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BioWorld - Thursday, December 18, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Medicare puzzle

Skin substitutes take a hit in Medicare doc fee final for 2026

Nov. 3, 2025
By Mark McCarty
The U.S. CMS has adopted an aggressive payment policy for skin substitutes in the Medicare physician fee schedule for 2026, although the payment rate is sufficiently higher than the agency had proposed to mollify some critics.
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Magnifying glass atop paperwork

OIG sees continuing problems with DME payments

Nov. 3, 2025
By Mark McCarty
The Office of Inspector General (OIG) said in a new report that the U.S. Medicare program had overpaid a group of providers of durable medical equipment (DME) by nearly $23 million between 2018 and 2024, an amount that is a significant drop from prior years, but which OIG said calls for further reforms for the Medicare DME program.
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Dexcom G7 CGM

Halloween turns scary for Dexcom despite strong Q3

Oct. 31, 2025
By Annette Boyle
Dexcom Inc. executives may have thought a $30 million beat of the consensus estimates for third quarter revenue and 20% year-over-year organic growth provided a treat to shareholders, but investors seemed to feel tricked instead. The continuous glucose monitoring powerhouse saw its share price drop a frightening 17% in the first two hours of trading on Oct. 31, pushing it down by one-third from its peak of $89.53 in late July. Investors appear to have been spooked by the company’s conservative projections for 2026, following issues with its G7 sensor, which management said have been largely resolved.
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Smartphone displaying Stethophone app

Sparrow feathers nest with C$10M for Stethophone expansion

Oct. 30, 2025
By Annette Boyle
Sparrow Acoustics Inc., dba Sparrow Bioacoustics Inc., closed a C$10 million (US$7.15 million) financing round to support continued adoption of its U.S. FDA-cleared Stethophone platform, which allows bioacoustics detection of structural and rhythmic heart anomalies directly through a smartphone. Sparrow is a Software as a Medical Device and the first medically cleared product that uses smartphones to capture and decipher cardiac sounds.
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Pill, syringe, ampoules on US flag

Is US about to cede biotech leadership role?

Oct. 30, 2025
By Mari Serebrov
No Comments
John Crowley doesn’t worry about where his kids’ toys are made, but he told the Senate Health, Education, Labor and Pensions Committee that he does care where their medicines are made. His concerns, as a father and as president/CEO of the Biotechnology Innovation Organization, are becoming more urgent, he testified at an Oct. 29 HELP hearing on the future of biotech in the U.S.
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3D heart in chest
TCT 2025

Data suggest more than 10M people in the US have bad heart valves

Oct. 29, 2025
By Mark McCarty
The prevalence of valvular heart disease in the U.S. is tough to peg with any great precision, but an extrapolation of data from a new study would put the number at roughly 10.6 million people, a staggering number when the clinical and fiscal implications are considered.
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Penumbra STORM PE
TCT 2025

Penumbra takes TCT by STORM

Oct. 27, 2025
By Annette Boyle
Penumbra Inc.’s 'resoundingly positive' results from its STORM-PE trial could see current guidelines for anticoagulant use in pulmonary embolism swept away in favor of mechanical thrombectomy. A deluge of favorable comments by experts and analysts followed the presentation during a late-breaking session at Transcatheter Cardiovascular Therapeutics, the annual scientific symposium of the Cardiovascular Research Foundation, which showed more than 50% improvement in treatment effect from Penumbra’s computer-assisted vacuum thrombectomy system plus anticoagulation compared to anticoagulation alone within two days with no increase in major adverse events.
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withings connected scale

Withings provides interdisciplinary support to GLP-1 weight loss

Oct. 24, 2025
By Annette Boyle
Sustaining healthy weight loss is about so much more than cutting calories or injecting drugs, as many GLP-1 users are finding out. Withings SA continues to expand its obesity care management ecosystem and the capabilities of its connected scale to support patients through their weight loss journey and their lives after reaching goal, potentially addressing the vexing problem of patients rapidly regaining all – and often more – weight once they discontinue the drugs.
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Pen and ripped contract

Staar adjourns Alcon merger meeting until November

Oct. 24, 2025
By Holland Johnson
Staar Surgical Co. reported on Oct. 24 that it had adjourned its special meeting of stockholders scheduled in connection with its proposed $1.5 billion sale to Alcon AG in the face of objections from some of its major shareholders and at least three proxy firms.
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10-28-Boston-Science_Global-Headquarters_Marlborough,-Mass

Boston Sci Farapulse, Watchman boost Q3 performance

Oct. 23, 2025
By Annette Boyle
With the number of beats Boston Science Corp. has posted in recent years, it could be auditioning as a heavy metal drummer. Third quarter results kept up the streak, with overall sales 2% ahead of consensus at $5.07 billion and earnings per share of 75 cents, 5% above the Street’s expectations. The company’s two market-transforming products, Watchman and Farapulse, led the strong across-the-board performance, which would be no surprise by now except when looking at the stunning growth rates and sales both posted in the same quarter last year.
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