Medtech Insight - News And Expert Analysis For Medtech Decision Makers since 1975

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.

SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.