As more COVID-19 antibody testing becomes available, one question has been on everybody’s mind: Does the presence of antibodies to SARS-CoV-2, the virus responsible for the global pandemic, mean that people are protected from future infection? To that end, Genscript Biotech Corp., of Piscataway, N.J., has applied for emergency use authorization (EUA) with the U.S. FDA to market a test that specifically recognizes neutralizing antibodies to SARS-CoV-2. Read More
The latest U.S. FDA town hall for testing for the COVID-19 included a few updates on serological testing, but perhaps the most important take-away was when Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiology, advised attendees that performance expectations regarding next-generation sequence (NGS) testing for the SARS-CoV-2 virus will closely resemble those of conventional molecular testing. Read More
Hesperos Inc.'s Human-on-a-Chip in vitro system demonstrated two types of responses of the immune system in a study conducted with Hoffman-La Roche Pharmaceuticals and the University of Central Florida. Read More
Westport, Conn.-based Lumendi LLC revealed that the first endoscopic appendectomy has taken place using its Dilumen Endolumenal Interventional Platform (EIP). The procedure represents a change from traditional appendectomies, which are performed through open or laparoscopic surgery, requiring an incision of the abdominal wall. Read More
TORONTO – Toronto-based Epineuron Technologies Inc. reported the completion of a financing round to develop and clinically validate neuroregenerative technology intended for the recovery of patients suffering from peripheral nerve injuries. Designated a breakthrough device by the U.S. FDA, the “nerve bandage” uses brief bioelectronic stimulation of injured nerves to “upregulate” associated genes that accelerate nerve regeneration. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Fractyl, Surgical Information Sciences. Read More
Keeping you up to date on recent developments in orthopedics, including: IMPACT study shows 25% reduction in health care costs associated with earlier prosthetic care; Human growth hormone treatment after ACL injury may prevent loss of muscle strength; Osteoporosis treatment may also protect against pneumonia. Read More
