Integra Lifesciences Holdings Corp., of Plainsboro, N.J., said in its latest 8K filing that it has decided to voluntarily remove all the company’s Cerelink systems – which are indicated for intracranial pressure monitoring – due to customer reports that these monitors were returning inaccurate pressure readings.
The U.S. FDA granted breakthrough device designation to startup Brainspec Inc. for its non-invasive virtual brain biopsy system. The company uses standard magnetic resonance imaging equipment to measure brain chemistry rather than to create images, providing a more detailed view of pathophysiology involved in a range of neurological disorders.
The U.S. FDA has identified a recall of Medtronic cardiac electrophysiology devices as a class I event due to the risk of an inadequate delivery of energy to restore normal rhythm, a recall that affects more than 87,700 units in total. Dublin-based Medtronic plc., said, however, that it is developing a software patch that will remedy the issue, a fix the company said will emerge in late 2022.
After five years, the U.S. FDA finally released a final rule for over-the-counter hearing aids along with an associated guidance, a development that was stipulated by the FDA Reauthorization Act (FDARA) of 2017. Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, was among several HHS officials who appeared on the Aug. 16 briefing to tout the rule, each of which promised that the rule would spark competition that would in turn take a significant bite out of the cost of acquiring a hearing aid.
It is one thing to watch a U.S. FDA inspection fail to meet with the agency’s expectations regarding compliance with the Quality System Regulation, but it’s another to have four opportunities to respond to the inspectional findings and still end up with a warning letter.
The U.S. FDA granted Preceptis Inc. an expanded clearance for its Hummingbird Tympanostomy Tube System for office-based pediatric ear tube procedures. The device was previously cleared in children 6-24 months, but the new clearance allows in-office procedures in all children six months and older. The minimally invasive device is designed to create an incision so the ear tube can be delivered using a single pass down the ear canal, without the use of general anesthesia.
The controversies over the use of ethylene oxide (EtO) as a medical device sterilant were quelled by the COVID-19 pandemic, but the U.S. Environmental Protection Agency (EPA) has resurrected the issue.
The U.S. FDA’s breakthrough devices program has engendered a tremendous amount of interest on the part of industry, but an Aug. 2 report by the law practice of Epstein Becker & Green P.C., suggests that the value of the program may be overblown. The report states that only 44 of the more than 600 devices that have been granted access to the program have successfully emerged – a number that was updated Aug. 3 by the FDA to 54 – which is still a rate that suggests that the breakthrough devices program might not be as helpful as billed.
The U.S. FDA posted notice of a class I recall for two hemodialysis catheters made by Covidien Inc., the Palindrome and Mahurkar catheters, due to a catheter hub defect that could lead to mixing of venous and arterial blood. No deaths and only one injury have been reported in connection with the defect, but the recall affects more than 1 million devices that went into distribution starting in June 2017, one of the numerically larger recalls in recent years.
The U.S. FDA has proposed to down-classify optical diagnostic devices and electrical impedance spectrometers from class III to class II, but there was little support for such a change in the first day of a two-day advisory hearing. The panelists saw the risk of a false negative for melanoma as too high to allow such devices to go through the 510(k) program, and thus manufacturers of these devices may continue to be required to file PMAs, replete with costly studies and long timelines to approval.
