Expert: Cybersecurity Requirements In Omnibus Bill Will Provide Visibility For Industry
New cybersecurity regulations passed as part of the year-end omnibus bill included software bills of materials (SBOMs) which will provide visibility to manufacturers and regulators.
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A report from the Health-ISAC, Finite State and Securin found a large increase in vulnerabilities in healthcare devices since 2022.
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.
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.