The FDA reported March 25 that Smiths Medical Inc., is recalling a series of oral and nasal endotracheal tubes because the diameters of the tubes may present with “a smaller diameter than expected.”
The U.S. Medicare program took several bites out of rates paid for radiation oncology services under the physician fee schedule, but stakeholders are again gaining traction on Capitol Hill with a plea for intervention.
Alcon AG plans to acquire Lensar Inc. for up to $430 million in a transaction expected to close in the latter half of the year. The acquisition will add Lensar’s Ally robotic cataract laser treatment system, Streamline software technology and Lensar legacy laser system to Alcon’s cataract surgery portfolio and expand global access to Lensar’s femtosecond laser technology.
Third-party litigation funding (TPLF) has a checkered reputation in the U.S. med-tech industry and the practice has now raised hackles in the European Union as well. The European Commission recently posted a document explaining how EU-wide legislation would map onto member state law, the results of which suggest that any pan-EU legislation would be at best a tricky exercise in policymaking.
Researchers from the Albert Einstein College of Medicine filed for protection of the development of a lateral geniculate nucleus (LGN) visual prosthetic device with implantable electrode arrays that stimulate the LGN and restore vision.
Histoindex Pte Ltd. launched its laboratory-developed test for metabolic dysfunction-associated steatohepatitis (MASH), Fibrosight, in the U.S. as the company’s first in a suite of next-generation digital pathology solutions.
Several American states are forging into a legislative vacuum where regulation of AI is concerned as Congress continues to delay action. Adoption of AI regulations on a state level increases the risk of a fragmented regulatory landscape, as already exists in U.S. privacy law, further complicating the path forward for med-tech companies deploying AI algorithms.
Researchers from The Ohio State University have filed for protection of Neurothread, a wire-type neurotransmitter-sensing platform that utilizes the cross-section of commercially available ultrathin microwires as microelectrodes.
The final U.S. Medicare national coverage determination for transcatheter tricuspid valve replacement (TTVR) devices comes with an expected coverage with evidence development mandate, but some analysts expect that TTVR devices will face competition from tricuspid transcatheter edge-to-edge repair (T-TEER) devices, the subject of an impending national coverage analysis.
The politicization of the U.S. FTC continued March 18 with President Donald Trump firing the two remaining Democratic commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya. The action leaves what’s supposed to be a five-member bipartisan panel with just two members, both of whom are Republicans. The commission already was down one member, as former Chair Lina Khan’s term expired last year and Trump’s appointee, Mark Meador, is awaiting Senate confirmation with a vote expected yet this month.