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. Read More
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. Read More
LONDON – Clinical genomics specialist Congenica Ltd. has raised $50 million in a series C round that will enable it to extend beyond its roots in rare disease diagnosis to personalized medicine in cancer, and health and wellness, while expanding its geographical reach. Read More
Preparing for a Biden presidency in which COVID-19 will be a top priority, the Joe Biden-Kamala Harris transition team named a board of scientists and public health experts Nov. 9 to advise the team on how to respond to the surging pandemic in the U.S. Read More
PERTH, Australia – Gbs Inc. reported filing an initial public offering on the Nasdaq for $20 million, as the company looks to launch the first noninvasive SARS-Cov-2 test. A subsidiary of Sydney-based The Iq Group Ltd. (NSX:IQG), Delaware-based Gbs has developed a biosensor platform that enables real-time diagnostic point-of-care (POC) tests, and the funds raised will enable the company to launch its SARS- CoV-2 test and a saliva glucose test. Read More
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. Read More
Wellcome Leap has launched its first program, dedicating $50 million to help develop human tissues, organoids and full organs. The Human Organs, Physiology and Engineering (HOPE) program is looking to bring biologists and engineers together to develop both therapeutic organs as well as organs that can be used in vitro to help discover and develop new medications. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akida, Applied UV, Apyx Medical, Cleveland Clinic, Concept Medical, Epic, Orbusneich, P+F, Protec Scientific. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medicine, Nightware, Nuvasive. Read More
Keeping you up to date on recent developments in cardiology, including: What is causing COVID-19 blood clots?; Using machine learning to predict survival rates with OHCA; Remote cardiac rehabilitation proves itself. Read More
