With a regulatory framework and test plan in place, US FDA says it will use the rest of the year to run experiments in its pre-cert pilot program to figure out what metrics it needs to gather and processes it needs to develop to make the new paradigm for digital health products a reality. The agency says it plans to update stakeholders as needed on its progress.
US FDA plans to experiment with its digital pre-certification pilot program over the next year and will update stakeholders depending on what the agency learns, according to FDA’s top official on digital health.
FDA has been developing the pre-cert program over the past year and a half, and recently fully launched a pilot...
Barcelona-based INBRAIN Neuroelectronics is partnering with Mayo Clinic to test whether its graphene-based cortical brain computer interface can enhance standard DBS in Parkinson’s, aiming for more precise adaptive therapy and improved gait outcomes.
A Sept. 17 panel at LSX in Boston discussed how brain-computer interface devices (BCIs) work, potential applications for BCIs, partnership, the investment landscape, ethical considerations and the five to 10-year outlook for the neurotech sector.
About 30% of providers flagged cybersecurity and data privacy as concerns while 40% pointed to patient engagement platforms as a challenge. By contrast, only 10% of respondents viewed AI and Gen AI applications or critical system upgrades as urgent priorities.
The US FDA will hold a public meeting of its Digital Health Advisory Committee in November to focus on generative AI-enabled medical devices to treat mental health.
The US FDA has approved Medtronic’s Altaviva, a subcutaneous device implanted near the ankle that offers a new treatment option for adults with urge urinary incontinence.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.
