TORONTO – Toronto-based Sqi Diagnostics Inc. has reported significant clinical progress developing three novel COVID-19 tests for submission for U.S. FDA emergency use authorization.

The U.S. FDA has granted emergency use authorization (EUA) to Genscript USA Inc. for its Cpass SARS-CoV-2 Neutralization Antibody Detection Kit, the first commercially available test to detect neutralizing antibodies in individuals previously infected with the novel coronavirus. The serology test measures levels of neutralizing antibodies in samples from patients recovering from COVID-19 as well as people vaccinated against the SARS-CoV-2 virus.

The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.

The controversy over the U.S. FDA’s authority to regulate lab-developed tests (LDTs) took on a new set of considerations due to the COVID-19 pandemic. However, a June 22 memo by HHS General Counsel Robert Charrow pokes holes in the FDA’s argument on several fronts. Among these is the question of whether an LDT can be regulated by the FDA, given that a test is not usually offered for sale across state lines.

The COVID-19 pandemic has affected the U.S. FDA on the postmarket side as well as on the premarket side, but the focus of pandemic-driven warning letters has shifted over time. Amanda Johnston, senior attorney at Gardner Law of Stillwater, Minn., said on a Nov. 5 webinar the FDA’s emphasis lately has been closer to the agency’s traditional enforcement considerations after an initial wave of warnings dealing with flatly fraudulent products.

The U.S. FDA has granted breakthrough device designation to Salvia Bioelectronics BV for its implantable neurostimulation system to treat chronic migraine. The designation, which provides for priority review and consultation with the agency on product development, underscores the need for effective treatments for the costly and debilitating condition. According to a summary in a patent filing, the wireless system comprises a treatment pulse generator unit and an implantable electrode unit to provide neurostimulation therapy for headaches.

Boston Scientific Corp. has scooped up an approval from the U.S. FDA for the Ranger drug-coated balloon to help those with peripheral artery disease in the superficial femoral artery and proximal popliteal artery.