This week, the FDA issued a cybersecurity threat to gene sequencing platforms from Illumina and Amazon announced it was getting out of the fitness wearables business, while researchers announced a breakthrough in Parkinson's diagnostics.

This week, the US FDA announced the Class I recall of Fresenisu Kabi’s Ivenix Infusion System. Also: Successful trial results from Boston Scientific, Ancora partners with Egnite, and trade groups object to the Environmental Protective Agency’s proposed rules on ethylene oxide.

News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.

A temporary reimbursement boost for Shockwave’s C² coronary intravascular lithotripsy (IVL) is coming to an end. John Leppard, Senior Healthcare Analyst & VP at Washington Analysis breaks down what that means for CMS.