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Medical Devices
* Courtesy of Edwards Lifesciences
Edwards receives FDA approval for mitral valve replacement system
The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.
By Elise Reuter • Dec. 23, 2025
* Sarah Silbiger via Getty Images
FDA posts Class I recall notice about Medtronic heart vent catheters
The company received three complaints about patients who had perforation injuries linked to the devices.
By Nick Paul Taylor • Dec. 23, 2025
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New medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff
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Abbott receives FDA approval for Volt PFA system
Abbott can now compete with Medtronic, Boston Scientific and J&J in the U.S. for the fast-growing pulsed field ablation market.
By Elise Reuter • Dec. 22, 2025
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Abbott receives clearance for heart delivery device in premature babies
Physician feedback has informed a delivery device designed to make procedures safer and easier.
By Nick Paul Taylor • Dec. 22, 2025
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Medtronic’s diabetes spinoff MiniMed files for IPO
MiniMed is pitching the breadth of its portfolio as an advantage over more focused rivals such as Dexcom and Insulet.
By Nick Paul Taylor • Dec. 22, 2025
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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
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Pulse Biosciences wins FDA approval to begin PFA catheter study
Shorter, nanosecond pulses for treating atrial fibrillation differentiate the company’s approach from existing pulsed field ablation systems on the market.
By Susan Kelly • Dec. 18, 2025
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Robot developers make strides in 2025
Medtronic and CMR Surgical got the FDA’s green light this month, while SS Innovations applied for clearance. Catch up on the latest in surgical robotics in this coverage roundup.
By Susan Kelly • Dec. 18, 2025
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XCath targets better brain aneurysm outcomes with robotic approach
The Houston-based startup is developing capabilities for endovascular aneurysm repair and stroke treatment that it hopes can bridge a skills gap and get patients treated faster.
By Susan Kelly • Dec. 18, 2025
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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
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CMR Surgical gains FDA clearance for new robot
As competition intensifies among surgical robot makers, CMR said its soft tissue platforms are the second most used systems in the world.
By Susan Kelly • Dec. 17, 2025
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Dialysis cannulation can be difficult. A startup is working to improve it.
X9 is building an ultrasound-guided device used to simplify the process of inserting a needle for cannulation.
By Elise Reuter • Dec. 17, 2025
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CMS considers expanding TAVR coverage to asymptomatic patients
Medicare reimbursement for aortic stenosis patients without symptoms could accelerate procedure growth for Edwards Lifesciences, which requested the CMS review, analysts said.
By Susan Kelly • Dec. 16, 2025
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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
* Courtesy of Philips
Philips to acquire SpectraWAVE
SpectraWAVE makes technologies to help diagnose and guide treatment decisions for coronary artery disease.
By Elise Reuter • Dec. 15, 2025
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FDA needs more staff, authority to oversee device recalls, watchdog finds
“FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the U.S. Government Accountability Office said.
By Elise Reuter • Dec. 15, 2025
* Retrieved from AtriCure on December 12, 2025
AtriCure treats first patients with dual PFA/RF system
Combining pulsed field ablation and a radiofrequency technique in one platform is expected to reduce procedure times.
By Susan Kelly • Dec. 12, 2025
* Elise Reuter/MedTech Dive, data from MedTech Dive
Mick Farrell named chair of AdvaMed board
The Resmed CEO will serve a two-year term on the medtech lobbying group’s board.
By Elise Reuter • Dec. 12, 2025
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Impulse Dynamics raises $158M to commercialize heart failure device
By strengthening heart contractions, Impulse’s device could improve quality of life, restore functional capacity and enhance tolerance for exercise.
By Nick Paul Taylor • Dec. 11, 2025
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Intuitive wins 3 new indications for da Vinci SP system
The robotic surgery market leader’s single port system can now be used in inguinal hernia repair, gallbladder removal and appendectomy procedures.
By Susan Kelly • Dec. 11, 2025
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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
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Teleflex inks deals to sell 3 businesses for $2B
Needham analysts said Teleflex’s inability to secure a price above the low end of their expectations could reflect “the continued poor performance of UroLift.”
By Nick Paul Taylor • Dec. 10, 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
* Courtesy of Medtronic
Medtronic changes investor relations leadership ahead of diabetes spinout
Ryan Weispfenning has elected to take up the challenge of creating and leading the investor relations function at the planned new diabetes company.
By Nick Paul Taylor • Dec. 9, 2025
* Courtesy of Whoop
Deep Dive
What 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
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