Digital Health
-
Getty Images
FDA gets mixed feedback on performance monitoring for AI
Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.
By Elise Reuter • Dec. 16, 2025 -
Getty Images
FDA pilots allowing digital health devices access to CMS payment program
Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.
By Nick Paul Taylor • Dec. 10, 2025 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Courtesy of Whoop
Deep DiveWhat medtech firms can learn from Whoop’s warning letter
An FDA warning letter about the wearable company’s blood pressure feature raises questions about the blurring lines between medtech and wellness.
By Elise Reuter • Dec. 8, 2025 -
Getty Images
Ceribell wins FDA clearance for seizure-detection algorithm in neonates
By acquiring new accounts and expanding into NICUs managed by existing clients, Ceribell calculates it can unlock a $400 million market.
By Nick Paul Taylor • Nov. 25, 2025 -
Getty Images
Health tech venture capital investment rebounds in 2025: report
Funding through the third quarter surpassed last year’s total, according to PitchBook. Meanwhile, average deal sizes are skyrocketing as high valuations — especially for AI startups — drive larger rounds.
By Emily Olsen • Nov. 24, 2025 -
Courtesy of Apple
Jury orders Apple to pay Masimo $634M in patent fight
Apple said it plans to appeal the verdict, which could delay Masimo’s collection of the damages by as much as two years, one analyst said.
By Susan Kelly • Nov. 17, 2025 -
Courtesy of Synchron
Synchron raises $200M to prepare for brain computer interface launch
The company will use the money to accelerate pivotal trials and prepare for commercial launch of the Stentrode BCI system.
By Nick Paul Taylor • Nov. 7, 2025 -
Mario Tama via Getty Images
J&J awards first grants from AI surgery fund
Mayo Clinic and QAS.AI will receive funding and mentorship to help advance their projects.
By Elise Reuter • Oct. 27, 2025 -
Courtesy of MedTech Innovator
ProfileHemorrhage can be a serious problem after pregnancy. Here’s how one medtech founder is tackling it
Kelsey Mayo, CEO of Armor Medical, received the grand prize in MedTech Innovator’s pitch competition for a wearable technology to detect serious blood loss early.
By Elise Reuter • Oct. 23, 2025 -
Courtesy of Oura
Ōura to pursue FDA clearance of blood pressure feature for smart ring
The company has received approval to validate and define the feature in a study that is scheduled to start this year.
By Nick Paul Taylor • Oct. 20, 2025 -
Courtesy of Ōura
Ōura raises $900M to develop new health features
The investment values the smart-ring maker at $11 billion.
By Elise Reuter • Oct. 17, 2025 -
Elise Reuter/MedTech Dive, data from MedTech Dive
5 AI takeaways from AdvaMed’s conference
Medical device firms discussed privacy, regulations and prioritizing projects as AI becomes more prevalent in the industry.
By Elise Reuter • Oct. 14, 2025 -
Getty Images
Digital health funding outpacing last year as huge rounds increase: report
Investment in 2025 has reached $9.9 billion, exceeding the $8.4 billion that was raised through the third quarter last year, according to Rock Health.
By Emily Olsen • Oct. 9, 2025 -
Alamy
FDA seeks feedback on monitoring real-world performance of AI devices
The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.
By Nick Paul Taylor • Oct. 1, 2025 -
Permission granted by Medtronic
Medtronic expands AI, robotics hub in London; Virtuoso robot gets FDA breakthrough status
The Medtronic center will facilitate surgeon collaboration and AI-powered decision support. At Virtuoso Surgical, a robotic approach to bladder lesion removal is expected to improve precision.
By Susan Kelly • Sept. 24, 2025 -
Getty Images
Cardiosense names Eric Meizlish as CEO
Cardiosense’s switch to a leader with experience scaling healthtech companies comes as it works to build on the recent 510(k) clearance of CardioTag.
By Nick Paul Taylor • Updated Sept. 25, 2025 -
Sarah Silbiger via Getty Images
FDA warns on unauthorized blood pressure, infant monitoring devices
Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.
By Elise Reuter • Updated Sept. 18, 2025 -
Kayla Bartkowski via Getty Images
GOP bill extends telehealth flexibilities, sidesteps ACA subsidies
The continuing resolution would fund the government, and preserve the flexibilities, through Nov. 21. But the bill makes no mention of extending more generous financial assistance for people who buy plans on the exchanges.
By Emily Olsen • Sept. 17, 2025 -
Courtesy of Aidoc
Deep DiveHow three companies are using foundation models in radiology
Some firms, such as Aidoc, are working directly with the FDA. Others, such as HOPPR, are offering their foundation models for medtech companies to build their own AI tools.
By Elise Reuter • Sept. 16, 2025 -
Permission granted by Radiology Partners
Deep DiveFoundation models are medtech’s newest trend. But what are they?
The AI models, which are built on massive datasets and can be adapted to multiple tasks, have become a part of medtech companies’ lexicon in the past few years.
By Elise Reuter • Sept. 15, 2025 -
Permission granted by Ketryx
AI firm Ketryx raises $39M, adds former Medtronic CEO as investor
The company, which helps medtech companies with AI compliance, has raised more than $55 million to date.
By Elise Reuter • Sept. 5, 2025 -
Anna Moneymaker/Getty Images via Getty Images
Deep DiveWhite House data sharing plan boasts big ambitions, but has scant details
Improving health data exchange is a worthy goal, but the initiative has to overcome challenges like data security, under-resourced providers and slow technology uptake, experts say.
By Emily Olsen • Aug. 27, 2025 -
Courtesy of Paige
Tempus inks $81M Paige buyout to support AI model development
CEO Eric Lefkofsky said that buying Paige “substantially accelerates” Tempus’ effort to build the largest foundation model in oncology.
By Nick Paul Taylor • Aug. 26, 2025 -
Courtesy of Apple
Apple updates smart watches with blood oxygen feature after customs ruling
Apple said it was able to bring a redesigned blood oxygen feature to its devices after a recent U.S. customs ruling.
By Elise Reuter • Aug. 14, 2025 -
Permission granted by Johnson & Johnson
Q&AShan Jegatheeswaran shares J&J’s vision for AI in the OR
By combining surgical video with other insights, Jegatheeswaran hopes Johnson & Johnson can support better outcomes in procedures.
By Elise Reuter • Aug. 13, 2025
