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Edwards’ adjustable heart valve for children lands FDA approval

The device could help young patients avoid multiple open-heart surgeries as they grow, FDA officials said.

FDA to prioritize guidance on AI, surgical robots next year

The FDA outlined its A-list and B-list guidance priorities for the 2027 fiscal year.

Medtronic drug-coated balloon gets FDA breakthrough status

Medtronic plans to study the device in patients with peripheral artery disease below the knee, a historically difficult condition to treat.

Data privacy concerns could hold patients back from using AI

Although artificial intelligence has quickly become integrated into our daily lives, Americans say they’re becoming increasingly concerned about their health data.

FDA selects first 5 participants for READI-Home initiative

The innovation challenge is focused on developing home devices that could help reduce hospital readmissions.

Medtronic reveals cardiac mapping and ablation software clearances

The regulatory authorizations come as Medtronic looks to differentiate itself in the fast-growing pulsed field ablation market targeted by rivals Abbott, Boston Scientific and J&J.

Abbott launches Freenome’s colorectal cancer screening test

Abbott will sell Freenome’s SimpleScreen CRC test in the U.S. alongside the Cologuard Plus stool-based test it gained in the $21 billion acquisition of Exact Sciences.

GE HealthCare hires new global chief AI officer

Rodolphe Katra has joined from Medtronic to lead GE HealthCare’s efforts to connect devices, software and data.

Oura delays IPO

Citing market uncertainty, the smart ring maker plans to delay a public offering that it had expected to raise up to $2.2 billion.

US-China trade board carves path for tariff relief on $60B of goods

The board has proposed lower tariffs on U.S.-bound household goods and toys, but the White House did not specify reduction amounts or an implementation date.

Sofinnova raises 82M euros to fund medtech startups

The venture capital firm expects to launch up to eight new medtech ventures over the next five years.

Carlsmed names new CFO

Former ZimVie CFO Richard Heppenstall fills the vacancy created by the departure of Leo Greenstein, who is leaving Carlsmed to pursue other professional interests.

Intuitive expands push into cardiac market with CE mark

After de-emphasizing heart surgery for decades due to limits with its earlier platforms, the surgical robot maker is eyeing the large market in cardiovascular disease treatment.

FDA issues draft guidance for surgical robots

A two-day public workshop on evaluating robotic surgery systems with autonomous or remote capabilities is also on the agency’s agenda, as telesurgery advances globally.

GE HealthCare to explore applying generative AI to radiation therapy workflows

The company has teamed up with a Mass General Brigham research team to help care teams access patient-specific information.

Telerobotic surgery is advancing around the world. Will the US embrace it?

Medtech companies are preparing for a day when telesurgery, performed by a surgeon often hundreds of miles from the patient, could become a viable option for more people.

Lab test providers want Medicare payment reform. Will Congress pass it?

Facing maximum Medicare payment cuts, test providers Quest Diagnostics and Labcorp are urging lawmakers to revamp the rate-setting process, but getting a bill through Congress this year will be a challenge.