Digital Technologies
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 American Medical Association says years of advocacy have resulted in Medicare policy changes that are a big win for physicians and patients.
A report from the HHS suggests using wearables and electronic health records to identify childhood chronic illness causes. It urges the FDA to expedite digital health device approvals while ensuring safety. The report also highlights the need for advisory panel and user fee transparency.
Microbot wins FDA nod for Liberty, Medtronic’s Hugo showed positive results in hernia repair in clinical studies, Obvius Robotics reports first human procedure with CERTA, Ronovo closes a $67m financing round with JJDC, and Quantum expands Epione CE marking to bone tumors.
Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.
Israeli device firm Fairtility recently obtained US FDA clearance for the CHLOE platform, which uses AI to make embryo assessments performed as part of in vitro fertilization more transparent, efficient and reliable.
Salient's inflammatory bowel disease test, built on the start-up’s Signal platform, is planned to launch in March 2026. The company leverages rich data from existing wellness tests to develop signatures, focusing on conditions that are often misdiagnosed and disproportionately affect women.
The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.
Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.
The US International Trade Commission has banned smart rings from Ultrahuman and RingConn after Oura Health's patent infringement case. Ultrahuman countersued, claiming Oura infringes its intellectual property. Sales and marketing of the affected rings will cease on October 22.
A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.
Medtronic beat first-quarter revenue and EPS estimates, raised guidance, and added two board members and special committees as Elliott takes a stake.
AI-driven medtech M&A slowed slightly in volume but tripled in value in early 2025, with buyers focusing on AI-driven diagnostics, surgical tech and analytics. Industry experts expect continued high-value deals as firms defend market share and pursue workflow-enhancing AI.
Philips says the expansion of its facility in Reedsville, PA, will not only boost its capacity to produce AI-enabled ultrasounds that are used in hospitals across the US but will also create 120 well-paying jobs.
Freespira’s device has been FDA-approved to treat panic disorders and PTSD. CEO Joe Perekupka told Medtech Insight the company’s innovative approach includes patient coaching, insurance partnerships to identify potential users, and lobbying for broader insurance coverage for digital therapeutics.
Synchron is preparing a pilot study of its fully wireless, second-gen brain-computer interface after an ALS patient controlled an iPad solely by thought. If all goes as planned, Synchron’s BCI will move into pivotal trials in 2026.
Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.
Fresh off an IPO, spinal implant maker Carlsmed is preparing to launch a new cervical fusion application for its aprevo tech. Medtech Insight has two perspectives on these recent moves: CEO Mike Cordonnier and the doctor who performed the first spinal fusion using the technology.