Haemonetics Corp. received CE mark certification for the Savvywire pre-shaped pressure guidewire, a sensor-guided three-in-one guidewire for transcatheter aortic valve implantation. The solution, which is expected to enhance TAVI procedures and improve patient outcomes, is already being used in procedures in European countries.
China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
Meta Pharmaceuticals Inc. announced that the FDA has granted rare pediatric disease designation to its investigational new drug META-001-PH for the treatment of primary hyperoxaluria (PH), an autosomal recessive metabolic disorder in which oxalate is overproduced and deposited in the body.
The U.S. Medicare program’s final rule for fiscal year 2025 inpatient care retains several controversial proposals, but some device makers fared well in their new technology add-on payment (NTAP) applications, including Dublin-based Medtronic plc, which won NTAP payments for two devices.
The U.S. FDA’s device center is working to refine its regulation of artificial intelligence algorithms, but the agency is recommending that industry be more forward-thinking in a blog that urges device makers to fully adopt a life cycle management mindset for these systems.
The U.S. Department of Health and Human Services (HHS) is 6-1 so far in blocking court challenges to the Medicare price negotiation program mandated by the Inflation Reduction Act (IRA). The department’s latest victory came July 31 when a federal district judge in New Jersey tossed a complaint filed by Novo Nordisk A/S, citing a lack of jurisdiction on the court’s part and the company’s lack of standing.
The possibility of a 2025 approval looks to be off the table for Actinium Pharmaceuticals Inc.’s Iomab-B, at least in the U.S. In a move that H.C. Wainwright analyst Joseph Pantginis dubbed “a major surprise,” the FDA has requested a head-to-head study demonstrating overall survival before it will consider approving the radiotherapy candidate for use in patients with active relapsed or refractory acute myeloid leukemia.
The U.K. National Institute for Health and Care Excellence endorsed the use of testing for the CYP2C19 genotype for management of clopidogrel usage after ischemic stroke and heart attack, but the agency is specific about the use of tests by Genedrive plc and Genomadix Inc. in point-of-care settings as alternatives to lab testing.
Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920.
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