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News We’re Watching: V-Champs Winners Named, Recalls for Fresenius Infusion Pumps and GE Vents, FCC Updates Rural Telehealth Rule

 
• By Brian Bossetta, Hannah Daniel, and Elizabeth Orr

This week, the FDA announced that a new eStar form for 510(k)s will be available in February; Fresenius infusion pumps were recalled due to mechanical issues; and an FCC final rule encouraged the use of telehealth.

Regulatory News We're Watching
• Source: Shutterstock

A new version of the US Food and Drug Administration’s eSTAR PDF Template for medical device submissions will be required starting 4 February.

Version 4, the version previously required for 510(k)s, will be retired on that date. The new form includes a greater number of cybersecurity requirements beyond risk management plans.

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News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

 
• By Brian Bossetta, Marion Webb, Elizabeth Orr, and Natasha Barrow

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News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

 
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This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.