The U.S. FDA draft guidance for select updates for premarket evaluation of class II atherectomy devices arrived with a lack of clarity that prompted device makers and clinicians alike to request the FDA address several sources of ambiguity. One of these is whether the agency should distinguish between particulate matter from the device vs. calcium particulates from the treated artery, while another is whether particulate evaluation is required only for devices with a coating.

Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year.

Aidoc Inc., a provider of artificial intelligence (AI) solutions in radiology, has won U.S. FDA clearance to market the first software solution for flagging and triaging incidental pulmonary embolism (PE). The AI technology, which includes triaging and notification algorithms, is an “always on” technology that analyzes chest CT scans in real time and alerts the radiologist to any potentially abnormal findings – possibly speeding up diagnosis by hours.

Drug and medical device manufacturers have several compliance matters to deal with under the False Claims Act (FCA), only one of which is the Anti-Kickback Statute (AKS). Nonetheless, the AKS might be a good area for members of industry to emphasize, given that it accounted for the vast majority of federal enforcement actions in fiscal year (FY) 2019, according to a new report by Gibson, Dunn & Crutcher LLP.

Patient engagement is increasingly the order of the day in the device development process as the U.S. FDA has made clear, a consideration that drove the Oct. 22 FDA advisory hearing. A patient representative said patients want to take part as early as possible in the development process for software as a medical device (SaMD), and Pat Baird, director of global software standards for Royal Pillips NV, said industry is very much open to ideas about bringing the patient perspective on board earlier in that process.