ARTICLE SUMMARY:
Medtechs express concern that recent FDA draft guidance will expand the number of devices subject to formal usability testing; unlike many digital health companies, Kandu Health is embracing health system regulations to advance its new model for post-acute stroke care; in Consultants Corner, Bassil Akra advises companies on how to best leverage the extended MDR timelines; and industry pushes CMS on more Medicare Advantage accountability.
