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.

The Medicare Payment Advisory Commission said in a recent report that Medicare spending in the U.S. is poised to nearly double to $1.9 trillion over the coming eight years, a figure that is likely to apply ever-increasing price pressures on makers of devices, diagnostics and pharmaceuticals.

The Medicare Payment Advisory Commission said in a recent report that Medicare spending in the U.S. is poised to nearly double to $1.9 trillion over the coming eight years, a figure that is likely to apply ever-increasing price pressures on makers of devices and diagnostics.

The U.S. FDA released another series of regulations for de novo devices, but the attendant regulation is not always available for these de novo devices.

The U.S. Court of Appeals for the Federal Circuit has overturned a jury finding that Labcorp Inc. was entitled to damages of $4.7 million in a dispute with Qiagen Inc. The case presented another test of the doctrine of equivalents and affirmed that this doctrine has its limits where accusations of infringement are concerned.

Australia’s Therapeutic Goods Administration recently reported that it has concerns about the use of digital scribes, stating that any such software that analyzes or interprets clinical conversations may qualify as a regulated medical product.

Several cardiology societies in the U.S. have updated their guidelines for management of hypertension, which for the first time includes and endorsement of renal denervation (RDN). Two companies are poised to benefit from the news, including Medtronic plc with its Symplicity Spyral device and Recor Medical Inc., and its Paradise RDN system.