The U.S. FDA has rewritten the emergency use authorization (EUA) for the Laboratory Corp. of America Holdings Inc. (Labcorp) COVID-19 polymerase chain reaction (PCR) test to allow for diagnostic testing of those who are asymptomatic and those who have no reason to suspect they are infected with the SARS-CoV-2 virus.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Fortress Diagnostics, Lemaitre Vascular, MedPAC.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Color, Labcorp, Rapid Medical, Stratus Medical, Zebra Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atox, Bruker, Cell and Gene Therapy Catapult, Cpi, Healthimation, Masimo, Microfluidx, Nanthealth, Nemaura, OpenNMS, Orcam, Perimeter Medical Imaging, Telix Japan, Transenterix, Wishbone Medical.
The question of screening for the COVID-19 pandemic continues to absorb the interest of both the U.S. FDA and test developers, and Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said in a July 22 webinar that the FDA is “very interested” in a fingerstick test at the point of care for screening purposes, adding that the agency sees any such applications as a priority.
Edwards Lifesciences Corp. reported better-than-expected results when it released its second quarter earnings late July 23, with revenue down 15% to $924 million, from $1.1 billion in the same period of 2019. The results beat Wall Street consensus of $797.5 million, and reflected an uptick in surgical procedures that had been delayed by the COVID-19 pandemic. The Irvine, Calif.-based company sustained a net loss of $121.9 million, or $0.20 per share, based on generally accepted accounting principles (GAAP), a sharp drop from $242.3 million, or $0.38 per share, in the same quarter last year. However, adjusted earnings looked brighter at $0.34 per share.
Keeping you up to date on recent developments in neurology, including: Novel drug delivery particles use neurotransmitters as a 'passport' into the brain; SARS-CoV-2 infection of non-neuronal cells, not neurons, may drive loss of smell in patients with COVID-19; Pandemic to accelerate adoption of electronic patient portal for epilepsy.
With no new cases reported for more than 100 days, Taiwan appears to have successfully contained the spread of COVID-19 and has drawn attention to its medical achievements. Experts said at BIO Asia-Taiwan conference this week that with continuous government and investor support, the East Asian nation could move further up to join other leading biotech players.
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