The FDA is not accepting new medical device registration applications funded by user fees during the ongoing partial federal government shutdown. The medtech industry hasn’t been complaining about it yet, but time will tell, according to some experts. Applications for devices covered by the agency’s 510(k) and Premarket Approval (PMA) processes accepted before Dec. 22 […]
Medicare’s bundled ortho payments yield modest savings
Medicare’s randomized trial of a new bundled payment model for hip and knee replacement surgeries led to $812 in savings per procedure, a 3.1% reduction in costs when compared with traditional means of paying for care, according to new research. The study from Harvard T.H. Chan School of Public Health and Harvard Medical School found that the […]
What should the Mann Foundation do next?
Dr. Robert Greenberg, the Mann Foundation’s new executive chairman, has ideas about where to take one of medtech’s top research and development outfits. He explained more at DeviceTalks West in December. The new executive chairman of the Alfred E. Mann Foundation for Scientific Research sees the foundation continuing its mission of developing devices for unmet medical needs. The foundation […]
‘Pacemaker for the brain’ could help people with epilepsy, Parkinson’s
A new neurostimulator developed by engineers at the University of California, Berkeley, can listen to and stimulate electric current in the brain at the same time, potentially delivering fine-tuned treatments to patients with diseases like epilepsy and Parkinson’s. The wireless, artifact-free neuromodulation device (WAND) works like a “pacemaker for the brain,” monitoring its electrical activity […]
FDA gives Edwards’ Sapien 3 Ultra TAVR the nod
Edwards Lifesciences (NYSE:EW) can now market its Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) device in the United States. The FDA approved the device for severe, symptomatic aortic stenosis patients for whom open-heart surgery is considered an intermediate or greater risk, the Irvine, Calif.-based company said. For the Ultra, Edwards has added a taller […]
Medtronic founder Earl Bakken knew how to inspire his employees
Earl Bakken made history when he invented the battery-powered, wearable cardiac pacemaker in a Minneapolis garage in 1957. But three years later, the company he co-founded was floundering and desperately needed cash. To show the board of directors that the $200,000 they had raised would be put to good use, Bakken wrote a mission statement for the […]
IBM’s AI-aided fingernail sensor could help with cardio, Parkinson’s treatment
IBM has developed a fingernail sensor that it says may help healthcare providers fine-tune treatment for certain cardiovascular and neurological conditions such as Parkinson’s disease. The wearable, wireless device measures how a person’s fingernail bends and moves throughout the day – a key indicator of grip strength. The prototype sensor continually collects data and feeds […]
How an ‘imaging needle’ can help prevent brain bleeds
A team of researchers and clinicians led by the University of Adelaide in South Australia has found that an “imaging needle” may reduce the risk of dangerous brain bleeds in patients undergoing brain biopsy. Published today in the journal Science Advances, the study describes how they fashioned the imaging device with a tiny fiber-optic camera encased […]
What you need to know about growing cyber threats to medtech
Medical devices are an especially rich cybersecurity target for malicious activity by those seeking commercial gain or just trying to wreak havoc. And while data theft is a serious threat, the risks posed by hacks that involve the expanding universe of networked medical devices can be especially menacing. Nach Davé and John Pappan, Premier Research […]
Monteris Medical expands access to NeuroBlate System with Anthem win
On the heels of a coverage update from health insurance giant Aetna, Monteris Medical has achieved a similar win from Anthem when it comes to epilepsy patients gaining access to Monteris’ NeuroBlate system. Anthem’s clinical utilization management guidelines for laser interstitial thermotherapy, which Monteris announced today, allows Anthem beneficiaries with refractory epilepsy to access the minimally invasive […]
FDA opts not to change device class definitions
The medtech industry appears to have won a round in the regulatory arena. The FDA issued a final rule amending its regulations on classifying and reclassifying medical devices under the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in 2012. Published today in the Federal Register, the rule says it “provides for the […]
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