Wearables giant Fitbit Inc. has kicked off its first large-scale, virtual study to evaluate how well its wrist-worn technology can spot episodes of irregular heart rhythm that might indicate atrial fibrillation (AF). The study, part of a broader plan to equip Fitbit devices with new tools to speed the detection of a range of conditions, is open to people in the U.S. ages 22 and older who own a Fitbit that tracks heart rate. Read More
The U.S. FDA continues to modify its emergency use authorization (EUA) policy for testing for the SARS-CoV-2 virus, although workplace testing is still on the agency’s to-do list. The FDA’s Tim Stenzel noted on a May 6 briefing that serological tests for antibodies must now demonstrate an overall sensitivity of 90% and overall specificity of 95%, a set of standards that might challenge some tests that are available under the EUA policy. Read More
Stem cells haven’t exactly panned out as hoped when it comes to approved therapeutics. There are only a couple that have received a nod from the FDA in very specific indications. But the ongoing COVID-19 pandemic could push stem cells back into the limelight and more firmly establish them as therapeutically relevant. Read More
Brisbane, Calif.-based Caredx Inc. has reported a strategic alliance with Weill Cornell Medicine that makes the company the exclusive development and commercialization partner for Uromap, a urine-based gene-expression test for acute cellular rejection in kidney transplant recipients. Read More
After a long approval process, Monmouth Junction N.J.-based Cytosorbents Corp. received clearance to bring its Cytosorb blood purification technology to treat cytokine storm and deadly inflammation in critically ill and cardiac surgery patients, to the Mexican market. The COVID-19 pandemic may delay marketing plans to roll-out the product in the Latin American country. Read More
Even as the world grapples with COVID-19, researchers and public health officials are trying to apply its lessons to future outbreaks. In our series “The next pandemic,” BioWorld explores the strategies and technologies that could improve the fight against future outbreaks, from robust surveillance to rapid vaccines. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Headsafe, Foundation Medicine, Setpoint Medical. Read More
Keeping you up to date on recent developments in orthopedics, including: Scientists regenerate neurons in mice with spinal cord injury and optic nerve damage; Trial questions benefits of organic nitrates for bone health; Mind-controlled arm prostheses that 'feel' are now a part of everyday life; Biomaterial immune control discoveries could reduce implant rejection. Read More
