Brian Bossetta

A GAO report finds wearables can improve clinical care but flags accuracy variability, workflow integration hurdles, and reimbursement uncertainty as barriers to broader adoption — and offers three policy options to address them.

Hamilton Medical is recalling certain coaxial breathing circuit sets after identifying a valve defect that can cause inadequate ventilation and oxygen desaturation. The Class I recall is associated with four serious injuries but no deaths and follows an early alert the agency posted in June.

The FDA's device center will hold a public meeting in September on how regulatory science must evolve to keep pace with advances in medical technology. Discussions will focus on AI and digital health, emerging technologies, and new approaches to evidence generation and testing.

The FDA has endured 18 months of instability and upheaval; and though it has met key review targets, the agency's device center has not been unscathed. But experts differ on the degree of damage the agency has sustained and how effectively it can carry out its public health mandate going forward.

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.