Latest from Brian Bossetta
During a webinar hosted by Sedgwick, a pair of regulatory experts discussed how medtech firms can optimize their engagement with the FDA, especially when it comes to communicating recalls and corrective actions.
The US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee convened Wednesday to discuss germicidal ultraviolet (GUV) devices as a mode of disinfection, a technology that has emerged since the COVID-19 pandemic.
The US FDA is launching a pilot to promote access and safety to digital health devices. Developed by the agency’s device center, the pilot will evaluate a new, risk-based enforcement approach for certain types of digital devices to treat several conditions.
The US FDA says Olympus has updated its instructions for a device used in many endoscopic procedures after reports of serious injuries. The class I recall follows the FDA blocking imports of other scoping devices from the Japanese firm earlier this year.
AdvaMed Backs Bill That Would Create ‘Consistent’ Reimbursement Pathway For Algorithm-Based Services
Pending legislation in the US House of Representatives would allow Medicare patients to benefit from some of the latest and most innovative technologies. The bipartisan bill would establish a clear pathway for reimbursement for algorithm-based healthcare services approved by the FDA.
With the roll out of agentic AI, the US FDA continues to expand its capabilities, following the launch of Elsa, its generative AI tool in May.
