Middle East and Italy for its Unyvero, ...Learn More
Hurel enters partnership with Optivia Biotechnology
Hurel, a North Brunswick, N.J., cell-based test company, has entered into a marketing and technology collaboration with ...Learn More
Getinge's sales rise in Q1
Getinge posted a 19% increase in year-over-year sales in the first quarter, bringing in $775 million. ...Learn More
EU patent covering silver coating system issued to aap Implantate
A European patent has been secured by aap Implantate for its silver coating technology designed for medical implants as well ...Learn More
Emergency cannula from CardiacAssist approved by EU
European regulators have granted CardiacAssist CE mark approval for its PROTEK Duo, a minimally invasive emergency cannula ...Learn More
House bill would roll back medical device tax
Rep. Alma Adams, D-N.C., has introduced a bill that would repeal the 2.3% excise tax on medical devices. ...Learn More
FDA approves 2 defibrillators from Biotronik
The FDA has granted Biotronik approval for its Inventra DX, an implantable, ultra-high-energy cardioverter defibrillator. ...Learn More
U.S., Canadian regulators approve picosecond laser for treating pigmented lesions
The FDA has granted Syneron Candela expanded approval for its PicoWay, a picosecond laser previously approved for use in ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22 | Washington, D.C. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
We all need people who will give us feedback. That's how we improve.
Bill Gates, businessman and ...Learn More
Trial underway for Boston Scientific's renal denervation device
A 100-patient, multisite study has been launched by Boston Scientific to test the efficacy of Vessix, its renal denervation ...Learn More
Avera Health, Theranostics expand proteomic panel deal
Theranostics Health has entered into an expanded commercial and development deal with South Dakota-based Avera Health for ...Learn More
University enters colon cancer Dx technology deal with DiaCarta
The University of Potsdam in Germany has agreed to license its noninvasive method of diagnosing colon cancer to Hayward, ...Learn More
OpGen appoints 2 new execs
Kevin Krenitsky, who previously served as chief commercial officer at Foundation Medicine, has been tapped to serve as ...Learn More
Arteriovenous graft from Vascular Flow shows positive results in trial
A European study showed promising results for Vascular Flow Technologies' Spiral Flow, an arteriovenous graft that copies ...Learn More
Sunshine Heart asked to adjust protocol for heart device trial
The FDA has asked Sunshine Heart to make changes to its protocols for the multisite study of its C-Pulse, a heart failure ...Learn More
Cell-based analysis system from Fluxion debuts in U.S.
The IsoFlux EMT enrichment system, an instrument designed to separate rare circulating tumor cells from samples of blood, ...Learn More
Taiwan to implement changes to medtech registration, approval
Changes to the registration and approval of medtech products are to be enforced by Taiwanese regulators starting July 1. ...Learn More
Presbyopia device from AcuFocus lands FDA nod
The Kamra inlay system, a corneal implant developed by AcuFocus to enhance vision in patients suffering from presbyopia, has ...Learn More
Abbott's OTC glucose monitor approved by FDA
The FDA has granted Abbott Laboratories approval for its FreeStyle Precision Neo, an over-the-counter tool designed to ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
There's only one corner of the universe you can be certain of improving, and that's your own self.
Aldous Huxley, ...Learn More
Sanford Health signs stent graft technology deal with Medtronic
Sanford Health has agreed to license its stent graft system, a technology that treats thoracoabdominal aortic aneurysms, to ...Learn More
Funding round pulls in $9.6M for Ortho Kinematics
A Series C equity funding round has brought in $9.6 million for health care diagnostics firm Ortho Kinematics. ...Learn More
Masimo's oximetry tool to be part of CapsuleTech's patient monitoring system
A partnership was formed between CapsuleTech and Masimo to incorporate the latter's SET Measure-through Motion and Low ...Learn More
Q4 revenue increases for Transgenomic
Transgenomic generated $7.7 million in revenue in the quarter ending Dec. ...Learn More
Researchers working on cellphone-based malaria diagnostics
A rapid-response, cellphone-based diagnostic test for malaria is being developed by researchers from Michigan State ...Learn More
SpineFrontier's device used in anterior cervical disc fusion in Va.
A patient with cervical stenosis and cervical spinal spondylolis at Newport News-based Bon Secours Mary Immaculate Hospital ...Learn More
Group A strep test from Focus Diagnostics scores FDA clearance
The Simplexa Group A Strep Direct, a PCR test developed by Focus Diagnostics, received 510(k) clearance from the FDA. ...Learn More
EU approves HIV-1 assay from Cepheid
The Xpert HIV-1 Qual, a qualitative HIV-1 test developed by Cepheid for early diagnosis in infants and individuals who are ...Learn More
CAS Medical Systems gains expanded FDA approval for oximeter
The FDA has granted CAS Medical Systems expanded labeling approval for its Fore-Sight Elite tissue oximeter to include ...Learn More
Cervical cancer test from Cancer Genetics lands conditional OK in N.Y.
The New York State Department of Health has given Cancer Genetics conditional licensure to expand its push for wider use of ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, 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
If you are irritated by every rub, how will your mirror be polished?
Rumi, poet and ...Learn More
Ortho Kinematics gains nearly $10M in Series C financing
Austin, Texas-based Ortho Kinematics has obtained almost $10 million in a Series C funding round that includes Medtronic as ...Learn More
Novation enters group purchasing deal with RTI Surgical
Novation, a health care group purchasing organization, has struck a deal giving its more than 100,000 members access to RTI ...Learn More
Frankenman, Boston Scientific enter endoscopic products development deal
Boston Scientific said it has struck a strategic partnership with Frankenman Medical Equipment to develop and produce ...Learn More
Analysis: U.S. market for biocompatible materials to hit $5.5B in 2018
An analysis by ReportBuyer predicts the biocompatible materials market in the U.S. ...Learn More
Nihon Kohden America appoints new CEO
Dr. Constantine Wilson has been promoted from chief operating officer to CEO of Irvine, Calif.-based Nihon Kohden America. ...Learn More
Shoulder fracture cage from Conventus scores FDA clearance
The PH Cage, a shoulder fracture cage developed by Conventus Orthopaedics that expands within the bone, has received 510(k) ...Learn More
BioFire files de novo submission for encephalitis, meningitis Dx panel
BioMerieux unit BioFire has filed a de novo submission with the FDA for its FilmArray Meningitis/Encephalitis Panel. ...Learn More
EU approves robotic PAD catheter from Hansen
European regulators have granted Hansen Medical CE mark approval for its 10-French Magellan, a robotic catheter designed to ...Learn More
EU approves HCV viral load test from Cepheid
The Xpert HCV Viral Load, a test developed by Cepheid to confirm and monitor hepatitis C virus infection, has received the ...Learn More
Perseon gains expanded FDA approval for ablation device
The FDA has granted Perseon expanded approval for its MicroThermX microwave ablation technology, which previously was ...Learn More
FDA Submissions Strategy Workshop
June 23-24AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and execution ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Fear defeats more people than any other one thing in the world.
Ralph Waldo Emerson, ...Learn More
Cyberonics-Sorin deal approved by U.S. regulators
The pending all-stock merger of Cyberonics with Italy's Sorin Group for $1.4 billion has received approval from antitrust ...Learn More
Termination date for Zimmer-Biomet deal extended to July 23
The termination date for Zimmer Holdings' pending merger with Biomet for $13.4 billion has been moved from April 24 to July ...Learn More
Funding round brings in $3.3M for U.K.-based firm
A Series A financing round pulled in $3.3 million for Congenica. ...Learn More
Equity funding round pulls in $2.3M for Novacyt
A private equity placement brought in $2.3 million for Paris-based Novacyt. ...Learn More
Certified public accountant named CFO of Tegra Medical
Craig Campbell, a certified public accountant with almost 25 years of finance and accounting experience, was tapped to serve ...Learn More
Helius gets FDA nod to begin trial enrollment for brain stimulator device
The FDA has given Helius Medical approval to enroll patients with chronic balance problems caused by mild to moderate injury ...Learn More
Anterior lumbar retractor from TeDan Surgical debuts in U.S.
The Phantom AL Retractor System, a device intended to provide better visualization during anterior lumbar interbody fusion ...Learn More
EU approves transcatheter pacing technology from Medtronic
European regulators have granted Medtronic CE mark approval for its Micra device, a leadless transcatheter pacing system. ...Learn More
IDE application for bone scaffold submitted by Anika Therapeutics
An investigational device exemption application has been filed with the FDA by Anika Therapeutics to begin a late-stage ...Learn More
Waters instrument approved for in vitro Dx use in China
Waters' Acquity UPLC I-Class IVD/Xevo TQ-S IVD LC-MS technology was approved by China's Food and Drug Administration for use ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...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
Have patience. All things are difficult before they become easy.
Saadi, ...Learn More
J&J unit, Ichor Medical collaborate on hepatitis B drug-device combo
San Diego-based Ichor Medical Systems has entered into a licensing and development deal with Janssen Pharmaceuticals, a unit ...Learn More
Funding round brings in $15M for ReCor Medical
A Series D financing round led by Otsuka Holdings pulled in $15 million for ReCor Medical. ...Learn More
Funding round brings in $1.5M for Israel-based firm
A funding round pulled in $1.5 million for Leviticus Cardio. ...Learn More
Maker of cancer-screening technology bought by Roche
Roche Holding has agreed to pay an undisclosed sum to buy CAPP Medical, a California-based firm that has developed a system ...Learn More
Firm wins $1.5M grant for HIV/AIDS assay
The NIH awarded Rheonix a phase II grant worth $1.5 million under its Small Business Innovation Research program to continue ...Learn More
EverGene, Affymetrix to team up in genotyping service deal in Japan
A deal was reached between Affymetrix and EverGene to cooperate on a personal genomics service in Japan. ...Learn More
Bone fracture device from IlluminOss shows positive results in study
Research in the Journal of Biomedical Materials Research Part B: Applied Biomaterials showed promising results for ...Learn More
Smartphone-enabled device shows promise in detecting cancer
A study in the Proceedings of the National Academy of Sciences describes a device that could be used along with smartphones ...Learn More
FDA grants breakthrough status to peanut allergy patch
The Viaskin Peanut, an electrostatic patch developed by DBV Technologies, has obtained breakthrough designation as a ...Learn More
FDA labels Intuitive Surgical's drapes recall as Class II
A recall initiated by Intuitive Surgical involving about 440,000 Microtek Medical drapes has been labeled Class II by the ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Vanity and pride are different things, though the words are often used synonymously. A person may be proud without being vain. Pride relates more to our opinion of ourselves, vanity to what we would have others think of us.
Jane Austen, ...Learn More
Funding round brings in $20M for EBR Systems
A financing round involving former Medtronic executive Stephen Mahle has pulled in $20 million for EBR Systems. ...Learn More
AngioDynamics gains license for EmboMedics' microspheres
EmboMedics has agreed to license its resorbable microspheres to AndioDynamics, a Latham, N.Y.-based firm, for $11 million. ...Learn More
Improved sales productivity drives Q1 revenue growth for Bacterin
Bacterin generated between $9.4 million and $9.5 million in total net revenue in the first quarter, a 5% to 7% increase over ...Learn More
Q4 sales jump for molecular imaging firm
Advanced Accelerator Applications generated $24.6 million in sales for the fourth quarter of 2014, compared with $18.6 ...Learn More
Finance veteran named CFO of Cepheid
Ilan Daskal, who has over 20 years of experience in finance, has been tapped to serve as the CFO of Cepheid. ...Learn More
Trial enrollment for Vertos Medical's back pain treatment completed
Vertos Medical has completed patient enrollment for a multisite, randomized and controlled trial of its minimally invasive ...Learn More
HemCon wins approval for wound care products in China
Chinese regulators have granted Portland, Ore.-based HemCon Medical Technologies approval to market its entire wound care ...Learn More
Senate hearings on repealing medical device tax planned
Hearings on repealing the 2.3% tax on medical devices could happen in the Senate Finance Committee in the near future. ...Learn More
FDA approves study of CardiAQ's mitral valve implant
CardiAQ Valve Technologies has received an investigational device exemption from the FDA to conduct an early feasibility ...Learn More
Medtech price control order endorsed in India
India's Task Force on Medical Devices has endorsed the inclusion of medical devices in the Essential Commodities Act and ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Iron rusts from disuse; water loses its purity from stagnation ... even so does inaction sap the vigor of the mind.
Leonardo da Vinci, artist and ...Learn More
Final guidance for expedited medtech approval unveiled by FDA
The FDA has issued final guidelines on policies designed to expedite the approval of medtech products for irreversibly ...Learn More
Molecular Dx lab acquired by Rosetta in $2M deal
Rosetta has agreed to pay $2 million in cash plus 500,000 ordinary shares to buy PersonalizeDx, a molecular diagnostics ...Learn More
Report: Orthobiologics market in North America to reach $2.4M by 2019
A MicroMarketMonitor report predicts the North American market for orthobiologics will hit $2.4 million by 2019, with a 7.7% ...Learn More
Q1 revenue increases for SpineGuard
SpineGuard posted a 47% increase in year-over-year revenue during the first quarter, driven by the higher sales of its ...Learn More
Company veteran named chief scientific officer of Osiris
Alla Danilkovitch has been appointed chief scientific officer of Osiris Therapeutics, a company focused on regenerative ...Learn More
FDA clears IV monitoring tool from Va. firm
The FDA has given ivWatch 510(k) clearance to market the ivWatch Model 400, a device that can spot adverse extravasation and ...Learn More
Directional atherectomy tool from Medtronic debuts in U.S.
The HawkOne, a directional atherectomy system developed to address extremely calcified lesions in lower extremities' blood ...Learn More
Firm seeks humanitarian exemption for biofiltration system
The FDA has been asked by Aethlon Medical to grant its Hemopurifier biofiltration system a humanitarian device exemption ...Learn More
EU approves Sophia Genetics' tool to detect BRCA gene variations
European regulators have granted Sophia Genetics the CE-IVD mark for its device that can diagnose copy number variations in ...Learn More
Canada approves heart pump from HeartWare
Health Canada has given Massachusetts-based HeartWare the go-ahead to market its implantable left ventricular assist device ...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
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Each man must look to himself to teach him the meaning of life. It is not something discovered; it is something molded.
Antoine de Saint-Exupery, ...Learn More
Stakeholders debate merits of speeding up regulatory review of devices, drugs
Former FDA Commissioner Margaret Hamburg has raised concerns about congressional efforts to speed up the drug and medical ...Learn More
Debt funding round nets $7.5M for DxTerity
Debt financing from SWK Funding will bring in as much as $7.5 million for DxTerity Diagnostics. ...Learn More
Atlas eyes $5M in financing to monetize spinal implant systems
Atlas Spine is hoping to raise $5 million in a Series B funding round involving OfferBoard Securities. ...Learn More
Microbiome, Biocartis team up in rapid blood assay deal
A global partnership deal was reached between Microbiome and Biocartis to develop a polymerase chain reaction-based rapid ...Learn More
2 Japanese medtech firms widen gastroenterology, urology deal in U.S.
Japanese device-makers Olympus and Terumo have completed a deal to broaden their business partnership in the U.S. ...Learn More
DARPA backs development of blood-sampling device
The Defense Advanced Research Projects Agency awarded Tasso and its partner GenTegra a grant worth $2.9 million to advance ...Learn More
Biotronik records first U.S. patient implanted with pacemaker system
A patient at Lenox Hill Hospital in New York was the first in the U.S. ...Learn More
FDA OKs diabetic retinal screening software
Intelligent Retinal Imaging Systems, software that is used for retinal screening, has obtained FDA clearance to screen for ...Learn More
Surgical navigation tool from Synaptive Medical scores FDA clearance
The FDA has granted Synaptive Medical clearance for its BrightMatter Guide, a surgical navigation system for use during ...Learn More
Ablation tool from Perseon gets FDA nod
The MicroThermX, a microwave ablation device from Perseon, has received 510(k) clearance from the FDA. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...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
Never be bullied into silence. Never allow yourself to be made a victim. Accept no one's definition of your life; define yourself.
Harvey Fierstein, actor and ...Learn More
Trial underway for Medtronic's ablation device
A one-year, 1,000-patient registry study was launched by Medtronic to test the use of its Gold device, a pulmonary vein ...Learn More
Equity funding round pulls in more than $5M for Minn. firm
A private equity offering has brought in over $5 million for Pursuit Vascular, according to a recent regulatory filing. ...Learn More
N.J. molecular Dx firm obtains funding boost
A Series A funding round led by Prime Value Capital Management has brought in an undisclosed sum for Admera Health. ...Learn More
South Korean firm launches U.S. division in Calif.
Seegene Technologies, the U.S. subsidiary of South Korean firm Seegene, has opened in Concord, Calif. ...Learn More
Study to look at health care apps and devices for seniors
AARP announced plans to collaborate with Pfizer and UnitedHealthcare on an initiative to determine how people ages 50 and ...Learn More
Video system monitors vital signs using skin color changes
Rice University researchers have developed DistancePPG, a video system to measure pulse and breathing rate by analyzing ...Learn More
Advanced Breath Diagnostics' gastroparesis test lands FDA nod
The FDA has granted Brentwood, Tenn.-based Advanced Breath Diagnostics approval to market its Gastric Emptying Breath Test, ...Learn More
ReShape allowed to bypass FDA advisory panel meeting for weight-loss device
A requirement that would have ReShape Medical attend an advisory committee meeting for the premarket approval filing of its ...Learn More
Hospira receives FDA warning over manufacturing practices at Italian plant
The FDA has issued a warning letter to Hospira over manufacturing practice violations at its facility in Liscate, Italy. ...Learn More
FDA labels Zimmer's knee implant recall as Class II
A recall initiated by Zimmer involving 11,658 Persona Trabecular Metal Tibial Plate knee implants has been labeled Class II ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
FDA Submissions Strategy Workshop
June 23-24AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and execution ...Learn More
Indecision and delay are the parents of failure.
George Canning, ...Learn More
Funding round brings in $55.5M for Natera
Natera has obtained $55.5 million in a private financing round led by Sofinnova Ventures. ...Learn More
IPO could pull in up to $35.2M for microbial genetics analysis firm
OpGen filed plans Monday with the U.S. ...Learn More
Dentistry school receives grant to develop test for HIV antibodies, viral RNA
Researchers from New York University College of Dentistry have been awarded a $335,000 grant from the National Institutes of ...Learn More
Report: Worldwide nonfusion spinal device market poised for growth
A Medical Market Research report forecasts the worldwide market for nonfusion spinal devices will grow through 2019. ...Learn More
Cogentix to move production facility to Westborough, Mass.
Cogentix Medical said it intends to transfer its manufacturing plant in Natick, Mass., to a 24,400-square-foot facility in ...Learn More
U.S. patent covering bone matrixes issued to Bacterin
Bacterin has secured a U.S. patent for some demineralized bone matrixes in its OsteoSponge devices. ...Learn More
FDA clears surgical hydrogel from Augmenix
The FDA has granted Augmenix clearance for its SpaceOAR hydrogel system under the agency's de novo program. ...Learn More
Ethicon gains expanded FDA approval for surgical sealant patch
The FDA has granted Ethicon expanded approval for its Evarrest, a fibrin sealant patch previously approved as an adjunct ...Learn More
Blood glucose monitor from Abbott approved by Indian regulators
Indian regulators have granted Abbott approval for its FreeStyle Libre Pro Flash, a wearable sensor device that can monitor ...Learn More
China clears Cytori to market regenerative cell technology
Cytori Therapeutics' Celution System has obtained clearance from Chinese regulators. ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Just remember, once you're over the hill you begin to pick up speed.
Charles Schulz, ...Learn More
Medtronic reports positive trial results for peripheral stent
A 287-patient, three-year multisite study showed promising results for Medtronic's EverFlex, a self-expanding nitinol stent ...Learn More
Medtronic gains license for artificial pancreas technology
DreaMed Diabetes, a medtech firm in Israel, has agreed to license its GlucoSitter artificial pancreas system to Medtronic. ...Learn More
Former Hologic executive joins Royal Philips as global imaging CEO
Rob Cascella has been tapped to serve as CEO of Royal Philips' global diagnostic imaging business. ...Learn More
World Institute of Pain founder named to Stimwave's medical advisory board
Dr. ...Learn More
Wearable defibrillator from Zoll shows positive results in study
A study in the journal Heart Rhythm showed promising results for Zoll Medical's LifeVest, a cost-effective, wearable ...Learn More
Immunexpress develops rapid diagnostic test for sepsis
Immunexpress has developed a diagnostic tool that can screen for sepsis in just an hour. ...Learn More
Idaho firm designs smartphone-based autism diagnosis tool
Behavior Imaging's new app, Naturalistic Observation Diagnostic Assessment, can speed up the diagnosis of children who are ...Learn More
Microbial ID tool from Bruker scores FDA clearance
An expanded variant of the MALDI Biotyper, a clinical microbiology technology developed by Bruker, has received 510(k) ...Learn More
Medtronic agrees to pay $4.4M to settle spinal surgery device lawsuit
Medtronic has reached a $4.4 million settlement deal with the federal government to resolve a lawsuit accusing the firm of ...Learn More
FDA labels Philips' CT scanner recall as Class II
A recall initiated by Philips Healthcare involving 424 CT scanners has been labeled as Class II by the FDA. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Technical Writing for Regulatory Submissions
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Ill habits gather by unseen degrees, as brooks make rivers, rivers run to seas.
Ovid, ...Learn More
Dutch diabetes clinic and research center acquired by Medtronic
Medtronic has purchased Diabeter, a Dutch clinic and research facility for diabetes patients, for undisclosed terms. ...Learn More
Roche's bid to buy majority stake in cancer Dx firm gets shareholder OK
Roche's plan to acquire a majority stake in Foundation Medicine, a cancer molecular diagnostics company based in Cambridge, ...Learn More
Miracor widens U.K. presence with new sales office, 2 heart device trials
Miracor Medical Systems, the Austrian maker of the PICSO impulse system, has opened a new sales unit in Manchester, England. ...Learn More
Firm wins $1.5M grant for antibiotic-resistant TB test
The NIH awarded InSilixa a phase II grant worth $1.5 million under its Small Business Innovation Research program for the ...Learn More
Report: Surgical microscope market to hit $806.6M by 2020
A MarketsandMarkets report predicts the market for surgical microscopes will be worth $806.6 million by 2020, with a ...Learn More
Report: Worldwide hip implant market poised for growth
A Medical Market Research report forecasts the worldwide hip implant market will see a 2.98% compound annual growth rate ...Learn More
FDA expands approval of AirStrip fetal, maternal monitoring kit
A second FDA clearance was granted to AirStrip for its wireless maternal and fetal monitoring kit, Sense4Baby. ...Learn More
Group A strep test from Alere scores FDA clearance
The i Strep A molecular test, developed by Alere, has received 510(k) clearance from the FDA. ...Learn More
Heart valve from On-X Life gets OK on expanded label from FDA
The FDA has granted On-X Life Technologies expanded labeling approval for its aortic heart valve to include reduced ...Learn More
EU approves home dialysis system from Baxter
European regulators have granted Baxter International CE mark approval for its HomeChoice Claria, a home peritoneal dialysis ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, 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
Honest disagreement is often a good sign of progress.
Mahatma Gandhi, social ...Learn More
Maker of biliary devices acquired by Boston Scientific in $62.5M deal
Boston Scientific has agreed to pay $62.5 million upfront to acquire Mountain View, Calif.-based Xlumena and its Hot Axios ...Learn More
Vision-Sciences concludes merger with Uroplasty to form Cogentix
The merger combining Vision-Sciences and Uroplasty into Cogentix Medical was completed Wednesday. ...Learn More
Deal gives Orthofix option to buy migraine-device firm
Orthofix has struck a deal that includes an 18-month option to purchase eNeura and its SpringTMS, an FDA-approved device ...Learn More
Funding round brings in $3.4M for Boston-based Dx firm
A private placement pulled in $3.4 million for MetaStat. ...Learn More
Higher test volume drives Q4 revenue growth for GeneNews
GeneNews generated $557,457 in revenue in the quarter ending Dec. ...Learn More
Studies underway for Luminex's Aries diagnostic platform, HSV assay
Luminex has begun its clinical trials for the Aries molecular diagnostics system, a lower-throughput sample-to-answer ...Learn More
Bone fixation device from BioMedical Enterprises debuts
The Speed Titan, a nitinol-based bone fixation system, has been launched by BioMedical Enterprises. ...Learn More
FDA meeting to discuss computer modeling's use in medtech development
The use of computational modeling and simulation strategies in medical device evaluation and development will be discussed ...Learn More
Upgrades for Lensar's cataract laser device cleared by FDA
Streamline, the collective name for Lensar's five new application technologies for its Lensar Laser System, has received ...Learn More
New York Genome Center gets OK to offer clinical exome tests in state
The New York State Department of Health has granted the New York Genome Center approval to offer its clinical exome test in ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Attach yourself to those who advise you rather than praise you.
Nicolas Boileau-Despreaux, poet and literary ...Learn More
Medtronic's heart valve obtains wider approval from FDA
The FDA has granted Medtronic expanded approval for use of its CoreValve system, a transcatheter aortic valve-replacement ...Learn More
DePuy gains exclusive rights to market Radlink's imaging system
A global sales deal has been struck between DePuy Synthes and Radlink to allow DePuy to exclusively market Radlink's Galileo ...Learn More
Quest Diagnostics forms joint venture with contract research firm
A joint venture was formed that will merge the clinical trial laboratory businesses of Quest Diagnostics and Quintiles ...Learn More
Stryker to build center of excellence in Ireland
Stryker is planning to set up an international center of excellence in Cork, Ireland. ...Learn More
Q3 net sales show growth for Orthofix
Orthofix generated $101 million in net sales during the company's fiscal year 2014 third quarter, which is an increase of ...Learn More
Former executive at Analogic joins Insulet as CFO
Michael Levitz has been tapped to serve as chief financial officer at Insulet. ...Learn More
Hansen enters partnership with China National Medical Device
Hansen Medical has entered into a distribution deal with China National Medical Device for its Magellan surgical robot ...Learn More
Tenn. firm enters distribution deals with 25-plus global partners
Knoxville, Tenn., firm EDP Biotech has struck deals with over 25 distribution partners in South America, Asia and Europe ...Learn More
SynCardia gets FDA OK to launch study of heart failure device
SynCardia Systems has received an investigational device exemption from the FDA to conduct a trial to evaluate the use of ...Learn More
China clears Hangzhou Berry Genomics to market prenatal test
The NextSeq CN500, a noninvasive prenatal test developed by Hangzhou Berry Genomics, has obtained premarket clearance from ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
To praise is an investment in happiness.
George Adams, newspaper ...Learn More
Zimmer-Biomet deal approved by EU regulators
The pending merger of Zimmer Holdings with Biomet for $13 billion has received approval from antitrust regulators in Europe. ...Learn More
Merger of Vision-Sciences, Uroplasty gets shareholder approval
Shareholders approved an all-stock merger combining Uroplasty and Vision-Sciences into Cogentix Medical. ...Learn More
Exact Sciences' colorectal cancer test scores reimbursement win from Tufts Health
The use of Exact Sciences' Cologuard, a noninvasive stool-based test that screens for colorectal cancer markers, will be ...Learn More
Funding round brings in nearly $1.27M for Saphena Medical
Saphena Medical has raised almost $1.27 million via a Series B preferred stock sale, bringing the company closer to its $3 ...Learn More
Novation enters group purchasing deal with Benvenue
Novation, a health care group purchasing organization, has struck a deal giving its more than 100,000 members access to ...Learn More
External fixation device from Zimmer debuts in U.S.
The XtraFix, a modular instrument that facilitates external fixation procedures, was launched by Zimmer. ...Learn More
D-Eye unveils smartphone-connected retinal imaging device
D-Eye has unveiled a new system designed to be affixed to a smartphone to capture high-resolution retinal images and videos. ...Learn More
Insulin management system from Medtronic approved in U.K.
The U.K. ...Learn More
Mass spectrometry tool from Thermo Fisher submitted to FDA as Class I device
The Prelude LX-4 MD HPLC, a mass spectrometry instrument, has been registered by Thermo Fisher Scientific with the FDA as a ...Learn More
Heart valve from Medtronic wins approval in Japan
Japanese regulators have given Medtronic approval to market its CoreValve, a transcatheter aortic valve-replacement device, ...Learn More
FDA Submissions Strategy Workshop
June 23-24AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and execution ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
The most common way people give up their power is by thinking they don't have any.
Alice Walker, ...Learn More
Pentagon extends supply contract with Royal Philips for $77.2M
The Defense Department has renewed its contract with Royal Philips for the sixth one-year option on a nine-year deal, for an ...Learn More
J&J partners with Google to develop surgical robots
Google and Johnson & Johnson have agreed to team up on the creation of a robotic surgical platform that combines ...Learn More
Funding round brings in $3.25M for surgical mesh maker
Kips Bay Medical has obtained $3.25 million in a private placement that includes its founder, Manny Villafana, as an ...Learn More
Veracyte, Sanofi firm enter marketing deal for gene expression test
Genzyme, a Sanofi firm, struck a five-year deal that started Jan. ...Learn More
Venture capitalist named to Avedro's board
David McIntyre, a partner in the health care venture capital firm Apple Tree Partners, has been tapped to serve on the board ...Learn More
Pivotal study begins for Obalon's weight-loss device in U.S.
Obalon Therapeutics has started a set of pivotal studies to test the use of its ingestible gas-filled balloon in losing ...Learn More
Bioness tests neuromodulation device for overactive bladder
Bioness has kicked off a six-month study in Canada that aims to test its minimally invasive StimRouter Neuromodulation ...Learn More
Fetal micro-pacemaker lands humanitarian exemption from FDA
The FDA has granted a humanitarian device exemption approval for a fully implantable fetal micro-pacemaker designed by ...Learn More
Voyant receives FDA OK for TraumaCad Mobile tool
Voyant Health has obtained FDA clearance to market the mobile version of its TraumaCad solution. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
You are surrounded by hundreds of people more timid than you are.
Fred Barton, ...Learn More
Colo.-based maker of hearing aid implants acquired by Medtronic
Medtronic has concluded the purchase of Sophono, a Boulder, Colo.-based maker of magnetic hearing aid implants, for ...Learn More
Radlink signs hip imaging deal with J&J unit
Radlink has agreed to license its Galileo positioning system to DePuy Synthes, a Johnson & Johnson unit. ...Learn More
Medtech startup pulls in $1.52M from funding round
An ongoing financing round being led by Cultivation Capital has brought in $1.52 million for Cardialen. ...Learn More
Atlas technology drives Q4 revenue growth for Roka Bioscience
Roka Bioscience generated $1.4 million in revenue in the quarter ending Dec. ...Learn More
ISO certification granted to MolecularMD's quality management system
The British Standards Institution has granted MolecularMD certification for the company's quality management system for its ...Learn More
Advanced bone matrix from Stryker debuts in U.S.
The BIO4, a viable bone matrix with endogenous bone-forming cells, is being launched by Stryker at the American Academy of ...Learn More
FDA clears external fixation technology from Wright Medical
The Salvation, an external fixation system developed by Wright Medical for ankle and foot surgeries, has received 510(k) ...Learn More
Stryker's spinal repair device cleared by FDA
The FDA has given Stryker 510(k) clearance to market the Lite Plate System, a lateral and anterior lumbar plate technology ...Learn More
EU approves biotherapy monitoring tool from Theradiag
European regulators have granted Theradiag, a French diagnostics firm, CE mark approval for its Stelara biotherapy ...Learn More
Instructions for cleaning duodenoscopes released by Olympus
Olympus has urged health providers to adopt as quickly as possible the new instructions it issued Thursday for cleaning ...Learn More
Advertising and Promotion of Medical Devices
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See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It's easy to have faith in people who have already proved themselves. It's much tougher to believe in people before they have proved themselves. But that is the key to motivating people to reach their potential.
John Maxwell, writer and motivational ...Learn More
Zimmer-Biomet deal approved by Japanese regulators
The pending merger of Zimmer with Biomet for $13.35 billion has received approval from antitrust regulators in Japan. ...Learn More
Maker of cell therapy device for diabetes gains $44M in Series A financing
Semma Therapeutics has obtained $44 million in a Series A funding round that includes Medtronic as an investor. ...Learn More
Intellirod Spine gains rights to X-spine Systems' spinal implants
Licensing and distribution deals were struck between Intellirod Spine and X-spine Systems to give Intellirod the right to ...Learn More
Amgen, Dako expand collaboration on companion Dx development
Dako has entered into an expanded development deal with Amgen. ...Learn More
J&J unit, Royal Philips enter partnership for development of handheld blood test
Royal Philips has struck a development deal with Janssen Pharmaceutica, a unit of Johnson & Johnson. ...Learn More
Boston Scientific's anti-stroke device debuts in U.S.
Doctors at Cedars-Sinai Medical Center in Los Angeles and Providence Saint John's Health Center in Santa Monica, Calif., ...Learn More
Robot-assisted hip-replacement system from Stryker debuts in U.S.
A total hip arthroplasty tool for the Mako robotic surgical platform was launched by Stryker during a conference of the ...Learn More
Zyga records first commercial use of updated spine device in U.S.
A patient at Reno Orthopaedic Clinic in Nevada was the first to undergo surgery using Zyga Technology's updated SImmetry ...Learn More
FDA clears spinal fixation technology from K2M
The NILE Alternative Fixation Spinal System, developed by K2M, has received 510(k) clearance from the FDA. ...Learn More
Vital Art and Science receives second FDA clearance for vision test
A second FDA clearance was granted to Vital Art and Science for its smartphone eye test application called myVisionTrack. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, 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
Never interrupt someone doing something you said couldn't be done.
Amelia Earhart, ...Learn More
Funding round brings in $11M for Osprey Medical
A private placement pulled in $11 million for Osprey Medical. ...Learn More
Deal to give Global Enterprises majority stake in molecular Dx firm
A deal was struck Tuesday by diversified holding firm Global Enterprises Group to acquire a majority stake in Predictive ...Learn More
Fund to support medtech, other life-science firms introduced in Poland
The Joint Polish Investment Fund I, a venture capital fund devoted to investments in life-science companies, has been ...Learn More
Teleflex records first surgery using percutaneous surgical system
A patient at the Cleveland Clinic was the first to undergo a procedure using Teleflex's Percuvance Percutaneous Surgical ...Learn More
Carestream partners with medical specialists to develop 3D extremity-imaging device
A 3D conebeam CT scanner for extremities is being developed by Carestream Health in collaboration with specialists in ...Learn More
Virtual-reality platform from EchoPixel debuts in U.S.
The True3D Viewer, a platform that can change anatomical data into virtual-reality images, was launched by EchoPixel. ...Learn More
Production milestone hit by Vistek Medical for medtech components
Vistek Medical has produced 2 million medical components and implants, which is a production milestone for the company. ...Learn More
Proposal to repeal medical device tax introduced in Senate
A bill that would repeal the 2.3% excise tax on medical devices and increase taxes on oil and gas companies to replace the ...Learn More
Rapid Ebola test from Cepheid receives FDA approval for emergency use
Cepheid's Xpert Ebola, a PCR-based test for the Ebola virus, has been given authorization for emergency use by the FDA. ...Learn More
N.J. approves use of 2 molecular Dx tests from Admera Health
The New Jersey Department of Health has approved the clinical use of Admera Health's OncoGxOne and PGxOne Plus ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...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 does not matter how slowly you go as long as you do not stop.
Confucius, philosopher and ...Learn More
Abiomed's blood pump system lands FDA nod
The FDA has granted Abiomed approval to market its Impella 2.5 System, a miniature blood pump that preserves heart ...Learn More
Series C round pulls in $19M for OrthoSensor
OrthoSensor has obtained $19 million in a Series C financing round of preferred stock. ...Learn More
Simplify Medical acquired by Australian private-equity shop
M.H. ...Learn More
Former Qiagen Marseille managers set up new cancer Dx firm
The former executive management team of Qiagen Marseille has established HalioDx, an immuno-oncology diagnostics company, ...Learn More
Benvenue Medical announces new CFO
John Dahldorf has been appointed chief financial officer of Benvenue Medical, a maker of minimally invasive devices for ...Learn More
Diabetes technology improves, but patients still need support
Diabetes self-care has benefited from technologies such as the continuous glucose monitor, lancet-based glucose meters that ...Learn More
Cryoablation device from AtriCure being promoted for new indication
CryoIce, a cryoablation device from AtriCure, is being promoted for temporary relief of pain in cardiac and thoracic surgery ...Learn More
AdvaMed commends budget proposal that includes medical device tax repeal
A congressional budget resolution that includes language to repeal the 2.3% excise tax on medical devices was praised by ...Learn More
For more:
Read the entire statement from AdvaMed Senior Executive Vice President JC Scott about the possible repeal of the medical ...Learn More
Canada OKs next-generation sequencing system from Illumina
A medical device license was granted by Health Canada to Illumina's MiSeqDx tool, a next-generation sequencing system, ...Learn More
EU approves Oncomine fusion panel from Thermo Fisher
European regulators have granted Thermo Fisher Scientific the CE-IVD mark for its Oncomine Solid Tumor Fusion Transcript, a ...Learn More
Short Course on Adaptive Design
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Our greatest weakness lies in giving up. The most certain way to succeed is always to try just one more time.
Thomas Edison, ...Learn More
Final guidance for reusable medtech product labeling, instructions unveiled by FDA
The FDA has issued final guidelines governing instructions and labeling for reusable medical devices, as well as guidelines ...Learn More
Drug-device combo maker sets IPO's midpoint price at $40M
SteadyMed Therapeutics offered 4.7 million shares in its initial public offering last week for a midpoint price of $40 ...Learn More
Medtech startup gets $5.9M boost
A funding round involving 52 investors brought in $5.9 million for InterVene, according to a regulatory filing with the ...Learn More
Pa. medtech firm takes in $3M in debt financing
Pennsylvania-based medtech firm Intact Vascular said in a filing with the Securities and Exchange Commission that it has ...Learn More
Calhoun Vision names former Bausch & Lomb exec as new CEO
Rick Heinick, former executive vice president and chief human resources and transformation officer at Bausch & Lomb, was ...Learn More
Sensor-embedded inhaler to track asthma of Ky. patients
The personalized asthma management system from Propeller Health will be used as part of a collaboration between public, ...Learn More
Positive results reported in 2 studies of Sebacia's acne management system
A novel approach using lasers, gold-coated particles and ultrasound to treat acne, developed by the clinical-stage medtech ...Learn More
MRI-safe pacemakers from Biotronik land FDA nod
The FDA granted Biotronik approval to market its dual- and single-chamber ProMRI Eluna pacemakers to be used with its Setrox ...Learn More
FDA clears catheter system from Vascular Pathways
The AccuCath 3.1" BC Midline Catheter, developed by Vascular Pathways for patients with challenged peripheral vasculature, ...Learn More
EU approves STD molecular Dx tests from Becton Dickinson
European regulators have granted Becton Dickinson CE mark approval for its BD Max CT/GC and CT/GC/TV tests. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...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 will either find a way or make one.
Hannibal, military ...Learn More
GOP senators include medical device tax repeal in budget proposal
A budget proposal that includes language to repeal the 2.3% excise tax on medical devices was introduced Wednesday by ...Learn More
Funding round brings in $16M for N.J. medtech firm
Svelte Medical Systems has obtained $16 million in a financing round led by New Science Ventures, CNF Investments and the ...Learn More
NanoString's breast cancer Dx test available in Canada
NanoString has struck a deal in which LifeLabs Medical Laboratory Services will offer its Prosigna Breast Cancer Prognostic ...Learn More
Stimwave to expand workforce, move headquarters to Fort Lauderdale, Fla.
Stimwave Technologies is planning to hire 20 more workers as it launches the Freedom Stimulator, an implantable device that ...Learn More
Q4 revenue soars for Veracyte
Veracyte generated $12.2 million in revenue in the quarter ending Dec. ...Learn More
Blue Belt's robotic surgery device debuts in Australia
A patient at Mater Hospital in Sydney was the first in Australia to undergo a procedure using Blue Belt Technologies' Navio ...Learn More
FDA clears advanced PAD testing technology from Semler
A next-generation system developed by Semler Scientific for peripheral artery disease testing has received 510(k) clearance ...Learn More
FDA OKs study of Simplify Medical's artificial cervical disc
Simplify Medical received an investigational device exemption from the FDA to conduct a study comparing its Simplify Disc, ...Learn More
EU approves bone screw system from Silver Bullet
European regulators have granted Silver Bullet Therapeutics CE mark approval for its OrthoFuzIon Cannulated Bone Screw ...Learn More
FDA labels Medtronic's sheath recall as Class I
A recall involving Medtronic's FlexCath Select Steerable Sheath has been categorized by the FDA as Class I. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Ever tried. Ever failed. No matter. Try again. Fail again. Fail better.
Samuel Beckett, ...Learn More
Zimmer-Biomet deal likely to be approved by EU regulators, sources say
The acquisition of Biomet by Zimmer for $13.4 billion is set to receive conditional approval from antitrust regulators in ...Learn More
Growth-stage Dx company gets $4M boost
DiabetOmics has obtained $4 million in a funding round led by Ventureast. ...Learn More
Lucigen pulls in $2.2M from private financing round
A private financing round has brought in $2.2 million for Wisconsin-based Lucigen. ...Learn More
DNA testing company gets funding boost to develop new Dx tests
Spartan Bioscience, an on-demand DNA testing firm, has obtained an investment from Canon USA to finance the development of ...Learn More
MPTronic enters distribution partnership with SST Group
SST Group has struck a deal to exclusively distribute MPTronic's RDM device in Canada and the U.S. ...Learn More
Who are medtech's favorites in Congress?
Check out an analysis of the political donations the medical device industry gave legislators last year. Read the ...Learn More
Report predicts strong growth for wearables market through 2020
An IndustryARC report predicts an annual growth rate of 21.3% through 2020 for the global wearable medical devices market. ...Learn More
New deadline set for comments on drug-device combo GMP rules
The FDA has moved the deadline from March 30 to April 29 for comments on the draft good manufacturing practices guidance for ...Learn More
Requirements for Class IV medtech products updated in South Korea
The Ministry of Food and Drug Safety in South Korea will require clinical data for a large number of Class IV medical ...Learn More
Peripheral stent from Medtronic gets expanded approval from FDA
The FDA has granted Medtronic expanded approval for use of its Protege GPS stent in treating peripheral artery disease ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...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
People won't have time for you if you are always angry or complaining.
Stephen Hawking, theoretical ...Learn More
U.S., EU regulators approve "leadless" ICD from Boston Scientific
The Emblem S-ICD, a "leadless" implantable cardiac defibrillator developed by Boston Scientific, has obtained FDA approval ...Learn More
Maker of diabetes management tool gains $16.5M in Series B financing
Glooko has obtained $16.5 million in a Series B funding round that includes Medtonic as an investor. ...Learn More
Deal to acquire Ivera Medical finalized by 3M
3M has concluded its proposed acquisition of Ivera Medical, a San Diego firm that makes the Curos port connector caps for ...Learn More
Ariz. molecular Dx firm gets $3.9M boost
A private equity offering involving 24 investors has brought in $3.9 million for Scottsdale, Ariz.-based Provista, according ...Learn More
Q4 revenue increases for Calif. molecular Dx firm
CareDx reported a 36% year-over-year revenue increase in the quarter ending Dec. 31. ...Learn More
Positive results reported in 2 studies of Glide Technologies' injection system
The Glide SDI, a solid dose injection system developed by Glide Technologies, demonstrated promising results in two clinical ...Learn More
Test uses single drop of blood to produce point-of-care results
A device that can offer point-of-care results by analyzing one drop of blood has been developed by Cleveland-based Apollo ...Learn More
SpineFrontier records first use of spinal-fusion device in North America
A patient at USMD Hospital at Arlington in Texas has undergone anterior cervical disc fusion using SpineFrontier's Arena-C ...Learn More
Program focuses on using Big Data to advance medical device, drug approval process
The "FDA: Advancing Medical Innovation" initiative was unveiled by the Bipartisan Policy Center to ask Congress to allow the ...Learn More
AmpliVue molecular Dx assay from Quidel wins FDA nod
The AmpliVue Trichomonas Assay, developed by Quidel, has obtained clearance from the FDA. ...Learn More
Short Course on Adaptive Design
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
The vitality of a new movement in art must be gauged by the fury it arouses.
Logan Pearsall Smith, ...Learn More
Becton Dickinson-CareFusion deal closes today
Becton Dickinson and CareFusion said their proposed $12 billion merger will close today after it was approved last week by ...Learn More
NuCryo Vascular enters distribution partnership with Vascular Solutions
The PolarCath, a balloon catheter designed to alter and dilate atherosclerotic plaque, was launched by Vascular Solutions in ...Learn More
Novation to continue deal with Bacterin for bone matrix, allograft technologies
A deal between Bacterin and Novation has been extended, allowing members of Novation to access proprietary Bacterin ...Learn More
MicroRNA-based test drives revenue growth for Rosetta in 2014
Rosetta Genomics generated $1.3 million in revenue in 2014, compared with $709,000 in 2013. ...Learn More
Medtronic reports positive trial results for heart valve
A 747-patient, multisite study in the U.S. ...Learn More
ISO certification granted to Accelerate Diagnostics' quality-management system
Accelerate Diagnostics has been granted ISO certification for its quality-management system. ...Learn More
Zimmer records first use of shoulder-replacement device in U.S.
An American patient has undergone reverse shoulder replacement using Zimmer's Vivacit-E Liner, marking the first time the ...Learn More
Cobas DPX assay from Roche gets CE mark
European regulators have granted Roche CE mark approval for its cobas DPX assay, which detects parvovirus B19 and hepatitis ...Learn More
FDA clears use of Toshiba's 4DCT with Aquilion scanner
Toshiba America Medical Systems has obtained FDA clearance to sell its Infinix 4DCT in combination with the company's ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
You cannot shake hands with a clenched fist.
Indira Gandhi, prime minister of ...Learn More
Heart device from Boston Scientific lands FDA nod
The FDA has approved Boston Scientific's Watchman Left Atrial Appendage Closure Device, which is intended to minimize the ...Learn More
Ohio imaging firm sets IPO's midpoint price at $52M
ViewRay said it intends to offer 4 million shares in its initial public offering at $12 to $14 per share, making the ...Learn More
N.C. metabolomics firm gets $5M boost
An additional $5 million was raised by Metabolon in a Series E funding round extension, bringing its total for that round to ...Learn More
Q2 revenue increases for N.Y. Dx firm
Enzo Biochem generated $23.1 million in revenue in the quarter ending Jan. ...Learn More
Ultrasound good alternative to MRI for gluteus tendinitis
Ultrasound was nearly equal to MRI for identifying gluteus tendinitis in patients with greater trochanter pain syndrome, ...Learn More
Eko Devices raises $2M, prepares clinical trials for EHR-connected stethoscope attachment
Eko Devices has raised $2 million in funding and is preparing to begin clinical trials of its EHR-connected stethoscope. ...Learn More
Tracking program for medtech-tied adverse events approved in India
A nationwide materiovigilance program was approved by the health ministry of India to make sure that medical devices are ...Learn More
Stent-delivery device from Lombard wins approval in Japan
Japanese regulators have given Lombard Medical Technologies approval to market its AorFlex system in that country. ...Learn More
EU approves Volcano's lesion-assessment tool
Regulators in Europe have given Volcano CE mark approval for its iFR Scout software, a tool that analyzes serial lesions and ...Learn More
Medical Device Complaints, MDRs and Reports
March 18-19Arlington, Va.FDA staff (invited) and experts are coming together to discuss setting up a complaint system, ...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
A person will sometimes devote all his life to the development of one part of his body -- the wishbone.
Robert Frost, ...Learn More
Rules for disinfecting reusable medical devices finalized by FDA
The FDA has finalized its guidelines governing the disinfecting and cleaning of endoscopes and other reusable medical ...Learn More
Maker of bariatric surgical devices obtains $50M loan
Athyrium Capital Management has granted Apollo Endosurgery a loan package worth $50 million. ...Learn More
Wis. imaging systems startup obtains $4.5M boost
HealthMyne, which has developed a clinical imaging analytics technology, has raised $4.5 million in a Series A funding ...Learn More
Analysis: Small bone orthopedics market grew over 7% in 2014
An analysis by ReportBuyer found a more than 7% increase in the U.S. ...Learn More
Q4 revenue increases for Trovagene
Trovagene generated $56,000 in revenue in the quarter ending Dec. ...Learn More
U.S. trial begins for Medtronic's drug-eluting stent
A U.S. ...Learn More
Assurex taps technology provider in pharmacogenomics test deal
Luminex has struck a deal to use its xTag, a universal tag technology, in improving the capacity and processing speed of ...Learn More
EU OKs precision medical instruments from JustRight Surgical
European regulators have granted JustRight Surgical CE mark approval to market all of its FDA-cleared precision medical ...Learn More
Somna Therapeutics gets FDA nod for acid reflux device
Somna Therapeutics received FDA approval for the REZA BAND, a medical device that applies pressure to the neck to reduce ...Learn More
EU restores approval of aortic valve implants from St. Jude
European regulators reinstated the CE mark to the 25-mm and 23-mm versions of St. ...Learn More
Short Course on Adaptive Design
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Love is the only force capable of transforming an enemy into a friend.
Martin Luther King Jr., civil rights ...Learn More
Zimmer floats $7.65B debt for merger deal
Zimmer is offering senior notes worth $7.65 billion to help finance its merger with Biomet's parent company, LVB ...Learn More
N.J. insulin pump maker sets IPO's midpoint price at $75M
Valeritas said it intends to offer 5 million shares in its initial public offering at $14 to $16 per share, making the ...Learn More
Wash. mitral valve device maker gets $15M boost
An additional $15.2 million was raised by Cardiac Dimensions in a funding round extension, bringing its total for that round ...Learn More
Q4 revenue soars for Invitae
Invitae generated $875,000 in revenue in the quarter ending Dec. ...Learn More
Australian state looks to support medtech with $1.7M investment
A plan to invest almost $1.7 million in a medtech knowledge hub has been announced by the government of New South Wales, ...Learn More
Smiths Medical to move headquarters to Plymouth, Minn.
Smiths Medical is transferring its headquarters from Arden Hills, Minn., to Plymouth, Minn. ...Learn More
Stimwave records first U.S. patients implanted with pain-relief device
Patients at the National Institute of Pain in Lutz, Fla., were the first in the U.S. ...Learn More
Sponge-detection technology from RF Surgical debuts in U.S.
The RF Assure Detection System X, designed to help surgical teams avoid leaving sponges inside a patient's body, was ...Learn More
Web-based tool helps determine MRI compatibility of devices
An online tool called ProMRI System Check was unveiled by Biotronik. ...Learn More
EU approves cochlear implant, 3 electrodes from Advanced Bionics
HiRes 90K Advantage, a cochlear implant developed by Advanced Bionics for patients with single-sided deafness, has obtained ...Learn More
Medical Device Complaints, MDRs and Reports
March 18-19Arlington, Va.FDA staff (invited) and experts are coming together to discuss setting up a complaint system, ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
You gain strength, courage and confidence by every experience in which you really stop to look fear in the face.
Eleanor Roosevelt, first ...Learn More
Calif. robotic surgery device maker gets $35M boost
A private placement involving a syndicate of investors has pulled in $35 million for Hansen Medical. ...Learn More
Commercial assets of Covis acquired by Concordia in $1.2B deal
Concordia Healthcare, a medtech firm in Ontario, has agreed to pay $1.2 billion to buy the commercial assets of Covis ...Learn More
U.S. investors pump $14.3M into Australian molecular Dx firm
A financing round has brought in about $14.3 million for Australian molecular diagnostics company Genetic Technologies after ...Learn More
Bacterin enters distribution partnership with Spartan Medical
Spartan Medical has struck a deal to distribute Bacterin's proprietary products to medical facilities affiliated with the ...Learn More
Higher sales in China help fuel Q4 revenue growth for Mindray
Mindray Medical International generated $399 million in the quarter ending Dec. ...Learn More
Varian Medical to expand facility in Ga.
Palo Alto, Calif.-based Varian Medical Systems has announced plans to open a hub in Fulton County, Ga., by expanding its ...Learn More
Fio, Corgenix team up on rapid Ebola test
A partnership deal was reached between Corgenix Medical and Fio to develop a technology that will provide patients in remote ...Learn More
Illumina partners with Merck Serono on cancer test development, marketing
Illumina and Merck Serono have agreed to collaborate on the creation of a universal oncology test that would help in the ...Learn More
Registrants grapple with new medtech nomenclature system in Russia
The more rigorous requirements for filing products together in a single registration as well as the missing and incomplete ...Learn More
Tornier's shoulder repair device cleared by FDA
The Simpliciti shoulder-repair device from Amsterdam-based orthopedics firm Tornier has received 510(k) clearance from the ...Learn More
Molecular Diagnostics and the Changing Landscape
March 12-13Washington, D.C. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
All my life, I always wanted to be somebody. Now I see that I should have been more specific.
Jane Wagner, writer and ...Learn More
Spinal device maker gets $3M boost
A private placement divided into two tranches pulled in about $3 million for Aurora Spine. ...Learn More
SEC filing: Sigma-Aldrich paid $170M for Cell Marque
Sigma-Aldrich paid around $170 million in October to buy Cell Marque, a maker of in vitro diagnostic antibody kits and ...Learn More
Vt. medtech firm purchased by Graphic Controls
Graphic Controls, a maker of medical, gaming and industrial products, agreed to pay an undisclosed sum to acquire ...Learn More
Exact Sciences enters co-promotion deal with Ironwood
Ironwood Pharmaceuticals struck a nonexclusive deal to co-promote Exact Sciences' Cologuard, a colorectal screening test, ...Learn More
Higher test volume drives Q4 revenue growth for Biocept
Biocept generated $76,000 in revenue in the quarter ending Dec. 31, compared with $19,000 in the same period a year earlier. ...Learn More
U.S. patent covering syringe cartridge issued to Minimus Spine
Minimus Spine has secured a U.S. ...Learn More
FDA clears Dx display tool from Barco
The Nio 5MP LED, a diagnostic display system from Barco, has obtained clearance from the FDA. ...Learn More
Zoll gains FDA OK for automated CPR system
The ResQCPR system, an automated cardiopulmonary resuscitation device from Zoll Medical, has received premarket approval ...Learn More
FDA authorizes use of Kaneka's kidney-failure device
The FDA has authorized the use of Kaneka's Lixelle Beta 2-microglobulin Apheresis Column, a device used together with ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
The higher we are placed, the more humbly we should walk.
Cicero, ...Learn More
Myriad's $200M share repurchase program wins board approval
A plan by Myriad Genetics to buy back $200 million of company stock in a repurchase program was approved by the company's ...Learn More
Shareholder vote on Uroplasty/Vision-Sciences merger set for March 30
Shareholders of Vision-Sciences and Uroplasty will vote March 30 on whether to approve an all-stock merger combining the two ...Learn More
Funding round brings in $1.2M for microbial genetics analysis firm
A private financing round brought in $1.2 million for OpGen, a Gaithersburg, Md.-based microbial genetics analysis company. ...Learn More
Instruments, consumables drive Q4 revenue growth for NanoString
NanoString Technologies generated $15.6 million in revenue in the quarter ending Dec. ...Learn More
Higher test volume drives Q4 revenue growth for Foundation Medicine
Foundation Medicine generated $18.7 million in revenue in the quarter ending Dec. ...Learn More
Report: Global market for medical imaging devices poised for growth
A Persistence Market Research report predicts the worldwide medical imaging market will be worth $35 billion by 2020, with a ...Learn More
FTC cracks down on melanoma risk detection apps with unsupported claims
The Federal Trade Commission has taken action against the marketers of the MelApp and Mole Detective mobile applications for ...Learn More
Laser delivery system for Cynosure's dermal repair device cleared by FDA
The 532 nm Laser Delivery System, developed by Cynosure, has obtained clearance from the FDA. ...Learn More
National medtech monitoring system sought by FDA
A Brookings Institution report commissioned by the FDA calls for the establishment of a collaborative national surveillance ...Learn More
FDA labels GE Healthcare's MRI systems recall as Class I
A recall involving GE Healthcare's MRI systems with superconducting magnets has been categorized by the FDA as Class I. ...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
Nothing great in the world has been accomplished without passion.
Georg Wilhelm Friedrich Hegel, ...Learn More
Maker of bladder-control device acquired by Medtronic
Advanced Uro-Solutions, the maker of the Nuro percutaneous tibial nerve stimulator to address bladder-control problems, was ...Learn More
Public offering brings in $9M for molecular Dx firm
Signal Genetics raised $9 million in gross proceeds from its now-closed public offering of about 3.2 million shares. ...Learn More
NIH backs development of microbial molecular Dx test
The NIH has given a $5 million grant to Accelerate Diagnostics and Denver Health Medical Center to fund the development of a ...Learn More
Report: Global preclinical imaging market poised for growth
A Life Science Industry Research report forecasts the worldwide preclinical imaging market will see a 6% compound annual ...Learn More
Industry veteran named executive chairman of OrthAlign's board
Gary Henley was selected to serve as executive chairman of OrthAlign's board. ...Learn More
CMS to cover outpatient use of Medtronic's drug-coated balloon catheter
Procedures using Medtronic's In.Pact Admiral drug-coated balloon catheter in an outpatient setting will receive Medicare ...Learn More
EnteroMedics prepares to launch neurostimulation weight-loss device
The Minnesota firm EnteroMedics is preparing for the commercial release of its Maestro system, a neurostimulation implant to ...Learn More
Switzerland, China sign deal to improve medtech collaboration
An agreement between Switzerland and China seeks to boost cooperation in the medtech field. ...Learn More
Calif. lawmaker urges House oversight committee to investigate superbug outbreak
Rep. ...Learn More
VertiFlex gains FDA panel support for spinal stenosis system
A panel of advisers has endorsed VertiFlex's Superion Interspinous Spacer System for FDA approval. ...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
The best day of your life is the one on which you decide your life is your own. No apologies or excuses. No one to lean on, rely on, or blame. The gift is yours -- it is an amazing journey -- and you alone are responsible for the quality of it. This is...
Bob Moawad, ...Learn More
Proteomics services firm lowers IPO target to $2.3M, moves closing date
Proteomics International Laboratories moved the closing date for its initial public offering to Friday. ...Learn More
Ivera Medical to be acquired by 3M
Ivera Medical, a San Diego firm that makes the Curos port connector caps for needleless intravenous valves, is being ...Learn More
Maker of anesthetic device reaches deal with distributor
Medline Industries struck a distribution and marketing deal to offer Marathon Pharmaceuticals' Zingo device, a needleless ...Learn More
Report: Minimally invasive surgical tools market to reach $14.13B by 2019
A MarketsandMarkets report predicts the market for minimally invasive surgical instruments will grow to $14.13 billion by ...Learn More
Higher test volume drives Q4 revenue growth for Dx firm LabCorp
Clinical testing services company Laboratory Corp. ...Learn More
Growth in global arthroscopic devices market driven by less-invasive surgeries
A Medical Market Research report found that the worldwide market for arthroscopic devices is growing on the back of greater ...Learn More
Helius begins trial enrollment for brain stimulator device
The first three multiple sclerosis patients have been enrolled by Helius Medical Technologies in a clinical trial of its ...Learn More
Blue Belt hits milestone for robotic surgery device
A partial knee replacement surgery performed recently in Hampton, Va., marked the 1,000th time the Navio Robotic Surgical ...Learn More
23andMe's Bloom syndrome test gets clearance from FDA
23andMe received authorization from the FDA to market its direct-to-consumer genetic test designed to evaluate a person's ...Learn More
Covidien's varicose vein closure system lands FDA nod
The FDA has approved Covidien's VenaSeal, a closure system that treats varicose veins with a medical adhesive that ...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
Your only obligation in any lifetime is to be true to yourself.
Richard Bach, ...Learn More
Risk of potentially deadly infection prompts warning over reusable endoscopes
The FDA is warning the medical community about the use of devices designed for complex endoscopy procedures following a ...Learn More
AdvaMed: Indian medtech sector could reach $30B in the next decade
The medtech industry in India could be worth $25 billion to $30 billion over the next 10 years with the proper regulatory ...Learn More
AdvancedCath to be acquired by TE Connectivity in $190M deal
TE Connectivity, a Swiss maker of connectivity and sensor components for medical devices, said it will pay $190 million to ...Learn More
Wound care sales drive Q4 revenue growth for Acelity
Texas-based wound care firm Acelity generated $482.7 million in revenue in the quarter ending Dec. ...Learn More
Pulse oximetry devices drive Q4 sales growth for Masimo
Irvine, Calif.-based patient monitoring firm Masimo generated total sales of $161.8 million in the quarter ending Jan. ...Learn More
EOS reports Swiss installation of imaging system
A private clinic in Lausanne, Switzerland, that is recognized worldwide for orthopedic surgery has installed a unit of EOS ...Learn More
BARDA gives Duke, DxTerity $10.4M grant to develop radiation exposure test
The Biomedical Advanced Research and Development Authority awarded a $10.4 million grant to Duke University for its work ...Learn More
Report: Worldwide 3D printer technologies market to see sustained growth
A Visiongain report predicts the worldwide market for 3D printer technologies will grow to $2.8 billion by 2019 and continue ...Learn More
Calif. program awards $200,000 in funding for health data initiatives
Five programs aimed at advancing research by leveraging aggregated personal health information received a total of $200,000 ...Learn More
CMS to cover outpatient use of Bard's drug-coated balloon catheter
Procedures using C.R. ...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
Your present circumstances don't determine where you can go; they merely determine where you start.
Nido Qubein, businessman and motivational ...Learn More
Medtronic partners with CV health advocates to cut repeat strokes
The American Heart Association and American Stroke Association have partnered with Medtronic in a five-year effort to cut ...Learn More
Molecular Dx firm obtains $12.2M boost
Lineagen has raised $12.2 million in the second tranche of its Series C funding round led by HealthQuest Capital, bringing ...Learn More
Anavex, Amarantus sign deal for use of Alzheimer's biomarker assay
A deal between Amarantus BioScience Holdings and Anavex Life Sciences gives Anavex access to Amarantus' LymPro biomarker ...Learn More
Cook Medical, GPO sign pricing deal
Cook Medical and Premier, a group purchasing organization, have agreed to a tiered pricing arrangement giving GPO members ...Learn More
Sales of C. difficile tests drive Q4 revenue growth for Great Basin
Salt Lake City-based Great Basin generated $445,283 in revenue in the quarter ending Dec. ...Learn More
Biotronik's pacemaker safety claims hold up in MRI studies
Biotronik's ProMRI Evia/Entovis SR-T and DR-T pacemaker systems appear to be safe in certain cases for use with MRI, ...Learn More
CliniCloud unveils remote-care health kit
A new medical kit from CliniCloud includes a smartphone-enabled stethoscope and a wireless, noncontact thermometer that ...Learn More
Medtech innovation challenge retains Smith & Nephew as co-sponsor
The New Venture Competition, organized by the Massachusetts Medical Device Development Center to highlight early-stage ...Learn More
Herpes virus test from Seegene gets FDA clearance
Seegene received clearance from the FDA to market its TOCE technology-based assay for detecting herpes simplex virus types 1 ...Learn More
U.K. regulator names chairman of new medical device expert group
Dr. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews 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
Clarification
Tuesday's SmartQuote, credited to Hannah Szenes, should have identified her as a Hungarian-born paratrooper for the British ...Learn More
[I]f one advances confidently in the direction of his dreams, and endeavors to live the life which he has imagined, he will meet with a success unexpected in common hours.
Henry David Thoreau, writer and ...Learn More
Medtronic wins approval for balloon dilatation catheter in Europe
The Euphora Semicompliant Balloon Dilatation Catheter has been launched by Medtronic in Europe, which comes on the heels of ...Learn More
Public offering could bring in about $9M for Signal Genetics
Signal Genetics has priced the more than 3.2 million shares in its public offering at $2.80 each in hopes of obtaining about ...Learn More
Cardiovascular device sales drive Q3 profit growth for Medtronic
Medtronic reported $977 million in earnings in the quarter ending Jan. ...Learn More
NFL awards scouting combine contract to Carestream
The National Football League has struck a deal with Carestream Health for its DRX-1 digital radiography detector. ...Learn More
Analysis predicts global market growth for sports medicine devices
An analysis by ReportsnReports predicts that from 2014 to 2019, the worldwide market for sports medicine devices is ...Learn More
FDA clears versatile orthopedic fixation device from Dallen Medical
The Tensyn Plug, an adjustable orthopedic fixation device from Dallen Medical, obtained 510(k) clearance from the FDA. ...Learn More
FDA panels set review date for Avedro's corneal cross-linking system
The FDA's Ophthalmic Devices Panel and the Dermatologic and Ophthalmic Drugs Advisory Committee will jointly convene Feb. ...Learn More
Drug regulator set to assume control of medical devices in India
A five-day workshop on medical devices was organized by the Central Drugs Standard Control Organization of India as it ...Learn More
EU approves artificial cervical disc from Simplify Medical
Simplify Disc, developed by Simplify Medical with materials that are MRI friendly, has obtained CE mark approval in Europe. ...Learn More
Canada OKs proton therapy system from Mevion Medical
The Mevion S250, a proton therapy device developed by Mevion Medical Systems, was granted a medical device license by Health ...Learn More
Molecular Diagnostics and the Changing Landscape
March 12-13Washington, 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
Blessed are they who see beautiful things in humble places where other people see nothing.
Camille Pissarro, Danish-French ...Learn More
AdvaMed "Innovation Agenda" aims to advance U.S. medtech sector
AdvaMed has unveiled its "Innovation Agenda" to promote the global leadership of the U.S. medtech industry. ...Learn More
For more:
Read the press release about AdvaMed's "Innovation ...Learn More
San Diego-based cancer Dx firm aims to bring in $10M in public offering
Biocept is hoping to secure about $10 million in a public offering of 8 million shares of common stock at $1.25 apiece. ...Learn More
Roche buys genomics and translational oncology firm
Roche has purchased Signature Diagnostics, a translational oncology and genomics firm that specializes in blood plasma, ...Learn More
Firm wins $1.5M grant for HIV/AIDS assay
The NIH has awarded Rheonix a grant worth $1.5 million under the second phase of its Small Business Innovation Research ...Learn More
Industry veteran named interim CEO of JenaValve
Jan Keltjens has been appointed interim chairman and CEO of JenaValve, a maker of transcatheter aortic valve implants. ...Learn More
EU moves deadline to decide on Zimmer-Biomet deal to May 26
The European Commission has pushed back its deadline to decide on whether to approve Zimmer's pending acquisition of ...Learn More
Medtronic's varicose vein device shows positive results in study
A 225-patient study in the British Journal of Surgery showed promising results for ClosureFast, a varicose vein device ...Learn More
Smartphones as effective as other devices in tracking exercise
Researchers at the University of Pennsylvania in Philadelphia found smartphones were as effective as pedometers and ...Learn More
Bone void filler from Nanotherapeutics gets expanded approval from FDA
The FDA has granted Nanotherapeutics expanded approval for its NanoFuse demineralized bone matrix for use with patients' own ...Learn More
Recognized medtech standards updated in U.S.
The FDA has updated its list of recognized standards to include two concerning the use of small connectors for gases and ...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
Happiness grows at our own firesides, and is not to be picked in strangers' gardens.
Douglas Jerrold, British ...Learn More
Hansen gains FDA nod to expand Sensei surgical robot study
The FDA has allowed Hansen Medical to expand a clinical trial of its robot-assisted surgery platform Sensei in treating ...Learn More
C.R. Bard enters distribution partnership with Boston Scientific
Boston Scientific has struck a limited distribution deal to offer C.R. ...Learn More
Medtech firm gains $1.6M in Series B financing
Pursuit Vascular, a Maple Grove, Minn.-based startup that developed the FDA-cleared ClearGuard HD infection-fighting rod, ...Learn More
Drug-eluting stent technology from Micell debuts in Europe
The MiStent, a sirolimus-eluting stent developed to treat restenosis, is being launched by Micell Technologies in Europe. ...Learn More
Tebu-bio obtains rights to market genome imaging test in Europe
Fort Collins, Colo.-based KromaTiD has struck a distribution deal with French company tebu-bio to help bring KromaTiD's ...Learn More
Aurora Spine's spinal fusion implant debuts in Switzerland
A doctor at Clinique Generale-Beaulieu in Geneva has performed Switzerland's first implantation of the ZIP ULTRA minimally ...Learn More
Neovasc's stent-like device shows promise in refractory angina trial
A study in the New England Journal of Medicine showed promising results for Neovasc's Reducer system, a device implanted in ...Learn More
VitalMedicals to develop more Google Glass-based solutions
VitalMedicals is supporting its effort to design Google Glass solutions for surgeons with $925,000 in recently raised ...Learn More
Study backs use of smartphone ECGs
A study in the Journal of Cardiovascular Electrophysiology found smartphone electrocardiogram monitoring was just as ...Learn More
Anti-stroke device from Silk Road wins FDA nod
The Enroute transcarotid neuroprotection system, a device developed by Silk Road Medical to cut the risk of strokes during ...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
You always have two choices: Your commitment versus your fear.
Sammy Davis Jr., American ...Learn More
Insulet to continue deal with Abbott for blood glucose monitor
An exclusive deal between Insulet and Abbott Laboratories has been extended, allowing integration of FreeStyle, Abbott's ...Learn More
Molecular Dx firm could bring in $20M in stock offering
Trovagene is hoping to secure $20 million in a public offering of roughly 4.4 million shares. ...Learn More
Belgian Dx firm aims to bring in $8.5M in public offering
VolitionRx offered 2.475 million shares in a public offering at $3.75 apiece, with net proceeds expected to reach $8.5 ...Learn More
Pfizer boosts generics, biosimilar pipeline with $17B Hospira buy
Pfizer agreed to pay about $17 billion in cash and debt to purchase Hospira, which specializes in developing biosimilars and ...Learn More
China unveils user fees for foreign medtech firms
A draft table issued by the China Food and Drug Administration would charge imported Class III device registrants an initial ...Learn More
MRI-safe pacemaker from Sorin wins approval in Japan
Japanese regulators have given Sorin Group the go-ahead to market its Kora 100 pacemaker in that country. ...Learn More
Medtech incubator upgrades phototherapy system for infantile jaundice
The Brilliance Pro phototherapy system, designed to treat children born with jaundice in developing countries, was launched ...Learn More
Accelerator welcomes new class of health tech startups
The accelerator Blueprint Health has selected several health IT companies to join its seventh class of startups. ...Learn More
Medtronic agrees to $1.25M settlement in billing case
Medtronic reached a $1.25 million settlement to resolve a whistleblower lawsuit in which its Ev3 unit, obtained in the ...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
Success is how high you bounce when you hit bottom.
George S. Patton, U.S. Army ...Learn More
Medtronic gains FDA OK for brain aneurysm device
The Pipeline Flex, an embolization device that Medtronic acquired in its recent merger with Covidien, has received premarket ...Learn More
Canon teams up with T2 Biosystems on Dx test for Lyme disease
A partnership deal to create a test panel that can quickly diagnose Lyme disease was reached by Canon U.S. ...Learn More
Life sciences, medical segments drive Q1 revenue growth for Becton Dickinson
Becton Dickinson generated $2.05 billion in revenue in its fiscal first quarter, which ended Dec. 31. ...Learn More
New products, infusion systems help fuel Q2 revenue growth for CareFusion
CareFusion posted $1.07 billion in revenue in the quarter ending Dec. 31, a 16% increase over the same period last year. ...Learn More
EU approves noninvasive prenatal assay from Premaitha
The Iona test, developed by Premaitha, has obtained CE mark approval in Europe. ...Learn More
Europe expands approval for Nevro's Senza spinal cord stimulation system
Nevro has earned additional approval from European Union regulators for the use of Senza, an implantable system for spinal ...Learn More
Large joint restoration market in U.S. could eclipse $9B in 2015
An iData Research report has projected that the large joint restoration market in the U.S. ...Learn More
Soft suture anchor introduced by Smith & Nephew
The SUTUREFIX Ultra soft suture anchor, designed for use in shoulder and hip labral repair, has been launched by Smith & ...Learn More
Hamburg resigning as FDA commissioner
Dr. Margaret Hamburg is resigning after nearly six years as FDA commissioner, according to officials. ...Learn More
Lombard's device for larger aneurysms lands FDA approval
The Aorfix Plus stent graft, developed by Lombard Medical Technologies, has obtained premarket approval from the FDA. ...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 is good to love many things, for therein lies the true strength, and whosoever loves much performs much, and can accomplish much, and what is done in love is well done.
Vincent van Gogh, Dutch ...Learn More
Drug-eluting balloon from Medtronic debuts in U.S.
The In.Pact Admiral system, a drug-eluting balloon developed by Medtronic as a treatment for patients with peripheral artery ...Learn More
Calif. molecular Dx firm aims to bring in $46.6M in IPO
AutoGenomics said it intends to offer 3.75 million shares in an initial public offering at $11 to $13 apiece, with net ...Learn More
Trice Medical stretches Series B round to $18.1M
Trice Medical raised an additional $6.5 million in a Series B funding round extension led by HealthQuest Capital, bringing ...Learn More
Product sales drive Q4 revenue growth for Affymetrix
Affymetrix generated $93.5 million in total revenue in the quarter ending Dec. ...Learn More
Pediatric device makers win grants from FDA-backed group
Three makers of medical devices intended for children with unmet medical needs will each get a $25,000 grant from the ...Learn More
Accuray reports Mexican installation of TomoTherapy system
Accuray has installed its TomoTherapy system at Fundacion de Cancer de Mama, a treatment center in Mexico City. ...Learn More
Device performs combination immunoassay with help of smartphone
Columbia University researchers have developed an enzyme-linked immunosorbent assay device, which uses a smartphone as its ...Learn More
Cohera's surgical adhesive lands FDA approval
The FDA has granted Cohera Medical approval for TissuGlu, a urethane-based internal adhesive designed for use in ...Learn More
Obama's budget proposal includes more FDA funding, higher user fees
President Barack Obama's fiscal 2016 budget request includes raising the FDA's total budget by 9% to $4.93 billion. ...Learn More
3D breast CT scanner from Koning gains FDA nod
The FDA has granted Koning approval to market its breast CT scanner. ...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
We often repent of our first thoughts, and scarce ever of our second.
Horace Walpole, British ...Learn More
Medtronic gains FDA OK for pulmonary heart valve
Melody, a transcatheter pulmonary heart valve developed by Medtronic, has obtained premarket approval from the FDA. ...Learn More
Follow-on offering brings in $38.3M for K2M Group
More than 2 million shares have been put up in a follow-on offering at $18.75 per share by K2M Group, bringing in $38.3 ...Learn More
Misonix strikes deal to buy back ultrasonic surgical tool
The Misonix BoneScalpel Ultrasonic Bone Cutting System, which is designed to support osteotomies and en-bloc bone removal ...Learn More
Hypertension device firm gains $1.9M in equity round
An equity round has pulled in $1.9 million for Verve Medical. ...Learn More
Knee and hip arthroplasty device from OrthAlign gets CE mark
The OrthAlign Plus system, developed by OrthAlign, has obtained CE mark approval in Europe. ...Learn More
Proteomics firm gains exclusive rights to market lung test in Canada
A licensing deal has been struck between Caprion, a proteomics company, and Integrated Diagnostics to allow Caprion to ...Learn More
Stryker unveils European base in Amsterdam
The European headquarters of Stryker officially opened last week in Amsterdam as the company looks to increase its Western ...Learn More
Implantable heart device introduced by Boston Scientific
The Extended Longevity implantable cardioverter defibrillator, which can help reduce preventable replacement procedures, has ...Learn More
Smartphone breath analysis tool targets early-disease detection
The SniffPhone project was launched by a Technion-Israel Institute of Technology group to develop a smartphone-based breath ...Learn More
Letter: ACA did not bring surge of new business to medtech companies
Medical technology companies do not enjoy expanded demand for their products because of increased insurance coverage under ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
To be prepared is half the victory.
Miguel de Cervantes, Spanish ...Learn More
Intuitive Surgical's $1B share repurchase program wins board approval
A plan by Intuitive Surgical to buy back up to $1 billion of company stock in a repurchase program funded through ...Learn More
$924M health care fund raised by OrbiMed
New York-based investment group OrbiMed has raised a fund worth $924 million. ...Learn More
Invitae amends IPO target to as high as $92.3M
An initial public offering by Invitae could bring in as much as $92.3 million in net proceeds, according to the company's ...Learn More
Fenner buys maker of bioprocessing devices in $29.9M deal
Fenner Drives has agreed to pay $29.9 million in cash to acquire Charter Medical, a maker of single-use Class I and II ...Learn More
InVivo could bring in about $12M in shares offering
InVivo Therapeutics is hoping to secure $12 million in a direct offering of 8 million shares priced at $1.50 apiece to two ...Learn More
Additional sizes of Medtronic's heart valve gain approval in Europe
European regulators have granted the CE mark to the 29mm and 26mm versions of Medtronic's CoreValve Evolut R System, which ...Learn More
Global market for refurbished devices to reach $9.37B by 2019, report predicts
The worldwide market for refurbished medical equipment and devices could be worth $9.37 billion by 2019 because of the wider ...Learn More
Home care provider signs telehealth deal with Cardiocom
A telehealth partnership deal was secured between Medtronic's Cardiocom business and LHC Group. ...Learn More
HIT vendor designs clinical trial tools
CliniOps has developed several tools that could be used to conduct efficient clinical trials. ...Learn More
Letter: Device tax has "profound negative effect" on U.S. jobs, innovation
The medical device tax has a "profound negative effect" on the nation's jobs and innovation, which is why repealing the tax ...Learn More
Bone tether plate from MedShape cleared by FDA
The FastForward Bone Tether Plate, developed by MedShape for its FastForward Bunion Correction System, has obtained ...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
What if you gave someone a gift, and they neglected to thank you for it -- would you be likely to give them another? Life is the same way. In order to attract more of the blessings that life has to offer, you must truly appreciate what you already have.
Ralph Marston, American ...Learn More
Avinger, Entellus raise share offerings in IPOs; Presbia IPO brings in $42M
Avinger has increased the number of shares it is offering in an initial public offering from 4.6 million to 5 million, ...Learn More
Ortho-Clinical Diagnostics signs transfusion diagnostics deal with Quotient
Ortho-Clinical Diagnostics entered into an exclusive agreement with Quotient and will pay $69 million for the rights to ...Learn More
Qualcomm partners with Roche on remote monitoring system
A partnership between Qualcomm Life and Roche will use Qualcomm's 2net Platform and Roche's cloud-based service to improve ...Learn More
Quest Diagnostics reports Q4 sales growth
Quest Diagnostics generated $1.88 billion in sales during the fourth quarter, 7% more than during the same period in 2013 ...Learn More
SpineGuard wins EU patent for guided pedicle screw
SpineGuard has secured a patent in Europe for the smart screw, which is a pedicle screw combined with the company's Dynamic ...Learn More
ISO certification granted to noninvasive prenatal assay from Premaitha
The International Organization for Standardization has granted Premaitha Health ISO certification for the company's Iona ...Learn More
App-sensor system helps track Parkinson's progression
Researchers in Spain are developing the PERFORM system, which uses a smartphone application and a network of sensors to ...Learn More
Study: WhatsApp shows promise in sharing, documenting clinical images
A study in the International Journal of Medical Informatics found that the WhatsApp Messenger shows promise as a tool for ...Learn More
Obama proposes $215M for personalized medicine initiative
President Barack Obama will ask Congress for $215 million to fund his precision medicine initiative, which aims to advance ...Learn More
For more:
Read the statement from AdvaMedDx Executive Director Andrew Fish about the administration's proposal to increase investment ...Learn More
"Right to try" bill introduced in Ill.
A bill that would permit terminally ill patients to get access to unapproved drugs and devices after those products have ...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
A contented mind is the greatest blessing a man can enjoy in this world.
Joseph Addison, British ...Learn More


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In the News
West Michigan woman first in world to get life-saving heart device
By: MLive.com | February 2015

A West Michigan woman with heart disease became the first in the world to receive a new life-saving medical device, thanks to a “full court press” by Spectrum Health to get permission from federal regulators.

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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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