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1 week ago | 
bioworld.com | Mark McCarty
NICE OKs conditional coverage of robotic surgeryThe U.K. National Institute for Health and Care Excellence (NICE) gave the nod to a total of 11 robotic surgical systems for use in the U.K.’s trusts, but this is no free pass as the agency expects the manufacturers of these systems to gather data under this conditional coverage framework. BioWorld MedTech Regulatory Europe NICE
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1 week ago | 
bioworld.com | Mark McCarty
Home » CMS suspends skin substitute local coverage determinations BioWorld briefs for April 16, 2025. BioWorld MedTech briefs for April 17, 2025. In a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate... The current treatment strategies for neurodegenerative diseases focus on targeting Aβ in Alzheimer’s disease (AD), α-synuclein aggregates in Parkinson’s disease...
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1 week ago | 
bioworld.com | Mark McCarty
Home » Regulatory attorney says CDRH reviewers easier to work withRegulatory attorney says CDRH reviewers easier to work withThe recent staff cuts at the U.S. FDA’s device center caught the attention of outsiders but also caught the attention of those who work on premarket applications for 510(k) and PMA filings. BioWorld MedTech Regulatory U.S. FDA Policy
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1 week ago | 
bioworld.com | Mark McCarty
AMA panel eyes CPT code for cardiac contractility modulationThe American Medical Association’s CPT editorial panel will meet May 1-3 to consider codes for several devices and services, but the most important of these might be the code for cardiac contractility modulation. BioWorld MedTech Regulatory U.S. CMS Medicare
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1 week ago | 
bioworld.com | Mark McCarty
CMMI again under pressure as CMS closes several programsThe 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. BioWorld MedTech Regulatory U.S. CMS Medicare
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1 week ago | 
bioworld.com | Mark McCarty
Impact of tariffs on supplies of semiconductor tough to calculateThe 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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1 week ago | 
bioworld.com | Mark McCarty
Gore petitions CMS to reassign DRG for thoracic branch devicesThe 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. BioWorld BioWorld MedTech Regulatory U.S. CMS Medicare
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1 week ago | 
bioworld.com | Mark McCarty
CMS disinclined to reassign TAVR procedures to higher-paying DRGThe 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. BioWorld MedTech Regulatory Cardiovascular U.S. CMS Medicare Policy
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1 week ago | 
bioworld.com | Mark McCarty
States active on privacy as Congress convenes work groupThe thicket of state-based privacy regulation in the U.S. grows thicker by the day, but Congress seems poised to step in with a bipartisan group that may propose legislation that preempts privacy law. BioWorld MedTech Regulatory FTC Policy
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2 weeks ago | 
bioworld.com | Mark McCarty
Home » Dems petition White House to ensure drug supply chains stay intact BioWorld briefs for April 10, 2025. BioWorld MedTech briefs for April 10, 2025. Boston Scientific Corp.’s up to $664 million acquisition of Bolt Medical Inc. closed just days after Bolt secured U.S. FDA 520(k) clearance for its intravascular... At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald...
