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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

March 13, 2025

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IPO money

With warming market, Hinge swings back to IPO

After scrapping plans for an IPO in 2022, Hinge Health Inc. is taking a more favorable view of going public given the increased support seen for health care and med-tech stocks in recent months. The San Francisco-based company, a digital provider of physical therapy services, filed a form S-1 with the U.S. SEC stating it plans to offer an unspecified number of shares of class A common stock on the New York Stock Exchange this year. Read More
3D illustration of Bivacor implanted in chest

Australian patient first to leave hospital with Bivacor TAH

An Australian man in his 40s with severe heart failure was implanted with a Bivacor Inc. total artificial heart (TAH) and has been discharged from the hospital. He remained at home with the artificial heart for 100 days until he received a transplant earlier this week. Read More
CDC headquarters

US CDC nomination withdrawn, reforms in the works

Shortly before the Senate Health, Education, Labor and Pensions Committee was to hold the first ever confirmation hearing for a U.S. CDC director March 13, it issued a statement saying the hearing was canceled due to the White House withdrawing its nomination of Dave Weldon, a physician and former congressman from Florida. Read More
Bhattacharya-Makary

Just one more vote to go for FDA, NIH nominees

As expected, the U.S. Senate Health, Education, Labor and Pensions Committee voted March 13 to send the nominations of Jay Bhattacharya as NIH director and Martin Makary as FDA commissioner to the Senate floor for confirmation. Bhattacharya received a narrow 12-11 party-line vote, but Makary picked up some Democratic support to secure a 14-9 vote. Read More
FDA icons and doctor

AMP says FDA asks too much of test validation in Section 564 draft

The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed. As an example, the Association for Molecular Pathology (AMP) said the draft’s recommendation for the use of 30 positive and 30 negative (30/30) samples for validation of lab-developed tests is likely to hamper test availability in an emergent situation, a time when samples are likely to be difficult to obtain. Read More

Appointments and advancements for March 13, 2025

New hires and promotions in the med-tech industry, including: Venturemed, Vicarious Surgical. Read More

Financings for March 13, 2025

Med-tech firms raising money in public or private financings, including: Microtransponder, Samsung, Surgicure. Read More

Other news to note for March 13, 2025

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Helius, Liquid Biosciences, Lucid, Mainz, Olympus, Revelation Neuro, Ziosoft. Read More

Regulatory actions for March 13, 2025

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ecential Robotics, Femasys, Lifeward, Paragonix Technologies, Perfuze, Spineart. Read More

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