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BioWorld - Saturday, December 20, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Microchip robotic manufacturing concept

Impact of tariffs on supplies of semiconductor tough to calculate

April 15, 2025
By Mark McCarty
The Trump administration sent several signals about the imposition of tariffs on semiconductors – a vital component for many devices. While imaging systems sell infrequently and may not suffer from a short-term crimp in supplies of semiconductors, items such as pacemakers sell by the hundreds of thousands each year in the U.S. a fact that makes semiconductor products a crucial component of the well-being of millions of Americans.
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Da Vinci Xi robot - Intuitive Surgical

J&J reports completion of first cases with Ottava robotic system

April 15, 2025
By Holland Johnson
Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic surgical system. The cases mark the first clinical experience with the Ottava system, which has been a long time in development.
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CMS logo and website

CMMI again under pressure as CMS closes several programs

April 15, 2025
By Mark McCarty
The Center for Medicare and Medicaid Innovation was founded with the objective of reducing Medicare spending, but many of the associated programs will be stood down by the end of this year thanks in part to a 2023 report detailing a significant increase, rather than a decrease, in spending associated with CMMI programs.
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Edwards Lifesciences Sapien M3

Edwards lands first CE mark for transfemoral mitral valve replacement

April 14, 2025
By Annette Boyle
Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.
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Illustration of TAVR device

CMS disinclined to reassign TAVR procedures to higher-paying DRG​

April 14, 2025
By Mark McCarty
The U.S. Medicare draft inpatient rule for fiscal 2026 discusses a number of coding proposals, although the agency seems disinclined to go along with a proposal to increase payment rates for TAVR devices by switching the procedures to a different diagnostic-related group.
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Medicare puzzle

Gore petitions CMS to reassign DRG for thoracic branch devices

April 14, 2025
By Mark McCarty
The new technology add-on payment for the TAG thoracic branch endoprosthesis is likely coming to an end, but the device’s manufacturer, Gore Medical Inc., petitioned CMS to reassign the procedure to a new diagnostic-related group that would more accurately reflect the costs of the related procedure.
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Lab mouse
Drug design, drug delivery & technologies

FDA wants a shift away from animal testing

April 14, 2025
By Lee Landenberger
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
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Dexcom G7 CGM

FDA clears Dexcom G7 15 Day

April 11, 2025
By Annette Boyle
The battle to claim the continuous glucose monitor with the longest wear time continues with Dexcom Inc.’s G7 15 Day continuous glucose monitor gaining U.S. FDA clearance on April 10 for adults with diabetes. The company said it now takes the lead with the 15-day duration, but Abbott Laboratories also offers 15 days of useful life for its Freestyle Libre 3 plus.
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David Luria Ziv Menshes

Cardiovia Viaone epicardial access system secures US FDA clearance

April 11, 2025
By Shani Alexander
Cardiovia Ltd.' Viaone epicardial access system received U.S. FDA clearance for treating cardiac arrhythmias. The device provides clinicians with a safe and minimally invasive technology to reach the heart’s outer surface, known as the pericardial space, without the need for a sharp needle, which can cause perforation.
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US flag, stock market chart, White House

Dems petition White House to ensure drug supply chains stay intact

April 10, 2025
By Mark McCarty
The Trump administration applied a 90-day hold on nation-specific tariffs, but a group of 26 House Democrats urged the administration to think carefully before acting on a threat to impose tariffs on pharmaceuticals.
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