Medtronic recalls embolization devices tied to 17 injuries, 4 deaths

Medtronic will remove one model of Pipeline Vantage devices from where they’re used and sold and will update the instructions for another model.

By Nick Paul Taylor • March 19, 2025

Monogram robot wins FDA OK; Vicarious hit by supplier woes

Monogram Technologies secured 510(k) clearance for its robotic knee replacement system, while Vicarious Surgical blamed supply chain issues for delaying its regulatory timeline.

By Susan Kelly • March 19, 2025

Insulet Chief Technology Officer Mark Field leaves

Amit Guliani, group vice president of software engineering, was named acting chief technology officer, effective immediately.

By Elise Reuter • March 18, 2025

Tariff uncertainty sparks manufacturing anxiety, especially among small firms

Shifting foreign suppliers could become more difficult as the Trump administration continues to enact new widespread tariff policies.

By Kate Magill • March 18, 2025

Top device firms report safety data late: BMJ

BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study found.

By Elise Reuter • 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

4 takeaways from AAOS 2025

Stryker unveiled its updated Mako surgical robot and orthopedic companies expect procedure volumes to remain steady despite recession fears.

By Elise Reuter • March 17, 2025

FDA adds hemodialysis devices to shortage list amid B. Braun disruption

The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.

By Nick Paul Taylor • March 17, 2025

Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing

Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical devices once they’re FDA-approved.

By Ricky Zipp • March 14, 2025

Vicarious Surgical appoints Sarah Romano as CFO

Romano will arrive at the robotics company just as Chief Operating Officer John Mazzola is set to retire on April 1.

By Nick Paul Taylor • March 14, 2025

EPA to reconsider emissions standards for medical device sterilizers

Last year, the EPA issued a final rule that would limit emissions of ethylene oxide, a cancer-causing gas used to sterilize medical devices.

By Elise Reuter • March 13, 2025

J&J’s Monarch robot wins FDA nod for AI software update

Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.

By Susan Kelly • March 13, 2025

Vivani to spin off neurostimulation business

The independent company will trade as Cortigent and advance brain implants to help people recover body functions such as vision and movement.

By Nick Paul Taylor • March 13, 2025

FDA accuses Mid-Link of copying or falsifying medical device test data

The agency will reject all data from the Chinese service provider’s studies after Mid-Link failed to address concerns outlined in a warning letter last year, FDA officials said.

By Nick Paul Taylor • March 12, 2025

Capstan brings surgical robot to valve replacement

Capstan Medical, a startup focused on robotic-assisted mitral and tricuspid valve replacement, recently completed its first patient implants.

By Susan Kelly • March 11, 2025

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

Orthofix’s fired execs’ lewd, ‘graphic’ texts surface in legal battle

Orthofix didn’t originally specify the reasons behind the 2023 firing of its CEO, CFO and CLO. Now, a court case is illuminating the story behind the terminations.

By Maura Webber Sadovi • March 10, 2025

New FDA pulse oximetry guidelines could stall under Trump

The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts raised concerns that it might not be finalized.

By Elise Reuter • March 10, 2025

Dexcom receives warning letter based on FDA inspections of 2 plants

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek clearance for new products.

By Nick Paul Taylor • March 10, 2025

FTC challenges $627M private equity takeover of Surmodics

The regulator said the buyout “would lead to a highly concentrated market for outsourced hydrophilic coatings and eliminate significant head-to-head competition.”

By Nick Paul Taylor • March 7, 2025

Illumina’s DNA sequencers hit with China import ban

Illumina is not banned from operating in the country and will continue to serve its existing customers, a company spokesperson said.

By Susan Kelly • March 6, 2025

Boston Scientific leads $175M investment in 4C Medical

The money will support an ongoing pivotal trial of 4C Medical Technologies' transcatheter mitral valve replacement device in the U.S. and Europe.

By Nick Paul Taylor • March 6, 2025

Philips pulls endovascular implant from market after 20 injuries

Philips stopped selling its Tack endovascular system because of cases where additional interventions were needed to remove the implant.

By Elise Reuter • March 5, 2025

Trump’s trade war heats up as countries retaliate against tariffs

Mexico, Canada and China all announced they would counter the president's orders after additional duties went into effect this week.

By Philip Neuffer , Edwin Lopez , Max Garland • March 4, 2025

Staar Surgical names Stephen Farrell as CEO

Farrell replaces Tom Frinzi on the heels of a challenging year for the eye implant maker marked by a demand slowdown in China, its largest market.

By Susan Kelly • March 4, 2025