The U.S. FDA approved the Proclaim XR spinal cord stimulation system by Abbott Laboratories for painful diabetic peripheral neuropathy (DPN). The system offers an alternative to patients for whom oral medications do not provide sufficient relief. About half of individuals with diabetes will eventually develop peripheral neuropathy which primarily damages the nerves running down the legs to the feet.
Brazilian health care regulator Anvisa unveiled new medical device rules that promise to simplify over two decades of accumulated directives, putting into force changes announced by the health care surveillance agency in 2022.
Diagnostics startup Geneoscopy Inc. said Tuesday it has completed a PMA submission for its noninvasive, stool-based, at-home screening test for the detection of colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals. The filing is based on positive results from the company’s pivotal CRC-PREVENT trial that met all primary outcome targets, including sensitivity and specificity for CRC and AA.
The U.S. FDA has posted yet another two regulations for devices granted market access via the de novo petition program, one of which addresses dry eye by means of pulsatile light emissions. This device may serve as a predicate for many 510(k) devices if estimates of prevalence in the tens of millions in the U.S. are any indication.
Bringing notified bodies (NBs) into a med-tech regulatory system has proven to be no mean feat in the European Union, but the U.K. Medicines and Health Care Products Regulatory Agency (MHRA) seems not to suffer from such impediments. The agency just added several in vitro diagnostic (IVD) technological areas to the roster of tests that can be reviewed by UL International UK, an addition that will help ensure patients can obtain the tests they need.
Selux Diagnostics Inc. received U.S. FDA 510(k) clearance for its next generation phenotyping (NGP) system, a rapid antibiotic susceptibility test (AST) platform that determines a bacteria’s susceptibility to 14 specific antimicrobial agents in less than six hours. Prompt identification of the narrowest effective antimicrobial for an infection is critical to the battle to preserve the efficacy of critical antibiotics and slow the development of ‘superbug’ infections.
The fifth medical device user fee agreement (MDUFA V) is a generous bump in monies for the U.S. FDA, some of which will go toward advancing the use of real-world evidence (RWE) in the agency’s regulatory decisions. The FDA just opened a docket for comment on how those monies might be doled out to entities other than the Medical Device Innovation Consortium (MDIC), an expansion that might nudge the regulatory science along a little more quickly and thus enhance the use of RWE for premarket submissions.
The new year always brings with it a series of New Year’s resolutions, and the U.S. FDA has apparently resolved to catch up on its backlog of de novo notifications. The earlier of the two de novo regulatory announcements is for a digital product by Minneapolis-based Nightware Inc., and its namesake kit for reduction of sleep disturbances, a regulation that arrives more than two years after the product was granted market access.
The U.S. FDA has given the green light to Abbott Laboratories Inc. for its Navitor next-generation transcatheter aortic valve implantation (TAVI) system for the treatment of patients with aortic valve stenosis who are at increased risk of open-heart surgery. Abbott won European approval of Navitor in May 2021.
The European Commission is spending €242 million (US$261 million) to create the first rescEU strategic reserve of chemical, biological, radiological and nuclear (CBRN) medical countermeasures.
