The opioid crisis in the U.S. has not yet been resolved, but FDA commissioner Robert Califf said April 19 the agency could do more to resolve the crisis if Congress granted the agency the authority to require that new opioid analgesics offer superior safety relative to currently approved products. Califf laid the blame for the crisis on manufacturers in stating that drug makers had “let us down” in failing to develop novel oral analgesics that avoid the addictive properties that helped to fuel the opioid crisis.
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.
Andera Partners led a $48.5 million series A financing round for Bioventrix Inc. which will allow the medical device company to complete its premarket approval (PMA) submission for the Revivent TC system. Andera joined Cormorant Asset Management and Squarepoint Capital as new investors in Bioventrix. Existing investors, Taglich Brothers Inc. and Richmond Brothers, also contributed to the fundraising.
Seemingly in response to the release of a proposed rule for ethylene oxide emissions by the U.S. Environmental Protection Agency, the U.S. FDA has released a second pilot program for device master files for sterilization of medical devices. This program is for single-use PMA devices only made by nine companies and allows the manufacturer or sterilizer to document the switch to radiation sterilization with an expedited review process.
Developers of clinical decision support (CDS) software have their hands full with a recent U.S. FDA final guidance on these products, but the picture promises to become more byzantine with the publication of a draft rule by the Office of the National Coordinator (ONC). The new ONC proposal would require a demonstration of transparency for decision support intervention (DSI) predictive functions in order for that software to qualify for ONC certification, a requirement that might not overlap neatly with the FDA’s own transparency requirements.
The U.S. FDA has granted de novo authorization to Moximed Inc. for its Misha knee system, a first-of-its-kind implantable shock absorber for people suffering from osteoarthritis (OA) of the knee. The device is intended to relieve pain and improve daily function in patients ineligible for, or not ready to undergo, joint replacement.
