The U.S. FDA reported Feb. 15 that Philips USA, a subsidiary of Amsterdam-based Royal Philips NV, recalled three models of the Brightview line of single photon emission CT (SPECT) systems due to an incident in which the system detector fell.

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.

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.

Body: The U.K.’s Medicines and Health Care Products Regulatory Agency (MHRA) has a program designed to facilitate more rapid market access for medical devices of urgent need, and now the agency has put money into the policy.

Just in time for Valentine’s Day, the circulatory system devices panel of the medical devices advisory committee for the U.S. FDA showed some love for Abbott Laboratories’ Triclip transcatheter edge-to edge repair (TEER) system for leaky tricuspid heart valves.

The U.S. FDA has posted information on the regulatory review period for several medical devices that incorporate patented inventions, such as the determination for the Simplify artificial cervical disc by Simplify Medical Inc., of Sunnyvale, Calif. According to the FDA, the company seeks to tack nearly 1,100 days back on to the patent in question, an additional three years that may play a significant role in the company’s attempt to monetize the patent in question.

The U.S. Patent and Trademark Office (PTO) has released a draft version of patent examiner guidelines to address the increasing use of artificial intelligence (AI) in the inventive process, reflecting the standing U.S. position that AI cannot be an inventor.

Insulet Corp. received the greenlight from EU regulators to combine its Omnipod 5 automated insulin delivery (AID) system with Abbott Laboratories Freestyle Libre 2 Plus sensor to treat individuals aged two years and older with type 1 diabetes.

The U.S. FDA approved a new feature for detecting obstructive sleep apnea (OSA) on the Samsung Galaxy watch and smartphone, Samsung Electronics Co. Ltd. said on Feb. 10.