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BioWorld - Monday, March 9, 2026
Home » Topics » Medical technology

Medical technology
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FDA stands up full ASCA program with three draft guidances

Sep. 23, 2024
By Mark McCarty
The U.S. FDA wrapped up the pilot version of the Accreditation Scheme for Conformity Assessment (ASCA) and reported the formation of a permanent ASCA program, which has been seven years in the making.
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In the clinic for September 23, 2024

Sep. 23, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Trisalus.
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cardiopulmonary support cannula
Patents

UCLA researchers file patent for cardiopulmonary support cannula

Sep. 23, 2024
By Simon Kerton
Researchers from UCLA’s Department of Cardiac Surgery filed for protection of a smart multistage peripherally inserted cannula with active fixation for temporary cardiopulmonary support which simultaneously drains both sides of the heart.
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Gavel with whistle

Company hit with $1M fine for inappropriate ads that ran 56 days

Sep. 23, 2024
By Mark McCarty
Azon Medical LLC, a supplier of medical products such as durable medical equipment, is on the hook for slightly more than $1 million for promoting the P-Stim device as eligible for Medicare coverage.
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Other news to note for September 23, 2024

Sep. 23, 2024
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Medici Medical, Morgan Scientific, Nanovibronix, Nova Biomedical, Paindrainer, Terumo Blood, Translumina, Vitalograph.
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Appointments and advancements for September 23, 2024

Sep. 23, 2024
New hires and promotions in the med-tech industry, including: Owens & Minor, Sensiva.
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Financings for September 23, 2024

Sep. 23, 2024
Med-tech firms raising money in public or private financings, including: Route 92 Medical, Sharps Technology.
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Regulatory actions for September 23, 2024

Sep. 23, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genetesis, Piur Imaging, Rhythm AI.
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White Euro symbol on blue background
LSI Europe Summit

European med-tech fundraising process remains challenging

Sep. 20, 2024
By Shani Alexander
Although financing is returning to the European med-tech market, it remains difficult for CEOs to raise funds for their products.
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Lab chip skin wound healing with electricity

Industry wary of CMS’s view of skin substitutes in doc fee draft

Sep. 20, 2024
By Mark McCarty
The draft Medicare physician fee schedule for calendar year 2025 provoked a strong backlash from physician societies due to a net cut in physician pay. Device makers have their own concerns, including the latest in a series of controversies over coverage of skin substitutes.
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