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Surgerii Robotics raises $100M to fund global expansion
The China-based surgical robot manufacturer is gearing up for growth after receiving Europe’s CE mark last year for its single port endoscopic system.
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STAAR shareholders reject Alcon’s revised buyout offer
The implantable lens maker said it would remain a stand-alone company after its shareholders turned down Alcon’s $1.6 billion offer.
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Stereotaxis wins FDA approval for robotically navigated ablation catheter
Stereotaxis’ CEO said the company has been “hampered clinically, commercially and strategically” by its prior dependence on a J&J catheter.
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Q&A
Ōura’s Ricky Bloomfield proposes new regulatory pathway for wearable health features
The chief medical officer is interested in an easier path to market for health screening features in wearable devices.
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Biobeat raises $50M to commercialize cuffless blood pressure monitor
The company will use the money to try to establish its cuffless device as a go-to option for 24-hour blood pressure monitoring in the U.S.
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Vicarious inks software partnership as it streamlines operations
Under the agreement, the engineering partner will be responsible for a significant portion of the software development for the Vicarious robotic system.
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Meet 5 medtech companies redefining surgical robotics
Executives at companies innovating a range of new robotic surgery platforms shared their progress and challenges in MedTech Dive's series of profiles.
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New Henry Schein CEO expected by mid-January as Bergman extends tenure
Stanley Bergman has worked at Henry Schein for 45 years, more than 35 of which he spent as CEO, and was due to retire at the end of 2025.
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Time’s up: Enhanced ACA subsidies expire
The expanded tax credits are officially dead after lawmakers failed to secure an extension before the end-of-year deadline. There’s still a chance, though a small one, that they could come back in 2026.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Profile
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.
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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.
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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.
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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.
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House passes Republican health bill without ACA subsidy extension
The legislation makes no mention of the financial assistance, setting the subsidies up to lapse in just a few weeks.
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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.
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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.
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Wyden pushes EHR vendors to adopt data privacy features
The influential senator pressed 10 health IT and EHR firms to implement features that give patients more control over the flow of their health data.
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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.