Court rulings favoring biopharma companies that have challenged the U.S. Department of Health and Human Services’ efforts to force them to unconditionally offer 340B prescription drug discounts to an unlimited number of contract pharmacies could become moot in the future if a bipartisan draft bill becomes law.
The European Union (EU) is steadily making progress on the Artificial Intelligence Act (AI Act), landmark legislation that will affect AI not just for medical uses, but for all uses across the EU economy.
The controversy over the use of paclitaxel (PTX) in devices used to treat peripheral artery disease (PAD) has taken roughly half a decade to unwind as regulatory agencies across the globe stand down their restrictions on the use of these devices.
Acepodia Inc. has obtained FDA clearance of its IND application for ACE-2016, an allogeneic γδ2 T-cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors.
The U.S. FDA has announced the next stage in its program to down-classify a series of in vitro diagnostics (IVDs) from class III to class II, a change that would significantly ease the premarket requirements for these test types. Much of the emphasis here is on companion diagnostic (CDx) tests, a category of products that is the focus of a separate FDA imperative, but there are those who view this down-classification regime as little more than a meager attempt to paste over a massive impending regulatory overhang.
Royal Philips NV recently received some good news from the U.S. FDA which cleared its latest transesophageal echocardiography (TEE) ultrasound transducer, amidst ongoing efforts with the regulatory body to address problems with its sleep business. The X11-4t Mini 3D TEE transducer is 35% smaller than previous versions and is designed to provide cardiologists with high quality 3D images of the heart and its internal structure.
Hologic Inc.’s focus on women’s health is looking like a brilliant move as the company lands U.S. FDA clearance for its Genius digital diagnostics system with the Genius cervical artificial intelligence algorithm, making it the first digital cytology system with clearance, the company said.
Edwards Lifesciences Corp. received some good news with the earlier-than-expected U.S. FDA approval of its Evoque tricuspid valve replacement system. The company beat out rival Abbott Laboratories for the honor of being the first transcatheter therapy to receive FDA approval.
In a historic first, the U.S. Centers for Medicare & Medicaid Services (CMS) sent out its opening offers Feb. 1 for the first round of prescription drug price negotiations.
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