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.

Neuromod Devices Ltd., which is developing an at-home, self-managed treatment for tinnitus, closed a €10.5 million (US$12.4 million) series B financing led by majority investor Fountain Healthcare Partners. The funds are earmarked for expanding European commercialization of the Lenire tinnitus treatment device, to scale up manufacturing, progress U.S. FDA regulatory approval and pursue opportunities with the U.S. Department of Veterans Affairs (VA).