Wandercraft SAS broadened its U.S. FDA clearance for the Atalante X to include rehabilitation in individuals with spinal cord injuries at levels T5 to L5. The self-balancing exoskeleton was already given the greenlight by the FDA for use in stroke rehabilitation in December 2022. “We are thrilled to have two FDA clearances, first for stroke and now spinal cord injury, in less than a year,” CEO Matthieu Masselin, told BioWorld.
Citing national security and intellectual property (IP) concerns, a bipartisan group of U.S. lawmakers is calling on three federal departments to investigate China’s Wuxi Apptec’s ties, and that of its subsidiary, Wuxi Biologics, to the Chinese Communist Party and the country’s People’s Liberation Army.
Seeking the root causes and possible solutions to the chronic drug shortages plaguing the U.S. health care system, the FTC and Health and Human Services jointly issued a request for information regarding how group purchasing organizations and drug wholesalers may be contributing to the shortages of generic drugs.
The ongoing saga of the Environmental Protection Agency’s (EPA) pending rule on ethylene oxide (EtO) made its way to a Feb. 14 hearing in the U.S. House of Representatives, which included the testimony of Lishan Aklog of Pavmed Inc., who warned that a significant curtailment of EtO as a sterilant for medical devices could hamper patient access to medical devices.
The U.S. Securities and Exchange Commission (SEC) said Feb. 14 that it may elevate the threshold for registration of venture capital (VC) funds from $10 million to $12 million, a move that would exempt at least a few med-tech VC funds from registration requirements.
The U.S. Court of Appeals for the Sixth Circuit made it clear that it’s the court’s purview, not a jury’s, to determine whether an expert’s testimony is “relevant and reliable” when it comes to issues such as causation. It gave that lesson Feb. 13 when it affirmed a lower court’s dismissal of multi-district litigation in which the plaintiffs claimed that Onglyza (saxagliptin) and Kombiglyze (saxagliptin/metformin hydrochloride), developed by Astrazeneca plc and Bristol Myers Squibb Co., caused their heart failure.
The U.S. FDA has approved Eicos Sciences Inc.’s Aurlumyn (iloprost) for treating severe frostbite. The injectable vasodilator, which opens blood vessels and stops blood from clotting, is now approved for adults to reduce finger or toe amputations and is, according to the FDA, the first-ever treatment option for severe frostbite. The drug, also referred to as ES-2001, had the FDA’s priority review and orphan drug designations for treating severe frostbite.
The demand for semaglutide, a GLP-1 drug, and other popular prescription weight-loss drugs is adding to the U.S. FDA’s regulatory load as more and more companies are offering unapproved knockoffs of the products directly to consumers. The FDA posted two warning letters Feb. 13 – to Miami-based US Chem Labs and a New-York company, Synthetix Inc. doing business as Helix Chemical Supply – citing the companies for misbranding unapproved semaglutide and tirzepatide, also a GLP-1 drug, by marketing them on the Internet, along with claims about their therapeutic benefits.
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