As device makers know all too well, the acronym NSE means not substantially equivalent, which is not the desired outcome in connection with a 510(k) filing. However, there’s another predicament that doesn’t look substantially equivalent, either. That’s the function of the FDA pre-certification concept and the 510(k) program as a whole. The reason this lack of equivalence is topical at this moment in regulatory history is that even a casual reading of recent tea leaves suggests that the agency is yet again on the march in an effort to excise the...

There's more to med tech than just money, but it's pretty tough to do much without it. Consequently, money is topical, but one expert sees a more difficult road ahead than anticipated for investors in digital health, while another says device makers are missing out on several opportunities to do their coffers some good on their way to market. Healthy skepticism over digital health Developers of digital health applications may be jubilant regarding the FDA’s efforts to modernize its approach to these virtual medical devices, but the new proposal regarding a full-fledged digital pre-cert program...

By Mark McCarty, Regulatory Editor Some devices are just the latest and best in class while others force clinicians to revisit long-held assumptions about the possibilities of a device type. This appears to be the case with an interim report of data from a study of the Heartmate 3 device, which not only handily bested the Heartmate II for freedom from disabling stroke at two years, but also prompted one observer to ask whether the time has come to try a left ventricular assist device against transplantation. Mandeep Mehra...

By Mark McCarty, Regulatory Editor Five-year data for novel cardiology devices are often unavailable before that iteration of the device has become obsolete, but those data are nonetheless important. Hans Gustav Thyregod of Copenhagen University Hospital reported five-year data for the first two generations of the Medtronic Corevalve device, stating that five-year mortality for lower-risk patients, those with STS scores of less than four percent, were equal for the Corevalve and surgical aortic valve replacement. Thyregod unveiled the new data set for the first two Corevalve iterations at this year’s meeting of the American College of Cardiology, and he noted...

ORLANDO, Fla. − It’s always difficult to explain why a device therapy reduces overall mortality without affecting mortality for the condition under treatment, but that’s the dilemma facing the trialists involved in the study of a lightweight defibrillator vest that tracks cardiac function. The Vest prevention of Early Sudden death Trial (VEST) presented just such a predicament, but the fact that many patients suffering an infarct are still subject to at least a 40-day waiting period for Medicare ICD coverage suggests that the Zoll Medical Lifevest will be well received by cardiologists for...

2017 was quite the year in terms of device regulations, but payers had an interesting time of it as well. Following are a couple of developments that promise to carry over into the new year, with unpredictable consequences. Tapping the NTAP for more jingle Distracted by tax reform? You might have missed a couple of bills sponsored by Reps. Tom Reed of New York and Dave Reichert of Washington, and the question of Medicare spending on the new technology add-on (NTAP) program is suddenly topical. H.R. 4679, the Ensuring Equal Access to Treatments Act of 2017, would impose a number...

Tom Waits once sang of a character named Small Change, who apparently "got rained on with his own .38," and device makers might sometimes have felt as though small changes to their devices didn't always work out so well, either. Waits is still among us, however, and the final 510(k) changes guidance is out. This effort to overwrite the K97 memo was no mean feat, although it was perhaps predictable that it would be a tough slog. After all, this guidance is easily one of the five most important guidances where FDA's regulation of medical...

We've all been witness to a variety of predicaments in terms of the FDA's premarket review of biologics, drugs and devices, but while controversies abound, there's also this nagging question of how words color perception. It's an important consideration, one that legislators and government agency employees might want to carefully think through before committing things to print. A good example is the term "accelerated approval." This is a term the FDA has itself used, so its understandable when the agency's critics blast the FDA for its seemingly hasty review process...

Two years ago, my youngest child was just learning how to walk and analysts were praising Abbott Laboratories' bioresorbable vascular scaffold. Flash forward today - my son is riding his bike like a true champ (with training wheels) and Abbott is  singing a different tune about bioresorbable stents. In fact, the Abbott Park Ill.-based company isn't singing any tunes about Absorb at all. Oh, what a difference two years can make. Earlier this month, Abbott announced that it was discontinuing sales of its Absorb stent - citing low sales as the reason. The news broke on a quiet Friday afternoon -...