US Senators Lay Out Concerns On FDA Digital Health Device Precertification Program

Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.

A proposed rule from Medicare would impact essential devices for many beneficiaries. AdvaMed says the rule would reduce incentives for companies to innovate and criticizes CMS for not providing the necessary information stakeholders need to fully understand the proposal’s implications.

Just ahead of its 28th meeting, the International Medical Device Regulators Forum has released a summary of the global uptake of its documents.

Political and regulatory pressures make revising the EU’s medtech regulations a tricky balancing act, two renowned medtech experts, Erik Vollebregt and Bassil Akra told Medtech Insight during a recent interview.