New York-based at-home testing startup Letsgetchecked said Friday that the U.S. FDA has granted emergency use authorization (EUA) for its COVID-19 Sure-track Test for signs of active SARS-CoV-2 infection. The polymerase chain reaction (PCR) nasal swab test is for use by at-risk individuals in the home and delivers results within 24 hours of a sample being received by the company’s CLIA-certified laboratory.
Few would dispute that the best way to find innovative solutions to the COVID-19 pandemic is through industry, academia and government working together. BioWorld data indicate that more than 45% of the biopharma deals with nonprofit entities (bio/nonprofit) in 2020 are indeed focused on fighting the globally-disruptive SARS-CoV-2 virus.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baibies, Letsgetchecked.
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
Doctors are reporting a proliferation of dangerous blood clots in the lungs and other major organs of COVID-19 patients, raising the risk of stroke and other life-threatening complications. While anticoagulant medications can reduce that risk, patients need careful monitoring to ensure their blood is neither too thick nor too thin. To that end, Los Angeles-based startup Neural Analytics Inc. is deploying its robotically assisted transcranial doppler (TCD) system for real-time identification of blood clots and disruptions in blood flow to the brain.
Like many companies, Rewalk Robotics Ltd. saw its financials hit by the COVID-19 pandemic. It revealed May 28 that its total revenue for its first quarter fell to $0.8 million, down from $1.6 million during the same period last year. The company, which focuses on solutions that give gait training and mobility for individuals with lower limb disabilities, acknowledged the effects of the pandemic, noting that several Rewalk Personal 6.0 devices were not delivered as a result.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airos Medical, GE Healthcare, Gynesonics, Quest Diagnostics.
