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Medtech companies tweak strategies as prices tumble
Strong competition in the medtech sector has led to declining prices for many medical devices, and hospitals face increasing ...Learn More
Funding round pulls in $6M for Via Surgical
A round of financing led by Benslie Investment Group has brought in $6 million for Israel-based Via Surgical. ...Learn More
Implanet America names new president
Brian Ennis has been tapped to serve as president of Implanet America. ...Learn More
First patient implanted with lateral lumbar cage recorded by VGI Medical
A patient at Flagler Hospital in Florida was the first to be implanted successfully with VGI Medical's VerteLP Lateral ...Learn More
Canada approves catheter tip location system from AngioDynamics
The Celerity PICC Tip Confirmation System with Navigation, a tip location technology developed by Latham, N.Y.-based ...Learn More
Optical coherence tomography technology from St. Jude debuts
The OPTIS Mobile System, which combines angiography co-registration and optical coherence tomography with fractional flow ...Learn More
Occlusion balloon from Spectranetics lands FDA clearance
The Bridge, an occlusion balloon from Colorado Springs, Colo.-based Spectranetics, has obtained 510(k) clearance from the ...Learn More
Obama seeks funding to create Zika vaccine, fight virus
President Barack Obama will request more than $1.8 billion in funding from Congress to fight the spread of the Zika virus in ...Learn More
EU OKs point-of-care platform, chlamydia test from Atlas Genetics
Regulators in Europe have given Atlas Genetics the CE-IVD mark for its io point-of-care platform and Chlamydia trachomatis ...Learn More
Meeting date set for FDA advisory panel to review cartilage implant from Cartiva
The FDA's Orthopaedic and Rehabilitation Devices Panel will convene April 20 to consider Cartiva's bid for premarket ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
Adaptability is about the powerful difference between adapting to cope and adapting to win.
Max McKeown, writer and leadership ...Learn More
Secondary shares offering could bring in $1.1B for Zimmer Biomet
Orthopedics company Zimmer Biomet is planning to sell 11 million shares in a secondary offering with the goal of securing ...Learn More
Share-buyback program initiated by Edwards Lifesciences
Edwards Lifesciences has entered into a deal to buy back $350 million in stocks from Morgan Stanley as part of a $750 ...Learn More
Offering could pull in about $5.8M for Titan Medical
Titan Medical said it intends to offer 8.9 million shares in an offering aimed at securing $5.8 million. ...Learn More
Biotronik, Maquet reach US distribution deal
A deal has been reached by Maquet Medical Systems to distribute the peripheral vascular devices of Berlin-based Biotronik in ...Learn More
Report forecasts growth for global digital X-ray market
A MarketsandMarkets report predicts the worldwide digital X-ray systems market will reach $10.46 billion by 2020, with an ...Learn More
First treatment using live-image guided embolic beads recorded by BTG, Philips
The first instance of a liver cancer patient being treated with BTG's LC Bead LUMI embolic beads together with Philips' 2D ...Learn More
Lombard Medical records first use of endovascular stent graft
A patient at the UK's University Hospital of South Manchester was the first to undergo endovascular repair using Lombard ...Learn More
N.Y. facility to evaluate cardiac rehabilitation tool's effectiveness
A clinical trial to evaluate the effectiveness of Moving Analytics' MOVN app beyond three months of use by cardiac ...Learn More
Study: Sentinel platform, iPod tool show promise in matching patients to their EHRs
An FDA-funded study said the agency's Sentinel database and iPod Touch-based app called the Hand-held Automated Notification ...Learn More
2 MRI-safe defibrillators from Medtronic get FDA approval
Medtronic's Compia and Amplia MRI Quad SureScan cardiac resynchronization therapy defibrillator devices have been approved ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Having just the vision's no solution; everything depends on execution.
Stephen Sondheim, composer and ...Learn More
Merger of TriVascular, Endologix completed
Santa Rosa, Calif.-based TriVascular Technologies has concluded its merger with Irvine, Calif.-based Endologix for $221 ...Learn More
Hemodialysis access graft acquired by Merit Medical in $18.5M deal
Salt Lake City-based Merit Medical Systems has agreed to pay $18.5 million in cash to acquire the HeRO hemodialysis access ...Learn More
Deal to acquire oxygen therapy device firm completed by ResMed
San Diego-based ResMed has concluded its purchase of Inova Labs, an Austin, Texas-based oxygen therapy medtech firm, for an ...Learn More
Fujifilm China enters expanded commercialization deal with Mauna Kea
Fujifilm China has reached a deal with Mauna Kea Technologies for commercialization of the latter's Cellvizio, a confocal ...Learn More
Report forecasts growth for worldwide knee reconstruction devices market
A MarketsandMarkets report predicts the worldwide market for knee reconstruction devices will reach $7.94 billion by 2020, ...Learn More
Medovex's facet joint syndrome device scores reimbursement win in Germany
The use of Medovex's DenerveX System to treat facet joint syndrome in the spine will be covered in Germany. ...Learn More
Startup developing technology to debug lab experiments
Misfit Wearables co-founders Sridhar Iyengar and Sonny Vu, along with Elicia Wong and Gary Tsai, have founded a new company ...Learn More
EU OKs pediatric glucose monitor from Abbott
Regulators in Europe have given Abbott CE mark approval to market its FreeStyle Libre, a flash glucose monitoring technology ...Learn More
Medtronic gains expanded approval for CoreValve device
The FDA has granted Medtronic expanded labeling approval for its CoreValve System. ...Learn More
Defining Value Webinar: Implications of New Value Frameworks for Devices
March 4 | WebinarDuring this one-hour webinar, you will hear an update on comparative effectiveness research in the US. ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
Whatever you think the world is withholding from you, you are withholding from the world.
Eckhart Tolle, ...Learn More
Surgical stapler and sealing device maker gets $11.2M boost
A Series B round of debt and equity financing has brought in $11.2 million for JustRight Surgical, a Louisville, Colo.-based ...Learn More
Financing round brings in $4M for BioDirection
A round of Series B convertible preferred stock funding has pulled in $4 million for Boston-based BioDirection. ...Learn More
Kalila Medical to be acquired by Abbott
Abbott has agreed to pay an undisclosed amount to purchase Kalila Medical, a Campbell, Calif.-based maker of steerable ...Learn More
Q1 revenue increases for Becton Dickinson
Becton Dickinson generated $2.99 billion in revenue in the quarter ending Dec. ...Learn More
Former Bioventus exec named CEO of Seno Medical
Tom Umbel has been tapped to serve as CEO of Seno Medical Instruments. ...Learn More
New trial site added by Active Implants for meniscal implant study
Active Implants has added a new location for a study of its NUsurface, an investigational meniscus implant designed to ...Learn More
Report: US market for breast cancer Dx devices to surpass $2B by 2020
A Pharmaion report predicts the US breast cancer diagnostic devices market will exceed $2 billion by 2020. ...Learn More
Worldwide market for cervical artificial discs set for growth
A Technavio report predicts the worldwide market for cervical artificial discs will exceed $1.08 billion by 2020. ...Learn More
FDA's review program enhancements get passing grade from assessors
An independent assessment group has given the FDA a passing score for the changes it made to enhance its review process ...Learn More
Draft guidance on medtech packaging codes released by FDA
Draft guidance has been published by the FDA allowing some medical device packaging to continue having National Health ...Learn More
Technical Writing for Regulatory Submissions
March 8 | Sunnyvale, Calif. ...Learn More
FDA Submissions Strategy
March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
The thing that makes you say, 'I want to do something' -- that is the beginning of talent.
Stella Adler, actress and ...Learn More
Irish medtech firm acquired by TE Connectivity in $895M deal
Switzerland-based TE Connectivity has agreed to pay $895 million in cash to purchase Creganna Medical, an Irish medical ...Learn More
Italian medtech firm purchased by Medtronic
Medtronic has agreed to pay an undisclosed sum to acquire Bellco, a privately held Italian company, from Charme Capital ...Learn More
Worldwide market for outsourced orthopedic manufacturing set for growth
A Technavio report predicts the worldwide market for outsourced orthopedic manufacturing will reach more than $2 billion by ...Learn More
GeneXpert systems, reagents drive Q4 revenue growth for Cepheid
Sunnyvale, Calif.-based Cepheid generated $147 million in revenue in the quarter ending Dec. ...Learn More
New reimbursement director, chief marketing officer named by TranS1
Chris Groppa was tapped to serve as reimbursement director and chief marketing officer at TranS1, a medtech firm that ...Learn More
Firm gets $2.25M grant for critical care monitoring system
The NIH awarded San Francisco-based Potrero Medical a $2.25 million Small Business Innovation Research grant. ...Learn More
Analogic to use Oncura's remote imaging tools to offer teleconsultation services
An ultrasound-based telemedicine program was unveiled by Analogic after it purchased Oncura Partners Diagnostics. ...Learn More
Carestream mobile module shows promise in trauma, wound care
A browser-based mobile care module was unveiled by Carestream Health to securely link caregivers at accident sites and ...Learn More
Robotic catheter kit from Hansen gets FDA clearance
The Magellan Robotic Catheter eKit, developed by Mountain View, Calif.-based Hansen Medical, has obtained 510(k) clearance ...Learn More
EU OKs MRI-safe defibrillators from Biotronik
Regulators in Europe have given Biotronik CE mark approval to market its Ilivia implantable cardioverter defibrillator and ...Learn More
510(k) Submissions Workshop
Feb. 22-23 | Irvine, Calif. ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
Your days are numbered. Use them to throw open the windows of your soul to the sun. If you do not, the sun will soon set, and you with it.
Marcus Aurelius, ...Learn More
Sage Products acquired by Stryker in $2.8B deal
Stryker has agreed to pay $2.8 billion to purchase Sage Products, a Cary, Ill.-based developer of devices for preventing ...Learn More
Deal to acquire Cardiac Science completed by Aurora Resurgence
Aurora Resurgence has concluded a deal to purchase the assets of Cardiac Science, a company producing automated external ...Learn More
Knee products drive net sales growth for Zimmer Biomet in 2015
Zimmer Biomet generated $5.9 billion in total net sales in 2015, a 28.3% increase over 2014. ...Learn More
Q4 revenue increases for Luminex
Luminex generated $60.4 million in revenue in the quarter ending Dec. ...Learn More
Chief innovation and strategy officer named by Royal Philips
Jean Botti has been named chief innovation and strategy officer of Royal Philips. ...Learn More
Additional sizes of Medtronic's stent get EU OK
European regulators have granted CE mark approval to the 5-millimeter and 4.5-millimeter versions of Medtronic's Resolute ...Learn More
Blood glucose monitor from LabStyle Innovations to debut this quarter
LabStyle Innovations is gearing up for a first-quarter release of its Dario blood glucose-monitoring device. ...Learn More
Phone app tracks Parkinson's disease symptoms
Researchers with the Oxford Parkinson's Disease Centre have been studying a mobile phone application that monitors the ...Learn More
Stented heart valve from LivaNova gets FDA approval
The Crown PRT, a stented aortic heart bioprosthesis from LivaNova, has obtained premarket approval from the FDA. ...Learn More
Ablation catheter recalled by J&J unit
A recall was initiated by Ethicon, a subsidiary of Johnson & Johnson, involving the catheter component of its Gynecare ...Learn More
California Proposition 65 Webinar: What to Know and What's Ahead
Feb. ...Learn More
PMA Submissions Workshop
Feb. 25-26 | Irvine, Calif. ...Learn More
The measure of a man is what he does with power.
Plato, ...Learn More
Spectral Medical announces stock sale to underwriters
A deal has been reached by Toronto-based Spectral Medical to sell $10 million worth of its shares to a consortium of ...Learn More
Funding round brings in $8M for BiO2 Medical
A secured term loan from Oxford Finance has brought in $8 million for San Antonio-based BiO2 Medical. ...Learn More
Program from Partners HealthCare encourages device, drug innovation among employees
Partners HealthCare has launched the second round of its Innovation Discovery Grants program that will offer up to $1 ...Learn More
Report forecasts growth for worldwide orthopedic trauma device market
A Persistence Market Research report predicts the worldwide market for orthopedic trauma devices will reach $9.4 billion by ...Learn More
Q2 revenue increases for Accuray
Accuray generated $109 million in revenue in the quarter ending Dec. ...Learn More
First patient implanted with Implanet's spine correction device recorded in Brazil
A patient undergoing idiopathic scoliosis surgery at Hospital do Servidor Publico Estadual was the first in Brazil to be ...Learn More
People with heart risk report low use of health tracking apps
A HealthMine survey of 501 people with heart disease or heart risks found that 27% were using fitness or health trackers, ...Learn More
AdvaMed: FDA has existing postmarket authorities over medical devices
Sen. ...Learn More
MR prostate imaging surface coil from Siemens gets FDA clearance
The SEEit surface coil, developed by Siemens Healthcare for MR prostate imaging, has obtained clearance from the FDA. ...Learn More
Arkray's blood sugar test strips recall labeled Class I by FDA
A recall initiated by Arkray involving 2,475 SPOTCHEM II glucose reagent test strips and SPOTCHEM II Basic Panel-1 reagent ...Learn More
Women's Executive Network Webinar: Executive Profiles
March 29 | WebinarDuring the one-hour webinar, two senior leaders in the medical device industry, Cathy Burzik and Judy ...Learn More
AdvaMed Women's Executive Network Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. ...Learn More
Lineage, personality, and environment may shape you, but they do not define your full potential.
Mollie Marti, ...Learn More
UK-based firm gets $14.3M boost
Multiple funding rounds have pulled in $14.3 million for UK-based firm Vascular Flow Technologies. ...Learn More
Vanadis Diagnostics acquired by PerkinElmer
PerkinElmer has agreed to pay an undisclosed sum to purchase Sweden-based Vanadis Diagnostics. ...Learn More
Equity funding round pulls in $2.1M for GTX Surgery
A round of equity financing involving four unnamed investors has brought in $2.1 million for GTX Surgery. ...Learn More
Molecular, sequencing units drive 2015 sales growth for Roche
Swiss pharmaceutical and diagnostics firm Roche Holding said its molecular diagnostics sales increased 7% from 2014, ...Learn More
Coroneo, Admedus reach distribution deal
Admedus has made a deal to exclusively distribute the heart valve surgical instruments and aortic annuloplasty ring of ...Learn More
New CFO, vice president named by Stryker
Glenn Boehnlein has been tapped to serve as vice president and CFO of Stryker starting April 1. ...Learn More
Accelerator welcomes 13 digital health firms
The Innovation Institute of Texas Medical Center has tapped 13 startups to join the digital health program of its TMCx ...Learn More
Drugmakers look to the Internet for data collection
Novartis is working with Qualcomm to develop an inhaler that can connect to the Internet to communicate information about ...Learn More
2 MRI-safe pacemakers from LivaNova win approval in Japan
Japanese regulators have given London-based LivaNova approval to commercialize two MRI-safe pacemakers in that country. ...Learn More
Lung cancer test from Veracyte gets approval in N.Y.
Veracyte's Percepta Bronchial Genomic Classifier has been approved by the New York State Department of Health. ...Learn More
Defining Value Webinar: Implications of New Value Frameworks for Devices
March 4 | WebinarDuring this one-hour webinar, you will hear an update on comparative effectiveness research in the US. ...Learn More
AdvaMed-BRG Compliance Executive Speaker Series
April 13, Irvine, Calif. | May 18, Sunnyvale, Calif. | Sept. 14, Chicago, Ill. | Oct. ...Learn More
The main ingredient of stardom is the rest of the team.
John Wooden, basketball player and ...Learn More
Funding round brings in $20M for Minnetronix
A round of equity financing from Altaris Capital Partners has brought in $20 million for Minnetronix, a St. ...Learn More
OncoCyte gains exclusive rights from Wistar Institute for lung cancer Dx test
OncoCyte has acquired the exclusive commercial rights to a blood-based lung cancer diagnostic it co-developed with the ...Learn More
Q1 revenue increases for Hologic
Bedford, Mass.-based Hologic generated $695.2 million in revenue in the quarter ending Dec. ...Learn More
Implantable device promising for type 1 diabetes
Researchers at Harvard University and the Massachusetts Institute of Technology have developed a device that could protect ...Learn More
Additional sizes of Biotronik's drug-coated balloon get EU OK
European regulators have granted CE mark approval to the 2.5-millimeter and 2-millimeter versions of Biotronik's Passeo-18 ...Learn More
DARPA seeks proposals for brain-computer initiative
The US Defense Advanced Research Projects Agency is inviting proposals for its Neural Engineering System Design initiative ...Learn More
Firms partner to establish medtech cybersecurity task force
Virginia Beach, Va.-based health care consulting company Divurgent and Asbury, N.J.-based cybersecurity firm Sensato are ...Learn More
Eli Lilly's insulin pen device gets FDA approval
The Humulin R U-500 KwikPen from Eli Lilly & Co., the first prefilled insulin pen device to utilize concentrated U-500 ...Learn More
EU approves cervical disc device from K2M
Regulators in Europe have given K2M Group Holdings CE mark approval to market its Rhine cervical disc technology. ...Learn More
FDA clears blood-draw system from Velano Vascular
A new version of San Francisco-based Velano Vascular's needleless blood-draw device has received 510(k) clearance from the ...Learn More
Tax Extender Legislation Webinar
Feb. 2 | WebinarOn Jan. 1, the suspension for the 2.3% excise tax on medical devices went into effect. ...Learn More
California Proposition 65 Webinar: What to Know and What's Ahead
Feb. ...Learn More
You can't always expect a certain result, but you can expect to do your best.
Anita Hill, lawyer and ...Learn More
IPO could pull in $86M for Tactile Systems
An initial public offering that could raise $86 million has been filed by Tactile Systems Technology. ...Learn More
Debt financing round pulls in $2.4M for Bigfoot Biomedical
A debt funding round involving six undisclosed investors has brought in $2.4 million for bionic pancreas maker Bigfoot ...Learn More
Funding round brings in $61M for exosome-based Dx and therapeutics maker
A round of Series B financing led by Flagship Ventures and ARCH Venture Partners has pulled in $61 million for Codiak ...Learn More
Q1 revenue increases for Siemens
Siemens Healthcare generated about $3.57 billion in revenue in the first quarter, an increase from roughly $3.09 billion in ...Learn More
Industry veteran named VP at SpineGuard
Steve McAdoo has been tapped to serve as vice president of business development for SpineGuard. ...Learn More
Intraoperative imaging market in North America set for growth
A report from MicroMarketMonitor predicts that by 2019, the North American market for intraoperative imaging could hit $1.09 ...Learn More
EU OKs meningitis/encephalitis panel from BioFire
BioMerieux unit BioFire Diagnostics received CE mark approval from European regulators to market its FilmArray ...Learn More
Neuroma management device from Polyganics gets FDA clearance
The NEUROCAP, a device developed by Polyganics to reduce the formation of neuromas, has obtained 510(k) clearance from the ...Learn More
EU approves 3D damage assessment device from Episurf Medical
The Epioscopy Damage Assessment Tool, developed by Episurf Medical, has obtained CE mark approval from European regulators. ...Learn More
Malaria test from Meridian Bioscience gets EU OK
The Illumigene Malaria test, developed by Meridian Bioscience, has obtained CE mark approval from European regulators. ...Learn More
Technical Writing for Regulatory Submissions
March 8 | Sunnyvale, Calif. ...Learn More
FDA Submissions Strategy
March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
When defeat comes, accept it as a signal that your plans are not sound, rebuild those plans, and set sail once more toward your coveted goal.
Napoleon Hill, ...Learn More
Funding round pulls in $7.5M for Jan Medical
A Series C financing round from Munich-based Brainlab has brought in $7.5 million for Mountain View, Calif.-based Jan ...Learn More
IPO could bring in $6M for PAVmed
PAVmed is planning to sell 1.2 million shares in an initial public offering with the goal of securing $6 million. ...Learn More
Scinovia looks to pull in $6M for blood-flow imaging device
Scinovia, a Durham, N.C.-based medtech startup, is looking to raise $6 million. ...Learn More
Pentagon, University of Michigan team up on TBI challenge
The Massey Foundation TBI Grand Challenge will be hosted by the Department of Defense and the University of Michigan Center ...Learn More
Intramedullary hip nail device from Orthopaedic Implant debuts
An intramedullary hip nail technology was introduced by Reno, Nev.-based Orthopaedic Implant. ...Learn More
Patent issued to Mach7's medical imaging modality
A US patent has been issued to Mach7 Technologies for the use of mobile devices to capture and upload medical imaging into ...Learn More
Dako wins expanded indication for complementary Dx tool
The PD-L1 IHC 28-8 pharmDx, a complementary diagnostic device from Dako, has been approved by the FDA for an additional ...Learn More
FDA releases draft guidance on designing, labeling interoperable devices
Draft guidance has been published by the FDA to assist medical device makers in designing products that are interoperable ...Learn More
US, EU regulators clear ultrasound from Fujifilm
The SonoSite Edge II, a portable ultrasound device from Fujifilm SonoSite, has obtained the CE mark in Europe and 510(k) ...Learn More
St. Jude's defibrillator leads recall labeled Class I by FDA
A recall initiated by St. ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
PMA Submissions Workshop
Feb. 25-26 | Irvine, Calif. ...Learn More
Obstacles can't stop you. Problems can't stop you. Most important of all, other people can't stop you. Only you can stop you.
Jeffrey Gitomer, business trainer and ...Learn More
Deal to acquire Liberator Medical completed by C.R. Bard
Murray Hill, N.J.-based C.R. ...Learn More
Kyoto University works with Panasonic to develop remote sensing system
Kyoto University and Panasonic have partnered to create a remote sensing technology for vital signs such as heartbeat ...Learn More
Worldwide market for knee, hip orthopedic surgery robots set for growth, study says
The global knee and hip orthopedic surgical robots market is predicted to reach $4.6 billion by 2022, according to a Market ...Learn More
New board member named by SpineFrontier
Jerry Goldstein has been tapped to serve on the board of directors at SpineFrontier. ...Learn More
Industry veteran named CEO of Bonesupport
Richard Davies has been appointed CEO of Bonesupport, a Swedish maker of bone substitutes and scaffolding systems for ...Learn More
Study begins for Mercator MedSystems' micro-infusion device
The first patient in a trial of Bullfrog, a micro-infusion system designed to address critical limb ischemia below the knee, ...Learn More
5 neurodevelopmental genetic tests from Ambry Genetics debut
Aliso Viejo, Calif.-based Ambry Genetics has introduced five genetic tests intended for neurodevelopmental disorders. ...Learn More
PMAs for depression-targeted cranial electrotherapy stimulators proposed by FDA
Makers of cranial electrotherapy stimulators whose devices are meant to treat depression would be required to file ...Learn More
EU OKs cervical disc device from K2M
The RHINE Cervical Disc System, developed by K2M Group, has obtained CE mark approval from European regulators. ...Learn More
510(k) Submissions Workshop
Feb. 22-23 | Irvine, Calif. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
To do anything in this world worth doing, we must not stand back shivering and thinking of the cold and danger, but jump in and scramble through as well as we can.
Sydney Smith, writer and ...Learn More
AdvaMed says FDA's medtech sterilization guidance increases testing requirements
AdvaMed said the final guidance issued by the FDA addressing sterile medical devices submitted for 510(k) clearance would ...Learn More
Deal to acquire On-X Life Technologies completed by CryoLife
CryoLife has concluded a $130 million deal to purchase On-X Life Technologies, an Austin, Texas-based maker of an aortic ...Learn More
MicroAire Surgical, Polyganics reach distribution deal
MicroAire Surgical Instruments has made a deal to exclusively distribute Polyganics' peripheral nerve repair products in ...Learn More
Paradigm's cancer Dx text scores reimbursement win from UnitedHealthcare
UnitedHealthcare will cover PCDx, a next-generation sequencing test developed by Paradigm to detect cancer. ...Learn More
Creation of UK unit expands SI-BONE's presence in Europe
Sacroiliac joint medtech firm SI-BONE has established a unit in the UK. SI-BONE UK will be the firm's third office in ...Learn More
China OKs NeuroMetrix's neuropathy Dx test
Waltham, Mass.-based NeuroMetrix has obtained approval from Chinese regulators for its DPNCheck, a point-of-care test for ...Learn More
Robotic surgery device prototype unveiled by Titan Medical
A prototype of Titan Medical's Sport, a robot-assisted surgical technology, was unveiled to investors in New York this week. ...Learn More
FDA clears spine system from Centinel Spine
The ALTOS, a posterior cervical thoracic stabilization technology from West Chester, Pa.-based Centinel Spine, has obtained ...Learn More
MRI scanner from Siemens lands FDA clearance
The Magnetom Amira, a 1.5-tesla MRI unit from Siemens Healthcare, has obtained clearance from the FDA. ...Learn More
Hernia repair biomaterial from Gore Medical cleared by FDA
The GORE SYNECOR, a biomaterial developed by Gore Medical for repairing hernia, has obtained 510(k) clearance from the FDA. ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
We only become what we are by the radical and deep-seated refusal of that which others have made of us.
Jean-Paul Sartre, philosopher and ...Learn More
Schwartz Biomedical unit brings in $300,000 in Series D funding round
BioPoly, the Fort Wayne, Ind.-based subsidiary of Schwartz Biomedical, has obtained $300,000 toward its goal of $5 million ...Learn More
Oncgnostics taps German lab distributor to offer product in Europe
Oncgnostics has secured a distribution deal with Greiner Bio-One, a German laboratory distributor, to help bring its GynTect ...Learn More
Report forecasts growth for worldwide ultrasound market
A Research and Markets report predicts the worldwide market for ultrasound devices will expand between 2015 and 2021 at a ...Learn More
New marketing director named by Medtech
Teresa Prego has been tapped to serve as marketing director at French surgical robotic firm Medtech. ...Learn More
Trial begins for Delcath's treatment for ocular melanoma
A planned 240-patient, Phase III study has been launched by Delcath to assess the pharmacokinetic profile, efficacy and ...Learn More
Patent issued to AlloSource's cartilage repair allograft
AlloSource, a nonprofit cellular and tissue network, has obtained a patent for its ProChondrix Cartilage Restoration Matrix. ...Learn More
Mobile cardiac telemetry patch from LifeWatch cleared by FDA
The LifeWatch Mobile Cardiac Telemetry Patch, developed by LifeWatch, has obtained 510(k) clearance from the FDA. ...Learn More
A summary of FDA's proposed LDT policy
The FDA has heightened scrutiny of laboratory-developed tests as more LDTs come on the market and more health care ...Learn More
FDA clears lumbar cage technology from VGI Medical
The VerteLP Lateral Lumbar Cage System, developed by VGI Medical, has received 510(k) clearance from the FDA. ...Learn More
Meeting date set for FDA advisory panel to review bioabsorbable stent from Abbott
The FDA's Circulatory System Devices Panel will convene March 15 to consider Abbott's bid for premarket approval of its ...Learn More
FDA Submissions Strategy
March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
Our business in life is not to get ahead of other people, but to get ahead of ourselves.
Maltbie Babcock, clergyman and ...Learn More
Funding round pulls in $19M for ZipLine Medical
A round of financing led by MVM Life Science Partners has brought in $19 million for ZipLine Medical. ...Learn More
Deal to merge Dx unit with Avant Diagnostics signed by Amarantus
A letter of intent has been signed by Amarantus Bioscience Holdings to combine its Amarantus Diagnostics unit with Avant ...Learn More
Shareholder vote on Mindray's management buyout set for Feb. 26
A general shareholders' meeting has been set for Feb. ...Learn More
Wireless sensors can track brain activity, then dissolve
Researchers at the Washington University School of Medicine and the University of Illinois report coming up with wireless ...Learn More
FDA clears esophageal cooling device from Advanced Cooling Therapy
The ECD-02, a device developed by Advanced Cooling Therapy, has received 510(k) clearance from the FDA. ...Learn More
Drug-eluting stent from Svelte Medical debuts in Europe
Svelte Medical Systems' SLENDER, a sirolimus-eluting coronary stent-on-a-wire integrated delivery device, has been launched ...Learn More
Meeting date set for FDA advisory panel to review heart monitor from Angel Medical
The FDA's Circulatory System Devices Panel will convene March 16 to consider Angel Medical Systems' bid for premarket ...Learn More
CDC guidance recommends Zika virus screening in pregnant women
New guidelines have been released by the CDC to boost early detection of Zika virus infection among pregnant women who ...Learn More
Japan OKs atrial occlusion products from AtriCure
Japanese authorities have approved the AtriClip left atrial appendage occlusion products by AtriCure. ...Learn More
HealthMyne's medical imaging analytics software lands FDA clearance
The FDA has granted 510(k) clearance to HealthMyne's analytics software that can help identify if a tumor is stable, ...Learn More
PMA Submissions Workshop
Feb. 25-26 | Irvine, Calif. ...Learn More
Technical Writing for Regulatory Submissions
March 8 | Sunnyvale, Calif. ...Learn More
The surest way to corrupt a youth is to instruct him to hold in higher esteem those who think alike than those who think differently.
Friedrich Nietzsche, ...Learn More
Radiofrequency device from Medtronic debuts in US
The OsteoCool, a radiofrequency ablation device intended for addressing painful spine metastases, has been launched in the ...Learn More
Molecular Dx firm gets $1.6M boost
The first tranche of a Series B financing round has brought in $1.6 million for Dublin-based HiberGene Diagnostics. ...Learn More
Q4 revenue increases for French molecular Dx company
Genomic Vision, a French molecular diagnostics firm, generated $1.1 million in revenue in the fourth quarter of 2015, a 127% ...Learn More
Former GI Dynamics exec named CEO of Ivenix
Stuart Randle has been tapped to serve as CEO of Ivenix, a developer of next-generation infusion pump technology. ...Learn More
New commercial director named by Zilico
Andrew Saipe has been tapped to serve as commercial director for UK-based cervical cancer diagnostic firm Zilico. ...Learn More
Survey: Consumers disagree with USPSTF's mammogram guidelines
A survey by health care technology firm HealthMine found that 67% of consumers believe mammograms should start before age ...Learn More
Studies examine application's effectiveness in detecting preterm birth risk
Two studies published in Ultrasound in Obstetrics & Gynecology found an application designed by a team of researchers from ...Learn More
New PET/CT system from Neusoft debuts
The NeuSight PET/CT system was launched by Neusoft Medical Systems. ...Learn More
Trademark system undergoes changes in Europe
Europe has implemented rules that make its trademark system easier to use, more effective and cheaper. ...Learn More
510(k) Submissions Workshop
Feb. 22-23 | Irvine, Calif. ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
If you are going to achieve excellence in big things, you develop the habit in little matters. Excellence is not an exception, it is a prevailing attitude.
Colin Powell, military leader and ...Learn More
Spinal implant firm gets nearly $27M boost
An equity and options offering involving eight unnamed investors has brought in almost $27 million for San Clemente, ...Learn More
Avita signs distribution deals for skin-treatment device in South Korea, Japan
Indee Medical has made a deal to distribute Avita Medical's ReCell, a device intended to address skin issues such as burns, ...Learn More
Medtech is a bright spot for Philadelphia
Venture capital funds invested more than $122 million in Philadelphia medtech startups and devices last year, compared with ...Learn More
Surgical robot maker to move operations to Nebraska Innovation Campus
Virtual Incision, a developer of tiny surgical robots, will relocate its operations to the Nebraska Innovation Campus in ...Learn More
Heart valve replacement from Edwards Lifesciences gets FDA IDE designation
The FDA has granted an investigational device exemption to Irvine, Calif.-based Edwards Lifesciences for a study of the ...Learn More
Anterior cervical plate technology from DeGen Medical debuts
The Hyper-C Anterior Cervical Plate System, an intervertebral fixation technology intended for cervical spine stabilization, ...Learn More
FDA clears redesigned duodenoscope from Olympus
Olympus' redesigned TJF-Q180V duodenoscope, which includes labeling and design modifications, has received clearance from ...Learn More
Cybersecurity draft guidance unveiled by FDA
The FDA has published draft guidance to help medical device companies determine and address their products' vulnerabilities ...Learn More
FDA labels Brainlab's image-guided surgical device recall as Class I
A recall involving Brainlab's Cranial Image-Guided Surgery System and Cranial Navigation Systems before Cranial 3.0 has been ...Learn More
Statistical Methods in Economic Evaluations Workshop
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9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
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Doing the best at this moment puts you in the best place for the next moment.
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IPO could pull in up to $51.8M for Senseonics
An initial public offering that could raise as much as $51.8 million has been filed by Germantown, Md.-based Senseonics. ...Learn More
Funding round brings in $4.5M for cancer diagnostics firm
A Series A equity funding round has pulled in $4.5 million for 20/20 GeneSystems. ...Learn More
Mich. medical school, Senior Scientific team up to work on breast cancer Dx device
A partnership deal was reached between the University of Michigan Medical School and Senior Scientific, a unit of Manhattan ...Learn More
Former Medtronic exec joins Bioventus as board chairman
Bill Hawkins has been tapped to serve as board chairman at Bioventus. ...Learn More
Neuro-tech startups aim to treat brain disorders
Startups are combining neuroscience and technology to develop devices that treat brain diseases such as Alzheimer's, ...Learn More
Patent issued to Band-Lok, Kapstone Medical
A US patent has been issued to orthopedic medtech firm Band-Lok and engineering firm Kapstone Medical for the Band-Lok ...Learn More
Study begins for Uptake Medical's lung therapy system
A registry trial has been launched by Tustin, Calif.-based Uptake Medical to assess clinical findings on the use of its ...Learn More
EU OKs electrophysiology recorder/stimulator from Imricor
The Advantage-MR, an electrophysiology recorder/stimulator technology from Imricor Medical Systems, has obtained CE mark ...Learn More
FDA clears cardiac ultrasound imaging device from Conavi
The Foresight ICE System, a device from Conavi Medical intended for intraluminal and intracardiac ultrasound visualization ...Learn More
Siemens' hemostasis device lands FDA clearance
The Sysmex CS-5100, a hemostasis technology from Siemens Healthcare, has received 510(k) clearance from the FDA. ...Learn More
2nd Annual AdvaMed Payment Policy Conference
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Medical Device Complaints, MDRs & Reports Workshop
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The worst part of success is trying to find someone who is happy for you.
Bette Midler, ...Learn More
EnteroMedics gets $11M funding boost
The second tranche of St. ...Learn More
Funding round pulls in $10.8M for ALung Technologies
A debt financing round involving 63 unnamed investors brought in $10.8 million for ALung Technologies. ...Learn More
Q2 revenue jumps for Medtech
Medtech generated almost $3.1 million in revenue in the second quarter of 2016, an increase from $1.2 million in the same ...Learn More
New board member named by HeartWare
Dr. ...Learn More
First surgery using hemi wrist device recorded by Extremity Medical
A patient in the UK was the first to undergo a successful surgery using the KinematX Modular Hemi Wrist technology from ...Learn More
Study: Patient app shows promise for diabetes management
A study in Diabetes Technology & Therapeutics found Twine Health's chronic condition management application for smartphones ...Learn More
Skin adhesive from OptMed cleared by FDA
The FDA has given 510(k) clearance to OptMed's BondEase, a topical skin adhesive not based on cyanoacrylate chemistry. ...Learn More
FDA device center publishes 2016-2017 strategic priorities
A list of strategic priorities was issued by the FDA's Center for Devices and Radiological Health for 2016 and 2017. ...Learn More
EU OKs male infertility Dx platform from Aytu BioScience
The MiOXSYS, an in vitro diagnostic platform developed by Aytu BioScience to help detect male infertility, has obtained CE ...Learn More
Radiofrequency device from Medtronic lands FDA OK
The OsteoCool Ablation System, a cooled radiofrequency ablation device from Medtronic, has obtained approval from the FDA. ...Learn More
Technical Writing for Regulatory Submissions
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FDA Submissions Strategy
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The man who can drive himself further once the effort gets painful is the man who will win.
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Funding round brings in $28M for V-Wave
A round of Series B financing involving Edwards Lifesciences and Johnson & Johnson Innovation has pulled in $28 million for ...Learn More
Catheter technologies firm purchased by SurModics
SurModics, an Eden Prairie, Minn.-based firm, has agreed to pay $7 million upfront plus another $7 million in potential ...Learn More
Catheter tip placement solution maker acquired by Teleflex
Wayne, Pa.-based Teleflex has agreed to pay an undisclosed sum to purchase Nostix, a Boulder, Colo.-based provider of ...Learn More
Preliminary results show Q4 revenue rise for GenMark Diagnostics
GenMark Diagnostics made $13.2 million in revenue for the fourth quarter, preliminary results showed, an increase of 35% ...Learn More
BCBS of Ill. to cover Biocept's cancer DNA tests
Blue Cross Blue Shield of Illinois will cover Biocept's assays that detect circulating tumor cells and circulating tumor ...Learn More
Digital ureteroscope from Boston Scientific debuts
The LithoVue, a single-use digital ureteroscope, has been launched by Boston Scientific. ...Learn More
Medtronic wins expanded indication for drug-eluting balloon in Europe
The IN.PACT Admiral, a drug-eluting balloon from Medtronic, has been approved by European regulators for an additional ...Learn More
Califf advances after Senate panel backs nomination to lead FDA
The Senate Health, Education, Labor, and Pensions Committee has recommended confirmation of cardiologist Robert Califf as ...Learn More
FDA clearance sought by BioFire for respiratory panel platform
BioFire Diagnostics has filed an application with the FDA seeking special 510(k) clearance for the use of its FilmArray ...Learn More
FDA labels Stryker's pleural drainage device recall as Class I
A recall involving Stryker's Fuhrman & Pneumopericardial drainage set has been categorized as Class I by the FDA. ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
PMA Submissions Workshop
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Who overcomes by force, hath overcome but half his foe.
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Funding rounds pull in $27.2M for Eye Tech Care
Two rounds of funding from Everpine Capital brought in about $27.2 million for Lyon, France-based Eye Tech Care. ...Learn More
Skin closure device maker gets $16.4M boost
A round of debt and equity funding involving 28 unnamed investors has brought in $16.4 million for Campbell, Calif.-based ...Learn More
Funding round brings in $3M for QuanDx
A round of Series B financing has pulled in $3 million for San Jose, Calif.-based QuanDx. ...Learn More
Preliminary results show Q4 revenue rise for NanoString
The total revenue generated by Seattle-based NanoString Technologies for the fourth quarter could reach as high as $22.1 ...Learn More
Calif. health system to use Proteus' ingestible sensor
South Lake Tahoe, Calif.-based health care provider Barton Health has begun prescribing Proteus Digital Health's Proteus ...Learn More
Pair of medtech products gain spotlight at CES 2016
Engadget magazine has selected the Owlet Smart Sock, a baby booty developed by Utah startup Owlet to monitor a child's blood ...Learn More
EU approves ultra high frequency ultrasound from Fujifilm VisualSonics
The Vevo MD, an ultra high frequency ultrasound developed by Fujifilm Sonosite subsidiary Fujifilm VisualSonics, has ...Learn More
Heart valve from LivaNova gets FDA approval
The Perceval, a sutureless heart valve replacement from London-based LivaNova, has obtained approval from the FDA. ...Learn More
Vascular closure device from Vivasure gains CE mark
A vascular closure technology from Vivasure Medical has received CE mark approval from European regulators. ...Learn More
Saudi Arabia approves proton therapy system from Varian
Varian Medical Systems has obtained medical device marketing authorization from the Saudi Food and Drug Authority to market ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
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510(k) Submissions Workshop
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An awake heart is like a sky that pours light.
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Financing round pulls in $9M for Bruin Biometrics
A funding round has brought in $9 million for Bruin Biometrics. ...Learn More
Clyra Medical Technologies enters financing deal with Sanatio Capital
A funding deal composed of an equity of $750,000 upfront and a commitment for an operating credit line worth $5 million was ...Learn More
Blood test maker enters concussion test deal with Royal Philips
A deal was reached between blood test developer Banyan Biomarkers and Royal Philips to create and commercialize a portable ...Learn More
Oncology software provider gets $175M boost
A Series C financing round led by Roche has brought in $175 million for Flatiron Health, a provider of cloud-based oncology ...Learn More
Lateral interbody device from K2M cleared by FDA
The FDA has given 510(k) clearance to K2M's CASCADIA Lateral Interbody System, a device that uses 3D printing to enable bony ...Learn More
Lymphedema assessment device from ImpediMed debuts in US
The L-Dex, a technology designed to help assess lymphedema, has been launched in the US by Carlsbad, Calif.-based ImpediMed. ...Learn More
Saudi Arabia OKs breast imaging system from Gamma Medica
Gamma Medica has received medical device marketing authorization from the Saudi Food and Drug Authority to market the ...Learn More
EU approves human leukocyte antigen typing tests from GenDx
The AlleleSEQR, a line of human leukocyte antigen typing tests from Utrecht, Netherlands-based GenDx, has obtained CE mark ...Learn More
Pedicle screw navigation guide from Mighty Oak Medical cleared by FDA
The FIREFLY Pedicle Screw Navigation Guide, developed by Mighty Oak Medical, has received 510(k) clearance from the FDA. ...Learn More
NeuroMetrix's upgraded pain relief device lands FDA clearance
An updated version of NeuroMetrix's Quell chronic pain relief wearable technology has received 510(k) clearance from the ...Learn More
Statistical Methods in Economic Evaluations Workshop
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Deal to acquire Blue Belt Holdings completed by Smith & Nephew
Smith & Nephew has concluded a $275 million deal to purchase Blue Belt Holdings, a firm specializing in orthopedic ...Learn More
Israel-based firm gets $10M funding boost
A round of financing has brought in $10 million for Pi-Cardia, a Rehovot, Israel-based maker of the Leaflex aortic valve ...Learn More
Financing round brings in $9M for BiO2 Medical
A round of Series D financing has pulled in $9 million for San Antonio-based BiO2 Medical. ...Learn More
Funding round pulls in $60M for Exosome Diagnostics
A Series B financing round has brought in $60 million for Exosome Diagnostics. ...Learn More
Glaukos' drug-eluting eye implant study gets FDA OK
The FDA has granted Laguna Hills, Calif.-based Glaukos approval for an investigational new drug trial of Travoprost, an ...Learn More
IBM designs app with Medtronic to predict hypoglycemia in patients
IBM and Medtronic have designed a wellness application that can predict hypoglycemic events in diabetes patients up to three ...Learn More
Diabetes data management platform from Insulet debuts
A data system using Glooko's diabetes management platform has been launched by Insulet for its OmniPod insulin technology. ...Learn More
PMA supplement for Integra's diabetic foot ulcer device OK'd by FDA
The premarket supplement filed by Integra LifeSciences for its Dermal Regeneration Template has obtained approval from the ...Learn More
Canada OKs febrile respiratory infection Dx test from RPS Diagnostics
A medical device license was granted by Health Canada to RPS Diagnostics' FebriDx test for detecting acute febrile ...Learn More
FDA clears robotic surgery software from Medical Surgery Technologies
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2nd Annual AdvaMed Payment Policy Conference
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Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
The only competition worthy of a wise man is with himself.
Washington Allston, painter and ...Learn More
Deal to acquire SurgiQuest completed by Conmed
Conmed has concluded its purchase of SurgiQuest, a provider of minimally invasive surgical devices, for $265 million. ...Learn More
Equity, debt funding round pulls in $60M for Benvenue
A round of debt and equity financing has brought in $60 million for Benvenue Medical. ...Learn More
Funding boost secured by Entac Medical
A Series A funding round led by Innova Memphis has brought in an undisclosed amount for Entac Medical. ...Learn More
Q4 revenue increases for Nanosphere
Nanosphere generated $6.8 million in revenue in the fourth quarter of 2015, a 48% increase from the same period in 2014. ...Learn More
2 lower-extremity products from Agent Medical debut
The ArthroBridge, a surgical implant designed to address hammertoes, has been launched by Agent Medical. ...Learn More
Predictive analytics, medication adherence sensors among digital trends to watch in 2016
The use of sensors in medication adherence tracking tools, the launch of predictive health analytics solutions for ...Learn More
Smart thermometer launched by Withings
A Wi-Fi-enabled thermometer was released by Withings at the Consumer Electronics Show. ...Learn More
Spine surgery robot from Medtech cleared by FDA
The FDA has granted 510(k) clearance to Medtech for its ROSA Spine robot system designed for use in spine surgeries. ...Learn More
EU OKs hypertension device from Vascular Dynamics
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Technical Writing for Regulatory Submissions
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Failure is a bruise, not a tattoo.
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Deal to acquire Bayer's diabetes care unit completed by Panasonic Healthcare
Panasonic Healthcare has concluded an approximately $1 billion deal to purchase the diabetes care unit of Bayer. ...Learn More
Ellipse Technologies purchased by NuVasive in $380M deal
NuVasive has agreed to pay $380 million upfront to acquire Ellipse Technologies, an Aliso Viejo, Calif.-based medtech firm ...Learn More
Financing round brings in $4M for Ortho Kinematics
A round of debt funding led by TEXO Ventures has brought in $4 million for Austin, Texas-based Ortho Kinematics. ...Learn More
3 Rex Medical vascular devices acquired by Argon Medical Devices
The purchase of three vascular devices from Rex Medical has been concluded by Argon Medical Devices. ...Learn More
New board member named by Conventus Orthopaedics
Scott Flora, the president of Scott Flora Consulting, has been tapped to serve on the board of directors at Conventus ...Learn More
Researchers to conduct clinical trials of artificial pancreas
Researchers from Harvard University and the University of Virginia will conduct two six-month clinical trials to test the ...Learn More
Expert says hand-held ultrasound could soon replace stethoscope
Cardiologist Eric Topol, chief academic officer of Scripps Health in San Diego, says he uses a portable echocardiogram ...Learn More
FDA clears cryoplasty inflation system from NuCryo Vascular
The PolarCath, a reusable cryoplasty inflation technology from NuCryo Vascular, has received 510(k) clearance from the FDA. ...Learn More
Torax's continence restoration device lands humanitarian exemption from FDA
The FDA has granted a humanitarian device exemption approval for Torax Medical's FENIX, a technology designed to address ...Learn More
China approves Bactiguard's foley catheter
The BIP Foley Catheter, developed by Stockholm-based Bactiguard, has received approval from Chinese ...Learn More
510(k) Submissions Workshop
Feb. 22-23 | Irvine, Calif. ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
If it scares you, it might be a good thing to try.
Seth Godin, writer and ...Learn More
Equity funding round pulls in $20M for GlySens
A round of equity financing involving 19 investors has brought in $20 million for GlySens. ...Learn More
Financing round pulls in $3.1M for Emperra
A round of funding led by Robert Bosch Venture Capital has brought in $3.1 million for Emperra, a digital health startup ...Learn More
Wireless cardiac monitor maker gets $3M funding boost
A debt financing round involving 25 unnamed investors has brought in $3 million for Endotronix, a Woodridge, Ill.-based ...Learn More
Cepheid, Henry Schein Medical reach distribution deal
US health care services and products provider Henry Schein Medical has made a deal to distribute Cepheid's GeneXpert ...Learn More
Medibio eyes heart-monitoring patch deal with Medtronic
Medibio is looking to leverage Medtronic's expertise to create a device that would monitor heart activity to detect mental ...Learn More
FDA OKs InVivo Therapeutics' pivotal spinal scaffold study
The FDA has granted InVivo Therapeutics approval to change a pilot trial of its bioabsorbable device for acute spinal cord ...Learn More
Tech contest organizers add testing stage, extend deadline
The announcement of Qualcomm Tricorder XPRIZE winners was moved to early 2017 after a second stage of consumer testing, ...Learn More
Tougher rules for vaginal mesh implants enforced in US
The use of vaginal mesh implants to address pelvic organ prolapse in female patients was reclassified by the FDA from the ...Learn More
Senate committee vote on FDA commissioner nominee set for Jan. 12
The Senate Committee on Health, Education, Labor and Pensions is set to meet Jan. ...Learn More
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There is happiness in duty, although it may not seem so.
Jose Marti, writer and political ...Learn More
Calif. venture firm aims to raise $175M for medtech fund
San Francisco Bay Area venture company HealthQuest Capital is looking to raise its second fund worth $175 million. ...Learn More
Molecular Dx firm gets $20.5M boost
A round of funding has brought in $20.5 million for Great Basin Scientific, a molecular diagnostics company in Salt Lake ...Learn More
Deal to acquire Clarient wrapped up by NeoGenomics
NeoGenomics has concluded its purchase of Clarient, a cancer diagnostic testing provider, from the Life Sciences unit of GE ...Learn More
MannKind taps former Insulet CEO for top job
Duane DeSisto has been named president and CEO of MannKind starting Tuesday. ...Learn More
Stretchable device can track heart rate using nanoparticles
Researchers at Seoul National University have developed a stretchable electronic device that can monitor heart rate ...Learn More
Report: Worldwide bariatric surgery devices market poised for growth
A Grand View Research report predicts the worldwide market for bariatric surgical devices will hit $2.8 billion by 2022. ...Learn More
Device adds patients' vitals into EHRs ahead of doctor's appointments
Vecna Technologies has designed the Vitals Chair, a device that records patients' biological information while they wait for ...Learn More
NHS reaches imaging, genomics data integration deal with Kanteron Systems
A partnership was reached between Kanteron Systems and the Open Source and Code 4 Health Programmes of England's National ...Learn More
FDA proposes early medtech warning system
The FDA has proposed creating a system that would give early warnings to the public about possible safety issues with ...Learn More
Statistical Methods in Economic Evaluations Workshop
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9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
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Never fear quarrels, but seek hazardous adventures.
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Mass.-based medtech firm gets $13.8M boost
A securities purchase deal has been reached by Waltham, Mass.-based NeuroMetrix with a private institutional health care ...Learn More
Equity funding round pulls in $6.1M for Inari Medical
A round of equity financing involving five unnamed investors has brought in $6.1 million for Inari Medical. ...Learn More
NSF awards $16M grant to study how implantable devices could combat paralysis
The National Science Foundation has awarded the University of Washington's Center for Sensorimotor Neural Engineering a ...Learn More
Trial begins for Anika Therapeutics' bone scaffold
The first patient in a study of Hyalofast, a hyaluronan-based scaffold with a concentrate of autologous bone marrow ...Learn More
Diabetic neuropathy test from NeuroMetrix debuts in Mexico
The DPNCheck, a test for diagnosing diabetic neuropathy, has been launched in Mexico by medtech firm NeuroMetrix. ...Learn More
EU OKs depressive disorder therapy system from Soterix Medical
Regulators in Europe have given Soterix Medical CE mark approval to market its 1x1 tDCS, a device designed to address major ...Learn More
FDA labels bioMerieux's antibiotic efficacy test recall as Class I
A recall of bioMerieux's Etest PIP/TAZO/CON-4 PTC 256 has been categorized by the FDA as Class I. ...Learn More
2nd Annual AdvaMed Payment Policy Conference
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SmartBrief will not publish Friday
In observance of New Year's Day, SmartBrief will not publish Friday. Publication will resume ...Learn More
Facts do not cease to exist because they are ignored.
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SeaSpine secures credit deal worth up to $30M
A three-year credit facility deal worth as much as $30 million has been secured by SeaSpine with Wells Fargo Capital ...Learn More
Molecular Dx firm gets $20.5M boost
Salt Lake City-based molecular diagnostics company Great Basin Scientific has reached a securities purchase deal with ...Learn More
Financing round brings in $2M for Tangen Biosciences
An equity financing round has brought in $2 million for Tangen Biosciences. ...Learn More
Health tracking device maker gets boost from Japanese global fund
An undisclosed amount has been invested by Japan's Dentsu Ventures Global Fund I in Cue, a San Diego medtech firm. ...Learn More
Wearable product development chip from Samsung in production
The Bio-Processor, a chip from Samsung Electronics intended for the development of wearable devices for the daily monitoring ...Learn More
Orthopedic, podiatric surgical device from Instratek debuts
The ToeTac, an implant designed for podiatric and orthopedic surgery, has been launched by global medtech firm Instratek. ...Learn More
AdvaMed to monitor CMS rule for DME prior authorization
Enforcement of a new CMS rule requiring prior authorization before durable medical equipment is paid for by Medicare will be ...Learn More
Planned guidance for fiscal 2016 issued by FDA
Three lists of guidance documents planned for publishing in fiscal 2016 have been released by the FDA's Center for Devices ...Learn More
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March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
Facts do not cease to exist because they are ignored.
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Calif. firm to float 5 million shares in IPO
Pulse Biosciences said it intends to offer 5 million shares in its initial public offering at $4 per share in hopes of ...Learn More
Gen-Probe acquires DiagnoCure's prostate marker assets in $4.7M deal
Hologic unit Gen-Probe has agreed to pay $4.7 million to purchase DiagnoCure's PCA3 prostate cancer biomarker assets. ...Learn More
Funding round pulls in undisclosed sum for HealPros
A round of Series A financing led by Sopris Capital has brought in an undisclosed sum for HealPros, a mobile diabetic ...Learn More
Patent issued to AlloSource's bone allograft
AlloSource, a nonprofit cellular and tissue network, has obtained a patent for its AlloStem Cellular Bone Allograft. ...Learn More
Cynvenio begins study of breast cancer combination test with ATGen
A pilot surveillance study has been launched by Cynvenio Biosystems and ATGen Global to assess the combination of Cynvenio's ...Learn More
2 universities partner on ventricular assist technology
The Duke University School of Medicine and National Cheng Kung University in Taiwan have agreed to collaborate on implanting ...Learn More
FujiFilm's reprocessing label for duodenoscopes lands FDA clearance
A revision of FujiFilm Holdings' manual reprocessing instructions for the ED-530XT duodenoscope has received clearance from ...Learn More
FDA labels Draeger's anesthesia workstation recall as Class I
A recall of 34 units of Draeger's Perseus A500, an anesthesia workstation, has been categorized by the FDA as Class I. ...Learn More
IDE Submissions Workshop
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Difficulties strengthen the mind, as labor does the body.
Seneca, ...Learn More
Mechanical valve maker purchased by CryoLife
CryoLife, a vascular and cardiac surgery firm, has agreed to pay $130 million upfront to acquire On-X Life Technologies ...Learn More
Funding round brings in $10M for Israeli cancer Dx firm
A round of private financing led by Pontifax and IntraCure has brought in $10 million for NovellusDx. ...Learn More
Firm acquires Avita Medical's respiratory unit in $2.64M deal
Medical Developments International has agreed to pay $2.64 million to purchase Avita Medical's respiratory division that ...Learn More
Interim CEO named by Avedro
Brian Roberts has been named interim CEO of Avedro, a Waltham, Mass.-based developer of corneal cross-linking technology. ...Learn More
Study shows positive results for Seno Medical's breast cancer Dx tool
A 100-patient study showed promising results for Seno Medical Instruments' Imagio, an opto-acoustic system intended to ...Learn More
Shenzhen Anke, Med Imaging System Sales reach distribution deal
Med Imaging System Sales, an equipment reseller, has made a deal to distribute the open MRI technologies from Shenzhen Anke ...Learn More
Wearable to track astronauts' conditions during space missions being developed
A partnership was formed between Hexoskin and the Canadian Space Agency to design a health platform that can track the vital ...Learn More
EU OKs cross-linking technology from Avedro
Regulators in Europe have given Avedro CE mark approval to market its Mosaic device, a technology designed to enhance vision ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
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510(k) Submissions Workshop
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The biggest adventure you can ever take is to live the life of your dreams.
Oprah Winfrey, media personality, businesswoman and ...Learn More
On-X Life Technologies to be acquired by CryoLife in $130M deal
Atlanta-based CryoLife reached a deal to purchase On-X Life Technologies, an Austin, Texas-based maker of aortic valve ...Learn More
Public offering of warrants, stock filed by CombiMatrix
A preliminary prospectus has been filed by CombiMatrix with the Securities and Exchange Commission for an offering of 8,400 ...Learn More
Lima acquired by private equity firm
EQT, a private equity firm, purchased a majority stake in Italian orthopedic company Lima Corporate. ...Learn More
Firm to sell molecular Dx unit back to co-founders
UK-based company EKF Diagnostics has agreed to sell Selah Genomics, a US-based molecular diagnostics firm, back to ...Learn More
OrbiMed to invest in health care markets through $950M fund
A venture capital fund valued at $950 million was closed by OrbiMed. ...Learn More
InSightec's ultrasound device scores reimbursement win from BCBS licensees
Blue Cross Blue Shield of Louisiana, Blue Shield of California, Highmark BCBS, Independence BCBS and Florida Blue will cover ...Learn More
Patent issued to Pinnacle Spine
A patent has been issued to Pinnacle Spine Group for its InFill, a technology designed to promote improved spinal ...Learn More
Cervical interbody fusion device lands FDA clearance
The Latitude-C Cervical Interbody Spacer System from DeGen Medical has obtained clearance from the FDA. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
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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
SmartBrief will not publish Friday
In observance of Christmas, SmartBrief will not publish Friday. Publication will resume ...Learn More
Who is the happier man, he who has braved the storm of life and lived or he who has stayed securely on shore and merely existed?
Hunter S. Thompson, journalist and ...Learn More
Funding round brings in $33.9M for InnFocus
A round of Series C financing has brought in $33.9 million for Miami-based InnFocus. ...Learn More
New funding round brings in $31.5M for Gelesis
Boston-based Gelesis has raised an additional $31.5 million in a round of funding, bringing its total funds raised to over ...Learn More
Public stock offering brings in $10M for Nanosphere
A public offering of shares has brought in $10 million for Nanosphere. ...Learn More
Report: Worldwide orthopedic devices market poised for growth
By 2022, the global market for orthopedic devices is projected to hit $82.5 billion, with a 6.1% compound annual growth ...Learn More
Blood-typing device from Bio-Rad cleared by FDA
The FDA has granted 510(k) clearance to Bio-Rad Laboratories for its TANGO infinity technology. ...Learn More
Biotronik's MRI-safe ICDs land FDA clearance
The Iperia implantable cardioverter defibrillator systems from Biotronik have received clearance from the FDA for use with ...Learn More
Insulin management device from Medtronic lands FDA approval
The Paradigm REAL-Time Revel, a device from Medtronic intended to manage insulin and monitor glucose levels, has obtained ...Learn More
FDA clears blood glucose monitor from LabStyle Innovations
The FDA has given 510(k) clearance to LabStyle Innovations, a mobile-health developer focused on diabetes, for its Dario ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
One can never consent to creep when one feels an impulse to soar.
Helen Keller, writer and political ...Learn More
Funding round pulls in $38.5M for Axonics
A round of Series B financing led by Edmond de Rothschild Investment Partners has brought in $38.5 million for Axonics ...Learn More
Assurex gets $15M boost
An equity funding round involving Series D investors has brought in $15 million for Assurex Health. ...Learn More
Financing round pulls in $10M for Neural Analytics
A round of Series A funding has brought in $10 million for Neural Analytics. ...Learn More
SI-BONE's joint fusion implant scores reimbursement win from Medicare contractor
The use of SI-BONE's iFuse Implant System will be covered by CGS Administrators, a Medicare Administrative Contractor, for ...Learn More
First surgery using cervical plating technology recorded by Xtant Medical
A patient at the Arizona Orthopedic Surgical Hospital was the first to undergo surgery using the Aranax Cervical Plating ...Learn More
Canada approves glaucoma therapy system from Bio Light
The IOPtiMate, a device developed by ophthalmic medtech firm Bio Light to treat glaucoma, has received approval from ...Learn More
FDA clears noninvasive monitoring device from GI Logic
The FDA has given 510(k) clearance to GI Logic for its noninvasive digestive system monitoring device, AbStats. ...Learn More
Canada OKs implantable cardioverter defibrillator from Medtronic Canada
A license was granted by Health Canada to Medtronic Canada's Evera MRI SureScan, an implantable cardioverter defibrillator. ...Learn More
Technical Writing for Regulatory Submissions
March 8 | Sunnyvale, Calif. ...Learn More
FDA Submissions Strategy
March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
Convince your enemy that he will gain very little by attacking you; this will diminish his enthusiasm.
Sun Tzu, military ...Learn More
Obama signs spending measure that suspends medical device tax
A $1.8 trillion federal measure composed of tax breaks and spending bills was signed into law Friday by President Barack ...Learn More
For more:
Read the news release in which AdvaMed, the Medical Imaging & Technology Alliance (MITA) and the Medical Device ...Learn More
2 groups agree to medtech development deal with Singapore incubator
The Feinstein Institute for Medical Research and i360medical are teaming up with Singapore's Diagnostics Development Hub to ...Learn More
OEM RFID provider acquired by GSI Group in $2.6M deal
Bedford, Mass.-based GSI Group has agreed to pay $2.6 million in cash to purchase SkyeTek, a Denver-based provider of UHF ...Learn More
Report forecasts market growth for top 10 medical devices
A Research and Markets report predicts the global market for the top 10 medical devices will hit $428.9 billion by 2020, ...Learn More
Use of electronic brachytherapy device advanced by iCAD
Nashua, N.H.-based iCAD has expanded the reach of its electronic brachytherapy technology outside of the US. ...Learn More
Former Veracyte exec joins Advanced Cell Diagnostics as CMO
Robert Monroe has been named chief medical officer at Advanced Cell Diagnostics. ...Learn More
Post-approval trial of W.L. Gore's stent graft begins
A planned 108-patient, post-approval study has been launched by W.L. ...Learn More
FDA readies for rush of medical-grade wearables
The FDA is preparing for an onslaught of medical-grade wearable devices. ...Learn More
FDA clears respiratory pathogen panel from Luminex
The NxTAG Respiratory Pathogen Panel, developed by Luminex, has received clearance from the FDA. ...Learn More
Fecal incontinence treatment system from Torax gets FDA approval
The FENIX Continence Restoration System, a device developed by Torax Medical for treating fecal incontinence, has obtained ...Learn More
PMA Submissions Workshop
Feb. 25-26 | Irvine, Calif. ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
When you believe you have lost your power and control, nothing will ever seem easy or simple.
Shannon Alder, ...Learn More
House OKs spending measure that would suspend medical device tax
The House this morning passed a $1.15 trillion federal spending measure that, among other things, would suspend the medical ...Learn More
Deal to acquire laser cataract treatment company completed by Alphaeon
Irvine, Calif.-based Alphaeon has concluded a $59 million deal to purchase Lensar, an Orlando, Fla.-based laser cataract ...Learn More
Financing round pulls in $7.5M for Checkpoint Surgical
A round of institutional funding led by First Analysis has brought in $7.5 million for Checkpoint Surgical, the ...Learn More
100th robotic spine device sold by Mazor Robotics
UConn Health has bought a Renaissance robotic spine surgery system from Mazor Robotics. ...Learn More
Study begins for AtriCure's endocardial catheter technique
The first patient in a clinical trial of an approach combining the use of an endocardial catheter and epicardial surgery for ...Learn More
Dx firm wins grant for EU study of colorectal cancer subtyping
The European Commission has given Agendia, a Dutch molecular diagnostics company, a grant worth $6.8 million to evaluate the ...Learn More
Imaging research tool from health policy institute debuts
The Neiman Imaging Types of Service, an open-source coding platform that allows Medicare and payer claims databases to be ...Learn More
FDA clears cervical plate system from Life Spine
The GRUVE, an anterior cervical plate technology from Life Spine, has received 510(k) clearance from the FDA. ...Learn More
EU OKs tissue implant from RegenScientific
The Renu Soft Tissue injectable implant developed by RegenScientific to treat soft tissue augmentation, vocal fold ...Learn More
Wearable defibrillator from ZOLL gets expanded approval for pediatric use
The FDA has granted ZOLL Medical expanded approval for use of its LifeVest wearable cardioverter defibrillator in some ...Learn More
510(k) Submissions Workshop
Feb. 22-23 | Irvine, Calif. ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
The final test of a leader is that he leaves behind him in other men the conviction and the will to carry on.
Walter Lippmann, ...Learn More
Acquisition of Zimmer Biomet assets for Japan completed by Lima
The purchase of assets from Zimmer Biomet for the Japanese market has been concluded by Lima Corporate following approval ...Learn More
Financing round pulls in $22M for Israel-based startup
A Series B funding round led by Walden Riverwood has brought in $22 million for Tel Aviv, Israel-based startup Vayyar ...Learn More
Genomic test maker gets $15M boost
A Series C funding round led by Omega Pharma founder Marc Coucke has brought in $15 million for Swiss genetics firm Sophia ...Learn More
Funding round pulls in $6M for Avenu Medical
A debt financing round involving 46 unnamed investors has brought in $6 million for California-based Avenu Medical. ...Learn More
Report predicts growth for remote patient monitoring market over 5 years
A Frost & Sullivan report predicts a 13.2% growth in the remote patient monitoring market from 2015 to 2020. ...Learn More
First surgery using ablation device recorded by LuxCath
Patients at Mount Sinai Hospital in New York were the first to undergo surgery using Boston-based LuxCath's catheter-based ...Learn More
Super-resolution microscope from Bruker debuts
The Vutara 352, a super-resolution microscope, has been launched by San Diego-based Bruker. ...Learn More
FDA clears multi-Dx device from Viatom
The Checkme Pro, a multidiagnostic device from China-based Viatom Technologies, has received 510(k) clearance from the FDA. ...Learn More
US, EU regulators clear pedicle screw system from K2M
The EVEREST Minimally Invasive XT Spinal System, a cannulated pedicle screw technology from medtech firm K2M Group Holdings, ...Learn More
EU clears study of Arch Therapeutics' hemostatic device
European regulators have granted Framingham, Mass.-based Arch Therapeutics clearance to begin a study of its AC5 surgical ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
Feb. ...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
Practice is the hardest part of learning, and training is the essence of transformation.
Ann Voskamp, ...Learn More
House deal on spending bill would suspend device tax
Bipartisan negotiators helped broker an agreement on the $1.1 trillion spending bill that would, among other things, suspend ...Learn More
For more:
Read the news release in which AdvaMed, the Medical Imaging & Technology Alliance (MITA) and the Medical Device ...Learn More
ReFlow, Maquet Medical Systems reach distribution deal
Maquet Medical Systems has made a deal to exclusively distribute ReFlow Medical's complete line of catheters starting in the ...Learn More
Firms enter deal to develop next-generation sequencing system
A strategic deal was reached between genomic service firm Novogene and Illumina to create a diagnostic technology for ...Learn More
Report forecasts growth for cervical total disc replacement device market
A Persistence Market Research report predicts the market for cervical total disc replacement devices will reach $1.8 billion ...Learn More
New interim CEO, president named by SuperSonic Imagine
Bernard Doorenbos has been named interim president and CEO of SuperSonic Imagine, a developer of ultrasound technology. ...Learn More
Contract supports development of product against blood loss
The US Army Medical Research and Materiel Command has awarded Arsenal Medical a contract worth over $14 million for the ...Learn More
Spine tumor ablation device from DFine debuts
The Long SpineSTAR Ablation device, developed to ablate metastatic spine tumors, has been launched by medtech firm DFine. ...Learn More
N.Y. researchers to examine effectiveness of concussion recovery app
A free mobile application that helps patients with concussions manage their recovery will be tested by a team of researchers ...Learn More
EU approves drug-eluting stent catheter from Svelte Medical Systems
The Slender, a sirolimus-eluting coronary stent-on-a-wire integrated delivery technology from New Providence, N.J.-based ...Learn More
Molecular Dx instrument from HiberGene gains CE mark
The HG Swift, a molecular diagnosis instrument developed by Dublin-based HiberGene Diagnostics, has received CE mark ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Employ your time in improving yourself by other men's writings, so that you shall gain easily what others have labored hard for.
Socrates, ...Learn More
Ireland facility to be opened by Medtronic
A facility that will manufacture the IN.PACT Admiral, a drug-coated balloon designed to address peripheral artery disease, ...Learn More
Funding round brings in $30M for AltheaDx
A Series C funding round has brought in $30 million for AltheaDx. ...Learn More
Medical tubing, catheter solutions maker acquired by Pexco
Pexco, a maker of specialty plastics, has paid an undisclosed sum to purchase Precision Extrusion, a maker of medical tubing ...Learn More
Dx imaging service firm acquired by BC Technical
BC Technical, a provider of medical imaging equipment, has reached a deal to purchase Legacy Medical Imaging, a diagnostic ...Learn More
St. Jude's neurostimulator device performs well in trial
A study showed promising results for St. ...Learn More
Surgical imaging platform from Stryker Endoscopy debuts
The 1588 AIM Platform, a surgical video system intended to boost patient anatomy visualization, has been launched by Stryker ...Learn More
Meeting date set for FDA advisory panel to consider leadless pacemakers
The FDA's Circulatory System Devices Panel is scheduled to meet Feb. 18 to develop guidelines for leadless pacemakers. ...Learn More
FDA clears radiopaque embolic bead from BTG
The LC Bead LUMI, a radiopaque embolic bead developed by BTG, has received 510(k) clearance from the FDA. ...Learn More
Burn-treatment device from Avita Medical wins expedited access status from FDA
Avita Medical's ReCell, a burn-treatment device developed for autologous cell harvesting, was given expedited access pathway ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Each of us must work for his own improvement, and at the same time share a general responsibility for all humanity.
Marie Curie, physicist and ...Learn More
Samsung and Medtronic partner to create digital health tools
A partnership between Samsung Electronics America and Medtronic will speed up the creation of digital health technologies ...Learn More
Funding round pulls in $25M for Eargo
A Series B financing round led by New Enterprise Associates has brought in $25 million for Eargo. ...Learn More
Merger of Senseonics, ASN Technologies completed
Senseonics Holdings announced Friday it has concluded its merger with ASN Technologies. ...Learn More
Edwards Lifesciences buys stake in mitral repair device firm
A stake in Baltimore-based Harpoon Medical with an exclusive option to buy was acquired by Irvine, Calif.-based Edwards ...Learn More
Sequenom names new president and CEO
Dirk van den Boom has been named president and CEO of Sequenom. ...Learn More
Study begins for BAROnova's obesity treatment device
The first four patients in a study of the TransPyloric Shuttle, a device intended to address obesity, has been enrolled by ...Learn More
Migraine treatment device from StimRelieve gets FDA IDE designation
The FDA has granted an investigational device exemption to Fort Lauderdale, Fla.-based StimRelieve for a study of the firm's ...Learn More
NIH names point-of-care technology strategy leader
The NIH has chosen Atam Dhawan to help advance its efforts to promote point-of-care technologies. ...Learn More
Russia OKs ultrasound device from EDAP
Russia's Federal Service for Surveillance in Healthcare has approved the Focal One, a high-intensity focused ultrasound from ...Learn More
Clearance for Medtronic's bone graft widened by FDA
The InFuse, a bone-growth protein from Medtronic, has been cleared by the FDA for additional indications. ...Learn More
Technical Writing for Regulatory Submissions
March 8 | Sunnyvale, Calif. ...Learn More
FDA Submissions Strategy
March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
He who fears being conquered is certain of defeat.
Napoleon Bonaparte, military and political ...Learn More
Financing round pulls in $5.5M for MicroTransponder
A round of funding led by Green Park & Golf Ventures brought in $5.5 million for Dallas-based MicroTransponder. ...Learn More
Nanosphere aims to bring in $9.1M in securities offering
Nanosphere said it intends to offer as much as $10 million in securities, with net proceeds expected to reach $9.1 million, ...Learn More
Verily teams up with J&J to form robot surgical platform firm
Verily Life Sciences, formerly Google Life Sciences, is teaming up with Johnson & Johnson to create Verb Surgical, a company ...Learn More
Cook Medical enters commercialization deal with Mauna Kea
A deal has been struck by Cook Medical for global commercialization of Mauna Kea's Cellvizio, a laser endomicroscopy ...Learn More
Study finds FDG PET/CT useful for predicting treatment outcomes in lymphoma
A study in the journal Radiology found that FDG PET/CT imaging can help doctors predict outcomes after stem cell ...Learn More
Study begins for Biotronik's closed-loop stimulation pacemaker
The first patients in a study of a pacemaker equipped with closed-loop stimulation has been enrolled by Biotronik. ...Learn More
NDA for ocular pain drug-device combo filed by Ocular Therapeutix
Ocular Therapeutix's new drug application for its Dextenza, an ocular pain treatment drug-device combination, has been ...Learn More
2 spine devices from CareFusion cleared by FDA
The FDA has granted 510(k) clearance to CareFusion for its 11-gauge AVAflex and 13-gauge AVAmax vertebral balloon devices ...Learn More
FDA clears leg, back pain relief device from Stimwave
The Stimwave Freedom-8A Spinal Cord Stimulation System, developed by Stimwave Technologies, has obtained clearance from the ...Learn More
Pre-implantation genetic screening test from CombiMatrix lands conditional OK in N.Y.
The CombiPGS, an array-based pre-implantation genetic screening test developed by CombiMatrix, has received conditional ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
PMA Submissions Workshop
Feb. 25-26 | Irvine, Calif. ...Learn More
Great leaders are almost always great simplifiers, who cut through argument, debate and doubt to offer a solution everybody can understand and remember.
Michael Korda, writer and ...Learn More
Funding round brings in $3.9M for OrthoSensor
A round of financing from nine unnamed investors brought in $3.9 million for Dania Beach, Fla.-based OrthoSensor. ...Learn More
Urological products supplier acquired by Comfort Medical
Comfort Medical has agreed to pay an undisclosed sum to purchase Medical Direct Club, a US distributor of urological ...Learn More
1M share repurchase program announced by Exactech
A plan by Exactech to buy back a million shares of company stock was approved by the company's board. ...Learn More
Truven's drug interaction platform to be added to Philips health management system
Truven Health Analytics has secured a partnership deal with Royal Philips to incorporate its Micromedex Solutions platform ...Learn More
Study begins for PolyPid's synthetic bone substitute
The first patient in a randomized, controlled study of BonyPid-1000, a synthetic bone substitute loaded with doxycycline and ...Learn More
Integrated Document Solutions boosts clinical image viewing with new software
An HTML5 image viewer that can be used with all modern Web browsers was introduced by Integrated Document Solutions. ...Learn More
FDA clears cooling cap from Dignitana
Swedish company Dignitana has received clearance from the FDA to market the DigniCap Cooling System, a cap designed to ...Learn More
Cerclage cable from DSM Biomedical cleared by FDA
DSM Biomedical's Dyneema Purity Radiopaque Cerclage Cable has obtained clearance from the FDA. ...Learn More
Neurostimulators from Medtronic land FDA clearance
Some devices from Medtronic's Activa portfolio of neurostimulators have received clearance from the FDA for full-body MRI ...Learn More
FDA labels Boston Scientific's guiding sheaths recall as Class I
A voluntary recall of Boston Scientific's Chariot Guiding Sheaths intended for peripheral vascular surgeries has been ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
Feb. ...Learn More
510(k) Submissions Workshop
Feb. 22-23 | Irvine, Calif. ...Learn More
If you're bored with life, if you don't get up every morning with a burning desire to do things, you don't have enough goals.
Lou Holtz, football ...Learn More
Venture capital firm gets $325M boost for health care-focused fund
Sofinnova Partners, a Paris-based venture capital firm, has brought in around $325 million for a new fund dedicated to the ...Learn More
Financing round brings in $14.4M for Clearside Biomedical
Clearside Biomedical has obtained $14.4 million toward its goal of $20 million in a round of equity funding involving nine ...Learn More
Medtech, Dx firm acquired by Flextronics
Flextronics agreed to pay an undisclosed sum to purchase Farm Design, a designer and developer of medtech and diagnostic ...Learn More
SouthGenetics enters prostate cancer Dx test deal with MDxHealth
MDxHealth has agreed to license its ConfirmMDx prostate cancer test to Uruguay-based SouthGenetics. ...Learn More
First patients implanted with lordotic technology recorded by Cutting Edge Spine
Patients at Mary Black Health System in Spartanburg, S.C., were the first to be implanted with the True Oblique Lordotic ...Learn More
Study of Heart Test Labs' heart screening device begins
A clinical trial to assess the use of Heart Test Laboratories' MyoVista in the early diagnosis of coronary artery disease ...Learn More
VidiStar's nuclear med software gets FDA nod
The FDA has granted 501(k) clearance to VidiStar's HeartView nuclear medicine software. ...Learn More
EU approves spinal fixation device from X-spine
The Certex OCT Spinal Fixation System, developed by Xtant Medical unit X-spine Systems, has obtained the CE mark from ...Learn More
Gastric balloon from Allurion Technologies gains CE mark
The Elipse Gastric Balloon, an ingestible device developed by Wellesley, Mass.-based Allurion Technologies to address ...Learn More
FDA grants CLIA certification to Diagnomics', Maverix's prenatal test
Diagnomics and Maverix Biomics said they have obtained CLIA certification for their Non-Invasive Chromosome Examination, a ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
If you don't know where you're going, you might not get there.
Yogi Berra, baseball player and ...Learn More
Firms partner to create 3D-printed tracheal splints
A deal has been reached between Materialise, a Belgium-based 3D printing firm, and Tissue Regeneration Systems to develop ...Learn More
Baylor College of Medicine to design blood-based tests with Biocept
Baylor College of Medicine and Biocept will create blood-based tests using the circulating tumor DNA and circulating tumor ...Learn More
Industry veteran named CEO, president of J-Pac Medical
Jeff Barrett has been appointed president and CEO of J-Pac Medical. ...Learn More
Study begins for Mitralign's tricuspid regurgitation treatment system
The first patient in a study of the Trialign device for addressing tricuspid regurgitation has been enrolled by Mitralign, a ...Learn More
European regulators approve CE mark study for ExThera's blood filter
A CE mark trial for Berkeley-Calif.-based ExThera Medical's Seraph device, a blood filter developed to eliminate bloodstream ...Learn More
IV medication management system from Becton Dickinson debuts
An automated intravenous medication management device was launched this week by Becton Dickinson at a pharmacists' meeting ...Learn More
Cepheid's flu, RSV assay gets FDA clearance, CLIA waiver
Cepheid has received a CLIA waiver and a 510(k) clearance from the FDA for its Xpert Flu+RSV Xpress, a point-of-care test to ...Learn More
Clearance for RevMedX's wound dressing widened by FDA
The XStat 30, a wound dressing developed by RevMedX, has received expanded 510(k) clearance from the FDA to be used in ...Learn More
Final warnings lifted by FDA for Angiodynamics' facilities in N.Y., Mass.
The FDA has closed out a warning letter it issued in May 2011 for AngioDynamics' facility in Queensbury, N.Y. ...Learn More
FDA Submissions Strategy
March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
The goal is not always meant to be reached, but to serve as a mark for our aim.
Joseph Joubert, ...Learn More
Medical temperature management firm gets $1.4M boost
Mercury Biomed, a medical temperature management company, has raised $1.4 million in new funding under a loan deal with the ...Learn More
KFx Medical's soft tissue fixation system acquired by Conmed
Conmed has purchased KFx Medical's AppianFx, a soft tissue fixation technology, for undisclosed terms. ...Learn More
Industry veteran named VP at Delphinus
Francis Dobscha was tapped to serve as quality and regulatory affairs vice president for Delphinus Medical Technologies, a ...Learn More
InVivo's spinal cord scaffold trial gets conditional FDA approval
The FDA has granted conditional approval to a protocol change that will transform InVivo Therapeutics' pilot trial of its ...Learn More
Firms enter deal to collaborate on smart spirometer, companion app
Pond Healthcare Innovation, a Swedish design company, and Novartis agreed to collaborate on the Air Smart spirometer and ...Learn More
Silicone handle ratchets from MedTorque debut in Europe
MedTorque's Tri-Gear silicone handle ratchets, developed for use in spine and orthopedic procedures, have been launched in ...Learn More
EU approves capsulotomy device from Mynosys
The Zepto, a technology developed by Fremont, Calif.-based Mynosys Cellular Devices for anterior lens capsulotomies, has ...Learn More
FDA to host medical device cybersecurity workshop with HHS, DHS
The FDA will host a public workshop with HHS and the Department of Homeland Security from Jan. ...Learn More
FDA clears Qfix's stereotactic radiosurgery immobilization system
The Encompass, a stereotactic radiosurgery immobilization device from Avondale, Pa.-based Qfix, has received 510(k) ...Learn More
PMA Submissions Workshop
Feb. 25-26 | Irvine, Calif. ...Learn More
Technical Writing for Regulatory Submissions
March 8 | Sunnyvale, Calif. ...Learn More
If you have always done it that way, it is probably wrong.
Charles Kettering, ...Learn More
SurgiQuest to be acquired by CONMED in $265M deal
Medtech firm CONMED has reached a deal to purchase SurgiQuest, the maker of the AirSeal System integrated access management ...Learn More
Funding round pulls in $40M for NxThera
A round of Series C funding led by Boston Scientific brought in $40 million for Maple Grove, Minn.-based NxThera. ...Learn More
CT/MRI parts, service firm acquired by BC Technical
West Jordan, Utah-based medical imaging parts supplier BC Technical has purchased MagnaServ Enterprises, a Stuart, ...Learn More
Shuwen Biotech, BioNTech Diagnostics reach distribution deal
China-based Shuwen Biotech has made a deal to exclusively distribute BioNTech Diagnostics' MammaTyper, a breast cancer ...Learn More
Higher sales drive Q2 revenue growth for Medtronic
Medtronic generated $7.06 billion in revenue in the quarter ending Oct. ...Learn More
FDA grants IDE approval for StimRelieve's craniofacial neuropathic pain device
The FDA has given medtech firm StimRelieve investigational device exemption approval to study the effectiveness of its ...Learn More
Free LifeMap app helps patients monitor COPD symptoms, triggers
A free application to help patients track chronic obstructive pulmonary disease symptoms has been released by LifeMap ...Learn More
FDA clears Philosys Gmate Smart Android companion app
The Android version of the companion application developed by Philosys for its Gmate Smart glucometer has received 510(k) ...Learn More
EU approves defibrillator from St. Jude
The Quadra Assura, a cardiac resynchronization therapy defibrillator from St. ...Learn More
Brazil OKs lower esophageal sphincter system from EndoStim
The EndoStim II, a lower esophageal sphincter stimulation device from EndoStim, has obtained approval from the Brazilian ...Learn More
510(k) Submissions Workshop
Feb. 22-23 | Irvine, Calif. ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
Correction
Because of an error in the source story, a summary published this week incorrectly stated that the FDA is seeking comments ...Learn More
Innovation is not about saying yes to everything. It's about saying NO to all but the most crucial features.
Steve Jobs, ...Learn More
Financing round pulls in $15M for Surefire Medical
A round of Series C funding led by Tullis Health Investors brought in $15 million for Surefire Medical. ...Learn More
Henry Schein gains exclusive rights to Medtronic's diabetes products
Henry Schein Medical has made a deal to distribute some of Medtronic's devices for type 2 diabetes in the US. ...Learn More
Deadline for Perseon acquisition moved by Galil Medical to Dec. 21
The deadline on Galil Medical's tender offer to purchase Perseon and its MicroThermX, a microwave ablation technology, has ...Learn More
Adgenix enters distribution deal with Premaitha Health
Adgenix has reached an exclusive deal to distribute UK-based Premaitha Health's Iona, a test that estimates a fetus's risk ...Learn More
Texas hospital debuts robotic surgery device
Hendrick Medical Center in Abilene, Texas, has been equipped with the da Vinci Xi, a robotic device designed for complex ...Learn More
Endoscopic balloon dilator from Olympus debuts
The EZDilate, an endoscopic balloon dilator, has been launched by Olympus. ...Learn More
Propeller Health to design inhaler sensor with GSK
A partnership was formed between Propeller Health and GlaxoSmithKline calling for Propeller to create a sensor that chronic ...Learn More
EU OKs meningococcus test from HiberGene Diagnostics
Regulators in Europe have given Dublin-based HiberGene Diagnostics CE mark approval to market its HG Meningococcus test. ...Learn More
China OKs Koning's 3D breast-scanning device
Koning has obtained approval from Chinese regulators for its KBCT, a device designed to deliver 3D breast scans for ...Learn More
FDA labels Royal Philips' vascular X-ray system recall as Class II
A recall initiated by Royal Philips involving three units of its Integris Allura Xper, a technology intended for vascular ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
Feb. ...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
Our chief want in life is somebody who shall make us do what we can.
Ralph Waldo Emerson, ...Learn More
Bone graft products maker acquired by Bioventus
Orthobiologics firm Bioventus has paid an undisclosed sum to purchase BioStructures, a medtech firm focused on bioresorbable ...Learn More
Negative-pressure wound treatment device acquired by Acelity
San Antonio-based Acelity has purchased Spiracur's Snap, a negative-pressure device designed to treat wounds that are hard ...Learn More
Medi-Cal agrees to cover Vermillion's ovarian cancer test
California's Medicaid program, Medi-Cal, will cover Vermillion's OVA1, a test designed to measure the likelihood that ...Learn More
Scientists design device to speed up stroke detection
A team of scientists from Cornell University's Baker Institute for Animal Health used grants from several groups including ...Learn More
Catheter from Covalon Technologies lands FDA clearance
The SilverCoat Silicone Foley Catheter from Canadian firm Covalon Technologies has received clearance from the FDA. ...Learn More
GE unveils medical image sharing platform
A platform unveiled by GE at the Radiological Society of North America meeting is capable of linking over 500,000 imaging ...Learn More
EU, Canada OK breast density assessment software from Densitas
The DM-Density software, developed by Densitas for assessing breast density, has obtained a medical device license in Canada ...Learn More
US, EU regulators OK deep vein thrombosis catheter from Boston Scientific
The AngioJet ZelanteDVT, a thrombectomy catheter from Boston Scientific, has obtained approval from the FDA and the CE mark ...Learn More
Spinal cord stimulation device from Greatbatch gets FDA approval
The Algovita, a spinal cord stimulation system from Frisco, Texas-based Greatbatch, has obtained premarket approval from the ...Learn More
Clearance for X-spine's screw systems widened by FDA
The Fortex and the Xpress 2 Pedicle Screw System, developed by Xtant Medical unit X-spine Systems, have been cleared by the ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires.
William Arthur Ward, ...Learn More
$39.2M credit deal secured by SI-BONE
A credit deal composed of a $4 million credit line and a $35.2 million senior secured term loan has been closed by SI-BONE ...Learn More
Funding round brings in $30.7M for NinePoint Medical
Bedford, Mass.-based NinePoint Medical has obtained $30.7 million toward its goal of $40.7 million in a round of equity ...Learn More
Firms reach instrument deal for robotic surgery system
Cadence Device has reached an agreement with Titan Medical to develop instruments for Titan's Sport, a robotic surgery ...Learn More
Former Medtronic exec named board chairman at VEXIM
Steve Swinson has been tapped to serve as board chairman at medtech firm VEXIM. ...Learn More
EU OKs respiratory influenza virus panel from Janssen Diagnostics
Regulators in Europe have given Janssen Diagnostics the CE-IVD mark for its Idylla Respiratory IFV-RSV Panel, which can ...Learn More
Spinal cord stimulation device from St. Jude debuts in Europe
The Proclaim Elite Spinal Cord Stimulation System, which manages chronic pain by delivering burst stimulation, has been ...Learn More
South Korea OKs ablation device from InSightec
The Exablate Neuro, a device developed by InSightec to treat behavioral, pain and movement disorders, was approved by South ...Learn More
EU approves cardiac assist device from Xenios
European regulators have granted Heilbronn, Germany-based Xenios CE mark approval to market its i-cor, a cardiac assist ...Learn More
Lung cancer screening systems from Siemens get FDA clearance
The Somatom CT systems, developed by Siemens Healthcare for low-dose lung cancer screening, have received clearance from the ...Learn More
Boston Scientific's atherectomy component recall labeled Class I by FDA
A recall initiated by Boston Scientific involving almost 1,000 components used with its Rotablator atherectomy system has ...Learn More
Medical Device Clinical Trials: Operational Challenges and Opportunities
Dec. ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
Feb. ...Learn More
None of my inventions came by accident. I see a worthwhile need to be met and I make trial after trial.
Thomas Edison, ...Learn More
MedTech Europe to vote on eliminating direct sponsorship of physician education
MedTech Europe will vote Dec. ...Learn More
French oncology institute partners with Vela Diagnostics on cancer test
The Gustave Roussy Institute of Oncology in France has struck a collaboration deal to use Singapore-based Vela Diagnostics' ...Learn More
Report highlights top medical imaging technology trends of 2015
A Peer60 report said radiation dose monitoring, speech recognition and image sharing tools were the top three medical ...Learn More
Report: Spinal biologics market to reach $2.4B by 2020
A MarketsandMarkets report predicts the market for spinal biologics will hit $2.4 billion by 2020, with a 4.4% compound ...Learn More
Second PMA module for breast tomosynthesis device submitted by Fujifilm
The second module of a premarket approval application for a digital breast tomosynthesis upgrade for the Aspire Cristalle ...Learn More
Sectra combines pathology, radiology PACS in cancer-detection tool
Sectra has integrated its pathology PACS and radiology PACS into a single system that the firm will release at RSNA 2015. ...Learn More
Ransomware expected to be a threat for medical devices next year, report says
A Forrester Research report predicts cases of ransomware involving lifesaving medical devices such as connected pacemakers ...Learn More
FDA seeks comments on proposed LDT regulatory framework
Comments on proposed stronger regulatory requirements for laboratory-developed tests are being sought by the FDA's Center ...Learn More
Robotic X-ray system from Siemens lands FDA clearance
The Multitom Rax, a twin robotic X-ray technology from Siemens, has received 510(k) clearance from the FDA. ...Learn More
EU OKs multiple myeloma test from SkylineDx
Regulators in Europe have given SkylineDx, a Rotterdam, Netherlands-based molecular diagnostics company, the CE-IVD mark for ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Everyone sits in the prison of his own ideas; he must burst it open.
Albert Einstein, theoretical ...Learn More
Medtech's economic contributions reach $2.6B in Memphis, Tenn.
A Greater Memphis Medical Device Council study found that the medtech industry has contributed over $2.6 billion to the ...Learn More
Compression systems maker acquired by BSN Medical
Hamburg, Germany-based BSN Medical has paid an undisclosed sum to purchase Wright Therapy Products, an Oakdale, Pa.-based ...Learn More
Natera takes $10M from $50M credit line
According to a regulatory filing, Natera has taken $10 million from its $50 million credit facility with UBS Bank. ...Learn More
Texas cancer center agrees to research deal with SyntheticMR
The MD Anderson Cancer Center in Houston is teaming up with SyntheticMR, a Swedish developer of medical imaging systems, to ...Learn More
Ingestible vital sign monitor developed by MIT researchers
Massachusetts Institute of Technology researchers have created a vital signs monitor that can be ingested to deliver ...Learn More
5 health devices among best inventions in 2015
TIME magazine listed five medical devices among its 2015 Best Inventions list. ...Learn More
Conformity assessment guidance for medical devices updated in Malaysia
Guidance clarifying the conformity assessment process has been released by Malaysia's Medical Device Authority. ...Learn More
Clearance for Entellus' multi-sinus dilation technology widened by FDA
The XprESS, a multi-sinus dilation device from Entellus Medical, now has additional clearance from the FDA. ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...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
SmartBrief will not publish Thursday and Friday
In observance of Thanksgiving in the US, SmartBrief will not publish Thursday and Friday. Publication will resume ...Learn More
The unexamined life is not worth living.
Socrates, ...Learn More
Funding round pulls in $36.5M for BAROnova
A Series D financing round led by Longitude Capital and Delos Capital brought in $36.5 million for BAROnova. ...Learn More
Toronto-based firm pulls in $4M in financing
A private placement deal with Longtai Medical brought in $4 million for Toronto-based Titan Medical. ...Learn More
Exactech obtains rights to market orthopedic implants in Australia
Exactech Australia has struck a deal to bring Mobelife's customized orthopedic implants to Australia. ...Learn More
2 preferred provider organizations agree to cover Biocept's cancer tests
Three Rivers Provider Network and Fortified Provider Network have agreed to provide reimbursement coverage for Biocept's ...Learn More
NaviGate records first human implanted with mitral valve device
A patient at San Borja Arriaran Hospital in Santiago, Chile, was the first human to be implanted with the transcatheter ...Learn More
UK creates $1.5B fund for malaria prevention
The UK is establishing a $1.5 billion initiative with the goal of eliminating malaria and other infectious diseases. ...Learn More
Smartphone-connected ultrasound device from Royal Philips debuts in US
Lumify, a technology designed to ease point-of-care diagnostics and make ultrasound more accessible, has been launched in ...Learn More
Intelemage beefs up capabilities of data-sharing tool
Intelemage will unveil an upgraded version of its advanced workflow, image exchange and telemedicine solution at the ...Learn More
EU OKs iontophoretic transdermal delivery device from The Medicines Co.
European regulators have granted The Medicines Co. ...Learn More
FDA panel sets review date for Medtronic's spine-stabilization device
The FDA's Orthopaedic & Rehabilitation Devices Panel will convene Feb. ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
Medical Device Clinical Trials: Operational Challenges and Opportunities
Dec. ...Learn More
It's hard to lead a cavalry charge if you think you look funny on a horse.
Adlai Stevenson II, political leader and ...Learn More
Medical equipment distributor to be acquired by C.R. Bard in $181M deal
C.R. ...Learn More
Irish medical-balloon company purchased by SurModics
Minnesota-based medical device coatings company SurModics has agreed to pay $19 million upfront plus potential milestone ...Learn More
Stroke device maker to be acquired by J&J subsidiary
Biosense Webster, the Diamond Bar, Calif.-based subsidiary of Johnson & Johnson, has agreed to pay an undisclosed sum to ...Learn More
New board member named by Quidel
Charlie Slacik has been tapped to serve on the board of directors at Quidel. ...Learn More
NovoCure reports positive study results for brain tumor device
A late-stage trial of patients with brain cancer showed promising results for Optune, a device developed by NovoCure to use ...Learn More
US patent issued to NeuroMetrix's neuropathy testing technology
Waltham, Mass.-based NeuroMetrix has obtained a patent from the US Patent and Trademark Office for a core technology in its ...Learn More
Caradigm adds e-prescribing of controlled substances software to portfolio
Caradigm has expanded its Identity and Access Management portfolio with the recent inclusion of its Electronic Prescribing ...Learn More
House speaker urged to set vote on medical device tax repeal by end of 2015
A bipartisan group of 44 new House members, led by Rep. ...Learn More
FDA OKs recharge-free spinal cord stimulation device from St. Jude
The Proclaim Elite Spinal Cord Stimulation System, developed by St. Jude Medical, has obtained approval from the FDA. ...Learn More
Heart failure treatment device from CVRx wins expedited access status from FDA
Medtech firm CVRx's Barostim device, designed for heart failure patients, was given expedited access pathway status by the ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
Feb. ...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
Business is all about solving people's problems -- at a profit.
Paul Marsden, ...Learn More
Strategic deal with Chinese municipality secured by AdvaMed
A strategic cooperation agreement has been reached between AdvaMed and the Xining Municipality's government in Qinghai ...Learn More
For more:
Read the news release for details about AdvaMed's strategic cooperation agreement with Xining, ...Learn More
Endologix-TriVascular deal clears US antitrust requirement
Santa Rosa, Calif.-based TriVascular Technologies and Irvine, Calif.-based Endologix have cleared an antitrust hurdle for ...Learn More
Series C round stretched by Fractyl to $57M
An additional $17 million has been raised by Waltham, Mass., company Fractyl Laboratories, bringing the total for its Series ...Learn More
Minn.-based interbody device maker gets $2.5M boost
The first tranche of a Series B funding round has brought in $2.5 million for Minnetonka, Minn.-based Vertebral ...Learn More
US patent issued to KATOR's suture anchor technology
Medtech startup KATOR has obtained a patent from the US Patent and Trademark Office for its suture anchor device. ...Learn More
Patent issued to Otoharmonics
A US patent has been issued to Otoharmonics for elements of its Levo device, a tinnitus technology intended to deliver ...Learn More
Azumio beefs up health app with nitric oxide testing feature
A partnership was formed between Berkeley Test and Azumio to include a nitric oxide testing tool to the latter's Argus ...Learn More
Nuance upgrades radiology communication, reporting tool
An updated version of the PowerScribe 360 radiology reporting and communication solution will be released by Nuance ...Learn More
EU approves heart device from Boston Scientific
European regulators have granted Boston Scientific CE mark approval to market its Watchman FLX, a device designed for left ...Learn More
Digital radiography software from Visaris lands FDA clearance
The Avanse, a software platform from Visaris Americas, has received 510(k) clearance from the FDA. ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
Medical Device Clinical Trials: Operational Challenges and Opportunities
Dec. ...Learn More
Character cannot be developed in ease and quiet. Only through experience of trial and suffering can the soul be strengthened, vision cleared, ambition inspired, and success achieved.
Helen Keller, writer and ...Learn More
Video laryngoscope maker acquired by Medtronic in $110M deal
Medtronic has agreed to pay $110 million in cash to purchase Aircraft Medical, a maker of video laryngoscopes based in ...Learn More
Laser systems maker to be acquired by Alphaeon
Irvine, Calif.-based Alphaeon has agreed to pay as much as $59 million to purchase Lensar, the Orlando, Fla.-based maker of ...Learn More
Calif.-based firm stretches funding round to $46M
Redwood City, Calif.-based Gynesonics has raised an additional $2.9 million in a round of financing led-by USP Group's Novit ...Learn More
Product sales drive Q3 revenue growth for Epigenomics
German molecular diagnostics company Epigenomics generated $502,482 in revenue in the quarter ending Sept. ...Learn More
CoorsTek Medical names new advisory board member
Dr. ...Learn More
Thermo Fisher to design companion Dx test with Pfizer, Novartis
Pfizer and Novartis are partnering with Thermo Fisher Scientific to create and market a companion diagnostic test to be used ...Learn More
Cervical discectomy, fusion guide system from Nexxt Spine debuts
The DT Elite, a guide technology intended to lessen the operative steps during anterior cervical discectomy and fusion ...Learn More
EU OKs knee technology from Moximed
European regulators have granted Hayward, Calif.-based Moximed CE mark approval to market its Atlas, a knee joint unloader ...Learn More
Canada approves wound irrigation device from Innovacyn
The Puracyn Plus Professional Formula, a wound irrigation and management system from California company Innovacyn, has ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Hard work spotlights the character of people: Some turn up their sleeves, some turn up their noses, and some don't turn up at all.
Sam Ewing, baseball ...Learn More
Funding round pulls in $20M for Zyga
A debt refinancing round co-led by Bridge Bank and Oxford Finance has brought in $20 million for Zyga Technology. ...Learn More
Mich.-based Ablative Solutions gets $2.4M boost
Ablative Solutions has obtained $2.4 million and is planning to raise $4 million more in a funding round involving 24 ...Learn More
Group B Strep Assay, growing customer base drive Q3 revenue growth for Great Basin
Salt Lake City-based molecular diagnostics company Great Basin Scientific generated $545,934 in revenue in the quarter ...Learn More
Blue Belt records first surgery in Los Angeles using orthopedic device
A patient at Silver Lake Medical Center was the first in Los Angeles to undergo partial knee replacement using the Navio, an ...Learn More
FDA clears MRI device from Mallinckrodt
The INOmax DSIR Plus MRI, a device developed by Malllinckrodt to deliver nitric oxide for inhalation during MRIs, has ...Learn More
Evena debuts updated version of smart glasses
Evena launched its Eyes-On Glasses 3.0. ...Learn More
Updates in VISUS' imaging software get FDA clearance
Version 4.7 of VISUS' JiveX software received clearance from the FDA. ...Learn More
Remote pacer monitor from Medtronic lands FDA approval
The MyCareLink Smart Monitor, an application-based remote monitor developed by Medtronic for patients with implanted ...Learn More
FDA clears bone graft substitute from Prosidyan
The FIBERGRAFT BG Morsels, a synthetic bone graft substitute from Warren, N.J.-based Prosidyan, obtained 510(k) clearance ...Learn More
Ultrasound device from Fujifilm SonoSite lands FDA clearance
The iViz, a portable ultrasound system from Fujifilm SonoSite, has received 510(k) clearance from the FDA. ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
Feb. ...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 cannot swim for new horizons until you have courage to lose sight of the shore.
William Faulkner, ...Learn More
SurgiQuest to be acquired by ConMed in $265M deal
Utica, N.Y.-based ConMed has reached a deal to purchase SurgiQuest, the Milford, Conn.-based maker of the AirSeal device for ...Learn More
Signostics gets $35M funding boost
Private funding from global investment firm KKR has brought in $35 million for Signostics, a developer of hand-held ...Learn More
Funding round pulls in $28M for ElMindA
A Series C financing round that included the Kraft Group, which owns the New England Patriots, brought in $28 million for ...Learn More
Financing round brings in $26.8M for Molecular Health
A round of private funding led by Dievini brought in $26.8 million for Molecular Health, maker of the TreatmentMAP ...Learn More
Denmark-based startup gets $1.6M boost
Myant Capital Partners unit Myant has invested $1.6 million in Denmark-based startup Cortrium. ...Learn More
Electronic contact lenses to be developed by e-Vision Smart Optics
A plan to create electronic contact lenses that can continuously adjust near, middle and far vision depending on the user's ...Learn More
3 endoscope reprocessors from Cantel Medical debut in Europe, Asia-Pacific
The Medivators Advantage Plus, an automated endoscope reprocessor with pass-through capability and an intuitive operating ...Learn More
EU OKs ADHD device from NeuroSigma
Los Angeles-based NeuroSigma Systems' Monarch eTNS system has been granted European CE mark approval as a treatment for ...Learn More
FDA clears imaging device from Perspectum Diagnostics
The LiverMultiScan, an imaging technology from Perspectum Diagnostics, has received 510(k) clearance from the FDA. ...Learn More
Artificial kidney from U. of Wash. wins expedited access status from FDA
The University of Washington Medical Center's Wearable Artificial Kidney was given expedited access pathway designation by ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Silence is the bluntest of blunt instruments.
Erica Jong, ...Learn More
$1B share repurchase program announced by Thermo Fisher
A plan by Thermo Fisher Scientific to buy back $1 billion of company stock in a repurchase program was approved by the ...Learn More
Equity funding round pulls in $32M for Avedro
A round of equity financing led by OrbiMed and InterWest Partners has brought in $32 million for Waltham, Mass.-based ...Learn More
Consumable products drive Q3 revenue growth for HTG
Tucson, Ariz.-based HTG Molecular Diagnostics generated $1 million in total revenue in the quarter ending Sept. ...Learn More
Industry veteran named CEO, chairman of Sientra
Jeffrey Nugent has been appointed chairman and CEO of Sientra, a manufacturer of breast implants. ...Learn More
$17.8M in funding awarded to fight malaria in Africa
The Global Fund to Fight AIDS, Tuberculosis and Malaria has allocated a three-year, $17.8 million grant in an effort to ...Learn More
Visual Dx device from LKC Technologies debuts
The RETeval Complete, a hand-held device that delivers useful diagnostics for abnormalities of the visual system, has been ...Learn More
FDA clears laser atherectomy catheter from Spectranetics
The Turbo-Power, a laser atherectomy catheter from Colorado-based Spectranetics, received 510(k) clearance from the FDA. ...Learn More
EU OKs ultrasound platform from Cephasonics
European regulators have granted California-based Cephasonics CE mark approval to market its cQuest Cicada ultrasound ...Learn More
2 cancer exome sequencing tests obtain approval in N.Y.
The New York State Department of Health approved Columbia University's cancer whole exome and transcriptome test. ...Learn More
FDA labels Hamilton Medical's ventilator recall as Class I
A recall of 1,128 units of Hamilton Medical's G5 Ventilator V2.31 and V2.00 has been categorized by the FDA as Class I, the ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
Medical Device Clinical Trials: Operational Challenges and Opportunities
Dec. ...Learn More
There is nothing noble in being superior to your fellow man; true nobility is being superior to your former self.
Ernest Hemingway, ...Learn More
IPO could pull in $75M for SurgiQuest
An initial public offering that could raise up to $75 million has been filed by Milford, Conn.-based SurgiQuest. ...Learn More
GM Medical Pacific enters distribution deal with Orthozon
GM Medical Pacific has reached a deal to exclusively distribute Orthozon's LUMIERE Minimally Invasive Access System in the ...Learn More
Firms partner to develop framework for companion Dx tests
UK-based Almac Diagnostics and Illumina agreed to collaborate in developing a framework for creating companion diagnostic ...Learn More
Fixation products, biologics drive Q3 revenue growth for Xtant Medical
Xtant Medical generated $20.9 million in revenue during the third quarter, a 6.5% increase over the same period a year ago. ...Learn More
Former Google exec named CEO of AliveCor
Vic Gundotra has been tapped to serve as CEO for San Francisco-based AliveCor. ...Learn More
Pair of Purdue brain researchers awarded grants from NIH
A pair of researchers at Purdue University have received grants from the NIH to study brains. ...Learn More
FDA clears MR imaging system from Perspectum Dx
The LiverMultiscan, an MR imaging technology from UK-based Perspectum Diagnostics, received 510(k) clearance from the FDA. ...Learn More
Medtech reporting, labeling guidance released in Malaysia
Guidance clarifying labeling and mandatory postmarket incident reporting of medtech products has been released by Malaysia's ...Learn More
FDA approving device applications at record speed
New policies at the FDA's Center for Devices and Radiological Health appear to have boosted the approval rate for medical ...Learn More
EU OKs familial hypercholesterolemia assay from Progenika Biopharma
European regulators have granted CE mark approval to Progenika Biopharma's Seqpro Lipo IS, which the company says is the ...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
Hard work without talent is a shame, but talent without hard work is a tragedy.
Robert Half, ...Learn More
CeloNova's interventional radiology products acquired by Boston Scientific
Boston Scientific has agreed to pay $70 million upfront plus potential milestone fees to purchase CeloNova Biosciences' ...Learn More
Q3 revenue increases for CareDx
Brisbane, Calif.-based CareDx generated total revenue of $7.2 million in the quarter ending Sept. ...Learn More
Spine surgeon joins Medovex's advisory board
Dr. ...Learn More
Cancer imaging expert named to HealthMyne's advisory board
Robert Gillies, who has published more than 240 articles on using imaging and spectroscopy to investigate the physiology of ...Learn More
Medtronic's leadless pacemaker performs well in trial
A study presented at a meeting of the American Heart Association showed promising results for Medtronic's Micra ...Learn More
OMNIBotics records first surgery in San Diego using robotic system
A patient at Alvarado Hospital Medical Center was the first in San Diego to undergo total knee replacement using robotic ...Learn More
Tissue staining system from Roche debuts
The Ventana HE 600, an eosin and hematoxylin staining device designed to improve technician and patient safety, has been ...Learn More
Congress weighs ACA device, excise taxes in spending bills
The federal government faces a shutdown Dec. ...Learn More
InnFocus gains FDA nod to expand Microshunt glaucoma drainage system study
The FDA cleared Miami-based InnFocus to expand a clinical trial of its Microshunt, a device intended to relieve eye pressure ...Learn More
3 patents issued to Ubiquity
Among three patents granted by the US Patent and Trademark Office to Ubiquity is one that covers the Medical Scan Clip-on, a ...Learn More
Medical Device Clinical Trials: Operational Challenges and Opportunities
Dec. ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
Feb. ...Learn More
Rule No. 1: Never lose money. Rule No. 2: Never forget rule No. 1.
Warren Buffett, investor and business ...Learn More
Fresenius, Spectral Medical reach distribution deal
Fresenius Medical Care has entered a nonexclusive deal to distribute Toronto-based Spectral Medical's endotoxin activity ...Learn More
Firms partner to market calorimeter system
Tokyo-based Pacific-Medico has made a multiyear deal to market St. ...Learn More
Q3 net sales, gross profit increase for Orthofix
Orthofix said its third-quarter net sales reached $101.2 million, a 4.1% increase over the same period last year. ...Learn More
Boston Scientific's heart device performs well in trial
A study presented at a meeting of the American Heart Association in Orlando, Fla., showed promising results for Boston ...Learn More
US patent issued to Intellijoint Surgical's core technology
Intellijoint Surgical has obtained a key patent from the US Patent and Trademark Office associated with its core technology ...Learn More
IEEE working on standards for mHealth tools, 3D printers
IEEE is working on two standards to aid the interoperability of 3D printers and medical devices. ...Learn More
Calif.-based firm submits premarket application for near vision inlay
An application submitted by Lake Forest, Calif.-based ReVision Optics seeking premarket approval for the Raindrop, a ...Learn More
Suture anchor system from KATOR lands FDA clearance
A suture anchor technology developed by Utah-based medtech startup KATOR has received 510(k) clearance from the FDA. ...Learn More
FDA clears interbody fusion device from Interventional Spine
The FDA has granted clearance to Irvine, Calif.-based Interventional Spine for its Opticage Expandable Interbody Fusion ...Learn More
2 CT scanners from Hitachi cleared by FDA
The Scenaria SE 128 and Scenaria SE 64 CT scanners from Hitachi Medical Systems America have obtained clearance from the ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Strong characters are brought out by a change of situation, and gentle ones by permanence.
Jean Paul Richter, ...Learn More
Medi-Cal enters supply deal with Arkray USA
The California Medical Assistance Program has finalized a contract giving its members access to Arkray USA's test strips, ...Learn More
Molecular Dx firm gets $3M funding boost
A private securities offering has brought in $3 million for Nashville, Tenn.-based Insight Genetics. ...Learn More
Report forecasts market growth for global nonfusion spine devices
A Future Market Insights report predicts that the global market for nonfusion spinal devices will grow steadily through ...Learn More
Blood culture tests drive Q3 revenue growth for Nanosphere
Northbrook, Ill.-based molecular diagnostics firm Nanosphere generated $4.9 million in revenue in the quarter ending Sept. ...Learn More
Frost resigns as executive VP, CFO of AngioDynamics
Mark Frost has stepped down as executive vice president and chief financial officer of AngioDynamics. ...Learn More
FDA clears hip guide system from Materialise
The Acetabular Cup Orientation System, a hip guide technology from Materialise, has obtained 510(k) clearance from the FDA. ...Learn More
Venous reflux treatment device from Medtronic debuts in US
The VenaSeal, a device designed to close superficial veins in the lower extremities of symptomatic venous reflux patients, ...Learn More
FDA clears sacroiliac joint technology from Si-Bone
The FDA has granted 510(k) clearance to San Jose, Calif.-based Si-Bone for its iFuse, a minimally invasive implant developed ...Learn More
Prostate device from Edap lands FDA clearance
The Ablatherm, a device developed by Edap to ablate prostate tissue, has received 510(k) clearance from the FDA. ...Learn More
Breast imaging software from Volpara cleared by FDA
The FDA has given 510(k) clearance to Volpara Solutions' VolparaDensity version 3.1, a breast imaging software. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
Show class, have pride and display character. If you do, winning takes care of itself.
Bear Bryant, football ...Learn More
Equity funding round pulls in $25M for Medrobotics
A round of equity financing brought in $25 million for Raynham, Mass.-based Medrobotics. ...Learn More
Public offering could bring in $12M for Cancer Genetics
Cancer Genetics, a molecular diagnostics company based in Rutherford, N.J., has priced the 3 million shares in its public ...Learn More
ResMed enters distribution deal with CareFusion
San Diego-based CareFusion has made a deal to distribute the nasal high-flow interface products of ResMed through ...Learn More
Implant maker to expand, move operations to Ohio
Vistek Medical, a maker of components and implants focused on the extremity, trauma, spine and orthopedic markets, is ...Learn More
New CEO named by Exosome Diagnostics
John Boyce was tapped to serve as CEO of Exosome Diagnostics. ...Learn More
FDA clears laser device from Syneron Medical
The FDA has granted clearance to Syneron Medical for its CO2RE CO2, a laser device for over 90 specific indications. ...Learn More
Knee system from DJO Global debuts
The EMPOWR 3D Knee technology, intended for younger patients who want to restore healthy knee motion, was launched by Vista, ...Learn More
Medtech review program changes to debut in Taiwan
Taiwanese regulators will implement changes on Tuesday that will make the medtech review program a two-step process instead ...Learn More
Brain biopsy surgery system from Deerfield Imaging cleared by FDA
The Symbis, a stereotactic surgery system developed by Deerfield Imaging for brain biopsy, has obtained 510(k) clearance ...Learn More
Review date for Guided Therapeutics' cervical scan moved to Nov. 30
A new meeting date of Nov. ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
Medical Device Clinical Trials: Operational Challenges and Opportunities
Dec. ...Learn More
A ship in harbor is safe, but that is not what ships are built for.
John Shedd, ...Learn More
Deal to acquire Terumo's surgical cannula line completed by MC3
Terumo Cardiovascular has concluded the sale of its surgical cannula line to MC3 Cardiopulmonary of Dexter, Mich. ...Learn More
Financing round pulls in $26.8M for Biological Dynamics
A round of Series C funding that included convertible debt has brought in $26.8 million for San Diego-based Biological ...Learn More
Report: Medtronic's R&D spending hits $1.64B in 2015
An integrated performance report from Medtronic said the company has invested $1.64 billion in research and development in ...Learn More
Q3 revenue rises for LDR
LDR generated $39.3 million in total revenue in the third quarter, a 9.5% increase from the same period last year. ...Learn More
Primary businesses drive Q4 revenue growth for Hologic
Hologic generated $702.8 million in revenue in the quarter ending Sept. ...Learn More
Cancer treatment study at Tuskegee University awarded $1.1M grant
Tuskegee University researchers have received a $1.1 million grant to study ways to improve cancer survival rates. ...Learn More
Portable ultrasound scanner from Alpinion debuts
The E-Cube i7, a laptop-style ultrasound scanner, was launched by Alpinion Medical Systems. ...Learn More
Incubation system from INVO Bioscience gets FDA clearance
Medford, Mass.-based INVO Bioscience has received clearance under the FDA's de novo program to market its INVOcell, a system ...Learn More
Oxygen therapy system by TherOx gets FDA IDE designation
The FDA has granted an investigational device exemption to Irvine, Calif.-based TherOx for an evaluation of the firm's ...Learn More
China approves Akers Biosciences' heparin allergy assays
Akers Biosciences has obtained clearance from the China Food and Drug Administration for two rapid diagnostics tests for ...Learn More
Working with Private Payers: Advocating for Your Medical Technology in the Age of Reform
Nov. 12 | 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
Out of clutter, find simplicity.
Albert Einstein, theoretical ...Learn More
Equity financing round pulls in $23.5M for Conventus Orthopaedics
A round of equity funding brought in $23.5 million for Maple Grove, Minn.-based Conventus Orthopaedics. ...Learn More
Share repurchase program worth $75M announced by Orthofix
A plan by Orthofix to buy back as much as $75 million of its stock in a repurchase program was approved by the company's ...Learn More
Report forecasts growth for medtech outsourcing in US
A report from Grand View Research predicted the US market for medtech outsourcing will hit $27.8 billion by 2022. ...Learn More
Firm gets $3.9M to advance treatment technology for ADHD
Mensia Technologies, a medtech firm focused on the central nervous system, has received a $3.9 million grant to develop its ...Learn More
EU OKs blood loss monitor from Gauss Surgical
European regulators have granted Los Altos, Calif.-based Gauss Surgical CE mark approval to market its Triton, a device ...Learn More
IHealth Lab offers low-cost blood pressure monitoring tool
A new, lower-cost smartphone-connected device was unveiled by iHealth Lab to allow users to track their blood pressure. ...Learn More
Anesthesia guidance device from Rivanna Medical debuts
The Accuro, an anesthesia guidance device, was launched by Rivanna Medical at an anesthesiologists meeting in San Diego. ...Learn More
Bone graft from Cerapedics wins FDA nod
The i-FACTOR Peptide Enhanced Bone Graft from Westminster, Colo.-based orthobiologics firm Cerapedics has obtained FDA ...Learn More
Canada approves knee osteoarthritis pain device from Anika Therapeutics
Health Canada has given Anika Therapeutics approval to market its Cingal, a device designed to address pain tied to knee ...Learn More
Respiratory assist device from ALung wins expedited access designation from FDA
ALung Technologies' Hemolung Respiratory Assist System was given expedited access pathway status by the FDA. ...Learn More
Medical Device Clinical Trials: Operational Challenges and Opportunities
Dec. ...Learn More
The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation
Feb. ...Learn More
It takes a great deal of bravery to stand up to our enemies, but just as much to stand up to our friends.
J.K. Rowling, ...Learn More
US antitrust waiting period cleared by HeartWare for Valtech Cardio deal
HeartWare International has cleared the final antitrust hurdle for its pending purchase of Valtech Cardio, an Israeli maker ...Learn More
Firms enter deal to create peritoneal dialysis systems
A partnership deal was reached between Fresenius Medical Care, a provider of dialysis products and services, and Debiotech ...Learn More
AtriCure opens new headquarters in Mason, Ohio
Atrial fibrillation device maker AtriCure opened its new, larger facility in Mason, Ohio, on Tuesday. ...Learn More
Q3 revenue rises for ConforMIS
ConforMIS generated $13.9 million in total revenue in the third quarter, a 20% increase from the same period last year. ...Learn More
Molecular Dx firm posts revenue increases for 2016 Q1
Myriad Genetics generated $183.5 million in total revenue in the quarter ending Sept. ...Learn More
Xtant Medical records first patient implanted with bone matrix putty
The first patient implanted with the OsteoSelect PLUS Demineralized Bone Matrix Putty was reported by Xtant Medical. ...Learn More
Patent issued to BioRestorative Therapies
Life sciences firm BioRestorative Therapies has obtained a US patent for its curved needle device. ...Learn More
Study shows positive results for Helius Medical's neurostimulation device
Research showed promising results for Helius Medical Technologies' Portable Neuromodulation Stimulator. ...Learn More
FDA releases guidance on proving medtech electromagnetic compatibility
The FDA has issued new guidance detailing the supporting documents that medtech firms should add to their premarket ...Learn More
Avedro gets approval for eye treatment device in China
Chinese regulators have granted Avedro approval to market its KXL, a corneal cross-linking device designed to address ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
Nothing is so painful to the human mind as a great and sudden change.
Mary Shelley, ...Learn More
Medication management solutions firm to be acquired by Omnicell
Omnicell has agreed to pay roughly $275 million to purchase Aesynt, a medication management firm. ...Learn More
Funding round may pull in more than $24M for Titan Medical
A private placement deal with Longtai Medical, a unit of Chinese medtech distributor Ningbo Long Hengtai International ...Learn More
Report predicts growth for spine surgery devices in Europe
A report from Medical Market Research Reports predicts the European market for spine surgery devices will hit $2.37 billion ...Learn More
Q3 revenue increases for NanoString
NanoString Technologies generated $15.7 million in revenue the quarter that ended Sept. ...Learn More
New CEO named by EnteroMedics
Dan Gladney was tapped to serve as CEO of St. Paul, Minn.-based EnteroMedics starting Nov. 16. ...Learn More
Audit committee chairman of Alphatec Spine retires
James Glynn retired Monday as chairman of Alphatec Spine's Audit Committee. ...Learn More
Positive results reported in 2 studies of Medtronic's drug-coated balloon
The In.Pact Admiral, a drug-coated balloon from Medtronic used in angioplasty procedures, showed promising results in two ...Learn More
Pedicle screw technology from Globus Medical debuts
The CREO MIS Pedicle Screw System, a thoracolumbar posterior stabilization device, has been launched by Globus Medical. ...Learn More
CE mark application for back pain device submitted by Mainstay Medical
A CE mark application has been filed by medtech firm Mainstay Medical for its ReActiv8 neurostimulation technology. ...Learn More
Open heart surgery delivery device recalled by Quest Medical
A recall was initiated by Quest Medical involving some lots of its 7001102, 5001102-AS and 5001102 Myocardial Protection ...Learn More
MedTech Compliance Boot Camp
Nov. 4-5 | Washington, D.C. ...Learn More
Working with Private Payers: Advocating for Your Medical Technology in the Age of Reform
Nov. 12 | Washington, D.C. ...Learn More
Change has to come for life to struggle forward.
Helen Hollick, ...Learn More
Steris to conclude merger with Synergy Health today
Mentor, Ohio-based Steris announced that its $2 billion merger with Synergy Health is expected to be completed today. ...Learn More
Sanomedics to sell Thermomedics to Positive ID
Sanomedics has been approved to sell its Thermomedics business and its Caregiver, a clinical-grade thermometer cleared by ...Learn More
Zoe Medical buys CAS Medical System's vital signs monitoring products
Zoe Medical has agreed to pay an undisclosed sum to acquire Branford, Conn.-based CAS Medical Systems' 740 Select vital ...Learn More
Accuray posts revenue increases for 2016 Q1
Accuray generated $89.6 million in revenue in the quarter ending Sept. ...Learn More
New chief commercial officer named by Anika Therapeutics
Richard Hague was tapped to serve as chief commercial officer at Anika Therapeutics. ...Learn More
New board member named by Molecular Diagnostics
Lee McCracken has been tapped to serve on the board of directors at Molecular Diagnostics. ...Learn More
ISO certification granted to InDevR
InDevR has been granted ISO certification for its quality management system for the manufacture, development and design of ...Learn More
Immunoassay platform from Quanterix debuts
The Simoa 2.0, a next-generation ultrasensitive immunoassay system, has been launched by diagnostic firm Quanterix. ...Learn More
Spine stimulation device from PathMaker wins expedited access designation from FDA
The FDA has given expedited access pathway status to PathMaker Neurosystems' MyoRegulator PM-2200, a device intended to ...Learn More
FDA discusses Integrity Applications' presubmission filing for glucose monitor
The FDA met with Integrity Applications to discuss the company's presubmission application for the GlucoTrack Model DF-F, a ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Don't wait for extraordinary opportunities; seize common occasions and make them great.
Orison Swett Marden, ...Learn More
Deal to acquire Lake Region Medical completed by Greatbatch
Frisco, Texas-based Greatbatch has concluded its purchase of Wilmington, Mass.-based Lake Region Medical for $1.73 billion. ...Learn More
Blue Belt Technologies to be acquired by Smith & Nephew in $275M deal
Smith & Nephew has agreed to pay $275 million to purchase Blue Belt Technologies. ...Learn More
Minn.-based firm gets $21M boost
Conventus Orthopaedics has obtained $21 million toward its goal of $23.1 million in a financing round involving seven ...Learn More
Financing round pulls in $20M for Qvella
A Series A funding round led by Whitecap Venture Partners and RA Capital Management has brought in $20 million for ...Learn More
Q3 revenue increases for NeoGenomics
Fort Myers, Fla., cancer genetic testing firm NeoGenomics generated $25.1 million in revenue in the quarter ending Sept. ...Learn More
Baxter names former Covidien exec chairman, CEO
Jose Almeida has joined Baxter International as an executive officer to facilitate his transition to take over as chairman ...Learn More
Nasal cannula from Teleflex debuts
The Comfort Flo Plus, a heated high-flow nasal cannula, has been launched by Wayne, Pa.-based Teleflex. ...Learn More
Light therapy device from Lucimed debuts in Europe
The Luminette, a light therapy system designed to relieve circadian rhythm issues, sleep disorders and seasonal affective ...Learn More
AdvaMed, other groups seek reforms to CMS' new technology add-on payment program
Medical innovator organizations, including AdvaMed and the Biotechnology Industry Organization, have expressed frustration ...Learn More
FDA clearance sought by Nephros for ultrafilter
Nephros, a River Edge, N.J.-based company, has filed an application with the FDA seeking 510(k) clearance for its S100 Point ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
Medical Device Clinical Trials: Operational Challenges and Opportunities
Dec. ...Learn More
One should always play fairly when one has the winning cards.
Oscar Wilde, ...Learn More
China-based firm buys Nipro Diagnostics in $273M deal
Sinocare Group, a marketer of blood glucose monitoring systems based in China, has agreed to pay about $273 million in cash ...Learn More
Perseon to be acquired by Galil Medical
Galil Medical has reached a deal to purchase Perseon and its MicroThermX, a microwave ablation technology, for $10.6 ...Learn More
Funding round pulls in $32M for Taris
A private financing round has brought in $32 million for Taris Biomedical. ...Learn More
New product sales drive Q3 revenue growth for Quidel
Quidel generated $46.8 million in the quarter that ended Sept. ...Learn More
New chairman named for AdvaMed's state medtech alliance
Shaye Mandle, CEO of the Minnesota trade group LifeScience Alley, was tapped to serve as chairman of AdvaMed's State Medical ...Learn More
Positive results reported in 2 studies of Medtronic's capnography monitors
Two capnography monitors from Medtronic showed promising results in separate clinical trials presented this week at an ...Learn More
Ostomy pouch output monitor from 11 Health debuts
Ostom-I Alert, a device and mobile application designed to track ostomy pouch output, has been launched by UK-based 11 ...Learn More
FDA OKs hydrocodone immunoassay from Thermo Fisher
An immunoassay developed by Thermo Fisher Scientific has obtained 510(k) clearance from the FDA to detect hydrocodone, a ...Learn More
Canada approves laser procedure from Cynosure
Health Canada has given Cynosure approval to market its MonaLisa Touch, a laser procedure intended to address symptoms tied ...Learn More
AROSurgical warned by FDA over changes to anastomosis clamp, sutures
A warning letter was issued by the FDA to AROSurgical over changes to the materials and sterilization methods of the ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
Medical Device Clinical Trials: Operational Challenges and Opportunities
Dec. ...Learn More
Inspiration is for amateurs; the rest of us just show up and get to work.
Chuck Close, painter and ...Learn More
Stryker looks to offer $750M in senior notes
Stryker announced that it will sell senior unsecured notes worth $750 million, which are due Nov. 1, 2025. ...Learn More
TriVascular Technologies reaches merger deal with Endologix
Santa Rosa, Calif.-based TriVascular Technologies and Endologix have agreed to merge in a cash-and-stock deal worth ...Learn More
Equity funding round pulls in $2.2M for Blockade Medical
A round of equity financing has brought in $2.2 million for Irvine, Calif.-based Blockade Medical. ...Learn More
Renescor secures strategic deal with Medtronic
A partnership between Medtronic and Renescor will bring managed health care services to Gbagada Cardiac and Renal Centre in ...Learn More
CareFusion enters interoperability deal with Edwards Lifesciences
A deal has been struck by Becton Dickinson unit CareFusion and Edwards Lifesciences to make their medical technologies ...Learn More
2 new board members named by RTI Surgical
Thomas McEachin and Christopher Sweeney have been tapped to serve on the board of directors at RTI Surgical. ...Learn More
Report forecasts growth for IoT health care market
A MarketsandMarkets report predicts the Internet of Things health care market will be worth $163.24 billion by 2020. ...Learn More
Saudi Arabian installation of X-ray technology reported by EOS
The Jeddah Scan Radiology Center in Saudi Arabia has become the first facility in the Middle East to be equipped with a unit ...Learn More
FDA clears endomicroscopy platform from Mauna Kea
The Cellvizio, a confocal laser endomicroscopy system from Suwanee, Ga.-based Mauna Kea Technologies, has obtained 510(k) ...Learn More
Pulse oximeter from Masimo lands FDA clearance
The MightySat Rx, a fingertip pulse oximeter developed by Masimo, has received 510(k) clearance from the FDA. ...Learn More
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Study the past if you would define the future.
Confucius, philosopher and ...Learn More
Minn. medtech startup gets $20M boost
A Series A funding round has brought in $20 million for Minnesota medtech startup Cardionomic. ...Learn More
Financing round pulls in $2M for Helius Medical
A round of funding from an unnamed investor brought in $2 million for Newtown, Penn.-based Helius Medical. ...Learn More
Equity funding round pulls in $1M for In2Bones
A round of equity financing involving 28 unnamed investors has brought in $1 million for In2Bones, a French developer of ...Learn More
Q3 revenue increases for Exiqon
Danish firm Exiqon generated $5.7 million in total revenue in the quarter ending Sept. ...Learn More
Ultrasound scanner from Siemens to debut at meeting
Siemens Healthcare's Acuson P500, a portable ultrasound scanner, is being introduced this week at the meeting of the ...Learn More
Deep vein thrombosis device from Devon Medical debuts
The Cirona 6300, a portable device designed for pneumatic compression therapy patients, has been launched by King of ...Learn More
Computer-aided detection software from Parascript approved by FDA
Parascript has received FDA approval for the use of its AccuDetect 7.0 software in mammography systems manufactured by ...Learn More
EU OKs ovarian cancer test from Vermillion
European regulators have granted Vermillion CE mark approval to market its Overa test for detecting ovarian cancer. ...Learn More
Balloon catheter from AV Medical is cleared by FDA
The Chameleon, an angioplasty balloon catheter from Israel-based AV Medical, has obtained 510(k) clearance from the FDA. ...Learn More
FDA clears catheter from Pryor Medical Devices
The FDA has granted clearance to Pryor Medical Devices for its ER-REBOA, a balloon occlusion catheter. ...Learn More
MedTech Compliance Boot Camp
Nov. 4-5 | Washington, D.C. ...Learn More
Working with Private Payers: Advocating for Your Medical Technology in the Age of Reform
Nov. 12 | Washington, D.C. ...Learn More
Your mind is for having ideas, not holding them.
David Allen, productivity consultant and ...Learn More
Follow-on offering could bring in $30M for Vital Therapies
San Diego-based Vital Therapies is looking to raise $30 million in a follow-on offering of shares. ...Learn More
Sequana Medical gets $9.3M boost
A round of financing has brought in $9.3 million for Swiss medtech firm Sequana Medical. ...Learn More
GE Healthcare unit to be acquired by NeoGenomics
NeoGenomics, a provider of genetic testing services focusing on cancer, has agreed to pay $80 million in cash plus 15 ...Learn More
Del Palma Orthopedics' foot fusion system to be acquired by Nextremity Solutions
A deal has been reached by Nextremity Solutions to purchase Del Palma Orthopedics' foot fusion device. ...Learn More
New president, CEO named by Christie InnoMed
Martin Roy was tapped to serve as president and CEO at Christie InnoMed, a Canada-based systems integrator and distributor. ...Learn More
Swiss researchers develop mini blood monitoring device for ICU
Swiss researchers said they developed a mini microfluidic device that ICU staff can use to monitor patient blood levels in ...Learn More
Study: Smartphone system boosts self-management of spina bifida
A study in the American Journal of Physical Medicine & Rehabilitation found the interactive Mobile Health & Rehabilitation ...Learn More
Bill that includes medical device tax repeal clears House
Legislation that includes a measure to repeal the 2.3% medical device tax was approved Friday by the House of ...Learn More
EU OKs cryoablation device from C2 Therapeutics
The Coldplay CryoBalloon Focal Ablation System, developed by Redwood City, Calif.-based C2 Therapeutics, has obtained the CE ...Learn More
Lower esophageal sphincter system from EndoStim gains CE mark
The EndoStim II, a lower esophageal sphincter device from Netherlands-based EndoStim, has received CE mark approval from ...Learn More
Recalls From A to Z: Regulations, Decisions, Procedures & Best Practices
Oct. 27-28 | Washington, D.C. ...Learn More
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. ...Learn More
The lesson will always repeat itself, unless you see yourself as the problem -- not others.
Shannon Alder, ...Learn More
Financing round pulls in $50M for Cohera Medical
A round of financing led by Kohlberg Kravis Roberts has brought in $50 million for Pittsburgh-based startup Cohera Medical. ...Learn More
Thermometer maker to be acquired by PositiveID
Delray Beach, Fla.-based PositiveID has agreed to pay $750,000 upfront plus milestone fees to purchase Thermomedics, the ...Learn More
Firms enter deal to create brain-targeted drug-delivery technology
Cerebral Therapeutics has struck an agreement with Flowonix Medical to create a device for delivering microdoses of drugs ...Learn More
Medtech firm gets $250,000 boost
Venture capital firm Innovacorp has invested $250,000 in medtech firm Densitas as part of a bigger round of seed funding. ...Learn More
Molecular biology sales drive Q3 revenue growth for BioMerieux
French in vitro diagnostics company BioMerieux generated $532.8 million in revenue in the quarter ending Sept. ...Learn More
EU OKs fluid-delivery technology from RenovoRx
The RenovoCath, developed by Los Altos, Calif.-based RenovoRx, has obtained the CE mark in Europe. ...Learn More
Thoracolumbar spine technology from Life Spine debuts
The CENTERLINE Thoracolumbar Spinal System has been introduced by Life Spine in a limited release. ...Learn More
China releases guidelines on medtech manufacturing practices
New guidelines have been published by the China Food and Drug Administration relating to good manufacturing practices of ...Learn More
Canada approves imaging system from MolecuLight
Health Canada has given MolecuLight approval to market its MolecuLight i:X, a hand-held fluorescence imaging system. ...Learn More
InSightec pursues FDA OK for ablation device
An FDA premarket approval application has been filed by InSightec for its Exablate Neuro, a device used to address essential ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Cybersecurity in a Connected Health Care System Workshop
Dec. ...Learn More
Mistakes should be examined, learned from, and discarded; not dwelled upon and stored.
Tim Fargo, writer and ...Learn More
Bulgarian contractor acquired by Bovie Medical
Bovie Medical, a Clearwater, Fla.-based maker of the J-Plasma surgical cutter and coagulator, has agreed to pay $570,000 to ...Learn More
Public stock offering brings in $15.7M for WaferGen
A public stock offering of 6.17 million shares has brought in $15.7 million for WaferGen Biosystems. ...Learn More
Funding round pulls in $9M for Surgical Theater
A round of financing brought in $9 million for Surgical Theater. ...Learn More
Signal Genetics enters deal with 3 preferred provider organizations
Evolutions Health Systems, USA Managed Care Organization and Stratose have agreed to provide reimbursement coverage for ...Learn More
New board member named by Baxter
Mike Mahoney has been tapped to serve on the board of directors at Baxter. ...Learn More
Patient monitoring system from Capsule lands FDA clearance
The SmartLinx Vitals Plus, a patient monitoring technology from Qualcomm unit Capsule Technologie, has received 510(k) ...Learn More
Radiography/fluoroscopy system from Toshiba to debut at meeting
The Ultimax-i FPD, a multipurpose radiography/fluoroscopy technology, will be launched by Toshiba America Medical Systems at ...Learn More
Cardiac defibrillators from Medtronic gain CE mark
European regulators have granted Medtronic CE mark approval for its implantable cardiac defibrillators. ...Learn More
FDA clears oral fluid screening test from Biophor Diagnostics
An oral fluid screening test developed by Redwood City, Calif.-based Biophor Diagnostics for d-methamphetamine with a limit ...Learn More
Clearance for LDR's cervical cage widened by FDA
The ROI-C Cervical Cage, developed by LDR, now has additional clearance from the FDA. ...Learn More
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. ...Learn More
Don't loaf and invite inspiration; light out after it with a club.
Jack London, writer and social ...Learn More
IPO pulls in $158M for NovoCure
An initial public offering brought in $158 million for NovoCure. ...Learn More
Funding round pulls in $57M for Silk Road Medical
An equity and debt financing round brought in $57 million for Silk Road Medical. ...Learn More
Gordian Surgical gets nearly $1M boost
A round of financing brought in almost $1 million for Gordian Surgical, a Trendlines Medical portfolio company. ...Learn More
Q3 revenue increases for Illumina
Illumina generated $550.3 million in total revenue in the third quarter, an increase from $480.6 million posted in the same ...Learn More
General counsel named at SeaSpine Holdings
Patrick Keran, who has more than 15 years of operational and legal experience, was named general counsel of Vista, ...Learn More
Report forecasts moderate growth for spine surgery devices, implants
A Transparency Market Research report predicts moderate market growth for spine implants and surgical devices through 2018. ...Learn More
Mobile X-ray system from Carestream debuts
The Motion Mobile, an X-ray unit that can be upgraded from computed radiography to a wireless digital radiography device, ...Learn More
FDA approves updated version of rapid HIV test from MedMira
The FDA granted MedMira marketing approval for its next-generation rapid HIV test, Reveal G4. ...Learn More
Cancer imaging device from Lightpoint gets CE mark
The LightPath Imaging System, developed by Lightpoint Medical to detect the faint luminescence of imaging agents used to ...Learn More
South Korea OKs radiation therapy device from ViewRay
A radiation therapy system developed by ViewRay has obtained approval from South Korea's Ministry of Food and Drug Safety. ...Learn More
PMA Submissions Workshop
Oct. ...Learn More
Working with Private Payers: Advocating for Your Medical Technology in the Age of Reform
Nov. 12 | Washington, D.C. ...Learn More
All great deeds and all great thoughts have a ridiculous beginning.
Albert Camus, writer and ...Learn More


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In the News
Building A Better Valve
By: New York Times | June 2015

The F.D.A. approved the new Edwards valve for high-risk patients; it had been available only in clinical trials. Medtronic also has a new version of its valve that cardiologists expect will soon be approved. 

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Plasma Makes Wounds Heal Quicker
By: Medical Design Technology | June 2015

Many people suffer from skin disorders. Open wounds are a particularly acute problem, especially among the elderly. PlasmaDerm, a new medical technology solution, uses plasma to facilitate faster healing of wounds.

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Wearable Device on Your Ear Controls Blood Loss
By: Medical Design Technology | June 2015

While neural stimulation technologies have been around for some time now, it seems the technology is just finally beginning to mature into the form of medical devices that can make a real impact on the lives of those who most desperately need them. 

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Toddler Walking With New Prosthetic Leg
By: NBC News | June 2015

A toddler undergoes a successful amputation below his left knee and learns to walk with a prosthetic leg.

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