AI
Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.
Backed by £50m of UK government funding, the new research center will delve into neural dynamics to develop novel devices ranging from brain implants to wearables.
Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.
Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.
It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?
FDA officials Michelle Tarver and Marty Makary discussed advancements in home healthcare during a podcast. They highlighted the importance of continuous glucose monitors, emphasized home healthcare's benefits for chronic diseases, and mentioned the agency's efforts to streamline device development.
The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.
"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.
Faction Imaging has come out of stealth mode following six years of research and development studying medical imaging workflows in India, Japan and the US.
Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics
GE HealthCare launches bkActiv S series – part of the bkPortfolio family of Active Imaging systems.
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.
Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.
Ellipsis said it will use its new funding to expand its AI-powered voice assistant Sage across health systems. Ellipsis is part of the global vocal biomarker market, which is expected to exceed $9bn by the end of 2033, according to a research market report.
European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.
The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.
Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.