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BioWorld - Sunday, July 5, 2026
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Medical technology
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Regulatory actions for July 3, 2025

July 3, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Matortho.
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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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Stock merger illustration

Terumo enters transplant biz with $1.5B Organox buy

July 3, 2025
By Annette Boyle
After making a significant strategic investment in Oxganox Ltd. earlier this year, Terumo Corp. returned to buy the company. This morning, the companies announced that Terumo would acquire Organox for $1.5 billion, marking Terumo’s entry into the organ transplant sector. The transaction is one of the largest exits ever for the U.K. med-tech sector.
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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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Single Shot PVI

Kardium beats expectations with $250M haul

July 2, 2025
By Annette Boyle
Kardium Inc. raised C$340 million (US$250 million) in an oversubscribed financing round to support commercialization of its Globe pulsed field ablation system for atrial fibrillation. Notably, the financing included an equity investment by an unnamed leading strategic investor. Kardium could receive U.S. FDA approval as early as this quarter and plans to launch Globe in the U.S. this year.
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AI-generated digital horse illustration

MDCG guidance document resurrects issue of standards for AI

July 2, 2025
The Medical Device Coordination Group (MDCG) posted a guidance document tackling the interaction between the Artificial Intelligence Act and the twin EU regulations for devices and diagnostics, but the lack of standards for AI development promises to impede efforts to bring these AI algorithms to the European market.
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Medtronic Vitalflow ECMO

Medtronic receives CE mark for its Vitalflow ECMO system

July 2, 2025
By Shani Alexander
Medtronic plc received a CE mark for its Vitalflow extracorporeal membrane oxygenation (ECMO) system, which provides temporary support for the heart and lungs in critically ill patients in intensive care units (ICU). The company said the Vitalflow ECMO system represents a ‘new paradigm’ in ECMO therapy as it is designed to simplify ICU operations and brings performance, ease of use and adaptability to the forefront of patient care.
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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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Appointments and advancements for July 2, 2025

July 2, 2025
New hires and promotions in the med-tech industry, including: Nuwellis.
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