Avanos Medical Inc. recalled 1,000 units of two of its Ballard Access suction systems for use in clearing artificial airways in neonatal and pediatric patients because of multiple complaints of cracked device manifolds. The recall affects 1,000 units distributed in the U.S. between October 2022 and January 2023, but this is the second recall of Avanos products in less than a year.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is a groundbreaking guidance that was enabled by legislation that allows the filing of PCCPs with all device types, not just software as a medical device (SaMD). However, a member of the FDA team acknowledged recently that this new approach to device change management could require that the agency revisit existing guidances such as a guidance for when to file a new regulatory submission for 510(k) devices, thus heralding a series of guidance revisions that may take several years to unwind.
Two tough years have taken a toll on Medtronic plc with a warning letter for its diabetes unit, a reorganization that will spin off its respiratory, patient care and renal groups and layoffs of an undisclosed number of employees that began last week. The announcement late Friday of the U.S. FDA approval of the Minimed 780G insulin pump system could be a turning point for the company that brings it back into the competition for the growing diabetes market.
Reach Neuro Inc. has been granted FDA breakthrough device designation for a rehab platform that delivers small electrical impulses to the spinal cord to help restore shoulder, arm and hand movement to individuals suffering from chronic stroke. The company said Avantis restores a patient's ability to control movement, not only giving the patient immediate relief, but making it possible to return to therapy and continue making even further improvements.
Rapidai Inc. received FDA 510(k) clearance for its Rapid NCCT Stroke technology, the latest tool in its portfolio of non-contrast-based solutions for shock and trauma care. The company claims it is the first and only medical device cleared by the agency to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging.
There are worse things for U.S. FDA-regulated companies than a warning letter from the agency, but both Abbott Point of Care Canada Ltd., and North American Diagnostics LLC were hit with a warning letter that included citations for failure to comply with the Quality System Regulation (QSR). North American may have believed it was no longer required to comply with the QSR as it ceased the manufacture of its COVID-19 rapid antigen test kits in July 2021, but the FDA advised the company that compliance is required so long as there is some chance that an adverse event arises in connection with the company’s product.
The U.S. FDA has cleared Aroa Biosurgery Ltd.’s 510(k) for its Enivo pump and catheter, which are key components of the company’s new Enivo tissue apposition platform. The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery. It has been cleared for use in removing surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
Neuromod Devices Ltd. will use the €30 million (US$ 32.78 million) financing it recently raised to launch its tinnitus treatment device, Lenire, in the U.S. where there are an estimated 50 million Americans suffering from tinnitus, CEO, Ross O’Neill, told BioWorld. “To get this financing closed is very exciting as we go into the U.S. market which is the biggest hearing market in the world,” he added.
The U.S. FDA has finalized a guidance for class II devices for treatment of peripheral artery disease that excludes drug-coated balloons (DCBs), which are regulated as class III devices. One of the issues the med-tech industry may have with the guidance is that it fails to acknowledge that a device accessory is in some instances exempt from the requirements of the 510(k) program even though the agency has a policy specific to that consideration.
Abbott Laboratories Inc. landed U.S. FDA clearance for its Freestyle Libre 3 integrated continuous glucose monitoring system (CGM)’s reader device a bit earlier than expected. With the regulatory greenlight for the durable medical equipment component received, the company is now pursuing coverage by the CMS for the entire Freestyle Libre 3 system. The system’s sensor received FDA clearance in May 2022.
