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BioWorld - Wednesday, December 24, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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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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Doctor with illustration of kidneys

CMS lists 6 specialists as part of hypertension team in RDN memo

July 15, 2025
By Mark McCarty
To the surprise of no one in the device industry, the Medicare national coverage analysis for renal denervation (RDN) includes both radiofrequency and ultrasound technologies, but the agency has listed a range of specialists to be part of the patient’s care team, including but not limited to an endocrinologist.
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Merger-arrows-black-white.png

BD’s biosciences & diagnostics unit in $17.5B merger with Waters

July 14, 2025
By Annette Boyle
Three months earlier than an expected update on a deal, Becton, Dickinson and Co. reported its biosciences and diagnostic solutions business will combine with Waters Corp. in a transaction valued at $17.5 billion. The resulting enterprise will operate under the Waters name and use its trading symbol (NYSE:WAT). Waters CEO Udit Batra will head the combined company.
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Stock merger illustration

Zimmer Biomet in $168M buy of ortho robotics maker Monogram

July 14, 2025
By Holland Johnson
Zimmer Biomet Holdings Inc. reported it is buying orthopedic robotics maker Monogram Technologies Inc. for an upfront payment of $4.04 per share in cash, corresponding to an equity value of approximately $177 million and an enterprise value of about $168 million.
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Cyber security padlock

Preemption of state privacy law on tap in cybersecurity hearing

July 14, 2025
By Mark McCarty
The continuing proliferation of U.S. state privacy law drew the attention of developers of med-tech wearables for some time, but a recent Senate hearing delivered the news to Congress that a failure to preempt it will slow digital health innovation to a crawl.
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