The French start-up has successfully implanted its ‘fishtail’ LVAD in a patient for 84 days, where it served as an effective bridge to transplant. Medtech Insight spoke to the company’s CEO, Louis de Lillers, to hear more about the company’s progress and his take on the evolving LVAD market.
Verida optimizes the entire imaging chain with AI, lowering system noise, elevating image quality and accelerating clinical workflow and marks a transformative milestone in CT, Philips claims.
Medtronic won FDA clearance for its Hugo surgical robot for urologic procedures, which Wiliam Blair analyst expects will draw interest from physicians. But he also says that Intuitive Surgical will remain the clear dominant player.
Pending legislation in the US House of Representatives would allow Medicare patients to benefit from some of the latest and most innovative technologies. The bipartisan bill would establish a clear pathway for reimbursement for algorithm-based healthcare services approved by the FDA.
Paradromics won FDA clearance to test its Connexus BCI in two people with severe speech impairment. The 2026 trial will assess whether the device can decode speech in real time.
With the roll out of agentic AI, the US FDA continues to expand AI capabilities across the agency. The latest AI deployment follows the agency’s May launch of Elsa, its generative AI tool, which marked ‘the dawn of the AI era’ at the FDA.
US healthcare innovation agency ARPA-H has announced a $100m initiative focused on building up the evidence base for fast-acting mental health treatments such as neuromodulation and digital therapeutics. The project is the first major initiative to be led by new ARPA-H director Alicia Jackson.
In September, the US FDA asked the public to weigh in on how AI-enabled medical devices perform in real-world settings. With the comment period now closed, the agency has heard back from dozens of stakeholders on how the agency can use clinical outcomes to better understand these devices.
Medical device companies are increasingly using AI to improve regulatory affairs strategies but face barriers such as risk aversion, regulatory clarity and data governance issues. Experts suggest a design control approach and human oversight to ensure successful AI integration.
Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.
