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BioWorld - Sunday, January 11, 2026
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Drug vials

Industry could feel fallout of Pfizer vaccine scrutiny

July 3, 2025
By Mari Serebrov
No Comments
In subpoenaing a former Pfizer Inc. official to appear before the U.S. House Judiciary Committee July 22, Judiciary Chair Jim Jordan, R-Ohio, signaled legislative steps Congress may take in response to allegations that Pfizer slow-walked its COVID-19 vaccine development in 2020 so the trial results wouldn’t have to be disclosed until after the presidential election.
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Fraud blocks under magnifying glass

New US working group to step up FCA enforcement

July 3, 2025
By Mari Serebrov
No Comments
The U.S. Health and Human Services and the Justice Departments are bringing more resources to their crack down on False Claims Act (FCA) violations involving drugs, medical devices and Medicare fraud.
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U.S. Capitol building, Washington D.C.

House passes H.R. 1, restoring R&D tax cuts

July 3, 2025
By Mark McCarty
The House of Representatives passed H.R. 1, also known as One Big Beautiful Bill, which will restore personal income tax cuts that expired in 2022. However, the bill also restores research and development tax credits, a provision that drew immediate praise from industry.
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CMS logo and website

OIG presses CMS to act on overpayments related to global episodes

July 2, 2025
By Mark McCarty
The U.S. Office of Inspector General issued a report stating the Medicare program often pays for physician services that are not performed post-surgery, but the Centers for Medicare & Medicaid Services responded it is in no position to immediately begin tracking all excess payments under these global codes.
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CMS logo and website

CMS eyes competitive bidding for CGMs, insulin pumps

July 1, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services posted the draft home health rule for calendar year 2026, which includes a proposal to subject continuous glucose monitors and insulin pumps to competitive bidding, but the agency is also considering a more rapid pace of replacement of these technologies.
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tricuspid regurgitation

New York Valves: More options, more valves

July 1, 2025
By Annette Boyle
Aortic valve repair and replacement continue to grab attention appropriate for the number of people affected, but the heart’s other three valves are finally gaining some respect as med-tech companies and analysts recognize the size of the potential total addressable market.
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Handshake with charts, maps, data

US agencies to assemble health care fraud data fusion system

July 1, 2025
By Mark McCarty
The U.S. Department of Justice reported June 30 that several hundred defendants were charged with health care fraud of more than $14 billion, but the more important news may be that federal agencies are standing up a data sharing system that will make this kind of enforcement more effective.
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Judge's gavel with US flag

Another court orders halt to US HHS reorganization

July 1, 2025
By Mari Serebrov
No Comments
Without using the words “universal” or “nationwide,” a U.S. district judge granted a preliminary injunction July 1 to stop the Department of Health and Human Services’ (HHS) reorganization plan, along with any workforce reduction that’s part of the plan.
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Wall Street sign

Med-tech IPOs gain steam going into Q3

June 30, 2025
By Annette Boyle
The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022.
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tissium

Tissium’s polymer solution set to transform nerve repair after FDA nod

June 30, 2025
By Shani Alexander
Could the U.S. FDA’s de novo marketing authorization for Tissium SA’s Coaptium Connect, an atraumatic sutureless solution for peripheral nerve repair, signal a transformative shift away from sutures in nerve surgery? Only time will tell.
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