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BioWorld - Thursday, December 4, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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India map on technology concept background

CDSCO issues draft guidance for medical device software

Oct. 24, 2025
By Mark McCarty
India’s Central Drugs Standard Control Organization (CDSCO) posted a draft guidance for medical device software, providing some clarity about the agency’s expectations for this class of products even if it seems to break no new ground.
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World globe, DNA sequencing illustration.

Advamed goes 21st Century digital with its code of ethics

Oct. 23, 2025
By Mark McCarty
The Advanced Medical Technology Association has updated its code of ethics for interactions with health care professionals, which includes some much-needed updates that address both the burgeoning reliance on data and the increasing emphasis on the part of U.S. regulators on data security.
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Europe map, white on blue

Medtech Europe says EU Innovation Act no substitute for regulatory fix

Oct. 22, 2025
By Mark McCarty
The European Commission has proposed legislation that would ease some of the EU’s barriers to innovation, but MedTech Europe said that while the European Innovation Act would be helpful, it is no substitute for fixing what’s already ailing the EU med-tech industry.
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3D rendering showing osteoporosis in the femur

NICE nods to AI in detection of osteoporosis-driven vertebral fracture

Oct. 22, 2025
By Mark McCarty
Vertebral compression fractures are one of the more obvious signs of osteoporosis but can be difficult to diagnose, one of several reasons the U.K. National Institute for Health and Care Excellence has given the nod to five AI products that can improve rapid detection of these fractures.
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US flag, gavel, book

Dexcom faces class action lawsuit following FDA warning

Oct. 21, 2025
By Mark McCarty
San Diego-based Dexcom Inc., is the target of a class action lawsuit in U.S. district court over the company’s G7 continuous glucose monitors, an action which follows a U.S. FDA warning letter by a mere seven months and a recall announced in July, suggesting that litigation often follows other sources of bad news for firms in the med-tech business.
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United Kingdom flag, map

UK CMA’s merger remedies draft seeks level competitive field

Oct. 20, 2025
By Mark McCarty
The U.K. Competition and Markets Authority (CMA) has issued draft guidelines for remedies for mergers and acquisitions, which the agency insists incorporates some regulatory flexibility. However, CMA said its approach is premised on the notion that any regulated transaction should have zero effect on competition in the affected industry, a premise that would seem to quash any transaction that leads to fewer companies in that industry.
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Interconnected nodes representing a digital supply chain network

MHRA announces winners in AI Airlock challenge

Oct. 20, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency reported the winners of the second phase of the AI Airlock challenge, which includes the Tortus AI, a medical scribe system developed by physicians in the U.K. National Health Service.
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US flag, gavel, book

USPTO proposes limits on administrative patent challenges

Oct. 16, 2025
By Mark McCarty
The U.S. Patent and Trademark Office (PTO) has proposed to limit the use of administrative challenges to patents when the patent in dispute is already the subject of litigation in district court, a change that many in the life sciences might see as an improvement over the current hyper-litigious environment.
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Wooden stamp with China flag

China’s NMPA seeking closer ties to regional regulators

Oct. 15, 2025
By Mark McCarty
China’s National Medical Products Administration (NMPA) recently met with a delegation from Singapore’s Health Sciences Authority (HSA) to discuss cooperation in the two agencies’ regulation of medical products, part of a series of efforts by NMPA to expand its use of regulatory reliance.
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Japanese flag

PMDA makes case for Japan as a haven for innovation

Oct. 15, 2025
By Mark McCarty
Japan has long been one of the premier markets for medical technology, but this market has suffered from a reputation for slow adoption of technologies outside the cardiovascular device space, a problem the Pharmaceuticals and Medical Devices Agency is keen to address.
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