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BioWorld - Friday, January 23, 2026
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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U.S. Capitol building, Washington D.C.

Cassidy leans in harder on AMA’s CPT coding committee

Dec. 3, 2025
By Mark McCarty
Sen. Bill Cassidy, R-La., who chairs the Senate Health, Education, Labor and Pensions Committee, released another letter to the American Medical Association regarding the activities of the AMA committee for CPT coding activities.
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More uncertainty at FDA as Pazdur plans to resign

Dec. 2, 2025
By Mari Serebrov
No Comments
So much for stability at the U.S. FDA. Three weeks after accepting the position as director of the FDA’s CDER, Richard Pazdur has informed the agency of his intention to retire at the end of the year.
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3-30-fractyl-revita.png

Fractyl procedure sustains weight loss after GLP-1s

Dec. 2, 2025
By Annette Boyle
Glucagon-like peptide-1 (GLP-1) receptor agonists clearly help patients shed pounds, but many regain all - or more - of the weight once they discontinue the medications. Fractyl Health Inc. could offer an enduring solution with its Revita procedure. Six-month results from its open-label REVEAL-1 cohort of individuals with obesity who lost 15% or more of their total body weight on a GLP-1 therapy maintained that loss after discontinuing the drugs and undergoing the Revita procedure.
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Medicare puzzle

Medicare’s competitive bidding program draws opposition

Dec. 2, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services has posted the home health final rule for calendar year 2026 and has established a framework for competitive bidding for products such as continuous glucose monitors, a move that is struggling to find support among stakeholders.
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SS Innovations International Inc. SSi Mantra 3 robotic surgical system

SS Innovations SSi Mantra surgical robot sees increasing demand

Dec. 2, 2025
By Shani Alexander
SS Innovations International Inc. is experiencing rapid growth and rising demand for its SSi Mantra 3 surgical robotic system. Its revenues are increasing, and so are installations and procedures driven by the design features and affordability of the SSi Mantra, said Sudhir Srivastava, chairman of the board and CEO of SS Innovations. “The system that we have created is, in my personal opinion, better than anything that exists out there because of its various differentiating features and cost effectiveness,” he told BioWorld.
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Boston Scientific Farapoint

Boston Sci's Farapoint secures CE mark

Dec. 1, 2025
By Annette Boyle
Proving its latest addition to the Farapulse pulsed field ablation (PFA) platform is no turkey, Boston Scientific Corp.'s Farapoint PFA catheter received CE mark as the U.S. celebrated Thanksgiving. Farapoint is indicated for ablation of the cavotricuspid isthmus, specifically to treat right atrial flutter.
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Illustration of lungs with cancer inset

Prognomiq launches Provue Lung LDT for early lung cancer ID

Nov. 26, 2025
By Holland Johnson
Prognomiq Inc. reported the launch of its Provue Lung, a novel blood-based laboratory developed test designed to help improve detection of lung cancer at its earliest, most treatable stages.
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Medicare puzzle

OIG sees potential for savings in Medicare CGM coverage

Nov. 26, 2025
By Mark McCarty
The Office of Inspector General issued a report stating that the Medicare program could save “tens of millions of dollars” in a single year on continuous glucose monitors and associated supplies if the Centers for Medicare & Medicaid Services acted to apply price pressure on suppliers.
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CMS logo and website

Cardiology societies laud Medicare coverage of EP procedures at ASCs

Nov. 26, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services will cover certain cardiac electrophysiology procedures in ambulatory surgical centers in 2026. This change which drew the support of both the Heart Rhythm Society and the American College of Cardiology, which could increase device utilization.
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Accumulation of nanorobots in a bladder tumor by microscopy.

ARPA-H sees a bright future for autonomous surgery microbots

Nov. 25, 2025
By Mark McCarty
The Advanced Research Projects Agency for Health (ARPA-H) is taking aim at the shortage of medical services with a program designed to foster development of micro-robots, or microbots, which will autonomously conduct part or all of a variety of surgical procedures.
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