The UK’s medtech regulator is “going big on guidance” when it comes to artificial intelligence and software as a medical device, an expert from the agency has said, while legislation will be light in comparison to the EU’s planned AI Act.
“We do not intend to make a lot of changes for software and AI in legislation, because that isn’t the proper way to regulate [this technology]. It moves too fast and [legislation] is not flexible enough,” Johan Ordish, head of software and AI at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has said.
Instead, Ordish explained during a presentation at the Association of British HealthTech Industries (ABHI) regulatory conference in London, the MHRA...
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.
MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
