[Editor's Note: This article originally appeared on 16 October in In Vivo, Medtech Insight's sister publication.]
Applications in oncology are moving at a more deliberate pace owing to the distinctive nature of cancer patients’ needs. Less...
Digital biomarkers using data collected with wearable devices are making their way into clinical trials, largely in cardiovascular, respiratory and rare disease settings around physical activity metrics.
[Editor's Note: This article originally appeared on 16 October in In Vivo, Medtech Insight's sister publication.]
Applications in oncology are moving at a more deliberate pace owing to the distinctive nature of cancer patients’ needs. Less...
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.