Media Contact

News

The latest on how medical technology is changing lives for the better

SmartBrief
Vascular Solutions to be acquired by Teleflex in $1B deal
Telefex has entered into an agreement to pay about $1 billion for Vascular Solutions, maker of devices for minimally ...Learn More
Boston Scientific to acquire Neovasc's assets for $75M
Boston Scientific has reached a deal to acquire Neovasc's advanced biological tissue business, which makes components for ...Learn More
Impel NeuroPharma gets $36M boost
A round of Series C financing involving life science-focused companies venBIO, Vivo Capital and 5AM Ventures has brought in ...Learn More
Placement pulls in $1.4M for Proteomics
A placement of 6 million shares has brought in $1.4 million for Proteomics International Laboratories, which plans to use ...Learn More
B. Braun, Omnicell partner on IV infusion, compounding management
A collaborative agreement has been reached by B. ...Learn More
Senseonics expands exclusive distribution deal with Roche
A deal allowing Roche Holding to exclusively distribute Senseonics' Eversense System, a long-term implantable continuous ...Learn More
Study shows positive results for tumor-tracking linear accelerator
A 29-patient Japanese study presented at the annual meeting of the Radiological Society of North America showed positive ...Learn More
Sanovas announces launch of subsidiary, sinus treatment system
The RegENT sinus treatment system, designed to deliver controlled drug delivery and regional anesthetization in sinus ...Learn More
Brazil further extends compliance deadline for new INMETRO ordinance
The deadline for complying with the INMETRO electronic safety certification requirements for certain medical device makers ...Learn More
FDA clears Nanowear's remote cardiac monitoring undergarment
The FDA has granted early-stage nanosensor technology developer Nanowear a Class II 510(k) clearance for its iPhone-based ...Learn More
The task of leadership is not to put greatness into humanity, but to elicit it, for the greatness is already there.
...John Buchan, politician and writer
Offering could pull in $6M for Genetic Technologies
An offering of depositary shares involving unnamed US institutional investors could bring in $6 million in gross proceeds ...Learn More
Mass. digital health firm acquired by BioTelemetry
Telcare Medical Supply, a Massachusetts-based digital health company that markets diabetes management tools, has been ...Learn More
Skyline Medical gets $2M boost
An offering of common stock and warrants has brought in $2 million in gross proceeds for Skyline Medical, maker of the ...Learn More
Propeller, Italian spirometer firm reach systems integration deal
A collaborative agreement has been reached by Propeller Health and Italy-based Medical International Research to allow the ...Learn More
New technology center opened by Agilent in Calif.
A $14.7 million technology center has been opened by Agilent Technologies in Folsom, Calif., to support its Intuvo 9000 Gas ...Learn More
Siemens, Northwell Health partnership yields data that might improve stroke care
New York-based Northwell Health is working with Siemens Healthineers to improve population health under a four-year ...Learn More
Cardiac Dimensions' mitral valve repair device gets IDE from FDA
Cardiac Dimensions has obtained an investigational device exemption from the FDA to conduct a pivotal trial of its Carillon ...Learn More
Becton Dickinson adopts new OS for automated drug-dispensing system
Becton Dickinson announced Thursday that its automated drug-dispensing Pyxis ES system is now using the Windows 10 Internet ...Learn More
Japan OKs reimbursement of Medtronic's TAVR system
The Japanese Ministry of Health, Labor and Welfare has given Medtronic reimbursement approval for its CoreValve Evolut R ...Learn More
FDA clears BrightWater's convertible nephroureteral stent system
BrightWater Medical has secured clearance from the FDA to market its ConvertX Nephroureteral Stent System, which is designed ...Learn More
There is no greatness where there is no simplicity, goodness and truth.
...Leo Tolstoy, writer
Coloplast reaches $160M deal to acquire Comfort Medical
Coloplast on Wednesday announced it agreed to pay $160 million in cash to acquire Coral Springs, Fla.-based Comfort Medical, ...Learn More
Endonovo Therapeutics gets $5M boost
A round of funding involving an anonymous strategic investor has brought in $5 million for Los Angeles-based Endonovo ...Learn More
Trovagene reaches supply, distribution deal with Boreal Genomics
Trovagene and Boreal Genomics have agreed to co-develop urine and blood circulating tumor DNA assay kits for clinical ...Learn More
Report: Global hip, knee orthopedic surgical implant market poised for growth
A MarketResearchReports.biz report predicts the worldwide market for hip and knee orthopedic surgical implants will reach ...Learn More
Smith & Nephew appoints new chief financial officer
Graham Baker has been tapped to serve as chief financial officer at Smith & Nephew effective March 1. ...Learn More
Study shows positive results for Neuronix's Alzheimer's treatment system
A 131-patient, 10-site trial scheduled for presentation at the Clinical Trials on Alzheimer's Disease meeting showed ...Learn More
IBM companies debut AI, deep learning imaging solutions
A number of artificial intelligence and deep learning technologies have been introduced by IBM companies Merge Healthcare ...Learn More
21st Century Cures Act clears House
The 21st Century Cures Act, which contains provisions designed to accelerate discovery and availability of medical devices ...Learn More
AdvaMed lauds Trump's pick for HHS secretary
House Budget Committee Chairman Tom Price, R-Ga., has been chosen by President-elect Donald Trump to serve as HHS secretary ...Learn More
For more:
...Read the text of AdvaMed's congratulatory message to Rep. Tom Price on being nominated for HHS secretary.
EU OKs Abbott's hand-held blood testing system
European regulators have given Abbott CE mark approval for its i-Stat Alinity System, intended for measuring a variety of ...Learn More
I think we ought to read only the kind of books that wound and stab us. If the book we are reading doesn't wake us up with a blow on the head, what are we reading it for?
...Franz Kafka, writer
Medtronic enters integrated health solutions deal with Cleveland hospital
Medtronic has reached its first integrated health solutions agreement in the US, under which it will help operate the ...Learn More
Placement could pull in $7.64M for Ellex Medical Lasers
An institutional placement involving Petra Capital and Taylor Collison could bring in approximately $7.64 million for Ellex ...Learn More
Bio-Rad reaches partnership with Genetic Analysis
A partnership has been reached by Bio-Rad Laboratories and Norwegian clinical diagnostics firm Genetic Analysis under which ...Learn More
Analysis predicts growth for global lumbar spine fusion market
A Market Reports World analysis predicts the worldwide lumbar spine fusion market will see a 4.9% compound annual growth ...Learn More
New board member named by Mazor Robotics
Yuval Yanai, who has 30 years of experience in the medical device industry, has been tapped to serve on the board of ...Learn More
Trial begins for Micell's drug-eluting absorbable polymer coronary stent
The first patient in a randomized, double-blind trial of the MiStent SES sirolimus eluting absorbable polymer coronary stent ...Learn More
New version of visual analysis, quantification system debuted by Royal Philips
The IntelliSpace Portal 9.0, which uses machine learning to facilitate radiological detection, diagnosis and follow-up ...Learn More
EU OKs less-invasive implant procedure for Medtronic's HVAD system
European regulators have given Medtronic CE mark approval for a less-invasive approach to implanting its HVAD system left ...Learn More
NeuroMetrix's pain relief device secures EU approval
European regulators have given NeuroMetrix CE mark approval to market its Quell wearable pain relief device. ...Learn More
Quidel's herpes, varicella assay wins FDA clearance
Quidel has obtained clearance from the FDA for its Solana HSV-1+2/VZV assay, which is designed for the detection and ...Learn More
Concentrate all your thoughts upon the work at hand. The sun's rays do not burn until brought to a focus.
...Alexander Graham Bell, scientist and inventor
Valtech Cardio to be acquired by Edwards Lifesciences for up to $690M
Edwards Lifesciences has reached a cash-and-stock agreement to acquire Israel-based valve repair and replacement device ...Learn More
ApiFix obtains $5M in funding round
A round of Series B financing led by B. ...Learn More
Funding round pulls in $6M for Bovie Medical
A round of funding that included a secondary offering of 1.63 million shares has brought in $6 million in net proceeds for ...Learn More
GE, Boston Children's Hospital reach imaging partnership for pediatric diseases
GE Healthcare has partnered with Boston Children's Hospital to improve pediatric disease diagnosis and treatment through the ...Learn More
Tissue Regenix reaches deals for knee repair treatment distribution
Agreements have been signed by Tissue Regenix Group for the distribution of its OrthoPure XT knee repair treatment in ...Learn More
LG enters US medical imaging market with monitors, radiography device
LG Electronics has entered the US medical imaging device market with the introduction of a 27-inch surgical monitor, a ...Learn More
Adams simulations help diagnose knee problems
MSC's Adams, a multibody dynamics simulation solution, can provide the right insights to help get a better understanding of ...Learn More
Trial of Neovasc's replacement heart valve OK'd in Europe
Regulatory and ethics committee approval has been granted to Neovasc to conduct a 115-patient trial that will assess the ...Learn More
New feature for post-processing software unveiled by SyntheticMR
The REMyDI feature, which allows for automatic quantification of myelin volume in the brain, has been introduced by ...Learn More
FDA OKs breast biopsy accessory from Dilon, GE Healthcare
The FDA has given Dilon Diagnostics and GE Healthcare approval for a molecular breast imaging localization accessory for ...Learn More
Medtronic issues safety notice on hemodialysis machines
An urgent field safety notice has been issued by Medtronic concerning three fires connected to its Formula hemodialysis ...Learn More
It is impossible for anyone to begin to learn that which he thinks he already knows.
...Epictetus, philosopher
Abbott secures conditional EU OK for $25B St. Jude Medical deal
Abbott Laboratories' acquisition of St. ...Learn More
Offering pulls in $15.1B for Abbott
A public offering of senior notes has brought in $15.1 billion for Abbott, according to a regulatory filing. ...Learn More
Zimmer Biomet, IUIH team up on affordable musculoskeletal care
Zimmer Biomet has partnered with the Indo UK Institute of Health to enhance patient access to affordable musculoskeletal ...Learn More
New president, CEO named by DJO Global
Brady Shirley, the former president of surgical business at DJO Global, has been tapped to serve as president and chief ...Learn More
Collagen Matrix appoints new chief financial officer
Oystein Valberg, who has over 20 years of experience in corporate finance, has been tapped to serve as chief financial ...Learn More
Study shows positive results for Boston Scientific's HeartLogic system
A 900-patient study presented at the American Heart Association's Scientific Sessions showed positive results for ...Learn More
EU OKs micro-ultrasound system from Exact Imaging
European regulators have given Exact Imaging CE mark approval for its ExactVu micro-ultrasound platform for prostate imaging ...Learn More
Senate Dems hope for changes to 21st Century Cures bill despite GOP deal
Republican leaders in Congress said they have reached an agreement on the 21st Century Cures Act, which contains provisions ...Learn More
Xtant Medical's expandable interbody system cleared by FDA
Belgrade, Mont.-based Xtant Medical has obtained clearance from the FDA for its Xsert Lumbar Expandable Interbody System, a ...Learn More
FDA authorizes emergency use of Abbott's Zika assay
Abbott has obtained emergency use authorization from the FDA for its RealTime Zika assay, which is intended for the ...Learn More
Your assumptions are your windows on the world. Scrub them off every once in a while, or the light won't come in.
...Alan Alda, actor, writer and director
Deal to buy EndoChoice finalized by Boston Scientific
The acquisition of Georgia-based EndoChoice, valued at approximately $210 million in cash, has been completed by Boston ...Learn More
Funding round pulls in $45M for Shockwave Medical
A round of Series C financing has brought in $45 million for Shockwave Medical. ...Learn More
Helius extends contract with Army for neuromodulation stimulator trial
A sole-source cost-sharing contract between the Army Medical Research and Materiel Command and Helius Medical Technologies ...Learn More
New VP of sales, marketing named by Amedica
Dana Lyons, who has over 27 years of experience in medical device sales and sales management, has been tapped to serve as ...Learn More
Data show positive results for Corvia Medical's shunt device
One-year data from a 64-patient trial presented at the American Heart Association's Scientific Sessions showed positive ...Learn More
Digital therapeutics can reduce health care costs
Businesses can save money on health care costs by introducing digital therapeutics, which use technology such as sensors and ...Learn More
EU OKs drug-coated angioplasty balloon from Spectranetics
European regulators have given Spectranetics CE mark approval for its Stellarex 0.014-inch drug-coated angioplasty balloon, ...Learn More
FDA labels SentreHeart's guidewire recall as Class I
A recall initiated by SentreHeart involving certain lots of its FindWIRZ guidewire systems has been categorized by the FDA ...Learn More
SmartBrief will not publish Thursday, Friday
...In observance of Thanksgiving in the US, SmartBrief will not publish Thursday and Friday. Publication will resume Monday.
Birds sing after a storm. Why shouldn't people feel as free to delight in whatever sunlight remains to them?
...Rose Kennedy, philanthropist
Tender offers for $1.1B senior notes announced by Zimmer Biomet
Zimmer Biomet has announced tender offers for about $1.1 billion worth of its 5.75% senior notes due in 2039, its 4.25% ...Learn More
Share buyback program approved by Varian Medical
Varian Medical Systems has approved its plan to buy back about $700 million of its common stock in addition to the 4 million ...Learn More
Funding round pulls in $6.8M for Monteris Medical
A round of debt and options financing involving a pair of unidentified investors has brought in $6.8 million for Plymouth, ...Learn More
Spineway gets approximately $1.49M boost
An issue of 355,260 shares with attached warrants to China-based TINAVI Medical Technologies has increased Spineway's ...Learn More
Health care's new culture code
Roy Smythe, who is the chief medical officer for Valence Health, spoke at the IDSA Medical Conference about the uncanny ...Learn More
NeuroStar announces launch of depression outcomes registry
A registry has been launched by NeuroStar to track disease state outcomes in patients with major depressive disorder treated ...Learn More
Next-gen dual-therapy stent debuted by OrbusNeich
OrbusNeich has announced the launch of the Combo Plus, its latest-generation implantable dual-therapy stent that comes with ...Learn More
Marketing application for diabetes pump submitted by Intarcia
An application for marketing approval has been submitted by Intarcia Therapeutics to the FDA for its ITCA 650, an ...Learn More
Every book is a quotation; and every house is a quotation out of all forests and mines and stone quarries; and every man is a quotation from all his ancestors.
...Ralph Waldo Emerson, writer and lecturer
Funding round pulls in $36M for Genalyte
A round of funding involving Khosla Ventures and Redmile Group has brought in $36 million for Genalyte, which is developing ...Learn More
Micell Technologies obtains $26M in funding round
A round of equity and debt financing involving 51 anonymous sources has pulled in $25.8 million for Micell Technologies, ...Learn More
Funding round brings in $10M for Seventh Sense Biosystems
Seventh Sense Biosystems has raised $10 million in a round of Series C financing involving Novartis, Laboratory Corp. ...Learn More
Funding round brings in $5M-plus for 4Dx
A round of Series A financing has brought in more than $5 million for medical imaging startup 4Dx. ...Learn More
Analysis shows positive results for Novocure's tumor-treating field device
A long-term analysis of data from a Phase III trial presented at the annual meeting of the Society for Neuro-Oncology showed ...Learn More
Patient-matched glenoid implant debuted by Zimmer Biomet
The Comprehensive Vault Reconstruction System, a patient-unique glenoid implant intended for treating severe rotator cuff ...Learn More
Livongo unveils new features for blood glucose meter
Livongo has upgraded its FDA-cleared blood glucose meter to enable over-the-air downloading of software updates for the ...Learn More
Finalization of guidance on laboratory-developed tests postponed by FDA
The FDA has decided to delay finalizing its draft guidance governing laboratory-developed tests and will work with the new ...Learn More
Imagination is more important than knowledge. For knowledge is limited, whereas imagination embraces the entire world.
...Albert Einstein, theoretical physicist
Biocartis gets $34.7M boost, announces distribution deal with Thermo Fisher
A private placement has brought in $34.7 million for Belgian molecular diagnostics company Biocartis Group, which intends to ...Learn More
Texas Medical Center accelerator unveils 9 medtech startups
The Texas Medical Center's Innovation Institute has introduced nine medical device startups that have been housed at its ...Learn More
Juno Biomedical, Promenade partner to enhance stroke treatment device
A partnership has been reached by Juno Biomedical and Promenade Software to develop software for Juno Biomedical's CELLTech ...Learn More
GE Healthcare, UCSF reach deep learning algorithms partnership
GE Healthcare has teamed up with the University of California at San Francisco's Center for Digital Health Innovation to ...Learn More
Report predicts growth for global drug delivery technologies market
A GBI Research report predicts the worldwide market for drug delivery technologies will reach about $26 billion by 2020, up ...Learn More
Trial advances for InVivo Therapeutics' neurospinal scaffold
The ninth patient in a trial of the Neuro-Spinal Scaffold has been enrolled by InVivo Therapeutics. ...Learn More
Japan OKs cardiac imaging technology from HeartFlow
The Japanese Ministry of Health, Labor and Welfare has given HeartFlow approval for its HeartFlow FFRct Analysis, a ...Learn More
Rules for surgical instrument repair shops being weighed by FDA
The medtech industry has raised concerns over the safety risks associated with using reprocessed and repaired instruments ...Learn More
FDA finalizes guidance on 510(k) filings for MR diagnostic devices
A final guidance has been released by the FDA to assist manufacturers in submitting premarket notifications for magnetic ...Learn More
Risks with modular necks prompt recall of Smith & Nephew's hip implants
A recall was initiated by Smith & Nephew involving its Modular SMF and Modular Redapt hip implants because data analysis ...Learn More
Entering the China Device Market Virtual Workshop
In this virtual program, industry experts will provide a thorough overview and update on industry policies, recent CFDA ...Learn More
The unexamined life is not worth living.
...Socrates, philosopher
Inspire Medical Systems gets $37.5M boost, names new board members
A $37.5 million round of Series F financing led by Amzak Health has been completed by Maple Grove, Minn.-based Inspire ...Learn More
Funding round pulls in $13.2M for Apama Medical
A round of equity financing involving 63 anonymous investors has brought in $13.2 million for Campbell, Calif.-based Apama ...Learn More
San Diego medtech startup obtains $3.6M in funding round
A round of funding has pulled in $3.6 million for San Diego-based Clarify Medical. ...Learn More
Funding round brings in $2M for Astute Medical
A round of debt financing involving 13 anonymous sources has brought in $2 million for San Diego-based Astute Medical, an ...Learn More
Interventional cardiology, peripheral vascular devices poised for growth
An Allied Market Research report predicts the interventional cardiology and peripheral vascular devices market will hit $25 ...Learn More
CMS proposes coverage decision for leadless cardiac pacemakers
A policy that would permit coverage with evidence development for leadless cardiac pacemakers, such as Medtronic's Micra ...Learn More
Data positive for next-gen heart-pumping device
Six-month data from a study presented at the American Heart Association meeting found that use of St. ...Learn More
Olympus America unveils electric morcellator with containment bag
An electric morcellator that comes with a containment bag for preventing accidental spread of uterine cancer has been ...Learn More
Expanded use of Medtronic's stent retriever device approved by FDA
The FDA has given Medtronic an expanded approval for its Solitaire stent retriever device for use as an initial therapy for ...Learn More
EU OKs stent graft system from LimFlow
European regulators have given LimFlow CE mark approval for its LimFlow Stent Graft System, a device intended to improve ...Learn More
A person should set his goals as early as he can and devote all his energy and talent to getting there. With enough effort, he may achieve it. Or he may find something that is even more rewarding. But in the end, no matter what the outcome, he will...
...Walt Disney, cartoonist, film producer and business magnate
Distal Access' gynecology, urology assets acquired by Boston Scientific
Boston Scientific has paid an undisclosed amount to buy Distal Access' gynecology and urology portfolio, which includes the ...Learn More
Offering of AngioDynamics shares could pull in $40M
A secondary offering of 2.5 million shares has been priced by AngioDynamics in hopes of raising $40 million. ...Learn More
Funding round brings in $5M for Stasis Labs
A round of funding led by RTP-HC has brought in $5 million for Stasis Labs, which makes a patient monitoring system for ...Learn More
Xtant Medical gets $3.8M boost, expanded clearance for cervical cage
An offering of stock and warrants has brought in $3.8 million for Belgrade, Mont.-based Xtant Medical. ...Learn More
J&J Innovation, Janssen announce winners of health care innovation challenge
Johnson & Johnson Innovation and J&J unit Janssen have announced the winners of the World Without Disease QuickFire ...Learn More
NeoTract's Urolift system wins reimbursement from Medicare contractor
The use of NeoTract's Urolift system for benign prostatic hyperplasia will be covered by First Coast Service Options, a ...Learn More
Researchers create breathalyzer for blood glucose monitoring
A minimally invasive breathalyzer, currently the size of a small book, has been developed by researchers from Western New ...Learn More
Industry seeks changes in FDA's guidance on 510(k) device modifications
Industry stakeholders have urged the FDA to update its draft guidance on 510(k) device modifications, noting that the ...Learn More
New label for Bayer's permanent birth control device OK'd by FDA
An updated labeling for Bayer HealthCare's permanent birth control device Essure, which includes a new boxed warning and a ...Learn More
Russia OKs embolic prevention system from InspireMD
Russian regulators have given InspireMD approval to commercialize its CGuard Embolic Prevention System for treating patients ...Learn More
Whenever an individual or a business decides that success has been attained, progress stops.
...Thomas Watson, corporate leader
Gates Foundation awards $5M to Masimo
The Bill and Melinda Gates Foundation has awarded Masimo a grant worth around $5 million to aid in developing a low-cost ...Learn More
LeMaitre Vascular to buy Restore Flow Allografts for $14M
Burlington, Mass.-based LeMaitre Vascular has reached a deal to acquire Restore Flow Allografts, a tissue preservation ...Learn More
Seed funding round pulls in $1.2M for Genetesis
A round of seed financing co-led by Radical Investments and CincyTech has brought in $1.2 million for Mason, Ohio-based ...Learn More
Stryker, Indo UK Institute of Health partner on affordable orthopedic care
Stryker and the Indo UK Institute of Health's Medicity Program have reached a 20-year collaborative deal to provide patients ...Learn More
What it's like to be a woman in the corner office
Why is it still such a rarity to find women in the higher echelons of corporate life? ...Learn More
Scrutiny of sales reps in the OR is growing
Medical device industry reps are often present during joint replacements, cardiac defibrillator implantations and spinal ...Learn More
Royal Philips announces Canadian launch of spectral CT scanner
The IQon Spectral CT scanner, which delivers layers of retrospective data in one low-dose scan while allowing for ...Learn More
CRT-D from Medtronic approved by FDA
The FDA has given Medtronic approval for its Claria MRI Quad cardiac resynchronization therapy defibrillator SureScan device ...Learn More
St. Jude's SCS system wins FDA nod for full-body MR-conditional label
St. ...Learn More
Premarket application for NSCLC companion Dx submitted by Thermo Fisher
A premarket approval application has been submitted by Thermo Fisher Scientific to the FDA for its Oncomine Universal Dx ...Learn More
My strength lies solely in my tenacity.
...Louis Pasteur, chemist and microbiologist
$250M credit deal secured by AngioDynamics
A credit agreement composed of a loan worth $100 million and a $150 million credit line has been secured by AngioDynamics ...Learn More
Funding round pulls in $40M for Intuity Medical
A round of financing led by PTV Healthcare Capital has brought in $40 million for Sunnyvale, Calif.-based Intuity Medical. ...Learn More
PillDrill obtains $3M in seed funding round
A round of seed financing has pulled in $3 million for PillDrill. ...Learn More
Medtronic's program for joint replacement episodes of care debuts
Medtronic has unveiled Medtronic Orthopedic Solutions to help providers meet CMS requirements for total joint replacement ...Learn More
Carl Zeiss eyes expansion through targeted takeovers
German medical device and optical systems maker Carl Zeiss is looking for companies to acquire in an effort to support its ...Learn More
Alcon sale being considered by Novartis, chairman says
Novartis is weighing a sale of its Alcon eye care division after failing to see growth from the unit over the past two ...Learn More
Data show positive results for Spectranetics' drug-coated balloon
Data from a trial presented at the Transcatheter Cardiovascular Therapeutics symposium showed positive results for ...Learn More
Upgraded software for genetics, pathology labs released by Agilent
The Cartagenia Bench Lab 5.0, an updated version of the Cartagenia Bench Lab software designed to support clinical genetics ...Learn More
Hologic's Aptima HCV, HBV Quant assays win approval in Canada
Health Canada has given Hologic approval for its Aptima HCV and HBV Quant assays, which are designed for use in detection of ...Learn More
Thrombotic events risk prompts recall of Concert Medical's coronary guidewires
A recall was initiated by Concert Medical involving some lots of its Galeo Pro coronary guidewires. ...Learn More
There are no secrets to success. It is the result of preparation, hard work and learning from failure.
...Colin Powell, statesman
Siemens announces plan to publicly list health care unit
Siemens on Thursday said it intends to publicly list its $15 billion health care business, Siemens Healthineers, as part of ...Learn More
Funding round pulls in $32M for ReVision Optics
A round of equity financing led by Johnson & Johnson Development has brought in $32 million for Lake Forest, Calif.-based ...Learn More
Offering of Bovie Medical shares could bring in $12M
Clearwater, Fla.-based Bovie Medical has priced an offering of 3 million shares of its common stock, half of which will come ...Learn More
Becton Dickinson partners with JDRF on extended-wear insulin delivery device
A research collaboration has been reached by Becton Dickinson and the Juvenile Diabetes Research Foundation to create an ...Learn More
Sophia Genetics integrates analytical tech with ArcherDx ctDNA kits
Sophia Genetics has partnered with ArcherDx to offer an integrated analytical and next-generation sequencing sample ...Learn More
Growth on the horizon for minimally invasive neurosurgery devices
A Future Market Insights report predicts worldwide growth for minimally invasive neurosurgery devices through 2025 due to ...Learn More
Illumina reaches genetic disorder research partnership with Mayo Clinic
Illumina and the Mayo Clinic have teamed up to create an informatics platform for automation and improvement of genomic ...Learn More
Upgraded syringe pump interoperability software launched by Smiths Medical
PharmGuard interoperability software, which provides bidirectional integration with IHE-compatible EMR systems, has been ...Learn More
Industry groups call for updated FDA rules on off-label communications
AdvaMed and other industry groups this week called on the FDA to update policies concerning communications about the ...Learn More
EU OKs Immucor's fifth-gen immunohematology instrument
European regulators have given Immucor the CE mark for its Echo Lumena, a fifth-generation immunohematology instrument ...Learn More
When I dare to be powerful, to use my strength in the service of my vision, then it becomes less and less important whether I am afraid.
...Audre Lorde, writer and civil rights activist
Offering could pull in $11M for Xtant Medical
An offering of 15 million units of common stock and warrants has been priced by Xtant Medical in hopes of obtaining $11 ...Learn More
TransEnterix, Getz Healthcare reach distribution agreement
Getz Healthcare has agreed to exclusively distribute TransEnterix's Senhance surgical robotics system in the New Zealand and ...Learn More
Horizon Discovery enters OEM deal with CareDx
CareDx has signed an original equipment manufacturer agreement that will allow it to use cell-free DNA-based molecular ...Learn More
New CPT code to cover Augmenix's SpaceOAR device
Augmenix on Wednesday announced its SpaceOAR device will be covered under a Category I, Current Procedural Terminology ...Learn More
New chief financial officer named by Exact Sciences
Jeff Elliott, a former senior research analyst at Robert W. ...Learn More
New site added by InVivo Therapeutics for neurospinal scaffold trial
The University of Iowa Hospitals and Clinics in Iowa City, Iowa, has been added by InVivo Therapeutics as a site for the ...Learn More
Syringe for Humulin R U-500 insulin debuted by Becton Dickinson
The BD U-500 Insulin Syringe has been launched by Becton Dickinson for patients with diabetes who use Eli Lilly and Co.'s ...Learn More
Trump victory may be good news for medtech industry
President-elect Donald Trump pledged throughout his campaign to repeal the medical device tax, a key legislative priority ...Learn More
Electrosurgical probes from joimax win FDA clearance
The FDA has given German medtech firm joimax clearance for its Vaporflex and Legato electrosurgical probes with radiowave ...Learn More
FDA grants second clearance for Kator's suture anchor device
The FDA has given Surgical Frontiers subsidiary Kator its second 510(k) clearance for the Kator Suture Anchor System, which ...Learn More
Success is the sum of small efforts, repeated day in and day out.
...Robert Collier, writer
Baxter raises share repurchase program to $1.9B
Baxter said Tuesday its plan to buy back $1.5 billion more of its stock has been approved by its board of directors, ...Learn More
Smiths Medical's IVF business acquired by CooperSurgical
Smiths Medical's in vitro fertilization segment, Wallace, has been sold by Smiths Group to CooperSurgical for approximately ...Learn More
Funding round pulls in $12.5M for Inspire Medical Systems
A round of equity financing involving 22 anonymous sources has brought in $12.5 million for Inspire Medical Systems, ...Learn More
Agendia enters distribution agreement with Cryogene, Mist
Lebanon-based Cryogene and its sister company, Mist, have agreed to distribute Agendia's MammaPrint gene expression-based ...Learn More
New VP of business development named by Clearside Biomedical
Rick McElheny, former senior vice president of corporate development at Sarvint, has been tapped to serve as vice president ...Learn More
Medinol wins Japan's approval for stent trial
Japan's Pharmaceutical and Medical Devices Agency has given Parsippany, N.J.-based Medinol approval to conduct a clinical ...Learn More
Boston Scientific's kidney stone retrieval device debuts in US, Europe
Boston Scientific has announced the US and European launch of its Dakota Retrieval Device, which features its OpenSure ...Learn More
Gene sequencing assay unveiled by Illumina
The TruSight Tumor 170, a 170 gene sequencing solution intended for supporting the tumor-profiling paradigm's transformation ...Learn More
EU OKs MR-conditional labeling for St. Jude Medical's CRT-P
European regulators have given St. ...Learn More
FDA clears posterior fixation system from SeaSpine
Carlsbad, Calif.-based SeaSpine has secured clearance from the FDA for its Mariner Posterior Fixation System, which is ...Learn More
Talent is a dreadfully cheap commodity, cheaper than table salt. What separates the talented individual from the successful one is a lot of hard work and study.
...Stephen King, writer
$4B deal to buy Cepheid finalized by Danaher
The acquisition of Cepheid, valued at $4 billion, has been completed by Danaher. ...Learn More
Chembio Diagnostics enters deal to buy Malaysian point-of-care Dx firm
Chembio Diagnostics has reached a deal to acquire RVR Diagnostics, a Malaysian firm that makes and distributes point-of-care ...Learn More
Point-of-care device interface developer acquired by Siemens
Conworx Technology, a Berlin-based point-of-care developer of device interface and data management solutions, has been ...Learn More
PAVmed, academic institutions team up on development of resorbable ear tubes
A licensing agreement for undisclosed terms has been reached by PAVmed with Tufts University, Massachusetts General Hospital ...Learn More
New managing director of international for EMEA named by Bioventus
Andrew McCartney has been tapped to serve as managing director of international for Europe, the Middle East and Africa at ...Learn More
Harnessing the power of value engineering
The global medical industry is evolving. ...Learn More
First implantation of bionic vision system recorded by Pixium Vision
A patient at Moorfields Eye Hospital in the UK was the first to undergo implantation and activation of Pixium Vision's IRIS ...Learn More
Biotronik announces US launch of Inventra HF-T CRT-D
The Inventra HF-T cardiac resynchronization therapy defibrillator, which delivers a higher-than-usual amount of energy on ...Learn More
Final guidance on device reporting, record keeping released by FDA
A final guidance has been released by the FDA to assist manufacturers in fulfilling regulatory requirements for reporting ...Learn More
Japan OKs bioresorbable heart stent from Abbott
The Japanese Ministry of Health, Labor and Welfare has given Abbott approval for its Absorb bioresorbable heart stent for ...Learn More
FDA clears Propeller's connected inhaler platform for GSK inhaler
The FDA has given Propeller Health 510(k) clearance for its Propeller connected inhaler platform for use with ...Learn More
If you look at what you have in life, you'll always have more. If you look at what you don't have in life, you'll never have enough.
...Oprah Winfrey, media personality, businesswoman and philanthropist
Tender offer for EndoChoice shares extended by Boston Scientific
An $8-per-share tender offer for EndoChoice shares has been extended by Boston Scientific until Nov. ...Learn More
CorWave obtains $17.1M in funding round
A round of Series B financing led by Novo Seeds has pulled in $17.1 million for CorWave, a developer of circulatory support ...Learn More
Funding round pulls in $2.15M for InnAVasc Medical
A round of equity financing involving 39 anonymous sources has brought in $2.15 million for InnAVasc Medical, according to ...Learn More
Seegene reaches molecular Dx test development deal with Hologic
Seegene has agreed to develop highly multiplexed real-time PCR reagents and assays using its MuDT, dual-priming ...Learn More
Report predicts growth for global anterior cervical fixation devices market
A report from Absolute Reports predicts the worldwide market for anterior cervical fixation devices will see a 1.54% ...Learn More
Medtronic pledges data sharing in effort to improve patient safety
Medtronic has committed to share individual de-identified patient-level data from its monitoring and diagnostic devices with ...Learn More
FDA post-approval study of gastric band finalized by Apollo Endosurgery
The post-approval study of the Lap-Band AP adjustable gastric band, a device designed to be positioned laparoscopically, has ...Learn More
Researchers develop contact lenses able to track blood glucose levels
Researchers from Oregon State University have developed a transparent sensor using an amorphous indium gallium oxide field ...Learn More
Final guidance on IDE for neurological devices released by FDA
A final guidance has been released by the FDA to assist sponsors in submitting investigational device exemptions to perform ...Learn More
Teleflex recalls intranasal mucosal atomization device
A recall was initiated by Teleflex Medical involving some lots of its LMA MAD intranasal mucosal atomization device, which ...Learn More
Start saving with the AdvaMed Purchasing Group
The AdvaMed Purchasing Group is a new member-only benefit that helps companies purchase the very best goods and services ...Learn More
A satisfied customer is the best business strategy of all.
...Michael LeBoeuf, writer and management professor
Abbott presents concessions to secure EU nod for $25B St. Jude deal
The European Commission has been offered concessions by Abbott Laboratories in an effort to obtain antitrust approval for ...Learn More
LumenR's tissue retractor acquired by Boston Scientific
The LumenR Tissue Retractor System, which is being developed for endoscopic resection of lesions in the gastrointestinal ...Learn More
San Antonio venture capital firm seeks more funding for medtech, biotech
San Antonio-based Fountainhead Investment Partners is raising additional money as it intends to invest in medical device and ...Learn More
Synaptive Medical secures investment from General Atlantic
Toronto-based Synaptive Medical on Thursday said it received an undisclosed amount of strategic investment from growth ...Learn More
EU awards RSP Systems $2.7M grant for glucose monitor
The European Union has granted Denmark-based RSP Systems a $2.7 million grant, through the Horizon 2020 framework, to ...Learn More
Report predicts growth for US spine implants market
A Research and Markets report predicts the US market for spine implants will see a 5.29% compound annual growth rate through ...Learn More
E-QURE wins conditional FDA OK for electrotherapy device trial
The FDA has granted Delaware-based E-QURE conditional approval to begin an investigational device exemption trial of its ...Learn More
Bipolar hot hemostasis forceps introduced by Pentax Medical
The HemoStat WideCup, a bipolar hot hemostasis forceps device, has been unveiled by Hoya Group division Pentax Medical for ...Learn More
Arterys' 4D cardiac imaging software wins FDA clearance
The FDA has given medical imaging software firm Arterys 510(k) clearance to market its Arterys Software in clinical settings ...Learn More
Vortex Biosciences' CTC capture system obtains FDA registration, EU nod
The VTX-1 Liquid Biopsy System developed by Vortex Biosciences has been registered with the FDA as a Class I medical device ...Learn More
California Proposition 65 Warning Regulations Webinar: What You Need To Know
Nov. ...Learn More
Top International Trade Issues For Medical Devices
Nov. ...Learn More
The weak can never forgive. Forgiveness is the attribute of the strong.
...Mahatma Gandhi, social reformer and independence movement leader
Funding round pulls in $16.6M for Neuravi
A round of debt financing involving IPF Partners has brought in approximately $16.6 million for Ireland-based Neuravi, which ...Learn More
Public offering could pull in $30M for Veracyte
Molecular diagnostics firm Veracyte aims to raise $30 million in gross proceeds in a public offering of 5 million shares. ...Learn More
Cohero Health obtains $9M in funding round
A round of Series A financing led by Three Leaf Ventures has pulled in $9 million for New York City-based Cohero Health. ...Learn More
Second Sight's retinal prosthesis system obtains reimbursement codes
Second Sight Medical on Wednesday said procedures using its Argus II Retinal Prosthesis System, which elicits visual ...Learn More
Report predicts growth for spine biologics market
The spine biologics market is expected to see growth through 2026 due to the demand for minimally invasive surgery and ...Learn More
4Tech appoints Hawkins chairman
Clinical-stage medical device company 4Tech has elected Bill Hawkins as chairman. ...Learn More
Analysis shows positive results for Boston Scientific's heart device
An analysis of procedural data published in the Journal of the American College of Cardiology showed positive results for ...Learn More
TytoCare's digital stethoscope for telehealth system wins FDA clearance
The FDA has given Israel-based TytoCare 510(k) clearance to market its digital stethoscope as part of its Tyto telehealth ...Learn More
FDA clears Neural Analytics' portable transcranial ultrasound system
The FDA has given Neural Analytics 510(k) clearance for its next-generation Lucid M1 system for transcranial Doppler ...Learn More
Boston Scientific's newest Lotus valve on hold in Europe
Boston Scientific has put utilization of its Lotus Edge heart valve on hold in Europe after receiving reports about a ...Learn More
The trouble in America is not that we are making too many mistakes, but that we are making too few.
...Phil Knight, corporate leader
Intellijoint Surgical obtains $8.2M in funding round
A round of Series A financing has pulled in approximately $8.2 million for Intellijoint Surgical, which offers the ...Learn More
Funding round pulls in $3.8M for Sunshine Heart
An offering of shares of two series of convertible preferred stock has brought in $3.8 million for Eden Prairie, Minn.-based ...Learn More
Merger with Aspen Park finalized by The Female Health Co.
A transformational merger with Aspen Park Pharmaceuticals has been completed by The Female Health Co. under modified terms. ...Learn More
Abiomed's Impella quality assurance program debuts
The Impella quality assurance program has been launched by Abiomed to improve recovery and survival outcomes in protected ...Learn More
Halt Medical gets license for InnerOptic's 3D guidance software
Halt Medical has secured a license to use InnerOptic Technologies' patented and FDA-cleared Aim 3D guidance software in its ...Learn More
Study shows positive results for Zimmer Biomet's fusion system
A 103-patient, multicenter trial showed positive results for Zimmer Biomet's Aspen MIS Fusion System as an adjunct to ...Learn More
Intact Vascular wins staged approval from FDA for endovascular system trial
Intact Vascular has obtained staged approval from the FDA for its investigational device exemption application to start ...Learn More
Masks for sleep apnea treatment unveiled by ResMed
The AirFit N20 nasal mask and the AirFit F20 full-face mask have been introduced by ResMed for use in continuous positive ...Learn More
Guidance on race, ethnicity data collection in trials updated by FDA
An updated guidance on collecting ethnicity and race data in clinical trials for medical devices, drugs and biologics has ...Learn More
Edwards Lifesciences' heart valve wins approval from Canada
Health Canada has given Edwards Lifesciences approval for its Intuity Elite rapid deployment aortic valve replacement ...Learn More
I have a simple philosophy: Fill what's empty. Empty what's full. And scratch where it itches.
...Alice Roosevelt Longworth, socialite and writer
XENIOS to be acquired by Fresenius Medical Care
Fresenius Medical Care has reached an agreement with German private venture capitalist zfhn Zukunftsfonds Heilbronn to ...Learn More
SyntheticMR reaches MRI partnership with Siemens
SyntheticMR, a medical imaging software firm based in Sweden, has announced a partnership with Siemens Healthineers to ...Learn More
Biodesix's lung cancer test wins reimbursement from 3 insurers
Humana, PreferredOne and Medical Mutual of Ohio have given Biodesix positive coverage decisions for its VeriStrat, a ...Learn More
ISO certification granted to Exact Imaging
Exact Imaging has been granted ISO 13485:2003 and EN ISO 13485:2012 certification for its quality management system for the ...Learn More
Report predicts growth for global capsule endoscopy market
A report from Wise Guy Reports predicts the worldwide capsule endoscopy market, valued at $178.8 million, will see a 14.8% ...Learn More
Four lessons learned: Managing 21CFR Part 11 Compliance for medical devices
Leveraging the mobile health space is a main concern for medical device manufacturers. ...Learn More
Study shows positive results for Stryker's 3D-printed interbody cages
A study presented at the North American Spine Society's annual meeting showed positive results for the 3D-printed Tritanium ...Learn More
FDA clears Corindus Vascular's second-generation robotic system
The FDA has given Corindus Vascular Robotics 510(k) clearance for its second-generation CorPath GRX, which builds on the ...Learn More
China to allow priority medtech review starting next year
Medical device manufacturers can apply for priority review by the China Food and Drug Administration beginning in January. ...Learn More
SeaSpine's anterior cervical standalone system wins FDA clearance
The FDA has granted SeaSpine clearance to market its Shoreline Anterior Cervical Standalone System, which features ...Learn More
Becton Dickinson's vaginal pathogen panel cleared by FDA
The FDA has given Becton Dickinson clearance for its BD Max Vaginal Panel under the agency's de novo program. ...Learn More
There is no failure except in no longer trying.
...Elbert Hubbard, writer, publisher and artist
Calif. medtech accelerator announces business growth services launch
A program called OCTANe Growth Services has been launched by Aliso Viejo, Calif.-based medtech business accelerator OCTANe ...Learn More
IPO pulls in $243M for Brazilian diagnostics company
An initial public offering has brought in $243 million for Centro de Imagem Diagnosticos, a Brazilian medical diagnostics ...Learn More
Atomo Diagnostics wins $3.6M grant from Gates Foundation
The Bill and Melinda Gates Foundation has awarded Sydney-based Atomo Diagnostics a $3.6 million grant to develop and ...Learn More
4 strategic distribution deals announced by Cardinal Health
Cardinal Health has reached four separate strategic distribution agreements with Biosensors International, Kaneka, Meril and ...Learn More
Report predicts growth for global pediatric interventional cardiology market
A Research and Markets report predicts the worldwide market for pediatric interventional cardiology devices will see a 9% ...Learn More
St. Jude Medical advises doctors to stop Nanostim cardiac pacemaker implants
St. ...Learn More
Zero-profile anterior cervical plate debuted by DePuy Synthes Spine
The ZERO-P NATURAL Plate has been launched by DePuy Synthes Spine to help support bone growth and stability during anterior ...Learn More
FDA releases final guidance on permanent contraception device labeling
A final guidance has been released by the FDA requiring the inclusion of a black box warning on the labeling of Bayer's ...Learn More
St. Jude Medical's patent foramen ovale occluder device wins FDA nod
St. ...Learn More
FDA clears temporary pacing device from BioTrace Medical
The FDA has given BioTrace Medical 510(k) clearance for its Tempo Lead, a temporary pacing device intended to be used in ...Learn More
Well-behaved women seldom make history.
...Laurel Thatcher Ulrich, historian
Abbott's acquisition of St. Jude Medical wins shareholders' vote
Abbott's pending acquisition of St. Jude Medical, valued at $25 billion, has obtained approval from St. ...Learn More
Telerehabilitation startup acquired by Zimmer Biomet
RespondWell, a startup that offers telerehabilitation technology, has been acquired by Zimmer Biomet for undisclosed terms. ...Learn More
Bonesupport obtains $37M in funding round
A round of oversubscribed equity and debt financing led by Tellacq has brought in $37 million for Sweden-based Bonesupport. ...Learn More
Funding round stretched by Titan Medical to $8.6M
An additional 2 million shares have been sold by Titan Medical from an overallotment option on its recent overnight ...Learn More
Report predicts growth for US surgical navigation, robotics market
An iData Research report predicts the US market for surgical navigation and robotics systems will reach $5 billion by 2023 ...Learn More
Health Care Services Corp. to cover MDxHealth's prostate cancer test
MDxHealth has secured a positive coverage policy from Health Care Services Corp. ...Learn More
Portable spine imaging system unveiled by DePuy Synthes Spine
A portable spine imaging system, the KICK System with FluoroExpress Software Module, has been launched by DePuy Synthes ...Learn More
Clearance for RTI Surgical's OCT system widened by FDA
The FDA has given RTI Surgical expanded 510(k) clearance for its Streamline OCT Occipito-Cervico-Thoracic System for use in ...Learn More
FDA OKs MR-safe indication for NuVasive's spine system
The FDA has granted NuVasive expanded clearance for its Magec system, a magnetically controlled growth modulation system ...Learn More
Quidel's Solana molecular platform wins FDA clearance
The FDA has granted Quidel 510(k) clearance for its Solana Strep Complete Assay for use in qualitative and quick detection, ...Learn More
ConvaTec sets price for London IPO
ConvaTec on Wednesday priced the initial public offering of about 33.8% of its shares on the London Stock Exchange, which ...Learn More
Stryker unveils implant delivery solution for ambulatory surgery centers
Ascential, an implant delivery solution intended for use in low-acuity spine surgeries, has been launched by Stryker to ...Learn More
Medicrea announces lifetime warranty for spinal rods in US
Medicrea, a French maker of spinal products, has launched the UNiD lifetime warranty program for its spinal rods, effective ...Learn More
Helix enters DNA sequencing partnerships, gets boost
Illumina investee Helix on Wednesday announced partnerships with the Icahn School of Medicine at Mount Sinai, National ...Learn More
New area VP of sales named by Spinal Elements
Steven Haayen, who has 10 years of experience in spine sales and management, has been tapped to serve as area vice president ...Learn More
Adaptive Biotechnologies' test detects immune changes for cancer treatment
Doctors at the Fred Hutchinson Cancer Research Center in Seattle successfully detected the presence of leukemia cells in a ...Learn More
Trial begins for Acutus Medical's imaging and mapping system
The first patient in a trial of Acutus Medical's AcQMap high-resolution imaging and mapping system has been treated using ...Learn More
Interbody systems debuted by K2M in US
CASCADIA's Interbody Systems, which include the CASCADIA TL, Lateral, AN, AN Lordotic Oblique and Cervical Interbody ...Learn More
FDA approves Medtronic's 34mm TAVR system
The FDA has given Medtronic approval for its CoreValve Evolut R 34mm transcatheter aortic valve replacement system for use ...Learn More
Many of life's failures are people who did not realize how close they were to success when they gave up.
...Thomas Edison, inventor and businessman
Danaher obtains credit facility worth $3B
A 364-day revolving credit facility worth $3 billion has been secured by Danaher for use as liquidity support for its US and ...Learn More
Perceptive Advisors secures $323M for health care debt fund
Perceptive Advisors has raised $323 million for its Perceptive Credit Opportunities Fund, which is dedicated to providing ...Learn More
IPO could bring in $25M for CollPlant
An initial public offering has been filed by Israel-based CollPlant in hopes of obtaining $25 million. ...Learn More
Funding round pulls in $675K for Belluscura
A round of oversubscribed funding has brought in $675,000 for Belluscura, a Tekcapital investee that specializes in ...Learn More
PharmaJet reaches collaborative deal with Vaccibody for HPV vaccine
A collaborative agreement has been reached by PharmaJet and Vaccibody to use PharmaJet's needle-free injection device for ...Learn More
First implantation of visual cortical prosthesis recorded by Second Sight
A patient at the University of California at Los Angeles was the first to undergo implantation using Second Sight Medical's ...Learn More
MiniMed Connect app for Android debuted by Medtronic
An Android version of the MiniMed Connect app has been launched by Medtronic in collaboration with Samsung. ...Learn More
FDA expands use of Ethicon's fibrin sealant patch
The FDA has given Johnson & Johnson subsidiary Ethicon an expanded indication for its EVARREST Fibrin Sealant Patch for use ...Learn More
EU OKs Svelte Medical's rapid-exchange coronary stent system
European regulators have given Svelte Medical Systems CE mark approval for its Direct Sirolimus-Eluting Coronary Stent ...Learn More
Recall of St. Jude's ICDs, CRT-Ds labeled Class I by FDA
A recall initiated by St. ...Learn More
I think it's a mistake to ever look for hope outside of one's self.
...Arthur Miller, playwright
Sale of large-joints business to Corin finalized by Wright Medical
Wright Medical has announced the completion of the $32.3 million sale of its legacy Tornier large-joints business, which ...Learn More
Danaher clears antitrust hurdles for $4B Cepheid purchase
Danaher on Monday secured antitrust clearances or the required waiting periods have expired in the US, Austria, Germany and ...Learn More
NovioSense raises funds for tear glucose sensor, taps new executive
A fourth round of financing has been completed by NovioSense to fund the clinical validation phase of its miniature tear ...Learn More
Illumina reaches companion Dx partnership with Q2 Solutions
An agreement has been reached by Illumina and Q2 Solutions, a clinical trials laboratory services organization, to develop ...Learn More
New president, CEO named by ConforMIS
Mark Augusti has been tapped to serve as president and CEO of ConforMIS effective Nov. 14. ...Learn More
Design from data: Cognoa CEO Vaughan on learning, failing, marketing and getting paid
Cognoa CEO Brent Vaughan talks about creating convenience with medtech apps and how an early diagnosis often leads to better ...Learn More
Jarvik Heart gets conditional FDA OK for pediatric heart assist device trial
The FDA has granted New York City-based Jarvik Heart conditional approval to begin an investigational device exemption study ...Learn More
Theranova HDx system launched by Baxter in 6 countries
Baxter announced the launch of its Theranova HDx hemodialysis therapy system in Australia, France, Germany, New Zealand, ...Learn More
Vascular Solutions' inflation device wins FDA clearance
The FDA has given Vascular Solutions 510(k) clearance for its Fluent inflation device for use in creating, maintaining and ...Learn More
FDA clears new version of Medtronic's directional atherectomy system
The FDA has granted 510(k) clearance to Medtronic for its new, smaller HawkOne 6 French directional atherectomy system for ...Learn More
Immucor's test wins FDA nod for sickle cell screening of blood donors
The FDA has granted Norcross, Ga.-based Immucor approval for its PreciseType HEA test for use in screening of blood donors ...Learn More
Knowing what must be done does away with fear.
...Rosa Parks, civil rights activist
Abbott's acquisition of Alere wins shareholders' vote
Alere shareholders voted in favor of approving the company's pending acquisition by Abbott Laboratories, valued at $5.8 ...Learn More
Irish medtech startup gets about $2.8M boost
A round of funding has brought in about $2.8 million for Ireland-based medical device startup Signum Surgical, a developer ...Learn More
Zimmer Biomet, Nextremity reach exclusive global distribution deal
Zimmer Biomet has agreed to exclusively distribute Nextremity Solutions' foot and ankle deformity correction products on the ...Learn More
Leadtek eyes medical electronics market with wearable device
Leadtek Research, a professional graphics card vendor based in Taiwan, is moving into the medical electronics market with ...Learn More
Augmenix to move its headquarters in Mass.
Augmenix plans to move its headquarters from Waltham, to Bedford, Mass., by the end of the year. ...Learn More
Trials to evaluate NICO's neurosurgical technology for hemorrhagic stroke
Indianapolis-based NICO and the Emory University School of Medicine in Atlanta will launch separate trials to assess early ...Learn More
Canada OKs insulin pump system from Medtronic unit
Health Canada granted a license to Medtronic Canada's MiniMed 630G insulin pump system for treating patients with diabetes ...Learn More
FDA, CMS to continue parallel review for innovative medical devices
The FDA and the CMS have announced they are extending indefinitely their parallel review program for innovative medical ...Learn More
FDA's guidance on companion IVDs draws industry comments
The FDA's draft guidance on the co-development of an in vitro companion diagnostic device with a therapeutic product drew ...Learn More
Roche's blood, plasma donor screening test wins FDA nod
The FDA has given Roche approval for its Cobas MPX test, a nucleic acid test that detects hepatitis B virus, hepatitis C ...Learn More
No man who continues to add something to the material, intellectual and moral well-being of the place in which he lives is long left without proper reward.
...Booker T. Washington, educator, writer and orator
iRhythm Technologies raises IPO target to $107M
An initial public offering has been priced by iRhythm Technologies, a wearable heart monitor maker, in hopes of obtaining ...Learn More
Propeller Health obtains $21.5M in funding round
A round of Series C financing has pulled in $21.5 million for Madison, Wis.-based Propeller Health, a startup that makes ...Learn More
Public offering pulls in $10M-plus for Biocept
A public offering of stock and warrants has brought in a little more than $10 million, before underwriting discount and ...Learn More
Vascular Designs launches crowdfunding effort for cancer treatment device
An Indiegogo crowdfunding campaign has been launched by Vascular Designs in hopes of raising $500,000. ...Learn More
Verb Surgical eyes new robotic platform to transform global surgery
Johnson & Johnson's joint venture with Verily Life Sciences, Verb Surgical, intends to use a "transformative agenda" in ...Learn More
First procedure using peripheral scaffold recorded by Elixir, Akesys
A patient at Auckland City Hospital in New Zealand was the first to undergo implantation using the PRAVA Sirolimus Eluting ...Learn More
InVivo Therapeutics adds new site for neurospinal scaffold trial
Beth Israel Deaconess Medical Center in Boston has been added by InVivo Therapeutics as a new site for the clinical trial of ...Learn More
Ankle fracture treatment system debuted by aap Implantate in US
The polyaxial Loqteq VA Distal Tibia and Fibula Plates 2.7/3.5, a system designed to facilitate treatment of ankle ...Learn More
FDA expands use of Avinger's atherectomy system
The FDA has given Avinger expanded indications for its Pantheris Lumivascular atherectomy system for use in diagnostic ...Learn More
Blood-loss risk prompts recall of Boston Scientific guide catheters
A recall has been initiated by Stryker's neurovascular division involving some Guider guide catheters that it distributes. ...Learn More
The minute you're satisfied with where you are, you aren't there anymore.
...Tony Gwynn, baseball player
Abbott CEO assures progress in deals with Alere, St. Jude Medical
Abbott Laboratories Chairman and CEO Miles White said during a third-quarter earnings call Wednesday that the company's ...Learn More
Arteriocyte Medical Systems acquired by Isto Holdings
Arteriocyte Medical Systems has been acquired by Isto Holdings, the parent company of Isto Technologies, for undisclosed ...Learn More
GF Securities, Quark Venture announce $500M health sciences fund
A global health sciences venture fund worth $500 million has been launched by Quark Venture and GF Securities in Vancouver, ...Learn More
Venture capital firm's second life sciences fund gets $140M boost
Spanish venture capital firm Ysios Capital has closed the Ysios BioFund II Innvierte, its second life sciences fund, at $140 ...Learn More
Funding round pulls in $35.5M for Bigfoot Biomedical
A round of Series A financing has brought in $35.5 million for Milpitas, Calif.-based Bigfoot Biomedical. ...Learn More
Study examines survival outcomes from post-surgical cardiac device use
A 39,546-patient, single-center study published in the journal Europace found patients who received pacemakers or ...Learn More
Researchers create smartphone spectrometer for cancer detection
A low-cost, lightweight smartphone spectrometer that simultaneously detects cancer biomarkers in up to eight samples has ...Learn More
Medtronic releases safety notice on deep-brain stimulation rechargers
A safety notice has been issued by Medtronic to its customers concerning the susceptibility of some of its Model 37751 ...Learn More
EU OKs soft tissue repair matrix from Collplant
European regulators have given Israel-based Collplant CE mark approval for Vergenix STR, a soft tissue repair matrix ...Learn More
FDA expands compassionate use of Avita's regenerative device
The FDA has given Avita Medical a third approval to expand the compassionate use of its ReCell regenerative medical device. ...Learn More
Let us not seek to fix the blame for the past -- let us accept our own responsibility for the future.
...John F. Kennedy, 35th US president
Abbott, St. Jude Medical to divest some assets for about $1.12B
St. ...Learn More
AdvaMed launches purchasing-group benefit offering for members
AdvaMed has debuted a benefit offering called the AdvaMed Purchasing Group to leverage purchasing power and ensure that its ...Learn More
J&J announces new Texas medical device innovation center
The Center for Device Innovation has been opened by Johnson & Johnson Innovation at the Texas Medical Center to advance the ...Learn More
Report predicts growth for worldwide medtech market
A report from market research firm Evaluate predicts the global medical device and technology market will reach almost $530 ...Learn More
Report: Global neuromodulation market poised for growth
The worldwide neuromodulation market is expected to reach $5 billion by 2021 due to an expanding aging population, growing ...Learn More
Trial begins for use of implant to treat congenital heart defects
A 50-patient pediatric clinical trial has been launched by St. ...Learn More
Hemostasis clip debuted by Boston Scientific
Boston Scientific has announced the launch of its Resolution 360 hemostasis clip, a device intended for providing physicians ...Learn More
Ethicon announces launch of high-precision surgical shears
The Harmonic HD 1000i surgical shears have been launched by Johnson & Johnson subsidiary Ethicon for use in procedures ...Learn More
Senators criticize FDA's program for reporting device-related adverse events
The FDA's retrospective summary reporting program for medical devices, which allows companies to report adverse events long ...Learn More
FDA clears Teleflex's midline catheter with Chlorag+ard Technology
The FDA has given Teleflex 510(k) clearance for its Arrow Midline catheter with Chlorag+ard Technology. ...Learn More
To be free is not merely to cast off one's chains, but to live in a way that respects and enhances the freedom of others.
...Nelson Mandela, activist and political leader
AdvaMed issues report on medtech industry trends, challenges
The medtech industry, which is dominated by smaller companies and older firms, has seen sharp declines in the number of ...Learn More
St. Jude Medical announces creation of cybersecurity advisory board
St. ...Learn More
Funding round could pull in $15.2M for Profound Medical
A round of funding led by GMP Securities brought in $13.2 million, plus the potential for $2 million more from an ...Learn More
Globavir, Bio-Rad reach licensing deal on dengue detection assay
Bio-Rad Laboratories and Globavir Biosciences have reached an agreement that allows Bio-Rad to license Globavir's PanGlob ...Learn More
Tricare now covers Exact Sciences' colon cancer test
Tricare has given a positive reimbursement decision for the use of Exact Sciences' Cologuard colon cancer screening test ...Learn More
Prevention vs. treatment: Why an individual specific diet (customization) matters for patients suffering from IBS
IBS is becoming increasingly prevalent among our population, topping the list of most common diagnosis made by ...Learn More
Study shows positive results for Intersect ENT's sinus implant
A 300-patient pivotal trial showed positive results for Intersect ENT's Resolve steroid-releasing sinus implant, a minimally ...Learn More
EU OKs dosimetry software from BTG, Mirada Medical
European regulators have given BTG and Mirada Medical CE mark approval for Simplicit90Y dosimetry software, which is ...Learn More
FDA guidances on NGS Dx tests for germline diseases draw industry comments
The FDA's draft guidances on next-generation sequencing-based diagnostic technologies for germline diseases have been lauded ...Learn More
EU expands approval for Medrobotics' robot-assisted surgery device
European regulators have given Raynham, Mass.-based Medrobotics expanded CE mark approval for its Flex robot-assisted ...Learn More
We must not say every mistake is a foolish one.
...Cicero, philosopher
Funding round pulls in $3.5M for Rivanna Medical
A round of financing has brought in $3.5 million for Charlottesville, Va.-based Rivanna Medical. ...Learn More
Deal to buy Immunetics finalized by Oxford Immunotec
Oxford Immunotec Global, a diagnostics company focused on immune-regulated conditions, has announced the completion of its ...Learn More
Public offering could bring in $10M for Biocept
A public offering of common stock and warrants has been priced by Biocept in hopes of obtaining about $10 million in gross ...Learn More
Report predicts growth for global spinal implants market
A Grand View Research report predicts the worldwide market for spinal implants will reach $19.54 billion by 2024 due to an ...Learn More
Report: Global MRI market poised for growth
The global market for MRI systems is expected to reach $8 billion through 2021 at a 5.7% growth rate, according to a BCC ...Learn More
New chief medical officer for global ophthalmic devices named by Carl Zeiss
Dr. ...Learn More
Study shows positive results for Rotation Medical's bioinductive implant
A study in the journal Arthroscopy showed positive results for Rotation Medical's collagen-based bioinductive implant for ...Learn More
Complex lens exchange system unveiled by VisionCare
The Lens Exchange System, a Class I medical device designed to facilitate complex lens exchange procedures, has been ...Learn More
Blood clot risk prompts recall of some Medtronic neurovascular products
A recall has been initiated by Medtronic involving some lots of its neurovascular products, namely the Alligator retrieval ...Learn More
FDA clears Royal Philips' S4-1 cardiac transducer for ultrasound device
The FDA has given Royal Philips 510(k) clearance to market an S4-1 cardiac transducer for its smart-diagnostic ultrasound ...Learn More
Be a good steward of your gifts. Protect your time. Feed your inner life. Avoid too much noise. Read good books, have good sentences in your ears. Be by yourself as often as you can. Walk. Take the phone off the hook. Work regular hours.
...Jane Kenyon, poet
European medtech accelerator gets $11.5M boost
MD Start, a European medtech accelerator backed by Medtronic, LivaNova and other investors, has secured $11.5 million in ...Learn More
N.C. medtech startup secures $6.3M in funding
A total of $6.3 million, which includes $5.2 million from a funding round and $1.1 million in convertible debt, has been ...Learn More
Funding round pulls in $7.5M for Titan Spine
A round of Series D funding involving Southlake Equity Group has brought in $7.5 million for Titan Spine, according to a ...Learn More
Titan Medical, Ximedica sign deal to restart surgical system development work
Titan Medical will restart development work on its Sport robot-assisted surgery platform under a deal with the system's ...Learn More
Report: Global cervical total disc replacement device market poised for growth
A MRRSE report predicts the worldwide market for cervical total disc replacement devices will see growth due to a low ...Learn More
CDC issues warning on infection risk from heart surgery devices
The CDC has warned patients and health care providers about the risk of serious bacterial infection from using potentially ...Learn More
Trial begins for Neural Analytics' next-gen portable diagnostic platform
The first patient in a Phase I trial of a next-generation portable diagnostic platform for early stroke detection in an ...Learn More
Titan Spine starts full US release of nanoLOCK surface technology
Titan Spine has announced the full commercial launch of its nanoLOCK surface technology in the US. ...Learn More
FDA seeks comments for guidance on software as a medical device
The FDA is asking for public feedback on a guidance produced by the International Medical Device Regulators Forum, which ...Learn More
Medtronic's full suite of MRI-safe cardiac devices OK'd by FDA
The FDA has given Medtronic approval for its full suite of MRI-safe SureScan MR-conditional pacemakers, cardiac ...Learn More
If you would be a real seeker after truth, it is necessary that at least once in your life you doubt, as far as possible, all things.
...Rene Descartes, mathematician and philosopher
Funding round pulls in $12M for Fortimedix Surgical
A round of Series A funding led by Dutch venture capital firm Chemelot Ventures has brought in $12 million for Fortimedix ...Learn More
Cruzar Medsystems gets $2.9M boost
A round of equity financing involving five anonymous sources has pulled in $2.9 million for Braintree, Mass.-based Cruzar ...Learn More
Celgene, Agios team up with Abbott on companion Dx development
Collaboration deals have been reached by Celgene and Agios Pharmaceuticals with Abbott to develop and commercialize ...Learn More
HTG reaches companion Dx development deal with Merck KGaA
An agreement has been reached by HTG Molecular Diagnostics and Merck KGaA to develop a companion diagnostic for use with ...Learn More
Report predicts growth for global minimally invasive surgery market
A Transparency Market Research report predicts the worldwide minimally invasive surgery market will reach $50.6 billion by ...Learn More
Trial begins for Novocure's tumor-treating field technology
The first patient in a Phase III pivotal trial of a tumor-treating field technology plus radiosurgery has been enrolled by ...Learn More
Study compares bioresorbable scaffold, drug-eluting stent in lesion treatment
A study in Catheterization and Cardiovascular Interventions found bioresorbable vascular scaffolds had similar scaffold area ...Learn More
Instrumentation Laboratory's automated immunoassay makes international debut
The HemosIL AcuStar VWF:CB assay, a fully automated chemiluminescent immunoassay designed to diagnose Von Willebrand disease ...Learn More
Report weighs analytics for helping HCPs assess device quality
A report released by the Case for Quality, a partnership between the Medical Device Innovation Consortium and the FDA, ...Learn More
Nidek's retinal evaluation device wins FDA clearance
Nidek has obtained 510(k) clearance from the FDA for its MP-3 microperimeter, a 12-megapixel fundus camera for use in ...Learn More
Nobody made a greater mistake than he who did nothing because he could do only a little.
...Edmund Burke, statesman and orator
Funding round pulls in $36M for Relievant Medsystems
A round of equity funding led by New Enterprise Associates has brought in $36 million for Redwood City, Calif.-based ...Learn More
VertiFlex obtains $15M in funding round
A round of debt financing involving six unnamed sources has pulled in $15 million for San Clemente, Calif.-based VertiFlex, ...Learn More
Synaptive Medical gets $3.7M boost
Synaptive Medical has secured $3.7 million in a round of equity financing involving 18 unnamed investors, according to an ...Learn More
Tepha completes buyout of royalty obligation to Metabolix
Lexington, Mass.-based Tepha has announced the completion of a deal with its former licenser and parent company Metabolix to ...Learn More
Report predicts growth for global orthopedic imaging market
A Future Market Insights report predicts the worldwide market for orthopedic imaging systems will see growth through 2026, ...Learn More
St. Jude issues alert on battery depletion risk in defibrillators
St. ...Learn More
Researchers create 3D-printed biodegradable vascular stent
Researchers from Northwestern University have developed a vascular stent that can be customized to fit a patient's blood ...Learn More
FDA releases final rule to amend custom device definition
A final rule has been issued by the FDA to add new statutory requirements for custom devices. ...Learn More
FDA clears allograft bone use with Spineology's interbody devices
The FDA has cleared the use of allograft bone with Spineology's Rampart Interbody Fusion Devices, which come sterile-packed ...Learn More
BioFire's respiratory panel wins FDA clearance, CLIA certification
BioFire Diagnostics, the molecular biology affiliate of bioMerieux, has obtained 510(k) clearance and a Clinical Laboratory ...Learn More
It is an incalculable added pleasure to any one's sum of happiness if he or she grows to know, even slightly and imperfectly, how to read and enjoy the wonder-book of nature.
...Theodore Roosevelt, 26th US president
$50M venture fund launched by Helsinn Healthcare
The Helsinn Investment Fund, a $50 million fund dedicated to companies with technologies and assets in cancer diagnostics ...Learn More
Roche Diagnostics confirms exit from Indian insulin pumps segment
Roche Diagnostics confirmed that it has pulled out of the insulin pumps segment in India to focus on providing ...Learn More
BioDirection eyes $15M funding, portable concussion test trials
BioDirection said it is hoping to secure $15 million in funding for use in building a commercial headquarters in western ...Learn More
Report predicts growth for US patient monitoring, diagnostic device market
An iData Research report predicts the US market for patient monitoring and diagnostic equipment will see growth in the ...Learn More
New executive VP, global chief medical officer named by Boston Scientific
Ian Meredith, a professor at Australia's Monash University and director of MonashHeart and Monash Health, has been tapped to ...Learn More
Taking production cost out of medical devices starts with design
There are many ways to approach the DFM/DFI process. ...Learn More
BioMerieux enters public-private partnership on sepsis biomarkers
BioMerieux has partnered with Sanofi, GSK, French microbiology tech innovation accelerator Bioaster, the Hospices Civils de ...Learn More
Patients with ischemic cardiomyopathy may benefit from LVADs
A study in the Journal of the American College of Cardiology found left ventricular assist device implantation may lead to ...Learn More
St. Jude Medical debuts fractional flow reserve measurement system
The PressureWire X Guidewire fractional flow reserve measurement system has been launched by St. ...Learn More
Clever Culture's automated plate assessment system cleared by FDA
Clever Culture Systems has obtained clearance under the FDA's de novo program to market its Automated Plate Assessment ...Learn More
FDA clears Viveve's electrocoagulation system
The FDA has given Viveve 510(k) clearance for its Viveve System, a device intended to be used in general surgical procedures ...Learn More
Sometimes, the shortest path between two points is serpentine.
...Christopher Benfey, literary critic
Tender offer for EndoChoice shares launched by Boston Scientific
A tender offer for EndoChoice shares has been launched by Boston Scientific at $8 per share as part of its acquisition of ...Learn More
Mass. investment firm gets $87M boost for medtech fund
Wellesley, Mass.-based venture capital firm BioVentures Investors has secured $87 million for its Fund IV, its fourth fund ...Learn More
iRhythm Technologies to float 5.35M shares in IPO
San Francisco-based iRhythm Technologies said it intends to offer 5.35 million shares in an initial public offering in hopes ...Learn More
RIVANNA gets $1.5M grant for ultrasound-based 3D imaging device
The NIH has awarded Charlottesville, Va.-based RIVANNA a $1.5 million grant under its Small Business Innovation Research ...Learn More
Funding round pulls in $5M for Harbor MedTech
A round of equity funding involving three investors has brought in $5 million for Harbor MedTech, bringing the company ...Learn More
Analysis predicts growth for global sports medicine devices market
A Zion Research analysis predicts the worldwide market for sports medicine devices will reach $8.63 billion by 2020 with a ...Learn More
First procedures using bioabsorbable pulmonary heart valve recorded by Xeltis
Three patients at the Pediatric Cardiac Centre in Hungary were the first to undergo implantation using Xeltis' bioabsorbable ...Learn More
EU OKs skin disease-treating devices from Ra Medical
European regulators have given Ra Medical CE mark approvals for its DABRA artherectomy catheter system and its Pharos ...Learn More
Final guidances on blood glucose monitoring systems released by FDA
Two final guidance documents have been released by the FDA outlining recommendations on the studies and criteria that can be ...Learn More
FDA clears plasmapheresis system from Fresenius Kabi
The FDA has given Fresenius Kabi 510(k) clearance for its Aurora Xi plasmapheresis system, a device that features a ...Learn More
Mistakes are part of the dues one pays for a full life.
...Sophia Loren, actress
Pfizer's infusion systems unit to be acquired by ICU Medical for $1B
Pfizer on Thursday announced it reached a deal with ICU Medical, a San Clemente, Calif.-based maker of devices for vascular ...Learn More
MDxHealth's prostate cancer test scores reimbursement win from Highmark
Blue Cross Blue Shield affiliate Highmark BCBS has given a positive coverage decision to ConfirmMDx, an epigenetic ...Learn More
Alphatec announces management changes, workforce reduction
Dennis Nelson, vice president of finance and corporate controller at Alphatec, was tapped to serve as the company's interim ...Learn More
New president named by Xtant Medical
Carl O'Connell has been tapped to serve as president of Belgrade, Mont.-based Xtant Medical effective Oct. 6. ...Learn More
First radical hysterectomy using surgical robot recorded by TransEnterix
A patient at Policlinico A. ...Learn More
IC could offer more efficient pacemakers
Boston Scientific and Microelectronic Circuits Centre Ireland have collaborated on a nanotechnology chip design meant to ...Learn More
St. Jude announces US launch of deep brain stimulation technology
The Infinity Deep Brain Stimulation system has been launched in the US by St. ...Learn More
FDA OKs Trice Medical's next-gen device for arthroscopy, endoscopy
Trice Medical has obtained approval from the FDA for its mi-eye 2, a second-generation disposable needle intended for ...Learn More
Siemens Healthineers' coagulation analyzer wins FDA clearance
The FDA has given Siemens Healthineers 510(k) clearance for its Xprecia Stride Coagulation Analyzer, a hand-held device ...Learn More
Nobody can go back and start a new beginning, but anyone can start today and make a new ending.
...Maria Robinson, writer
IPO brings in $75M for Obalon Therapeutics
Obalon Therapeutics has obtained $75 million in proceeds from its initial public offering of 5 million shares. ...Learn More
Funding round pulls in $30M for Enable Injections
A round of Series A financing led by ORI Healthcare Fund has brought in $30 million for Cincinnati-based Enable Injections, ...Learn More
Eccrine Systems gets $5.5M boost
A round of Series A financing has brought in $5.5 million for Cincinnati-based Eccrine Systems, which develops a wearable ...Learn More
DxTerity secures BARDA contract for radiation biodosimetry test
DxTerity Diagnostics has received a contract worth up to $150.1 million from the Biomedical Advanced Research and ...Learn More
Report predicts growth for global drug-device combination market
A Grand View Research report predicts the worldwide market for drug-device combination products will hit $17.7 billion by ...Learn More
Federal investments play vital role in research, development
The federal government may not get credit for fostering innovation amid restrictive rules and spending caps, but in reality ...Learn More
St. Jude Medical's cardiac mapping system released in Europe
St. ...Learn More
Researchers develop wearable microscope to detect biomarkers beneath skin
Researchers from the University of California, Los Angeles, and Verily Life Sciences developed a wearable microscope that ...Learn More
St. Jude Medical's spinal cord stimulation device wins FDA nod
St. ...Learn More
EU OKs Fortimedix Surgical's single-port surgery solution
European regulators have given Fortimedix Surgical CE mark approval for its FMX314, a single-port device intended for use in ...Learn More
Optimism is the faith that leads to achievement; nothing can be done without hope.
...Helen Keller, writer and political activist
Abbott seeks EU nod for $25B deal with St. Jude Medical
Abbott Laboratories asked for antitrust approval from the European Commission on Oct. 3 for its pending acquisition of St. ...Learn More
Deal to form respiratory solutions joint venture finalized by BD, Apax
Becton Dickinson has completed a deal with Apax Partners to launch a joint venture, which includes all business lines within ...Learn More
Funding round pulls in $3M for San Diego medtech startup
A round of funding led by Acquipharma has brought in $3 million for San Diego-based medtech startup Burl Concepts. ...Learn More
Cepheid, Novacyt reach HPV testing alliance
Cepheid has entered into a three-year, nonexclusive agreement with Novacyt to distribute the latter's NOVAprep vial, media ...Learn More
Analysis predicts growth for global orthopedic devices market
A Transparency Market Research analysis predicts the worldwide market for orthopedic devices will reach $41.2 billion by ...Learn More
J&J insulin pump has hacking risk, but threat is low, firm says
Johnson & Johnson's Animas One Touch Ping insulin pump potentially could be accessed by a hacker who could trigger an ...Learn More
Royal Philips releases imaging, measurement systems in Canada
Royal Philips on Tuesday announced the debut of its Volcano catheter-based imaging and measurement systems in Canada for use ...Learn More
Bone graft delivery system debuted by Stryker's spine division
The LITe BIO Delivery System, a hand-held device designed for facilitating bone graft material delivery in spine fusions and ...Learn More
Colon cleansing system from MOTUS GI cleared by FDA
The FDA has granted Israel-based startup MOTUS GI clearance to market its Pure-Vu System, which is designed for cleansing ...Learn More
EU OKs Profusa's injectable oxygen biosensor
European regulators have given Profusa CE mark approval for its Lumee Oxygen Platform, an injectable biosensor system ...Learn More
Don't loaf and invite inspiration; light out after it with a club, and if you don't get it you will nonetheless get something that looks remarkably like it.
...Jack London, writer and social activist
London IPO could bring in $1.8B for ConvaTec
ConvaTec on Monday said it plans to launch an initial public offering this year of at least 25% of its shares on the London ...Learn More
Alere bullish on Abbott merger completion after court order
Alere said it expects its pending merger with Abbott to be completed as planned after the Delaware Court of Chancery issued ...Learn More
Seed funding round pulls in $1.05M for QuiO
A round of seed funding has brought in $1.05 million for New York City based-startup QuiO. ...Learn More
Exosome Diagnostics enters liquid biopsy Dx partnership with Amgen
A partnership deal has been reached by Exosome Diagnostics and Amgen to develop a liquid biopsy test using Exosome's ...Learn More
NeoTract's UroLift system wins reimbursement from Geisinger, EmblemHealth
Geisinger Health Plan and EmblemHealth will provide coverage for procedures using NeoTract's UroLift System for benign ...Learn More
New executive VP, general counsel named by NuVasive
Joan Stafslien, who has over 20 years of experience in providing legal advice for medtech companies, has been tapped to ...Learn More
Best practices for transitioning from design to production
While developing a comprehensive BOM may not be the most exciting part of product development, it's certainly critical. ...Learn More
Valencia Technologies' neurostimulator gets IDE from FDA
The FDA has given Valencia Technologies an investigational device exemption to conduct a 300-patient trial of its eCoin ...Learn More
Data show positive results for Medtronic's surgical aortic valve
Data from a trial presented at the annual meeting of the European Association for Cardio-Thoracic Surgery in Spain showed ...Learn More
NSF awards $735K grant for Invictus' noise attenuation technology
The National Science Foundation has awarded Invictus Medical a Phase II grant worth $735,000 to advance development of its ...Learn More
EU OKs Edwards Lifesciences' hypotension monitor
European regulators have given Edwards Lifesciences CE mark approval for its Acumen Hypotension Probability Indicator, a ...Learn More
When you're that successful, things have a momentum, and at a certain point you can't really tell whether you have created the momentum or it's creating you.
...Annie Lennox, singer and songwriter
DOD taps Boston Scientific for $71M cardiovascular supplies contract
Boston Scientific has secured a $71 million contract from the Defense Department to provide the Army, Marine Corps, Navy, ...Learn More
NIH awards $2M for DoseOptics' radiation therapy imaging technology
The NIH has awarded Lebanon, N.H.-based DoseOptics a $2 million grant, which will be disbursed in the next two years, to ...Learn More
Public offering could pull in $1.28M for Delcath
A public offering of 425,000 shares has been priced by New York-based Delcath in hopes of obtaining $1.28 million. ...Learn More
Elekta, Brainlab reach technical exchange agreement
A technical exchange agreement has been reached by Elekta and Brainlab to improve the treatment capabilities and ...Learn More
Terumo, Cognate announce collaborative development deal
Cognate BioServices is expected to become a Terumo development and contract manufacturing center using the Quantum Cell ...Learn More
Data show positive results for Augmenix's hydrogel rectal spacer
Data from a Phase III trial presented at the meeting of the American Society for Radiation Oncology showed positive results ...Learn More
Owlstone Medical working on breath-based cancer detection system
A system that uses the Field Asymmetric Ion Mobility Spectrometer chip, along with a breath collection device called the ...Learn More
Titanium spinal implants debuted by ulrich medical in US
Musculoskeletal implant maker ulrich medical has released the uCerv titanium spinal implants in the US as an adjunct to its ...Learn More
Recalls of HeartWare's heart pumps labeled Class I by FDA
Two recalls initiated by Medtronic unit HeartWare International involving its HVAD heart pumps have been categorized by the ...Learn More
When you have that window of opportunity called a crisis, move as quickly as you can, get as much done as you can. There's a momentum for change that's very compelling.
...Anne Mulcahy, corporate leader
Intuitive Surgical to form lung cancer joint venture with Fosun
Intuitive Surgical has struck a deal with distribution partner Shanghai Fosun Pharmaceutical Group to form a China-based ...Learn More
Terumo makes bid for Abbott's medical device business
Japan-based medical device firm Terumo has made an offer to buy a portion of Abbott Laboratories' medical device business, ...Learn More
Strategic realignment plans announced by Sunshine Heart
Sunshine Heart plans to carry out a strategic realignment that will help it focus on its Aquadex FlexFlow system, a fluid ...Learn More
Funding round pulls in $11M for Cerapedics
A round of Series D financing has brought in $11 million for orthobiologics firm Cerapedics. ...Learn More
Manufacturing begins at Biotronik's new Singapore plant
An expanded manufacturing facility has been opened by Biotronik in Singapore to make its Solia S ProMRI pacing lead and ...Learn More
Report: Global cervical total disc replacement devices market poised for growth
A Persistence Market Research report predicts the worldwide market for cervical total disc replacement devices will reach ...Learn More
CareFirst to cover Vermillion's ovarian cancer test
The OVA1 ovarian cancer test from Vermillion will be covered by CareFirst BlueCross BlueShield under an agreement between ...Learn More
EU OKs aortic valve from Edwards Lifesciences
European regulators have given Edwards Lifesciences CE mark approval for its INSPIRIS RESILIA aortic valve, which comes with ...Learn More
Abbott's continuous glucose monitor wins FDA nod for professional use
Abbott has obtained approval from the FDA for its FreeStyle Libre Pro System for use in professional continuous glucose ...Learn More
Becton Dickinson's blood collection device cleared by FDA
The FDA has given Becton Dickinson 510(k) clearance for its Vacutainer Barricor plasma blood collection tube, a ...Learn More
Always do your best. What you plant now, you will harvest later.
...Og Mandino, writer
Mediation between Alere, Abbott concludes without resolution
Mediation to resolve the dispute between Alere and Abbott Laboratories over their pending $5.8 billion merger agreement has ...Learn More
Funding round could pull in $6M for InterRad Medical
A round of equity financing could bring in $6 million for Plymouth, Minn.-based InterRad Medical, according to a filing with ...Learn More
US taps Carestream for $150M medical image management contract
The US government has awarded Carestream a Digital Imaging Network-Picture Archiving and Communication System contract worth ...Learn More
BCBS of Neb. to cover SI-BONE's sacroiliac joint fusion device
Blue Cross Blue Shield of Nebraska will provide coverage for minimally invasive sacroiliac joint fusion procedures using ...Learn More
Report predicts growth for global minimally invasive surgery market
An iHealthcareAnalyst report predicts the worldwide minimally invasive surgery market will reach $9.8 billion by 2020 with a ...Learn More
Guidelines on diabetes technologies released by Endocrine Society
An Endocrine Society task force has released clinical guidelines recommending real-time continuous glucose monitoring ...Learn More
Endoscopic ablation system debuted by CardioFocus in US
The HeartLight Endoscopic Ablation System, which enables direct visual guidance of laser energy delivery for pulmonary vein ...Learn More
Medtronic's artificial pancreas wins FDA approval
The FDA on Wednesday gave Medtronic approval for its MiniMed 670G, an artificial pancreas that features a glucose sensor and ...Learn More
AdvaMed calls on India to harmonize device regulations with global standards
India's lack of separate regulations for medical devices not only impedes product innovation and development, but it also ...Learn More
Support catheter from Medtronic cleared by FDA
Medtronic has obtained clearance from the FDA for its TrailBlazer angled support catheter for use in the peripheral vascular ...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
Speculation and the exploration of ideas beyond what we know with certainty are what lead to progress.
...Lisa Randall, theoretical physicist
Boston Scientific reaches $210M deal to buy EndoChoice
Boston Scientific on Tuesday announced it will pay about $210 million to acquire Alpharetta, Ga.-based EndoChoice, maker of ...Learn More
Natus Medical to pay $145M for GN Otometrics
Natus Medical has agreed to buy GN Store Nord's GN Otometrics, a developer of hearing diagnostics and balance assessment ...Learn More
Hill-Rom's WatchChild acquired by PeriGen
Hill-Rom's WatchChild Fetal Monitoring System has been acquired by Princeton, N.J.-based fetal surveillance system developer ...Learn More
Funding round pulls in $35M for SentreHeart
A round of Series D financing has brought in $35 million for Redwood City, Calif.-based SentreHeart. ...Learn More
Stereotaxis gets $24M boost, names new board members
A private placement led by Masimo Chairman and CEO Joe Kiani and DAFNA Capital Management has brought in $24 million for St. ...Learn More
Public offering brings in $7.8M for CareDx
A public offering of about 2.3 million shares has pulled in $7.8 million in net proceeds for molecular diagnostics firm ...Learn More
W. L. Gore scores reimbursement win for iliac branch device
W. L. ...Learn More
Cognitive diabetes app introduced by Medtronic, IBM
Medtronic and IBM on Tuesday jointly unveiled Sugar.IQ with Watson, a cognitive app designed to help patients manage ...Learn More
AdvaMed comments on FDA's benefit-risk guidance for device enforcement
AdvaMed has submitted comments to the FDA concerning the agency's draft guidance on the factors it considers when weighing a ...Learn More
Medtronic's StealthStation software cleared by FDA
The FDA has given Medtronic clearance to market its StealthStation software for use in deep-brain stimulation therapy. ...Learn More
Every day, do something to move the ball forward.
...Jayne Atkinson, actress
IPO could pull in $75M for Obalon Therapeutics
An initial public offering of 5 million shares has been priced by Carlsbad, Calif.-based Obalon Therapeutics in hopes of ...Learn More
St. Jude shareholder approval sought for $25B Abbott merger
St. ...Learn More
Research center for chronic disease devices opens in Ireland
The Centre for Research in Medical Devices, representing an investment of about $76 million from various sources, has been ...Learn More
$50M technology accelerator launched by GE Healthcare
An accelerator called five.eight has been launched by GE Healthcare to provide 10 global health care startups with financial ...Learn More
PerkinElmer diagnostics business to become standalone segment
PerkinElmer on Monday said its diagnostics business will operate as a standalone segment with a focus on applied genomics, ...Learn More
SHS invests in German 3D-printed orthopedic device maker
Emerging Implant Technologies, a Germany-based developer of 3D-printed orthopedic devices and implants, has received an ...Learn More
Design for people, not diseases: Motivo reimagines the walker
Motivo Tour is like no walker you've ever seen. ...Learn More
Data show positive results for Accuray's stereotactic body radiotherapy device
Data from a 309-patient, 21-site study presented at an annual meeting of the American Society for Therapeutic Radiology & ...Learn More
Patient positioning system unveiled by ZDi Solutions
Knoxville, Tenn.-based ZDi Solutions has introduced the Z-System, an add-on to radiation therapy devices to provide patient ...Learn More
BrainScope's diagnostic device for traumatic brain injury cleared by FDA
The FDA has granted Bethesda, Md.-based BrainScope clearance to market its Ahead 300, a wearable medical device intended for ...Learn More
India updates draft medical device rules
Updated draft rules for medical devices have been released by the Central Drugs Standard Control Organization of India after ...Learn More
It's a poor sort of memory that only works backwards.
...Lewis Carroll, writer
IPO could pull in $86M for Calif. cardiac arrhythmia monitor maker
An initial public offering has been filed by San Francisco-based iRhythm Technologies in hopes of obtaining up to $86 ...Learn More
Global diabetes headquarters opened by Medtronic in Minn.
A facility has been opened by Medtronic in Plymouth, Minn., to serve as the global headquarters for its Non-Intensive ...Learn More
Private placement brings in $600K for Ventripoint
A private placement of shares and warrants has brought in $600,000 for Canadian firm Ventripoint Diagnostics. ...Learn More
Skyline Medical, GLG Pharma reach collaboration deal
GLG Pharma has agreed to develop rapid diagnostic tests, starting with tests to detect cancer biomarkers and infectious ...Learn More
NordicNeuroLab, Surgical Theater partner on diffusion tensor imaging
NordicNeuroLab's nordicBrainEx diffusion tensor imaging processing application will be integrated into Surgical Theater's ...Learn More
First procedure using Biosense Webster heart catheter recorded
The Texas Cardiac Arrhythmia Institute at St. ...Learn More
Safety intravenous catheter debuted by Hospira in US
The LifeShield Supercath 5 safety intravenous catheter has been released by Hospira in the US. ...Learn More
GE announces global launch of next-gen portable cardiovascular ultrasound
The Vivid iq, a portable compact cardiovascular ultrasound, has been launched globally by GE Healthcare. ...Learn More
Recommendations on device evaluation system released by FDA planning board
A report has been released by a planning board formed by the FDA and the Duke-Margolis Center for Health Policy to outline ...Learn More
FDA issues order to classify strabismus detection device
The strabismus ophthalmic detection device has been classified as a Class II medical device with special controls under an ...Learn More
All progress occurs because people dare to be different.
...Harry Millner, writer
Tridien Medical acquired by Hill-Rom unit
All outstanding shares of Tridien Medical, a maker of patient positioning devices and support surfaces, have been acquired ...Learn More
Becton Dickinson to invest $100M in Neb. facility expansion
Becton Dickinson has committed to investing $100 million in its Holdrege, Neb., factory, which manufactures syringes for ...Learn More
Canon invests $40M in T2 Biosystems
Canon USA has acquired a 19.9% stake in T2 Biosystems for $40 million. ...Learn More
GE, Trice Imaging reach cloud-based ultrasound partnership
A partnership has been reached by GE Healthcare and Trice Imaging to integrate Trice's Tricefy cloud-based image sharing ...Learn More
Data show positive results for Medtronic's drug-coated balloon
Data from two studies presented at the Vascular Interventional Advances annual conference showed positive results for ...Learn More
LivaNova announces US launch of next-gen ICDs, CRT-Ds
The Platinium implantable cardiac defibrillators and cardiac resynchronization therapy devices have been launched by ...Learn More
Becton Dickinson debuts wireless diagnostic device
The BD Veritor Plus System, a wireless diagnostic device that detects influenza A and B, group A strep and respiratory ...Learn More
Canada OKs Staar Surgical's intraocular lenses
Health Canada's Medical Devices Bureau has given Monrovia, Calif.-based Staar Surgical approval for its EVO Visian Toric ICL ...Learn More
FDA clears next-gen mobility tracker from Global Kinetics
Australia-based Global Kinetics has obtained 510(k) clearance from the FDA for its PKG Watch, an upgraded version of its ...Learn More
Whatever you want in life, other people are going to want too. Believe in yourself enough to accept the idea that you have an equal right to it.
...Diane Sawyer, journalist
SynCardia Systems acquired by Versa Capital
Tucson, Ariz.-based SynCardia Systems has been acquired by Versa Capital Management for undisclosed terms. ...Learn More
Public offering could pull in $7.8M for CareDx
A public offering of about 2.3 million shares has been priced by CareDx in hopes of obtaining $7.8 million in net proceeds. ...Learn More
Pharos Capital invests in TechLab
A controlling stake in Blacksburg, Va.-based TechLab, a maker of diagnostic tests for gastrointestinal diseases, has been ...Learn More
NIH backs study of CivaTech's targeted radiation device
The NIH has awarded Durham, N.C.-based CivaTech Oncology a $2.3 million grant to conduct a two-year study evaluating its ...Learn More
Sage Products plans facility expansion in Ill.
Sage Products, a medical device company acquired by Stryker early this year, is planning a two-phase, 27-acre expansion ...Learn More
Data show positive results for W. L. Gore's stent graft
Data from a single-arm Japanese study in the Journal of Vascular Surgery showed positive results for W. L. ...Learn More
Colonoscope device from GI View cleared by FDA
The FDA has given GI View 510(k) clearance for its Aer-O-Scope Colonoscope System, a disposable, self-propelled device that ...Learn More
Senate panel discusses FDA regulation of laboratory-developed tests
The Senate Health, Education, Labor and Pensions Committee held a hearing Tuesday to discuss whether laboratory-developed ...Learn More
FDA device center publishes 2017 science priorities
The FDA's Center for Devices and Radiological Health has released a report outlining its 10 regulatory science priorities ...Learn More
FDA clears spinal deformity system components from K2M
K2M has obtained clearance from the FDA to market the screw and connector components for its Mesa Spinal System, allowing ...Learn More
Man is only truly great when he acts from the passions.
...Benjamin Disraeli, prime minister
$4.2B deal to buy FEI finalized by Thermo Fisher Scientific
The acquisition of Hillsboro, Ore.-based microscope technology company FEI, valued at $4.2 billion, has been completed by ...Learn More
MEDX Ventures opens medtech incubator in Israel
Investment firm MEDX Ventures, along with partners that include Boston Scientific and Intellectual Ventures, has launched ...Learn More
Offering pulls in $7.9M for Titan Medical
An overnight offering of stock and warrants has brought in $7.9 million for Toronto-based Titan Medical. ...Learn More
Funding boost secured by Theranica Bio-Electronics
A round of seed financing has pulled in an undisclosed amount for Theranica Bio-Electronics, a newly established medical ...Learn More
Report predicts growth for global hip reconstruction devices market
The worldwide market for hip reconstruction devices will see growth through 2024 because of product advancement, an ...Learn More
C.R. Bard secures FDA approval to modify drug-coated balloon trial
The FDA has granted C.R. ...Learn More
N.Y. medical device startup secures patent for spinal surgical implants
Albany, N.Y.-based medical device startup ReVivo Medical has obtained a patent for its new implants intended for use in ...Learn More
Individualized total knee arthroplasty implant debuted by Zimmer Biomet
The Vanguard Individualized Design, a total knee arthroplasty implant, has been launched by Zimmer Biomet. ...Learn More
Boston Scientific's next-gen aortic valve system wins EU approval
European regulators have granted Boston Scientific CE mark approval for its Lotus Edge transcatheter aortic valve system, ...Learn More
EU OKs ViewRay's next-gen MRI-guided radiation therapy system
European regulators have given ViewRay CE mark approval for its MRIdian Linac technology, an advanced linear, ...Learn More
Cybersecurity Summit
Nov. ...Learn More
An organization's ability to learn, and translate that learning into action rapidly, is the ultimate competitive business advantage.
...Jack Welch, corporate leader and author
Illumina eyes expansion into clinical, consumer markets
Illumina, under the leadership of recently appointed CEO Francis deSouza, is looking to bring its sequencing offerings into ...Learn More
Baltimore device maker gets $500K boost
Baltimore-based medical device maker Awarables has secured a $500,000 investment from the Abell Foundation. ...Learn More
Analysis predicts growth for global spine biologics market
A ReportsWeb analysis predicts the worldwide market for spine biologics will see a 2.07% compound annual growth rate through ...Learn More
Report: Global optical imaging market poised for growth
A Transparency Market Research report predicts the global optical imaging market will hit $2.19 billion by 2020 with a 10.8% ...Learn More
CeloNova BioSciences announces leadership changes
Dennert Ware, executive chairman of San Antonio-based interventional cardiology technologies maker CeloNova BioSciences, has ...Learn More
Decoy tissue scaffolding aims to limit metastatic cancer
Researchers at the University of Michigan's Comprehensive Cancer Center have developed a device designed to mimic the ...Learn More
Trial begins for W. L. Gore's aortic branch device
The first patient in a 435-patient pivotal study of the Tag Thoracic Branch Endoprosthesis has been enrolled by W. L. ...Learn More
Ultrasound system debuted by Bioventus in Saudi Arabia
The Exogen ultrasound bone healing system has been launched by Bioventus in Saudi Arabia. ...Learn More
EU expands approval for Edwards Lifesciences' heart valve
European regulators have given Edwards Lifesciences expanded CE mark approval for its Sapien 3 transcatheter aortic valve ...Learn More
NuVasive's posterior fixation technology cleared by FDA for MAGEC system
The FDA has granted NuVasive clearance for its Reline posterior fixation system for use in implanting the MAGEC system to ...Learn More
Hormonal contraceptive device from Bayer wins FDA nod
Bayer has obtained approval from the FDA for its Kyleena, a long-acting reversible contraceptive device that prevents ...Learn More
The first step toward success is taken when you refuse to be a captive of the environment in which you first find yourself.
...Mark Caine, writer
Abbott unit to be acquired by J&J for about $4.33B
Johnson & Johnson will pay about $4.33 billion to acquire Abbott Laboratories' eye surgery equipment unit under an all-cash ...Learn More
Offering could pull in $300M for Agilent Technologies
An offering of senior notes due in September 2026 has been priced by Agilent Technologies in hopes of obtaining $300 ...Learn More
CMS to cover use of Silk Road Medical's transcarotid stent system
The Enroute Transcarotid Neuroprotection and Stent System from Sunnyvale, Calif.-based Silk Road Medical has obtained ...Learn More
Staar Surgical, Eye-Q Vision reach distribution deal
EyeQ Vision Private has agreed to distribute to 44 hospitals in north and west India Staar Surgical's EVO Visian ICL ...Learn More
Alphatec announces management changes
Leslie Cross, chairman of the board at Carlsbad, Calif.-based Alphatec, has been tapped to serve as interim CEO of the ...Learn More
Data show positive results for OptiNose's exhalation delivery system
Data from two Phase III clinical trials presented at the American Rhinologic Society's annual meeting showed positive ...Learn More
Sound-wave technology from Shockwave Medical wins FDA clearance
The FDA has given Fremont, Calif.-based Shockwave Medical clearance to market its Lithoplasty System for treating patients ...Learn More
Final rule on clinical trial results reporting released by HHS
A final rule has been issued by HHS requiring companies to post results of interventional studies involving FDA-approved and ...Learn More
Balloon dilation system from Acclarent approved by FDA
Irvine, Calif.-based Acclarent has obtained approval from the FDA for its Aera Eustachian Tube Balloon Dilation System, a ...Learn More
3D Medical Technology: Understanding the Legal and Regulatory Challenges, Opportunities and Strategies
Oct. ...Learn More
7th Annual Advertising and Promotion of Medical Devices Conference
Nov. 10-11 | Washington, D.C. ...Learn More
I never dreamed about success. I worked for it.
...Estee Lauder, entrepreneur
Zimmer Biomet acquires Dutch imaging company
Zimmer Biomet has announced its acquisition of Netherlands-based Clinical Graphics, an imaging company that makes 3D ...Learn More
Offering could pull in $1.2B for Thermo Fisher Scientific
An offering of senior notes due in 2026 has been priced by Thermo Fisher Scientific at an aggregate principal amount of $1.2 ...Learn More
Intarcia Therapeutics gets $215M boost
A round of financing led by Baillie Gifford has brought in $215 million for Boston-based Intarcia Therapeutics, bringing the ...Learn More
Funding round brings in $10M for Securus Medical
A round of Series C financing led by Boston Scientific has brought in $10 million for Cleveland-based Securus Medical Group, ...Learn More
Offering of senior notes filed by Agilent
An offering of senior notes due in 2026 has been filed by Agilent Technologies in hopes of obtaining an undisclosed amount ...Learn More
New VP of global operations, business services named by Medtronic
Mark Ploof, former chief customer experience officer at marketing firm YP, has been tapped to serve as senior vice president ...Learn More
Data show positive results for Medtronic's artificial pancreas system
Data from a three-month study, published in the Journal of the American Medical Association, showed positive results for ...Learn More
Varian Medical's high-resolution X-ray system wins FDA clearance
The FDA has granted Varian Medical Systems 510(k) clearance for its Nexus DR, a high-resolution X-ray system that features a ...Learn More
Meditech Spine's anterior cervical plate system cleared by FDA
The FDA has given Atlanta-based Meditech Spine clearance for its CURE Anterior Cervical Plate System, a titanium plate ...Learn More
GI Dynamics' EndoBarrier device clearance to be canceled in Australia
GI Dynamics said Wednesday it has been notified by the Australian Therapeutic Goods Administration that its EndoBarrier ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
A failure is not always a mistake. It may simply be the best one can do under the circumstances. The real mistake is to stop trying.
...B.F. Skinner, psychologist
Stryker announces acquisition of Instratek
Stryker on Wednesday said it agreed to pay an undisclosed amount to acquire Houston-based Instratek, which offers minimally ...Learn More
BiOptix Diagnostics acquired by Venaxis
Castle Rock, Colo.-based Venaxis has announced its acquisition of BiOptix Diagnostics, a Boulder, Colo.-based developer of a ...Learn More
Private placement pulls in $345M for Insulet
A private placement of convertible senior notes due in 2021 has brought in $345 million for Billerica, Mass.-based Insulet, ...Learn More
Offering could bring in up to $12M for Titan Medical
An overnight offering of stock and warrants has been announced by Toronto-based Titan Medical in hopes of obtaining $8 ...Learn More
Progenerative Medical, Acelity unit reach licensing agreement
San Antonio-based Progenerative Medical has secured exclusive global rights to the intellectual property and preclinical ...Learn More
Illumina signs co-marketing deal with Dovetail Genomics
An agreement has been reached by Dovetail Genomics and Illumina to jointly market Dovetail's in vitro proximity ...Learn More
EBR Systems' cardiac resynchronization system gets IDE from FDA
The FDA has given EBR Systems an investigational device exemption for its cardiac resynchronization therapy device called ...Learn More
Japan OKs Medtronic's insertable cardiac monitor system
The Japanese Ministry of Health, Labor and Welfare has cleared Medtronic's MRI-conditional Reveal Linq insertable cardiac ...Learn More
FDA clears Becton Dickinson's sexually transmitted infection assay
The FDA has given Becton Dickinson clearance to market its BD MAX CT/GC/TV assay, a triplex test designed for detecting ...Learn More
Carl Zeiss Meditec's laser device wins FDA nod for myopia
Carl Zeiss Meditec has obtained approval from the FDA for its VisuMax Femtosecond Laser for use in a cornea reshaping ...Learn More
The ability to learn is older -- as it is also more widespread -- than is the ability to teach.
...Margaret Mead, cultural anthropologist
Glooko merges with Diasend
Glooko and Diasend on Tuesday said they have merged into a unified entity under Glooko's brand name. ...Learn More
Offering could bring in $11.5M for OpGen
An offering of common stock has been filed by OpGen in hopes of obtaining up to $11.5 million. ...Learn More
Funding round pulls in $2M for N.C. medical imaging company
A round of angel investor funding has brought in $2 million for Greenville, N.C.-based RFPi, an early-stage company that ...Learn More
Illumina, Sophia Genetics reach co-marketing agreement
An agreement has been reached by Illumina and Sophia Genetics to jointly market their next-generation sequencing products ...Learn More
Adhezion Biomedical signs skin adhesives supply deal with Pfizer
Pfizer has secured exclusive US distribution rights for a line of high-strength topical skin adhesives containing 2-octyl ...Learn More
Report predicts growth for global anesthetic, respiratory devices market
A BCC Research report predicts the worldwide market for anesthetic and respiratory devices will hit almost $24.2 billion by ...Learn More
Trial begins for Insulet's artificial pancreas system
Billerica, Mass.-based Insulet has tested its hybrid closed-loop OmniPod Horizon Automated Glucose Control System on the ...Learn More
Ultrasound systems launched by Siemens Healthineers in Canada
The Acuson S Family Helx Evolution Touch ultrasound systems have been released in Canada by Siemens Healthineers. ...Learn More
FDA OKs expanded indication for Medtronic's drug-coated balloon
Medtronic has obtained expanded approval from the FDA for its IN.PACT Admiral drug-coated balloon for use in treating ...Learn More
Kerecis' fish skin cleared by FDA for surgical applications
The FDA has given Kerecis clearance to market its Omega3-rich fish skin for surgical applications, including lung, gastric, ...Learn More
FDA Submissions Strategy Workshop
Oct. ...Learn More
Excellent firms don't believe in excellence -- only in constant improvement and constant change.
...Tom Peters, writer and management consultant
Verily Life Sciences to create $500M diabetes joint venture with Sanofi
Verily Life Sciences, Alphabet's life sciences unit, and Sanofi will form a joint venture called Onduo to combine high-tech ...Learn More
Terumo announces collaboration deal with CytoSorbents
Terumo and CytoSorbents have entered into a strategic partnership deal to commercialize CytoSorbents' CytoSorb blood ...Learn More
AstraZeneca signs commercial supply agreement with Bespak
Consort Medical subsidiary Bespak has agreed to supply pressurized metered-dose inhaler technology, which includes inhaler ...Learn More
Report predicts growth for global neurostimulation devices market
A Grand View Research report predicts the worldwide market for neurostimulation devices will reach $9.8 billion by 2024 due ...Learn More
NuVasive announces changes in management
Jason Hannon has been promoted to president and chief operating officer at NuVasive, where he previously served as executive ...Learn More
Chief financial officer, executive VP of Acelity steps down
Tom Casey has resigned as chief financial officer and executive vice president at Acelity. ...Learn More
Microfluidics manufacturing: Advanced manufacturing techniques ease the process
A recent report suggests that the microfluidics market is expected to reach $7.5 billion by 2020. ...Learn More
Study shows positive results for Abbott's glucose monitor
Trial data published in The Lancet showed positive results for Abbott's FreeStyle Libre glucose monitor compared with ...Learn More
Ultrasound transducers to be unveiled by Kolo Medical
Three new SiliconWave ultrasound transducers, which are intended to provide better ultrahigh-resolution imaging performance ...Learn More
FDA clears tissue sealer from Ethicon
The FDA has given Johnson & Johnson subsidiary Ethicon 510(k) clearance for its ENSEAL X1 Large Jaw Tissue Sealer, a bipolar ...Learn More
Weight-loss system from Obalon Therapeutics gets FDA OK
The FDA has granted Obalon Therapeutics approval for the Obalon Balloon System, a swallowable intragastric device intended ...Learn More
A feminist is anyone who recognizes the equality and full humanity of women and men.
...Gloria Steinem, journalist and activist
Public offering could pull in $75M for Obalon Therapeutics
An initial public offering has been filed by Carlsbad, Calif.-based Obalon Therapeutics in hopes of obtaining up to $75 ...Learn More
Apollo Endosurgery, Lpath reach merger deal
A merger agreement has been reached by Austin, Texas-based medical device company Apollo Endosurgery and San Diego-based ...Learn More
AcuFocus obtains $66M in funding round
A round of funding led by KKR & Co. ...Learn More
Veniti gets $25M financing from Boston Scientific
A Series D equity financing of $25 million from Boston Scientific has been secured by St. ...Learn More
Funding round brings in $1.5M for Valeris Medical
A round of debt financing involving 18 anonymous sources has brought in $1.5 million for early-stage orthopedic firm Valeris ...Learn More
Report predicts growth for global spinal implants and devices market
A Grand View Research report predicts the worldwide market for spinal implants and devices will reach more than $19.54 ...Learn More
Study shows positive results for Smith & Nephew's wound therapy system
A 220-patient randomized, controlled trial showed positive results for Smith & Nephew's Pico negative-pressure wound therapy ...Learn More
Image quantification software from icometrix cleared by FDA
The FDA has granted icometrix 510(k) clearance for its icobrain image quantification software, which facilitates monitoring ...Learn More
Draft guidance on 510(k) third-party review program released by FDA
Draft guidance has been issued by the FDA to update its current thinking on a program through which third-party ...Learn More
FDA clears Carestream's extremity imaging system
The FDA has given Carestream 510(k) clearance for its Carestream OnSight 3D Extremity System, which allows capturing of 3D ...Learn More
PMA Submissions Workshop
Nov. 3-4 | Washington, D.C. ...Learn More
In a chronically leaking boat, energy devoted to changing vessels is likely to be more productive than energy devoted to patching leaks.
...Warren Buffett, investor
Insulet raises target for debt offering
An offering of convertible senior notes due in 2021 has been priced by Billerica, Mass.-based Insulet in hopes of obtaining ...Learn More
Funding round pulls in $18.3M for Vivasure Medical
A round of Series C financing led by Life Sciences Partners has brought in $18.3 million for Ireland-based startup Vivasure ...Learn More
Chrono Therapeutics gets $47.6M boost
A round of Series B financing led by Kaiser Permanente Ventures has pulled in $47.6 million for Hayward, Calif.-based Chrono ...Learn More
Avinger, HealthTrust reach group purchasing agreement
An agreement has been reached by Avinger and group purchasing organization HealthTrust that will allow HealthTrust members ...Learn More
Report predicts growth for Asia-Pacific spine surgery devices market
A Market Research Store report predicts the Asia-Pacific market for spine surgery devices will see growth through 2022 due ...Learn More
Monteris Medical's MRI-guided laser treatment gets IDE from FDA
The FDA has given Monteris Medical an investigational device exemption to conduct a study of its NeuroBlate System, an ...Learn More
Flower Orthopedics launches guide wire kits
The Ready-for-Surgery Guide Wire Kits for the Cannulated Screw FlowerCube have been launched by Flower Orthopedics. ...Learn More
Additive Orthopaedics' 3D-printed osteotomy wedge system cleared by FDA
The FDA has given Little Silver, N.J.-based early-stage orthopedics firm Additive Orthopaedics 510(k) clearance for its ...Learn More
EU OKs wireless neurostimulator from BlueWind Medical
European regulators have given BlueWind Medical CE mark approval for its small wireless neurostimulator called Vivendi, ...Learn More
Hologic's Zika test gains expanded emergency use status from FDA
Hologic has obtained expanded emergency use authorization from the FDA for its Aptima Zika test, which is designed to ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
Sept. 27-28 | Washington, D.C. ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
Sept. 28-29 | Washington, D.C. ...Learn More
I will not change just to court popularity.
...Margaret Thatcher, prime minister
Cogentix Medical reaches $25M securities purchase deal with Accelmed
A securities purchase agreement involving over 16 million shares has been reached by Cogentix Medical with private equity ...Learn More
Deal to buy Sequenom finalized by LabCorp
The acquisition of Sequenom, valued at about $302 million, has been completed by the Laboratory Corp. of America. ...Learn More
Bruker to acquire Oncovision's preclinical imaging business
A deal has been reached by Bruker to acquire Oncovision's preclinical imaging business for undisclosed terms. ...Learn More
Ohio tech companies receive $5M from JumpStart
Cleveland-based venture development organization JumpStart has invested a total of $5 million in eight local companies, ...Learn More
TransEnterix announces new brand identity for ALF-X surgical robot
A new brand name and logo were announced Wednesday by TransEnterix for its ALF-X robotic surgical system, which will now be ...Learn More
New COO, CFO named by DJO Global
Mike Eklund, who has more than 20 years of finance, operating and treasury experience at Dell, has been tapped to serve as ...Learn More
Study shows positive results for Nevro's spinal cord stimulation system
A study in the journal Neurosurgery showed positive results for Nevro's HF10 spinal cord stimulation system. ...Learn More
FDA clears multicontrast MR technique from GE Healthcare
The FDA has given GE Healthcare 510(k) clearance for MAGiC, a magnetic resonance image compilation multicontrast MR ...Learn More
Delaying DMEPOS reimbursement cuts would improve patient outcomes
Lawmakers should enact legislation that would delay cuts to Medicare reimbursements for durable medical equipment, ...Learn More
UDI compliance date extended by FDA for certain Class II devices
The date for complying with unique device identifier requirements for certain Class II devices, namely repackaged single-use ...Learn More
Wearable Devices Webinar: Regulatory and Litigation Risks
Sept. 15 | Virtual 1:00 p.m.-2:00 p.m. ...Learn More
10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
April 26-27, 2017 | Washington, D.C. ...Learn More
People will forget what you said. People will forget what you did. But people will never forget how you made them feel.
...Maya Angelou, writer
Danaher reaches $4B deal to acquire Cepheid
Danaher on Tuesday announced it will pay about $4 billion, including debt, to acquire molecular diagnostics firm Cepheid in ...Learn More
Funding round pulls in $40M for ROX Medical
A round of Series E funding led by Apple Tree Partners and Novartis Venture Fund has brought in $40 million for San ...Learn More
Fla. medical device startup gets $930K boost
Naples, Fla.-based Catalyst OrthoScience, an orthopedic medical device startup that makes the palm-sized Catalyst CSR ...Learn More
Medtronic announces opening of Vietnam office
Medtronic has opened an office in Ho Chi Minh City, Vietnam, in an effort to address cancer and cardiovascular diseases ...Learn More
Insulet announces services deal with ATS, leadership changes
Billerica, Mass.-based Insulet on Tuesday said it tapped ATS Automation Tooling Systems to build, design and install a ...Learn More
Study shows positive results for St. Jude Medical's aortic valve
A 100-patient, multicenter study published in the journal EuroIntervention showed positive results for St. ...Learn More
Implantable cardioverter defibrillators launched by Biotronik in Japan
Biotronik's MR-conditional Ilivia implantable cardioverter defibrillators, which come with the company's ProMRI and MRI ...Learn More
Premarket application for HPV assay submitted by Becton Dickinson
A premarket approval application has been submitted by Becton Dickinson to the FDA for its Onclarity HPV assay for use with ...Learn More
FDA OKs Cochlear's off-the-ear hearing device
The FDA has given Australia-based Cochlear approval for its Kanso Sound Processor, a small, wireless, off-the-ear hearing ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Failure is only the opportunity more intelligently to begin again.
...Henry Ford, industrialist
Sale of international operations to Globus Medical finalized by Alphatec
Alphatec said the sale of its international operations and distribution channel to Globus Medical, valued at $80 million, ...Learn More
Blockade Medical acquired by Balt International
Blockade Medical, a developer of endovascular devices, has been acquired by European medtech company Balt International for ...Learn More
Private placement pulls in $1.2M for GeneNews
A private placement of about 9.8 million units of stock and warrants has brought in $1.2 million for GeneNews. ...Learn More
Report predicts growth for global sports medicine devices market
A Transparency Market Research report predicts the worldwide market for sports medicine devices will continue to see a 4.4% ...Learn More
VP of operations for greater China named by Cook Medical
Jean-Marc Creissel has been tapped to serve as vice president of operations for the greater China region at Cook Medical. ...Learn More
Parfet resigns from Stryker's board
William Parfet has resigned as a member of Stryker's board of directors effective Aug. 31. ...Learn More
Medical device R&D projections and insights from the sidelines
The medical industry is on the move. ...Learn More
Bayer wins FDA nod to study permanent birth control device
Bayer has secured approval from the FDA to conduct an open-label, postmarket surveillance study of its permanent birth ...Learn More
Portable ultrasound platform to be unveiled by Ellex Medical Lasers
A portable ultrasound platform called the Eye One will be launched by Ellex Medical Lasers at the 2016 Congress of the ...Learn More
Guidance on 510(k) submissions for X-ray imaging devices issued by FDA
A new guidance has been released by the FDA on submitting 510(k) applications for solid-state X-ray-imaging devices, ...Learn More
FDA OKs expanded indication for Stryker unit's clot retrieval devices
Stryker subsidiary Concentric Medical has obtained expanded approval from the FDA for its Trevo ProVue and Trevo XP ProVue ...Learn More
Wearable Devices Webinar: Regulatory and Litigation Risks
Sept. 15 | Virtual 1:00 p.m.-2:00 p.m. ...Learn More
How can our works and thoughts, if they are always to be the fittest, continue always the same? Change, indeed, is painful, yet ever needful.
...Thomas Carlyle, philosopher
Stryker division announces acquisition of Ivy Sports Medicine
Ivy Sports Medicine, maker of the FDA-approved Ivy Sports platform collagen meniscus implant, has been acquired by Stryker's ...Learn More
Deal to acquire Stratatech finalized by Mallinckrodt
The acquisition of Stratatech has been completed by UK-based Mallinckrodt for undisclosed terms. ...Learn More
Funding round pulls in $3.45M for UK imaging startup
A round of funding has brought in $3.45 million for UK-based startup Micrima. ...Learn More
Exact Imaging gets $2.2M boost
Chinese biotech firm BioSciKin has invested $2.2 million in the Series C funding round of Exact Imaging, bringing the total ...Learn More
San Antonio startup obtains $350K in funding round
An offering of convertible notes has pulled in $350,000 for San Antonio-based Cardiovate, an early-stage developer of a ...Learn More
Soerensen to resign as CEO of Novo Nordisk
Lars Rebien Soerensen will step down as CEO of Novo Nordisk at the end of the year. ...Learn More
Trial begins for St. Jude Medical's left atrial appendage occluder
A 1,600-patient investigational device exemption trial has been launched by St. ...Learn More
Medtronic's sensor for iPro2 continuous glucose monitor gets FDA OK
Medtronic's Enlite sensor has been approved by the FDA for use with the company's iPro2 professional continuous glucose ...Learn More
Meeting dates set for FDA to hear input on off-label communications
A two-day meeting has been scheduled for Nov. ...Learn More
FDA clears next-gen dialyzer from B. Braun Medical
The FDA has given B. ...Learn More
7th Annual Advertising and Promotion of Medical Devices Conference
Nov. 10-11 | Washington, D.C. ...Learn More
Cybersecurity Summit
Nov. ...Learn More
Progress everywhere today does seem to come so very heavily disguised as chaos.
...Joyce Grenfell, actress
Phagenesis to be acquired by Nestle Health Science
Nestle Health Science has reached an agreement to acquire British medical device company Phagenesis for terms that include ...Learn More
Funding round pulls in $5M for Cernostics
A round of funding led by UPMC Enterprises has brought in $5 million for Pittsburgh-based oncology diagnostics firm ...Learn More
$1.47M NIH grant supports development of Novuson's ultrasound device
The NIH's National Heart, Lung, and Blood Institute has awarded Bothell, Wash.-based Novuson Surgical a Phase 2 Small ...Learn More
Qualcomm Life, Royal Philips reach connected health care partnership
A partnership has been reached by Royal Philips and Qualcomm Life to promote interoperability among personalized connected ...Learn More
Teleflex unit to close N.C. facility, cut jobs
Teleflex subsidiary Arrow will close its Asheboro, N.C., facility by 2017 and lay off a number of workers next month as part ...Learn More
New chief operating officer named by Brookhaven Medical
Scott Jones, who has over 20 years of health care industry experience, has been tapped to serve as chief operating officer ...Learn More
PharmaJet, WHO collaborate on polio eradication effort
PharmaJet announced a multiyear partnership with the World Health Organization under which it will provide its Tropis device ...Learn More
US patent issued for Implanet's technology platform
French medtech company Implanet has obtained a patent from the US Patent and Trademark Office for its JAZZ technology ...Learn More
EU OKs analysis software from BioTelemetry
European regulators have given BioTelemetry CE mark approval for its Holter analysis software, which can be used with any of ...Learn More
AdvaMed, others raise concerns on Open Payments data
Data made publicly available under the CMS Open Payments program lack context that would explain individual payments made by ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
Oct. ...Learn More
3D Medical Technology: Understanding the Legal and Regulatory Challenges, Opportunities and Strategies
Oct. ...Learn More
After you've done a thing the same way for two years, look it over carefully. After five years, look at it with suspicion. And after ten years, throw it away and start all over.
...Alfred Perlman, railroad executive
Funding round pulls in $2.35M for International Biomedical Devices
A round of convertible debt funding has brought in $2.35 million for Mount Pleasant, S.C.-based International Biomedical ...Learn More
TelePharm acquired by Cardinal Health
Cardinal Health has confirmed its acquisition of telemedicine software startup TelePharm for undisclosed terms. ...Learn More
Boehringer, Qualcomm Life team up on next-gen connected inhaler
Boehringer Ingelheim and Qualcomm Life will partner to create the next generation of Boehringer's Respimat connected inhaler ...Learn More
BioMerieux partners with Jackson Lab on infectious disease diagnostics
BioMerieux will partner with the Jackson Laboratory to create diagnostics for determining patients at risk for infections, ...Learn More
Skyline Medical signs joint venture agreement with Electronic On-Ramp
A letter of intent has been signed by Skyline Medical to form a joint venture with digital security services provider ...Learn More
Study shows promising results for BackBeat's dual-chamber pacemaker
A study presented at the European Society of Cardiology's annual meeting showed positive results for BackBeat Medical's ...Learn More
1-month data show positive results for Intralink-Spine's crosslinking device
Data from a study showed positive results for Intralink-Spine's Rejuve system, an injectable crosslinking device intended ...Learn More
Introducer sheath unveiled by W.L. Gore
The GORE DrySeal Flex Introducer Sheath has been launched by W.L. ...Learn More
EU OKs catheter system from Bluegrass Vascular
European regulators have given San Antonio-based medtech startup Bluegrass Vascular Technologies CE mark approval to market ...Learn More
Internal battery issue prompts ResMed ventilator recall in Australia
ResMed Astral 100 and Astral 150 ventilators, which are used to support patients with respiratory difficulties, have been ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
Sept. 28-29 | Washington, D.C. ...Learn More
I am suffocated and lost when I have not the bright feeling of progression.
...Margaret Fuller, journalist and activist
Immucor announces expansion plans for Wis. operations
Norcross, Ga.-based Immucor said it intends to expand its Brookfield, Wis., operations by hiring 64 employees and spending ...Learn More
Intersect ENT's drug-eluting implants score reimbursement win from CareFirst
CareFirst BlueCross BlueShield will cover the use of the Propel and Propel Mini sinus implants, which were developed by ...Learn More
Report predicts growth for endoscopic device market
A Research and Markets report predicts the market for endoscopic devices will see a high-single-digit compound annual growth ...Learn More
President, CEO to retire from Misonix
Michael McManus Jr. will retire as president and CEO of Farmingdale, N.Y.-based Misonix effective Sept. ...Learn More
Clinical, regulatory EVP of Titan Medical to step down
Dr. ...Learn More
Parkinson’s could potentially be detected by an eye test
Researchers may have discovered a method of detecting changes in the eye which could identify Parkinson’s disease ...Learn More
Study shows positive results for Medtronic's transcatheter pacing system
A study presented at the European Society of Cardiology Congress showed positive results for Medtronic's Micra transcatheter ...Learn More
CT scanner from Siemens Healthineers cleared by FDA
Siemens Healthineers has obtained clearance from the FDA for its Somatom Drive CT scanner, a system that comes with the ...Learn More
Final guidance on labeler codes released by FDA
A final guidance has been issued by the FDA clarifying that it will not enforce a deadline for complying with its ...Learn More
FDA clears laparoscopic surgical system from Fortimedix
The FDA has given Netherlands-based Fortimedix Surgical 510(k) clearance for its FMX314 single-port system, a device ...Learn More
Roche's Zika assay gains emergency-use status from FDA
Roche Holding has announced that the FDA has granted its LightMix Zika test emergency-use authorization for use in the ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
An individual has not begun to live until he can rise above the narrow horizons of his particular individualistic concerns to the broader concerns of all humanity.
...Martin Luther King Jr., civil rights activist
Chembio secures HHS contract to develop Zika test
Chembio Diagnostics has received a $5.9 million initial contract from HHS' Biomedical Advanced Research and Development ...Learn More
Abbott faces lawsuit from Alere over pending $5.8B merger
Alere has filed a lawsuit alleging Abbott Laboratories failed to promptly meet regulatory requirements -- including ...Learn More
Medtronic to cut back on some heart failure R&D to support HeartWare
Medtronic intends to reduce some of its research and development programs directed at heart failure to cover the cash burn ...Learn More
Bluedrop Medical obtains about $670K in funding round
A round of funding has brought in about $670,000 for Ireland-based startup Bluedrop Medical, which plans to use the money to ...Learn More
VP of regulatory affairs, quality assurance named by Sunshine Heart
Megan Brandt has been tapped to serve as vice president of regulatory affairs and quality assurance at Sunshine Heart, a new ...Learn More
Report predicts growth for global orthopedic implants market
A Grand View Research report predicts the worldwide market of orthopedic implants will reach $6.2 billion by 2024 due to ...Learn More
Hospital becomes first to use Edwards' heart valve since FDA approval
PinnacleHealth is the first hospital system to use Edwards Lifesciences' Edwards Intuity Elite valve for patients with ...Learn More
Combined angiography system debuted by Getinge, GE Healthcare
A combined angiography system intended for a wider range of surgical procedures and interventions in hybrid operating rooms ...Learn More
UK regulator updates guidance on apps, software as medical devices
An updated guidance has been released by the UK's Medicines and Healthcare products Regulatory Agency to clarify whether ...Learn More
HeartFlow's cardiac imaging platform gains NICE support
The UK's National Institute for Health and Care Excellence has endorsed the use of HeartFlow's cardiac imaging platform for ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
Like integrity, love of life was not a subject to be studied, it was a contagion to be caught. And you had to catch it from someone who had it.
...Lois McMaster Bujold, writer
Earlybird fund to invest up to $135M in medtech, diagnostics companies
The Earlybird Health Tech Fund, with a target size of up to about $135 million, has been launched by venture capital firm ...Learn More
Funding round pulls in $6M for Gobiquity
A round of Series B financing led by InterWest Partners has brought in $6 million for Gobiquity, maker of the GoCheck Kids ...Learn More
Rivanna Medical obtains $3M in funding round
A round of equity funding involving unnamed investors has pulled in $3 million for Charlottesville, Va.-based Rivanna ...Learn More
Offering could bring in $2.3M for MBio Diagnostics
A public offering of stock and warrant units could bring in $2.3 million for MBio Diagnostics, according to a filing with ...Learn More
CTL Medical, Firehouse Medical reach GSA partnership
A General Services Administration partnership has been reached by Dallas-based CTL Medical and Firehouse Medical, a ...Learn More
Baxter, Satellite Healthcare reach dialysis care partnership
Baxter International's Amia Automated Peritoneal Dialysis system will be offered by Satellite Healthcare to its peritoneal ...Learn More
Study shows positive results for InSightec's focused ultrasound system
A 76-patient study in the New England Journal of Medicine showed positive results for InSightec's ExAblate Neuro focused ...Learn More
Ethicon, Touch Surgery team up on surgical simulation app
A free mobile app that offers training on over 75 simulated surgical procedures has been developed through a partnership ...Learn More
Warning on programmable syringe pumps issued by FDA
A safety notice was issued by the FDA to health care providers about serious clinical consequences of therapy delay, ...Learn More
FDA clears post-dermal procedure device from Oculus
The FDA has given Petaluma, Calif.-based Oculus Innovative Sciences 510(k) clearance for its post-dermal procedure device ...Learn More
West Coast Diagnostics Summit
Nov. ...Learn More
The greater part of our happiness or misery depends upon our dispositions, and not upon our circumstances.
...Martha Washington, US first lady
Texas venture capital firm gets $75M boost for medtech, software fund
Austin, Texas-based S3 Ventures has secured $75 million for its sixth venture capital fund dedicated to local medtech and ...Learn More
US antitrust waiting period cleared by LabCorp for Sequenom purchase
LabCorp said Monday the required waiting period under US antitrust regulations has ended for its pending acquisition of ...Learn More
Canadian biotech firm acquired by Earth Science Tech
Boca Raton, Fla.-based Earth Science Tech said it acquired the majority of assets and business of BEO-ITS, a Canadian ...Learn More
Coloplast to expand workforce in US headquarters
Denmark-based Coloplast is looking to significantly expand its US operations with the addition of new employees at its ...Learn More
Global smart wearable health care devices, services market poised for growth
A Technavio report predicts the worldwide market for smart wearable health care devices and services will see a compound ...Learn More
Research firm predicts growth for global microbiology testing market
The worldwide microbiology testing market is expected to hit $5.77 billion by 2021 with an 11.5% compound annual growth rate ...Learn More
Trial begins for SRS Medical's temporary prostatic stent
The first patients in an FDA investigational device exemption study of the Spanner temporary prostatic stent have been ...Learn More
Edible, melanin-based battery introduced by scientists for medical devices
A digestible, non-toxic battery that can power 5-milliwatt ingestible medical devices for up to 18 hours has been unveiled ...Learn More
Bio2 Medical's embolism protection catheter cleared by FDA
The FDA has given Golden, Colo.-based BiO2 Medical 510(k) clearance for its Angel Catheter, a device that traps clinically ...Learn More
FDA clears expanded sizes of Amedica's interbody fusion device
Amedica has secured clearance from the FDA to market additional sizes of its Valeo II Lateral Lumbar device, which is ...Learn More
FDA Submissions Strategy Workshop
Oct. ...Learn More
That is the true perfection of man, to find out his imperfections.
...St. Augustine, philosopher and theologian
Deal to acquire HeartWare finalized by Medtronic
Medtronic has wrapped up its acquisition of HeartWare International. ...Learn More
Lombard Medical leaves US, considers sale
Lombard Medical Technologies on Monday said it pulled its sales force from the US and transferred most of its commercial ...Learn More
OraSure secures BARDA contract for Zika test development
OraSure Technologies has received a six-year, multiphased contract from HHS' Biomedical Advanced Research and Development ...Learn More
Study: After FDA warning, power morcellator use drops in US
The US rate of minimally invasive hysterectomies performed with power morcellators was 3% in 2015, down from almost 14% in ...Learn More
Siemens Healthineers North America names new SVP
Terry Coutsolioutsos, who has 25 years of medical device industry experience, has been tapped to serve as senior vice ...Learn More
First procedure using St. Jude Medical defibrillator recorded
The Golden Jubilee National Hospital in Scotland was the first to perform a procedure using St. ...Learn More
Study shows positive results for Abbott Vascular's drug-eluting stent
A study in Catheterization and Cardiovascular Interventions showed positive results for Abbott Vascular's Xience V ...Learn More
Next-gen blood glucose-monitoring system debuted by Roche unit
The Accu-Chek Guide, a next-generation blood glucose-monitoring system that connects to the Accu-Chek Connect diabetes ...Learn More
Medical device industry reaches deal with FDA on user fee program
The medical device industry has agreed with the FDA to pay $999.5 million under the agency's new five-year user fee program ...Learn More
Final guidances related to benefit-risk determinations released by FDA
A final guidance has been issued by the FDA to outline the factors the agency takes into consideration when making ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
Sept. 27-28 | Washington, D.C. ...Learn More
To love oneself is the beginning of a lifelong romance.
...Oscar Wilde, writer
Rio Grande Neurosciences terminates agreement to be acquired by Endonovo
Endonovo said it will not proceed with its $22 million acquisition of Rio Grande Neurosciences after its binding letter of ...Learn More
Private placement pulls in $13.75M for ViewRay
A private placement of about 4.6 million units of stock and warrants has brought in $13.75 million for ViewRay. ...Learn More
EU awards Dune Medical $3.4M grant for biopsy device development
The European Commission has given Dune Medical a grant worth about $3.4 million to develop a biopsy device that is based on ...Learn More
Patricia Industries reaches deal to buy LABORIE
Sweden-based Patricia Industries has agreed with Audax Private Equity to acquire Canada-based LABORIE, a developer of ...Learn More
Purchase of Neoptics' assets finalized by Presbia unit
The purchase of assets from Swiss firm Neoptics, maker of the Icolens implantable device for presbyopia, has been completed ...Learn More
Report: Global orthopedic devices market poised for growth
A Market Research Engine report predicts the worldwide market for orthopedic devices will hit $47.5 billion by 2020 with a ...Learn More
Deep brain stimulation could help brain trauma patients, but the technology needs a boost
Someone suffers from a brain injury every 15 seconds in the US. Some injuries are concussions while others are worse. ...Learn More
First implantations using abdominal stent graft system recorded by Endologix
Two patients at the Auckland City Hospital in New Zealand were the first to undergo implantations using Endologix's Ovation ...Learn More
Knotless sutures debuted by Ethicon
The Stratafix Spiral PDS Plus and Stratafix Spiral Monocryl Plus Knotless Tissue Control devices have been launched by ...Learn More
AdvaMed comments on FDA's guidance on patient-specific device data sharing
AdvaMed has submitted comments to the FDA concerning the agency's guidance on how medical device makers can share ...Learn More
FDA permits ImPACT to market devices for post-concussion cognitive testing
ImPACT Applications has obtained permission from the FDA to market its Immediate Post-Concussion Assessment and Cognitive ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Rio Grande Neurosciences terminates agreement to be acquired by Endonovo
Endonovo said it will not proceed with its $22 million acquisition of Rio Grande Neurosciences after its binding letter of ...Learn More
Private placement pulls in $13.75M for ViewRay
A private placement of about 4.6 million units of stock and warrants has brought in $13.75 million for ViewRay. ...Learn More
EU awards Dune Medical $3.4M grant for biopsy device development
The European Commission has given Dune Medical a grant worth about $3.4 million to develop a biopsy device that is based on ...Learn More
Patricia Industries reaches deal to buy LABORIE
Sweden-based Patricia Industries has agreed with Audax Private Equity to acquire Canada-based LABORIE, a developer of ...Learn More
Purchase of Neoptics' assets finalized by Presbia unit
The purchase of assets from Swiss firm Neoptics, maker of the Icolens implantable device for presbyopia, has been completed ...Learn More
Report: Global orthopedic devices market poised for growth
A Market Research Engine report predicts the worldwide market for orthopedic devices will hit $47.5 billion by 2020 with a ...Learn More
Deep brain stimulation could help brain trauma patients, but the technology needs a boost
Someone suffers from a brain injury every 15 seconds in the US. Some injuries are concussions while others are worse. ...Learn More
First implantations using abdominal stent graft system recorded by Endologix
Two patients at the Auckland City Hospital in New Zealand were the first to undergo implantations using Endologix's Ovation ...Learn More
Knotless sutures debuted by Ethicon
The Stratafix Spiral PDS Plus and Stratafix Spiral Monocryl Plus Knotless Tissue Control devices have been launched by ...Learn More
AdvaMed comments on FDA's guidance on patient-specific device data sharing
AdvaMed has submitted comments to the FDA concerning the agency's guidance on how medical device makers can share ...Learn More
FDA permits ImPACT to market devices for post-concussion cognitive testing
ImPACT Applications has obtained permission from the FDA to market its Immediate Post-Concussion Assessment and Cognitive ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Far away there in the sunshine are my highest aspirations. I may not reach them, but I can look up and see their beauty, believe in them, and try to follow where they lead.
Louisa May Alcott, ...Learn More
Garwood Medical Devices advances funding round
A round of Series A funding has brought in $2 million for Buffalo, N.Y.-based Garwood Medical Devices, bringing the company ...Learn More
Life sciences, tech fund secures $98.6M in private placement
A private placement has pulled in about $98.6 million for Cambridge Innovation Capital, a fund dedicated to life sciences ...Learn More
Purchase of ETE Medical, subsidiaries finalized by Confluent
The acquisition of ETE Medical and its units Biomedical Structures, a maker of biomedical textile implants, and Modified ...Learn More
Report predicts growth for Japanese orthopedic devices market
The Japanese market for orthopedic devices remains poised for growth, with its largest segment, the hand and wrist device ...Learn More
Getinge dismisses CEO, appoints acting chief
Alex Myers has been let go from his position as CEO of Swedish medtech company Getinge due to strategy differences. ...Learn More
RenovaCare creates stem cell suspension device for burn injuries
An experimental hand-held device called SkinGun, which takes about 90 minutes to spray stem cells on burn injuries to ...Learn More
Next-gen heated humidification system unveiled by Fisher & Paykel
The F&P 950 Heated Humidification System, designed to provide support for noninvasive, invasive and Optiflow nasal high flow ...Learn More
FDA clears respiratory viral test from Alere
The FDA has granted Alere 510(k) clearance for its Alere i RSV test, which is intended for detecting respiratory syncytial ...Learn More
Accelerator for Ion Beam Applications' proton therapy system cleared by FDA
Ion Beam Applications has obtained clearance from the FDA for a superconducting accelerator for its Proteus One, an ...Learn More
EU OKs Masimo's single-use acoustic respiration sensor
European regulators have given Masimo CE mark approval for its RAS-45, a single-use acoustic respiration sensor intended for ...Learn More
Quality Audit Readiness Webinar
Aug. 23 | Virtual 1:00 p.m.-2:00 p.m. EasternAre you ready to showcase your quality systems and face an FDA inspection? ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
If you have knowledge, let others light their candles at it.
Mark Rowse, ...Learn More
Square 1 Bank provides $10M credit line to ReVision Optics
A credit facility worth $10 million has been secured by Lake Forest, Calif.-based ReVision Optics from Square 1 Bank, a ...Learn More
Microbot merges with StemCells
Microbot, an Israel-based maker of miniature robots that can be used for cleaning artificial drainage pipes inside the body, ...Learn More
NLT Spine to be acquired by SeaSpine
A definitive agreement has been reached by Carlsbad, Calif.-based SeaSpine to acquire Israel-based medical device maker NLT ...Learn More
Becton Dickinson commits $20M to Utah facility expansion
Becton Dickinson said it will invest $20 million in the expansion of its Sandy, Utah, facility, which manufactures blood ...Learn More
Report predicts growth for US implantable medical devices market
A Transparency Market Research report predicts the US market for implantable medical devices will reach $73.94 billion by ...Learn More
Report: Worldwide spinal implants, devices market poised for growth
A Grand View Research report predicts the global market for spinal implants and spinal devices will reach $19.54 billion by ...Learn More
Medtronic releases warning, updates instructions on EnVeo R delivery system use
Medtronic has released a letter alerting doctors to take caution when using its minimally invasive EnVeo R delivery system ...Learn More
App for continuous positive airway pressure mask users debuted by ResMed
The myAir app, intended to improve adherence of patients with sleep apnea who use continuous positive airway pressure masks, ...Learn More
FDA OKs expanded indication for Edwards Lifesciences' heart valves
The Sapien XT and Sapien 3 heart valves from Edwards Lifesciences, previously approved for use in patients at high risk for ...Learn More
Electrical fault risk prompts recall of HeartWare's implantable heart pumps
HeartWare International has pulled an unspecified number of its HVAD implantable heart pumps with serial numbers preceding ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
If we are to achieve a richer culture, rich in contrasting values, we must recognize the whole gamut of human potentialities, and so weave a less arbitrary social fabric, one in which each diverse gift will find a fitting place.
Margaret Mead, cultural ...Learn More
Report: Top medtech firms transitioning to service offerings
A PwC Health Research Institute report shows leading medtech companies, including Medtronic, Stryker and Zimmer Biomet, are ...Learn More
B. Braun completes integration of pump with Epic's EMR system
AngioDynamics seeks more workers for N.Y. manufacturing line
AngioDynamics is looking to hire 25 more workers for its angiographic catheter manufacturing line at its Queensbury, N.Y., ...Learn More
Trovagene liquid biopsy tests gain insurance coverage
Blue Cross Blue Shield of Illinois has agreed to cover the use of Trovagene's full line of Trovera liquid biopsy tests. ...Learn More
New president, CEO named by Alphaeon
Murthy Simhambhatla, former president of Abbott Medical Optics, has been tapped to serve as president and CEO of Alphaeon. ...Learn More
New CFO named by Valeritas
Erick Lucera, who has more than 20 years of experience in medtech, biotech and specialty pharmaceutical investment and ...Learn More
Trial of InVivo's neuro-spinal scaffold yields improvement in another patient
Another patient in a trial of InVivo Therapeutics' neuro-spinal scaffold has demonstrated signs of improvement using the ...Learn More
Barrier membrane for oral surgery debuted by Citagenix
The Neomem FlexPlus, a single-layer collagen membrane, has been launched by Antibe Therapeutics' subsidiary Citagenix. ...Learn More
Senate bill would strengthen safeguards for contact lens sales
Sens. ...Learn More
FDA: Custom Ultrasonics' reprocessors still not to be used for duodenoscopes
The use of Custom Ultrasonics' System 83 Plus automated endoscope reprocessors in cleaning duodenoscopes is still not ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
April 25-26, 2017 | Washington, D.C. ...Learn More
I have learned over the years that when one's mind is made up, this diminishes fear.
Rosa Parks, civil rights ...Learn More
Rotation Medical gets $12M boost
An additional $12 million was raised by Plymouth, Minn.-based Rotation Medical in a Series B funding round extension. ...Learn More
Funding boost secured by Oculis
A round of Series A financing has brought in an unspecified amount for ophthalmological developer Oculis. ...Learn More
Funding round brings in $5.2M for ProteoMediX
A round of equity financing led by Altos Venture has pulled in about $5.2 million for Swiss diagnostics company ProteoMediX. ...Learn More
CS Medical, GE Healthcare reach distribution deal
GE Healthcare has agreed to distribute CS Medical's TD 100 automated transesophageal echocardiography ultrasound probe ...Learn More
Permanent CEO named by Cardiovascular Systems
Scott Ward, who has been serving as interim CEO of Cardiovascular Systems, was appointed to the position permanently. ...Learn More
Report predicts growth for global medical device funding
A CB Insights report predicts the global medical device industry will see more than 475 venture capital deals by the end of ...Learn More
Study shows positive results for Intuitive Surgical's robotic surgical system
A study in the journal Surgical Endoscopy showed positive results for Intuitive Surgical's da Vinci robotic surgical system. ...Learn More
Spinal Simplicity unveils next-gen fusion device
The next-generation Minuteman G3 fusion device has been introduced by Spinal Simplicity. ...Learn More
FDA OKs ablation catheter from Biosense Webster
The FDA has given Johnson & Johnson subsidiary Biosense Webster premarket approval for its Thermocool SmartTouch SF ...Learn More
Arineta's cardiac mapping CT device cleared by FDA
The SpotLight CT scanner, developed by Israel-based Arineta, has obtained 510(k) clearance from the FDA. ...Learn More
Quality Audit Readiness Webinar
Aug. 23 | Virtual 1:00 p.m.-2:00 p.m. EasternAre you ready to showcase your quality systems and face an FDA inspection? ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
A lot of people are afraid to say what they want. That's why they don't get what they want.
Madonna, ...Learn More
Del. biotech startup acquired by Zimmer Biomet
Zimmer Biomet has acquired Delaware-based biotechnology startup CD Diagnostics for undisclosed terms. ...Learn More
Mazor Robotics gets $20M boost from Medtronic
The second tranche of equity investment by Medtronic in Mazor Robotics, valued at $20 million, has been completed following ...Learn More
Qiagen announces share repurchase plan to return $250M to shareholders
Qiagen has announced a synthetic share repurchase proposal through which it intends to return about $250 million to ...Learn More
Insightec, Siemens reach collaborative strategic deal
Insightec and Siemens Healthineers have agreed to collaborate on the development of compatibility between Siemens Magnetom ...Learn More
CMS to cover use of Exact Sciences' colon cancer test every 3 years
Exact Sciences' Cologuard colon cancer test will receive Medicare Advantage coverage every three years without patient cost ...Learn More
President, CEO to retire from RTI Surgical
Brian Hutchison will retire as president, CEO and member of board of directors at Florida-based RTI Surgical. ...Learn More
A look at the industrial sterilization market
When choosing the right sterilization method to use, there are two questions that need to be answered: "What method(s) will ...Learn More
Study shows positive results for EnteroMedics' weight loss system
A study in the journal Obesity Surgery showed positive results for EnteroMedics' Maestro Rechargeable System as a ...Learn More
New version of laparoscopic procedure system debuted by Teleflex
The second-generation Percuvance Percutaneous Surgical System has been launched by Teleflex for use in percutaneous ...Learn More
AdvaMed comments on FDA's draft guidance on 3D printing
AdvaMed has submitted comments to the FDA concerning the agency’s guidance on 3D printing, including the recommendation that ...Learn More
Valve system from Edwards Lifesciences wins FDA nod
Edwards Lifesciences has obtained approval from the FDA for its Edwards Intuity Elite valve system, a rapid deployment ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
Wearable Devices Webinar: Regulatory and Litigation Risks
Sept. 15 | Virtual 1:00 p.m.-2:00 p.m. ...Learn More
It is our choices ... that show what we truly are, far more than our abilities.
J.K. Rowling, ...Learn More


sign up
for a daily briefing on top stories in the medical technology and diagnostics industries, FREE
In the News
Ex-Duke football player: How I had my heart attack (and what you can learn from it)
By: Fox News | July 2016

Heart disease is the number one cause of death for both men and women in the United States. Claiming approximately 1 million lives per year, heart attacks alone strike someone every 43 seconds. On January 20, 2014, that someone was me. 

Learn More
Fighting prostate cancer: Treatments evolve, from robotic surgery to hormonal therapy
By: NJ.com | June 2016

Robotic prostatectomy with the da Vinci is one of the latest surgical innovations used to treat prostate cancer.  

Learn More
Confronting A Global Radiotherapy Shortfall
By: Med Device Online | May 2016

As much as 60 percent of the world’s population does not have access to a cost-effective form of cancer treatment and management therapy that saves lives and improves clinical outcomes. 

Learn More
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.

Learn More


Twitter FeedTwitter
Twitter
@ AdvaMedUpdate