‘Refuse to Accept’ Decisions For Cyber Devices To Begin In October
The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.
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Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.
Medcrypt cybersecurity expert tells Medtech Insight that FDA requirements that launch on 1 October will push the industry as well as the agency in a positive direction.
News We’re Watching: Abbott FreeStyle Libre Recall, Medtronic Partners With DaVita, Free SBOM Software
This week, Abbott announced a class I recall of several glucose management systems. Additionally, Medtronic announced partnerships with DaVita and Qure.Ai; Heartflow closed a funding round; and BiVacor readies for artificial heart trials.