A quartet of healthcare giants including UnitedHealth, the largest single health insurer in the U.S., joins forces for the SharedClarity project, aiming to leverage their combined Big Data to get the best devices for the best prices.
Although current quality systems are likely sufficient, the FDA should look to lessons learned from recent catastrophes in developing risk mitigation strategies to better protect medical devices and related systems, an agency panel says.
If you read nothing else today, make sure you're still in the know with MassDevice +3.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
Welcome to the latest edition of the MassDevice.com's D+Vice Talk, our new webcast, in which we review medical device stories from the last week.
In this episode we talk about Wright Medical's salesperson-free sales model, the FDA's new appeals process proposal, winners and losers in the new Medicare reimbursement rates and Angelina Jolie's decision to undergo a preemptive double-mastectomy.
Volcano posts positive preliminary findings demonstrating the benefit of a hybrid iFR/FFR approach to simplify lesion assessment and avoid drugs.
Volcano Corporation (NSDQ:VOLC) posted positive early findings for its instant wave-Free Ratio (iFR) coronary lesion detector, with results form its Advise II trial supporting results from older retrospective publications, according to a report unveiled during a hot line late-breaking clinical trial session at the EuroPCR meeting in Paris, France.
Medical device giant Medtronic says its European CE Mark is the 1st ever regulatory approval for valve-in-valve treatment for patients with degenerated surgical aortic valves.
European regulators for the 1st time approved a medical device for transcatheter valve-in-valve treatment in patients with degenerated surgical aortic valves, granting CE Mark approval to medtech titan Medtronic (NYSE:MDT) for its CoreValve and CoreValve Evolut devices.
Johnson & Johnson subsidiary Biosense Webster enrolls its 1st patient in the reMARQable clinical study evaluating the nMARQ pulmonary vein isolation system in treatment of paroxysmal atrial fibrillation.
The FDA's Dental Products Panel is scheduled to deliberate on whether the agency should lower blade-form dental implants to a lower risk class.
An FDA advisory panel will consider in July whether to down-classify blade-form endosseous dental implants from the highest risk category to a less stringent class.
The FDA is now proposing to reclassify this pre-amendments class III device into class II because the federal watchdog believes that special controls, together with general controls, can effectively mitigate risks to health posed by these devices, according to the agency's federal register notice.
InspireMD presents new 6 month follow-up data showing better survival rates for its MGuard stent
InspireMD (OTC:NSPR) presented new 6-month follow up data for its MASTER trial showing lower mortality rates in patients treated with its MGuard stent. The company's findings were presented today at the STEMI symposium of the annual EuroPCR meeting in Paris, France.
The trial measured all-cause mortality for patients treated with the company's MGuard stents compared to a control group treated with bare metal stents or drug-eluting stents.