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BioWorld - Tuesday, June 16, 2026
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Regulatory actions for March 13, 2025

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.
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IPO money

With warming market, Hinge swings back to IPO

March 13, 2025
By Annette Boyle
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.
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3D illustration of Bivacor implanted in chest

Australian patient first to leave hospital with Bivacor TAH

March 13, 2025
By Tamra Sami
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.
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FDA icons and doctor

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

March 13, 2025
By Mark McCarty
The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed.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.
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Document illustration

US NIH grant peer review to get a bit of a makeover

March 12, 2025
By Mari Serebrov
Looking to shave $65 million from its annual expenditures while streamlining the first stage of its two-level grant review process, the U.S. NIH is proposing to centralize the peer review of all applications for grants, cooperative agreements and R&D contracts within its Center for Scientific Review.
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Appointments and advancements for March 12, 2025

March 12, 2025
New hires and promotions in the med-tech industry, including: Flat Medical , Orthofix Medical, Signum Surgical, Ultima Genomics.
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Financings for March 12, 2025

March 12, 2025
Med-tech firms raising money in public or private financings, including: Vantis.
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Other news to note for March 12, 2025

March 12, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cortigent, Glaukos, Kent Manufacturing, Minnetronix, Nanovibronix, Radiusxr, Rimsys, Sur-Seal, Topcon Healthcare, Vail Scientific, Vivani.
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Regulatory actions for March 12, 2025

March 12, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elute, GT Metabolic.
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Hands holding torn contract

Vivani looking to get slim with Cortigent neurostimulation spin

March 12, 2025
By Holland Johnson
The Vivani Medical Inc. combination appears to be over less than three years since its inception after the company reported plans to spin off Cortigent, the division that develops brain implants.
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