AI
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Courtesy of Philips
Philips wins FDA clearance for imaging device developed with Edwards
The system uses AI to optimize the placement of Edwards’ mitral valve repair device.
By Nick Paul Taylor • March 27, 2026 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher completes $8.9B buyout of Clario
Thermo Fisher plans to create a fast-growing business by integrating Clario’s data capture and management system with its existing capabilities.
By Nick Paul Taylor • March 25, 2026 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineAI tools are transforming the medtech space
As artificial intelligence becomes more prominent in the medtech sector, the technology is changing what it means to be a medical device — and attracting top companies.
By MedTech Dive staff -
Permission granted by GE HealthCare
GE HealthCare wins FDA nod for photon-counting CT technology
The 510(k) decision clears the company to challenge Siemens Healthineers for an emerging part of the CT imaging sector.
By Nick Paul Taylor • March 24, 2026 -
Getty Images
RadNet to acquire radiology AI company Gleamer
The acquisition will expand RadNet’s routine imaging portfolio and presence outside the U.S.
By Nick Paul Taylor • March 3, 2026 -
Courtesy of Labcorp
Labcorp expands PathAI pact to roll out digital pathology platform in US
Labcorp’s pathologists will use the software to review, interpret and manage digital images of slides for primary diagnosis.
By Nick Paul Taylor • Feb. 25, 2026 -
Stringer via Getty Images
GE HealthCare, BARDA ink $35M expansion to AI-enabled imaging deal
The jointly funded project positions GE HealthCare to develop ultrasound technologies that non-expert users can operate.
By Nick Paul Taylor • Feb. 18, 2026 -
Courtesy of Medtronic
Medtronic nets FDA clearance for robotic spine system
Called Stealth AXiS, the surgical system builds on Medtronic’s Mazor robotic platform, as the medical device maker takes market share in the $15 billion cranial and spinal technologies sector.
By Susan Kelly • Feb. 18, 2026 -
Courtesy of Siemens Healthineers
Siemens Healthineers, Mayo Clinic partner on neurodegenerative disease, cancer
An expanded collaboration between the two organizations will focus on prostate cancer and metastatic liver tumors, in addition to certain neurological disorders.
By Susan Kelly • Feb. 13, 2026 -
Rebecca Pifer/MedTech Dive
Epic rolls out AI charting tool as scribe market heats up
The vendor could prove a significant competitor in the AI notetaking space, given Epic’s leading market share in electronic health records.
By Emily Olsen • Feb. 6, 2026 -
Courtesy of Amazon
Amazon launches health AI chatbot for One Medical members
The assistant, which can answer health questions and help schedule appointments, comes on the heels of other health-focused AI tools from OpenAI and Anthropic.
By Emily Olsen • Jan. 22, 2026 -
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ECRI names misuse of AI chatbots as top health tech hazard for 2026
The nonprofit said technologies like ChatGPT have suggested incorrect diagnoses, invented body parts and otherwise provided information that could lead to harm.
By Nick Paul Taylor • Jan. 22, 2026 -
Getty Images
Trump issues 25% tariffs on narrow range of semiconductors
The levies, effective Jan. 15, do not cover products used for data centers and consumer applications, per a proclamation signed Wednesday.
By Antone Gonsalves , Phil Neuffer • Jan. 15, 2026 -
Courtesy of Whoop
FDA exempts more wearable, AI features from oversight
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.
By Elise Reuter • Jan. 8, 2026 -
stock.adobe.com/Kay A/peopleimages.com
HHS seeks input on speeding AI adoption in clinical care
The request for information comes as the Trump administration has largely taken a deregulatory stance on AI, in a bid to avoid hampering the technology’s rollout.
By Emily Olsen • Dec. 22, 2025 -
Carl Court via Getty Images
EU proposal would simplify Medical Device Regulation
If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare disease treatments.
By Elise Reuter • Dec. 19, 2025 -
Permission granted by Moon Surgical
Moon Surgical adds 5G and Wi-Fi to Maestro robots for cloud-based AI
The company provided an update on its efforts to win market share, revealing that Maestro has been used to treat over 2,300 patients across all sites of care.
By Nick Paul Taylor • Dec. 18, 2025 -
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 -
Andrew Harnik via Getty Images
Trump calls for federal policy framework preempting state AI laws
The executive order comes as Big Tech pushes back on local AI regulation while pouring billions into building out AI infrastructure and deploying new products.
By Makenzie Holland • Dec. 15, 2025 -
Courtesy of Mayo Clinic
GE HealthCare, Mayo Clinic expand partnership around radiology research
Ben Newton, GE HealthCare’s global head of oncology, said the partnership will shift radiation therapy from a “one-size-fits-all” approach to a personalized method.
By Elise Reuter • Dec. 9, 2025 -
Alex Wong via Getty Images
HHS outlines strategy to expand AI adoption
Although the strategy is internally focused to start, the agency said it will collaborate with the private sector and identify “priority” conditions and health issues that could be addressed with AI tools.
By Sydney Halleman • Dec. 8, 2025 -
Courtesy of Medline
PitchBook: AI tuck-in deals to drive M&A acceleration in 2026
Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.
By Nick Paul Taylor • Dec. 3, 2025 -
Kara Arundel/MedTech Dive
Lawmakers propose Medicare reimbursement pathway for AI devices
AdvaMed supports the legislation, which is intended to ensure AI-enabled devices receive an accurate CMS payment code.
By Nick Paul Taylor • Nov. 26, 2025 -
Courtesy of Philips
Philips, Edwards team on AI-based guide for mitral valve repair
Artificial intelligence combines ultrasound and X-ray images to give physicians a real-time 3D view of the repair device during transcatheter heart procedures.
By Susan Kelly • Nov. 19, 2025 -
Getty Images
Clairity raises $43M to commercialize breast cancer risk prediction tool
The funding will support reimbursement initiatives and partnerships to make Clairity Breast accessible across community imaging centers nationwide.
By Nick Paul Taylor • Nov. 17, 2025 -
Getty Images
Cornerstone raises $200M to commercialize surgical robot
The financing comes 11 months after Cornerstone raised $70 million to support the launch of its device in China.
By Nick Paul Taylor • Nov. 13, 2025
