In the first nine months of 2025, Tempus AI Inc. TEM achieved several key regulatory milestones that strengthened its position in AI-driven diagnostics. In September 2025, the company received FDA 510 ...

In the field of precision medicine, in vitro diagnostic devices (IVDs), such as companion diagnostics (CDx) and clinical trial assays (CTA), are vital for biomarker-driven subject eligibility, ...

Navigating The MDR and IVDR and Best Strategies for Compliance SAE Media Group is proud to announce the launch of the Medical Devices and IVD Conference, taking place on 14 – 15 November 2022 in ...

Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in ...

New Delhi [India], October 24: Indian IVD manufacturers face growing regulatory hurdles under the EU IVDR. I3CGLOBAL provides strategic CE Marking support to small, medium, and large-scale ...

Launching for the first time in London, UK on 14 and 15 November will be the Medical Devices & IVD Conference. The conference will consider the evolving regulatory landscape for digital health ...

Tempus AI, Inc. recently announced a multi-year collaboration with Whitehawk Therapeutics, Inc. to utilize its real-world dataset in advancing biomarker-focused oncology research and optimizing ...

More Lenient Guidelines May Inadvertently Lead to a Scarcity of Consented Samples Recently, no area has contributed more and increasingly complex layers to the bioethics debate than research employing ...

Dublin, Nov. 13, 2020 (GLOBE NEWSWIRE) -- The "Medical Device & IVD Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020 - 2030" report has ...

Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa. Prescriptive requirements for medical devices were not in force and advertisers and ...