Digital Health
-
Courtesy of Beacon Biosignals
Deep Dive5 tips for building a predetermined change control plan
The new framework is intended to make postmarket changes easier for products. Experts recommend having a clear roadmap and contacting regulators early.
By Elise Reuter • March 25, 2025 -
Mario Arango via Getty Images
Hospital-at-home companies DispatchHealth, Medically Home to merge
DispatchHealth CEO Jennifer Webster will lead the combined company once the deal closes, which is expected in mid-2025.
By Emily Olsen • March 21, 2025 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Chip Somodevilla / Staff via Getty Images
Quest, Google team on gen AI; GE Healthcare plans autonomous imaging
GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.
By Nick Paul Taylor • Updated March 20, 2025 -
Retrieved from Spectral AI on March 18, 2025
Spectral AI algorithms beat physicians in burn tissue assessments
The company plans to file the results with the FDA by mid-2025 and launch the product in 2026.
By Nick Paul Taylor • March 18, 2025 -
Courtesy of Hinge Health
Hinge Health, a virtual physical therapy firm, files for IPO
The digital health IPO market has slowed to a crawl in recent years, but experts say it could be poised for a turnaround in 2025.
By Emily Olsen • March 13, 2025 -
Don Wu via Getty Images
ECRI warns insufficient AI governance threatens patient safety
ECRI included other medtech-related threats on its list of patient safety concerns, noting that cybersecurity breaches can delay care and diagnostic errors can lead to improper treatment.
By Nick Paul Taylor • March 11, 2025 -
Permission granted by Medtronic
Q&AMedtronic’s Orleigh Bogle on changing the culture of surgical training
Bogle, Medtronic’s head of medical affairs for digital surgery, also discussed the company’s plans to train surgeons for its Hugo surgical robot.
By Elise Reuter • Feb. 6, 2025 -
Elise Reuter/MedTech Dive
Troy Tazbaz, CDRH digital health leader, resigns
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.
By Elise Reuter • Jan. 31, 2025 -
gorodenkoff via Getty Images
Sponsored by Altium365What’s next for medical device hardware development?
Discover how cloud-based tools and AI are transforming collaboration, innovation and speed to market.
Jan. 27, 2025 -
eggeeggjiew via Getty Images
Deep DiveTop healthcare technology trends in 2025
How the incoming Trump administration will regulate AI this year remains unclear. Meanwhile, experts say healthcare companies will continue bolstering cyber defenses to withstand increasing attacks.
By Emily Olsen • Jan. 17, 2025 -
Courtesy of Eko Health
Eko Health names Justin Spencer as CFO
Spencer’s arrival at Eko comes months after the digital health company appointed his former colleague Brent Lang to its board of directors.
By Nick Paul Taylor • Jan. 10, 2025 -
Leon Neal / Staff via Getty Images
4 takeaways from the FDA’s first digital health advisory committee
Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology, such as the use of complex models that can change quickly.
By Elise Reuter • Dec. 12, 2024 -
Just_Super via Getty Images
AI-enabled apps top ECRI’s list of health tech hazards in 2025
Other health tech hazards on ECRI’s annual list include the unmet technology support needs of home care patients, cybersecurity threats and substandard or fraudulent medical devices.
By Nick Paul Taylor • Dec. 9, 2024 -
Sarah Silbiger via Getty Images
FDA issues final guidance on postmarket updates to AI-enabled devices
By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.
By Elise Reuter • Dec. 4, 2024 -
Permission granted by Movano Health
Movano receives FDA nod for smart ring’s pulse oximeter feature
Movano Health plans to market the Evie Ring to organizations that run clinical trials and healthcare companies that are helping patients manage chronic diseases.
By Nick Paul Taylor • Dec. 3, 2024 -
Sittipol Sukuna via Getty Images
Sponsored by IFSThe power of composability: Overcoming field service management challenges in MedTech
Composable software seamlessly integrates with core systems, facilitating communication and real-time data sharing between diverse systems.
Dec. 2, 2024 -
Courtesy of Ōura
Dexcom invests $75M in Ōura, agrees to integrate smart rings and CGMs
The partnership will support data flows that enable people who use both companies’ devices to track how glucose levels affect other health metrics.
By Nick Paul Taylor • Nov. 20, 2024 -
bymuratdeniz via Getty Images
Sponsored by IFSTransforming MedTech innovation with complete asset and service lifecycle management
An effective lifecycle management strategy is essential, as the reliability and performance of these devices can be a matter of life and death.
Nov. 18, 2024 -
Courtesy of Tandem Diabetes Care
Tandem, Insulet tout Type 2 expectations as tech attracts new users
Insulet saw strong insulin pump adoption among new users with Type 2 diabetes following its recent FDA clearance, while Tandem plans to file a Type 2 submission by year’s end.
By Ricky Zipp • Nov. 8, 2024 -
Permission granted by Johnson & Johnson
J&J Medtech CIO Larry Jones resigns
Jones, who has led connectivity solutions for J&J’s surgical robots, announced his departure on LinkedIn.
By Elise Reuter • Updated Nov. 1, 2024 -
Emily Olsen/MedTech Dive
Deep DiveTech companies pitch AI platforms for healthcare, outline plans for responsible rollout
Google, Microsoft and GE Healthcare say they’ll power the next wave of AI advancement. But executives are split on how to offer the tools to providers responsibly — and whether all clinicians are equally ready for them.
By Susanna Vogel • Nov. 1, 2024 -
Emily Olsen/MedTech Dive
Health startups need consolidation after pandemic funding ‘sugar high’
M&A could allow startups to add products and capabilities in a more restrained funding environment, panelists said at HLTH.
By Emily Olsen • Oct. 24, 2024 -
Permission granted by GE Healthcare
GE Healthcare opens AI Innovation Lab to grow new projects
The AI Innovation Lab is designed to accelerate early concept artificial intelligence projects including tools to predict the recurrence of cancer and automate image interpretation.
By Nick Paul Taylor • Oct. 22, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceFDA, Health Canada give sneak peek into future AI regs
Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.
By Elise Reuter • Oct. 16, 2024 -
erdikocak via Getty Images
Digital health deal count declines in Q3, but check sizes stabilize: Rock Health
Startups notched 110 deals in the third quarter, compared with 133 in the second quarter. But average deal size held steady, suggesting investors are making “fewer, more focused bets,” according to the consultancy firm.
By Emily Olsen • Oct. 14, 2024
