Epstein Becker Green attorney Alaap Shah breaks down the HHS ONC’s 800-page rule on algorithm transparency and information blocking.
The Office of the National Coordinator for Health Information Technology’s (ONC) rule on algorithm transparency and information blocking may not directly affect medtech companies, but they may be subject to third-party liability consequences.
The ONC recently finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1)...
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.
Israeli device firm Fairtility recently obtained US FDA clearance for the CHLOE platform, which uses AI to make embryo assessments performed as part of in vitro fertilization more transparent, efficient and reliable.
Salient's inflammatory bowel disease test, built on the start-up’s Signal platform, is planned to launch in March 2026. The company leverages rich data from existing wellness tests to develop signatures, focusing on conditions that are often misdiagnosed and disproportionately affect women.
The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
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.
Ketryx relies on a combination of continuous validation, testing, and human oversight to ensure the platform remains compliant and reliable as AI capabilities evolve, CEO Kaminski said.
