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.
Medtech Insight spoke with Rambam Medical Center’s Michael Mimouni, who implanted the first 3D-bioprinted corneal graft in a human patient, about his hopes for Precise Bio’s approach. The patient is part of a Phase I trial evaluating PB-001 in patients with corneal edema.
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.
Medtech funding in 2025 sees a trend of fewer, yet larger deals with total funding of $3.6bn in Q1, $2.6bn in Q2 and $2.9bn in Q3, said LSI’s Nick Talamantes. In 2026, he expects a continued investor focus on more mature firms in areas of oncology, cardiology and neurology.
