March 13 - J&J Monarch update wins FDA OK | EPA to reconsider EtO limits

EPA to reconsider emissions standards for medical device sterilizers; Hinge Health, a virtual physical therapy firm, files for IPO; Labcorp to buy Opko unit’s cancer test assets for up to $225M; FDA accuses Mid-Link of copying or falsifying medical device test data

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March 13, 2025 | Today’s news and insights for medtech leaders

BROUGHT TO YOU BY — MedTech Dive’s studioID

New FDA Laboratory Developed Test Rules

More than 14 billion laboratory tests are ordered every year and are used to guide 70 percent of medical decisions. Explore new FDA regulations for laboratory developed tests in this playbook.

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.

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.

Hinge Health, a virtual physical therapy firm, files for IPO

The digital health IPO market has slowed to a crawl in recent years, but experts say it could be poised for a turnaround in 2025.

TRENDLINE

The latest tech powering clinical trials

Clinical trials have become a prime target for tech-driven innovations aimed at boosting efficiencies. From patient recruitment to boosting retention, explore how emerging tech is revolutionizing clinical trials in this Trendline.

Labcorp to buy Opko unit’s cancer test assets for up to $225M

Labcorp will acquire BioReference Health's oncology diagnostics operations as the lab company works to expand in high-growth testing areas.

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.

3 Ways Medtechs Can Succeed in Healthcare Sales

Learn how medical device sales teams are investing in training and skills development that teaches a human-centered approach to drive long-term success in this playbook.

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