BrightHeart, a specialist in AI-driven prenatal ultrasound, has announced it has received the CE mark for its flagship medical devices, enabling commercialisation of the B-Right AI Platform across the European Union. The company will make its European debut at the Fetal Medicine Foundation (FMF) Wor
Heartfelt Technologies has announced that the FDA has granted Breakthrough Device Designation to the first-of-its-kind Heartfelt device, an AI-powered home monitoring technology designed to identify worsening heart failure before patients require hospital care. The FDA Breakthrough Devices Program i
Spotlight Medical, a Paris-based oncology diagnostics company, has announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). The milestone advances Spotlight Medical’s European commercialisation strateg
BrightHeart, a global leader in AI-driven prenatal ultrasound, has announced it has received the CE mark for its flagship medical devices, enabling commercialisation of the B-Right AI Platform across the European Union. The company will make its European debut at the Fetal Medicine Foundation (FMF)
An AI technology already conducting one in nine urgent skin cancer assessments across the NHS is now certified for use on a standard smartphone. The development, unveiled at HLTH Europe, brings autonomous, clinical-grade cancer detection out of a clinical setting. Developed by British healthtech com
Cell and Gene Therapy Catapult (CGT Catapult) will provide investment to Lir Therapeutics (Lir) from the Innovate UK Cross Catapult Investment Pilot, to accelerate the development of nAAVigator, its AI-driven AAV capsid design platform. The investment will support Lir in advancing the biological val
AcuityMD has announced 80 million USD in new funding to elevate its platform with advanced AI capabilities and drive the company’s mission of accelerating adoption of medical technology. The Series C round was led by existing investor StepStone Group, with additional participation from Benchmark, Re
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, shares registration details for a forthcoming public engagement event on the safe use of AI in healthcare. The Patient Safety Commissioner, Professor Henrietta Hughes, has an
Doctor Care Anywhere, one of the UK’s leading digital healthcare providers, and Tandem Health, a leading European AI medical operating system, have announced a partnership to integrate Tandem’s AI operating system directly into Doctor Care Anywhere’s virtual primary care platform. Doctor Care Anywhe
AliveCor has announced it has received CE Mark (Conformité Européenne) for the Kardia 12L electrocardiogram (ECG) System powered by KAI 12L AI technology. The company says the Kardia 12L is the world’s first AI-powered, portable 12-lead ECG system featuring a unique, single-cable design for Health C
In this latest instalment of our video interview series, we sit down with Mark Ratnarajah, Paediatrician and UK Managing Director at Sword Intelligence, to discuss the practical application of Agentic AI within the NHS. As healthcare systems globally grapple with burnout and a mismatch between patie
Guideways, an AI company which says it is built to solve the problem of regulatory complexity delaying the approval of thousands of medical technologies that could save or improve patient’s live, has launched its agentic AI platform to help medical device teams reach patients faster. The platform de
