A district judge has issue an Aug. 27 ruling enjoining Biosense Webster Inc. from tying its support for cardiac mapping equipment to purchases of the company’s catheters used in these procedures. According to the Association of Medical Device Reprocessors, the ruling triples previously announced damages, which will now cost Biosense nearly $450 million for violations of state and federal antitrust law.

The U.S. Department of Health and Human Services reported Aug. 27 that Susan Monarez no longer occupies the post of director for the CDC, a development that arose within hours of the FDA’s approval of two COVID-19 vaccines with historically restrictive labeled indications.

The U.S. FDA’s draft guidance for package labeling recommendations for hernia mesh products did not draw a large volume of comments, but the Medical Device Manufacturers Association advised the agency that the information disclosed on package labels should be limited as the package is often too small to provide adequate readable information.

The U.S. FDA’s Aug. 11, 2025, warning letter to LeMaitre Vascular Inc. discloses that the agency was troubled by what it saw as problems with sterility-related processes used to manufacture the Artegraft device, findings that could complicate relations between the company and its customers.

A new entry in the peer-reviewed literature on Boston Scientific’s Agent drug-coated balloon seems to call into question whether in-stent restenosis should be treated with another stent, a discussion that could torque practice away from the stent-in-stent approach and toward the use of drug-coated balloons.

The U.S. Patent and Trademark Office has reacted to the Federal Circuit’s decision in Shockwave v. CLSI with a policy memo that draws tighter lines around the use of applicant admitted prior art in attempts to invalidate a patent during inter partes reviews.

The U.S. and the EU have signed off on a trade deal, which makes some important provisions for generic pharmaceuticals. However, Medtech Europe said in an Aug. 21 statement that it is concerned about the exclusion of medical technology, given the potential for negative effects on patient care.

The U.S. FDA has announced a class I recall for the Wallstent Monorail system by Boston Scientific Corp. of Marlborough, Mass, a device for treatment of carotid artery stenosis. The company advised customers in early July to return any unused inventory because the inner diameter of the stent is narrower than intended, which may lead to difficulties in extracting the delivery device after placement of the stent.

The U.K. National Institute for Health and Care Excellence has recommended that physicians in the U.K. use the least expensive, clinically appropriate TAVR device when possible, concluding a pricing review that commenced roughly a year ago.

A group of stakeholders including medical device makers have penned a letter to Centers for Medicare & Medicaid Services administrator Mehmet Oz to urge the agency to cover breakthrough medical devices, an attempt to resurrect administrative action on a question that legislators failed to address in 2024.