Insight
Hospitals and medical device manufacturers collaborate to mitigate cybersecurity risks associated with legacy medical devices. The cybersecurity teammates you may not know The FDA has promulgated regulations requiring ongoing medical testing for new medical devices. However, millions of connected medical devices are already being utilised, and few are designed to address today's cybersecurity risks. Many [...]
Early detection is crucial for effective treatment of colorectal cancer, but the initial stages are easily missed during endoscopy screenings. With GI Genius, Medtronic presents an AI-powered tool to help detect precancerous lesions in real-time. In an upcoming large-scale trial, the intelligent endoscopy module will demonstrate its benefit in the clinical context. Colorectal cancer is [...]
Written by Vladimir Murovec, Head of Life Sciences Regulatory, Osborne Clarke in Brussels The European Union has introduced a new product liability directive, replacing the previous directive 85/374/EEC, to address modern technological advancements and bolster consumer protection. Effective December 2026, the legislation seeks to harmonise liability standards across the EU, compelling pharmaceutical and medical device companies [...]
‘Extreme transparency’ is helping clinical teams at Karolinska University Hospital to deliver some of the best outcomes in the world. Gunnar Sandersjöö, head of the largest trauma centre in Sweden, explains the mechanisms behind a relentless pursuit of quality. Karolinska University Hospital is one of the most transparent hospitals in the world. High survival rates [...]
The Highland Marketing advisory board met to discuss Labour’s first 100 days in office, the Darzi review, the Budget, and prospects for technology in next year’s 10 Year Health Plan. Their view? The new government has got off to a slow start and needs to come through with a realistic plan for the future of [...]
By Peter Lu, Partner, McDermott Will & Emery Key Takeaways A recent announcement signals a relaxation of restrictions on foreign investment in Chinese healthcare. China will allow wholly foreign-owned hospitals in major cities. Foreign investors will be permitted to offer stem cell and gene therapies via a pilot program. Detailed requirements and procedures have not [...]
By Prof. Erik Ranschaert, Radiologist and Member of AI Centre of Excellence The landscape of radiology is undergoing a profound transformation. As someone who has been deeply involved in both clinical practice and the advancement of artificial intelligence in medical imaging, I've observed firsthand how Computer-Aided Detection (CAD) systems have evolved from simple assistance tools [...]
European Commission clarifies new rules for 2025, mandating early notification of potential medical device supply issues Article written by By Vladimir Murovec, head of Life Sciences Regulatory, Osborne Clarke in Brussels A recent legislative amendment to the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) has introduced an additional provision to both pieces of [...]
Health and med tech industry leaders are assessing the implications of a £22.6 billion uplift in funding for the NHS this year and next, and a £3.4 billion boost for capital spending next year. While the new money has been welcomed, they want to see the detail of how it will be distributed and a [...]
McDermott, Will & Emery on their predicted healthcare deal trends in 2025 As we enter the final quarter of 2024, we can reflect on a busy year that has been characterised by a steady uptick in deal activity in the healthcare and life sciences sectors across Europe. While transactional volume remains somewhat depressed and challenges [...]
