Avicenna.AI SAS received clearance from the U.S. FDA for two of its artificial intelligence (AI)-based solutions, Cina-Ipe and Cina-Aspects, which provide for the detection of pulmonary embolism (PE) and the assessment of stroke severity in CT scans, respectively.
The U.S. FDA released two draft guidances in the third week of March 2024, one of which is a modest edit of an existing guidance for pre-submission activities between the agency and manufacturers.
The U.S. FDA granted Neuronetics Inc. clearance for use of its Neurostar advanced therapy as an adjunctive treatment of major depressive disorder in patients aged 15 to 21, making it the first transcranial magnetic stimulation treatment (TMS) cleared for this age group, the company said.
The U.S. FDA has posted another proposed ban of the use of electrical stimulation devices (ESDs) for the treatment of self-injurious behavior, which revisits the controversy over their use by the Judge Rotenberg Center.
Stimlabs LLC received U.S. FDA approval for Corplex P, a wound care product that uses placental tissue to facilitate wound healing. “Corplex P is the first particulate device derived from human umbilical cord extracellular matrix indicated for the management of acute and chronic wounds,” Stimlabs CEO John Daniel told BioWorld.
The U.S. FDA’s pending final rule for regulation of lab-developed tests has proven unusually controversial even for the FDA, but Rep. Anna Eshoo (D-Calif.) stated in a March 21 hearing that congressional inaction has left the agency in an uncomfortable spot.
Vicore Pharma Holding AB was granted a U.S. FDA breakthrough device designation for Almee, a cognitive behavioral therapy (CBT) software, to be used as an adjunct treatment by patients with anxiety symptoms due to pulmonary fibrosis. Vicore developed the nine-week CBT digital therapy in partnership with Alex Therapeutics AB.
The U.S. FDA has followed up on reports of problematic syringes made by several companies in mainland China, recommending that U.S. suppliers, consumers and health care organizations stop using these products unless no alternatives are available. The agency said it has issued warning letters to three of these companies, at least one of which appears to have been the supplier of Monoject syringes that have been the subjects of recent FDA recalls.
The U.S. FDA is holding a series of town halls on the use of sterilization methods as alternatives to ethylene oxide (EtO) in response to other federal agency rulemaking, and some of these changes in sterilization methods will not require a new regulatory filing.
The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
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