Carl Zeiss Meditec AG recently received U.S. FDA clearance for the latest generation of its femtosecond laser, the Visumax 800, with its Smile pro software, for surgically treating nearsightedness, with or without astigmatism.
The U.S. FDA is undergoing a significant overhaul of operations which is designed in part to make the agency’s Office of Regulatory Affairs (ORA) more efficient and less obtrusive to product centers, such as the Center for Devices and Radiological Health.
Is it an unconstitutional taking when U.S. FDA reviewers disclose a brand company’s claimed trade secrets or confidential commercial information to would-be competitors? That’s a question the U.S. Court of Federal Claims has yet to answer. While the court dismissed some of Vanda Pharmaceuticals Inc.’s claims against the FDA, its Jan. 18 opinion left open the debate of whether such disclosures, intentional or inadvertent, are a per se or regulatory taking.
In a boon to older women worldwide, Bone Health Technologies Inc. received U.S. FDA clearance for its Osteoboost device, which reduces loss of bone strength in postmenopausal women. It is the first device cleared for intervention to slow loss of bone density or osteopenia before it advances to osteoporosis.
The question of the U.S. FDA’s statutory authority to regulate lab-developed tests (LDTs) is still percolating, and the FDA and the Centers for Medicare & Medicaid Services (CMS) have issued a joint statement that takes aim at that very question.
The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for $220 million in April 2023 and gained rights to STS-101.
Sometimes a small change of wording has a big effect on the implications of a U.S. FDA guidance, a notion that may apply to the U.S. FDA’s final guidance for the use of computational modeling in device premarket submissions.
Dermasensor Inc. received U.S. FDA clearance for its non-invasive skin cancer evaluation device that provides quantitative identification of all skin cancer types at the point of care and within seconds. The point-and-click device is designed to facilitate detection of skin cancers by primary care physicians (PCPs) and speed the time to diagnosis and treatment.
The U.S. FDA has announced a class I recall of Iveninx large-volume infusion pumps made by Fresenius Kabi USA of Lake Zurich, Ill., due to a mechanical issue with fluid valve pins that could cause the pumps to shut down. Fresenius is rolling out a remediation plan for more than 900 pumps affected by the recall, which to date has been associated with no reports of injury or death.
The ongoing controversy over the use of ethylene oxide (EtO) as a medical device sterilant has yielded a certification by the U.S. FDA for hydrogen peroxide as an alternative category A sterilant. The news is a welcome bit of relief for industry and for patients as the Environmental Protection Agency still seems bent on imposing what some in industry see as draconian controls on EtO, which is still employed to sterilize half of all medical devices used in the U.S. each year.