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BioWorld - Friday, July 18, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Heartflow FFRCT analysis Credit: Heartflow Inc.

Heartflow pumps up med tech IPOs

July 18, 2025
By Annette Boyle
Heartflow Inc. continued the steady rhythm of med-tech companies filing to go public, with an S-1 submitted to the U.S. SEC on July 17. The company joins 15 others that have completed IPOs in 2025 and one other in process – Carlsmed Inc., which a company spokesperson told BioWorld is expected to begin trading on the Nasdaq on July 22.
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Gavel and scales

US states continue to move deeper into FCA legislation

July 18, 2025
By Mark McCarty
The U.S. False Claims Act (FCA) is not the only statute governing the submission of false claims to federal agencies thanks to the more than 30 states with their own versions of the FCA. However, the federal government is providing states with more incentives to amplify their FCA-related activities, a development that raises the stakes for companies in the life sciences.
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Coins and charts

Abbott med tech bumps up Q2 results

July 17, 2025
By Annette Boyle
Abbott Laboratories’ second quarter results echoed Johnson & Johnson’s, with med tech performing the hero’s work with strong growth. Overall, Abbott slightly beat expectations with sales up 6.9% overall compared to 2Q 2024, largely boosted by the med-tech unit’s organic revenue increase of 12.2%, and worldwide sales for the quarter of $11.1 billion. Diabetes provided a particularly bright spot with 19.5% year-over-year growth for continuous glucose monitoring devices.
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Uroactive smart implant

Uromems gets OK for Uroactive stress urinary incontinence trial

July 17, 2025
By Shani Alexander
Uromems SAS received investigational device exemption (IDE) approval from the U.S. FDA, and clearance from the French National Agency for the Safety of Medicines and Health Products (ANSM), to begin a pivotal trial of its Uroactive smart implant.
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Heart and Optimizer Mini

Impulse Dynamics inches closer to Medicare coverage for CCM

July 17, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has issued a draft coverage memo for cardiac contractility modulation (CCM), which offers coverage with evidence development for the company’s Optimizer line of devices. CMS said it will issue the final coverage memo by Oct. 8, 2025, which will mark the achievement of an objective the company set for itself more than two decades ago.
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Johnson & Johnson signage

Med tech helps boost J&J to strong 2Q beat

July 16, 2025
By Annette Boyle
Johnson & Johnson beat analysts’ expectations for its second quarter results, led by medical device sales of $8.54 billion. All med-tech segments performed better than anticipated, with cardiology reporting exceptionally strong 22.3% growth. In addition, the innovative medicines division shocked the Street with 4.9% growth, despite the loss of patent protection for the blockbuster drug, Stelara.
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Tavipilot software

Caranx Medical gets FDA nod for TAVR software Tavipilot Soft

July 16, 2025
By Shani Alexander
Caranx Medical SAS secured clearance from the U.S. FDA for Tavipilot Soft, its AI-powered software which provides real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software, which tracks anatomical and instrumental landmarks in real-time to enable precise and accurate heart valve positioning and delivery, will allow a broader number of cardiologists to perform this complex procedure.
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Document illustration

CMS proposes again to end IPO list in outpatient draft

July 16, 2025
By Mark McCarty
For the second time in five years, the Centers for Medicare & Medicaid Services (CMS) has proposed to erase the inpatient-onlylist over a span of three years, stating that physicians are capable of deciding which site of service is best for their patients.
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Synchrony’s Libairty airway clearance system

Synchrony receives FDA OK for Libairty airway clearance system

July 15, 2025
By Shani Alexander
Synchrony Medical Ltd. received the greenlight from the U.S. FDA for its Libairty airway clearance system which is expected to transform the lives of people with chronic lung diseases. The company is now looking to raise $5 million in series A funding to support the launch of the product in the U.S. later this year.
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Telehealth illustration

CMS takes aim at skin substitutes, telehealth in 2026 doc fee draft

July 15, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has pulled off the gloves when it comes to spending on skin substitutes in the draft Medicare physician fee schedule for 2026, proposing a payment methodology that would slash spending by 90%. However, the doc fee draft also proposes to simplify the process by which telehealth coverage is provided for a physician service, a move that may significantly expand the types of services that can be handled without an in-office visit.
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