Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers, reports on a call for potential VBP pilots to be urgently identified. The UK’s Department of Health and Social Care has called for potential
After AbbVie announced the marketing authorisation from MHRA for ELAHERE, Med-Tech Insights spoke to the company to find out more. When do you anticipate mirvetuximab soravtansine will be available to eligible patients? Mirvetuximab soravtansine is now licensed as a monotherapy in the UK for the tre
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers, records World Health Organization recognition for UK’s medical device regulator. The World Health Organization (WHO) has recognised the UK’s
In 1995 the FDA approved the first AI-enabled medical device, an automatic interactive gynaecological instrument to analyse Papanicolau (PAP) cervical smears. Although the FDA has been reviewing and authorising AI-enabled devices for 30 years, for most of that time these devices were a relative rari
CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, has announced that the 100th patient has received treatment for communicating hydrocephalus with the eShunt System. The 100 patients were enrolled in pilot studies and in the STRIDE clinic
Cardiosense, a medical AI company transforming cardiovascular disease management has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CardioTag device, the first multimodal, wearable sensor that simultaneously captures high-fidelity electrocardiogram (E
Glasgow-based company CardioPrecision has successfully executed the first clinical cases of robotic aortic valve replacement through a tiny incision in the neck. Last year, the global leader in transcervical access for the treatment of structural heart disease demonstrated a proof-of-concept AVATAR
Sanome, a company building Clinical Decision Support tools to detect emerging health risks, has secured Class IIb CE certification and MHRA approval for MEMORI – an AI-enabled warning system for the early prediction/prevention of healthcare‑associated infections (HAIs) – at the same time as appointi
Cartherics, a biotechnology company developing off-the-shelf immune stem cell therapies focusing on high-impact women’s diseases, with lead programs in ovarian cancer and endometriosis, has unveiled its new cleanroom facility for clinical-scale manufacturing of cell therapy products. The facility wa
Samuel Bateman is a senior associate and patent attorney, and Chris Froud is a partner and patent attorney, at European IP firm, Withers & Rogers. Both specialise in advising innovative companies and developers in electronics and computing. The combination of enhanced imaging technologies and AI-pow
Sony Healthcare Solutions Europe and Siemens Healthineers have announced a strategic global collaboration that combines ARTIS, the high-end angiography system of Siemens Healthineers, with Sony’s cutting-edge NUCLeUS audio-visual management platform. Through the strategic alliance, the ARTIS systems
Ultromics, a pioneer in AI-driven cardiology diagnostics solutions, has announced it has raised 55 million USD through its Series C funding round. The funding round was co-led by L&G, Allegis Capital, and Lightrock. It also received continued support from Oxford Science Enterprises, GV, Blue Venture
