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BioWorld - Monday, June 29, 2026
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Regulatory actions for Sept. 22, 2025

Sep. 22, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Techsomed, Tempus.
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COVID-19 vial, syringe and vaccine card

Decide on COVID-19 shot at your own peril: ACIP

Sep. 22, 2025
By Randy Osborne
No Comments
The second day’s meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) took up guidelines related to COVID-19 vaccines, of which an outspoken skeptic is Health and Human Services Secretary Robert Kennedy – who in June fired all 17 members of ACIP and replaced them with names more to his liking.
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Med-tech gainers and losers for Sept. 15-19, 2025

Sep. 22, 2025
The top 10 med-tech stock gainers and losers for the week.
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Small-cell lung carcinoma cells under the microscope
Cancer

Rewiring SCLC: a neural path to therapy

Sep. 22, 2025
By Coia Dulsat
No Comments
Two back-to-back papers published in Nature on Sept. 10, 2025, shed new light on the unexpected role of neurons in shaping the evolution of small-cell lung cancer (SCLC). It’s already known that, in gliomas, cerebral cancer cells actively damage axons, contributing to tumor progression through direct neural disruption.
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Medtronic Altaviva

Medtronic's Altaviva bags FDA approval for incontinence

Sep. 19, 2025
By Annette Boyle
Medtronic plc received U.S. FDA approval for Altaviva, a minimally invasive implantable tibial neuromodulation device designed to treat urge urinary incontinence. Insertion near the ankle requires neither sedation nor imaging and patients walk out the clinic door with the device already activated.
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Organox metra

Organox liver perfusion device cleared by FDA during air transport

Sep. 19, 2025
By Shani Alexander
Organox Ltd.’s normothermic machine perfusion device, Metra, has been cleared by the U.S. FDA for use during air transport. The greenlight from the regulatory body paves the way for the broader use of donor organs that might otherwise be discarded, as the Metra system circulates oxygen and nutrient rich perfusate through the organ at near-body temperature, extending preservation times.
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U.S. flag, stethoscope

House committee advances Medicare breakthrough devices coverage bill

Sep. 19, 2025
By Holland Johnson
A committee of the House of Representatives advanced a bill that if passed will give eligible breakthrough medical devices four years of Medicare coverage.
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Appointments and advancements for Sept. 19, 2025

Sep. 19, 2025
New hires and promotions in the med-tech industry, including: DBV Technologies, Ivwatch, Nextern.
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Financings for Sept. 19, 2025

Sep. 19, 2025
Med-tech firms raising money in public or private financings, including: Sevaro.
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Other news to note for Sept. 19, 2025

Sep. 19, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Argá Medtech, Medical Care Technologies, Renalytix, Roche, Tempus AI, True-See, T Rx Capital.
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