Brian Bossetta

The FDA is seeking public comment on regulating generative AI-enabled medical devices and released a discussion paper on the topic. The agency wants feedback from stakeholders on risk assessment, premarket evaluation, postmarket monitoring and other issues relevant to AI device regulation.

Medline is correcting multiple surgical convenience kits containing B. Braun components affected by a recall of Huons' bupivacaine injection and informing customers to quarantine and discard the kits. The issue has been linked to 35 serious injuries and no deaths reported by B. Braun.

Whoop has launched a new program aimed at helping older adults manage chronic conditions through continuous health monitoring and personalized guidance. The company's Connected Care initiative will provide eligible Medicare beneficiaries with a 12-month Whoop membership and a blood pressure cuff.

Surgical Science has launched Aeris, a portable ultrasound simulator designed to make POCUS training more accessible without specialized rooms, equipment or anatomical models. The company plans to expand the pathology-focused platform into other fields with US orders expected to open in Q4 2026.

The FDA has issued another early alert involving Abiomed's Automated Impella Controllers, citing a purge cassette recognition problem. Three deaths and 37 serious injuries have been linked to the alert, which follows a series of recent safety events involving the Impella system.

The FDA has selected Epitel's wearable EEG system and Prapela's infant cardiac device as the first participants in its READI-Home Innovation Challenge, which aims to cut hospital readmissions. Up to nine devices may be selected; submissions close Sept. 30.

Updated FDA recommendations for dental composite resin devices 510(k)s, emphasize detailed product composition, predicate comparisons, labeling, shelf-life, biocompatibility and nonclinical performance testing.

Boston Scientific is recalling unused Infinion CX leads after reporting 1,081 serious injuries linked to electrical signal disruption or lead-wire fracture. The FDA has classified the spinal cord stimulator recall as Class I, its most serious recall category.

The FDA's appointment of Jared Seehafer as its first deputy commissioner for technology and AI is attracting a mixed bag of approval and caution. Supporters cite his regulatory and technology experience, while some question his investment background.

CDRH's Rare Disease Impact Initiative seeks to advance the development and authorization of devices to treat rare diseases. The effort aims to address development challenges, identify unmet device needs, strengthen collaboration, and provide resources including a Rare Disease Medical Device List.