Meridian Bioscience (Nasdaq:VIVO) announced today that the FDA re-authorized the emergency use authorization (EUA) for its COVID-19 test. Cincinnati-based Meridian received EUA from the FDA on Nov. 10, 2021, for its Revogene SARS-CoV-2 assay. Following authorization, it was determined that the original design of the assay would not detect the Omicron variant, leading Meridian to […]
COVID-19
Masimo’s SafetyNet monitoring reduced length of COVID-19 hospital stays, study says
Masimo (Nasdaq:MASI) announced that a two-part retrospective study demonstrated the impact of its SafetyNet monitoring system. Irvine, California-based Masimo’s study, led by Dr. Hemali Patel and colleagues at the University of Colorado and UC Health (UCH) in Aurora, Colorado, evaluated the impact of remote patient monitoring of COVID-19 patients using SafetyNet on hospital length of […]
BD launches combination COVID-19, flu, RSV diagnostic test
BD (NYSE:BDX) today announced it has launched a new molecular diagnostic combination test for SARS-CoV-2, influenza A and B and respiratory syncytial virus (RSV) following CE mark approval. The BD Max test uses a single nasal swab or nasopharyngeal swab sample to determine if a patient has COVID-19, the flu or RSV. Franklin Lakes, N.J.-based […]
Dexcom focuses on early diabetes diagnosis as COVID links emerge
New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s […]
How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff […]
Former SCWorx CEO indicted over alleged COVID-19 rapid tests scheme
The U.S. Dept. of Justice announced that Marc Schessel of SCWorx was indicted for charges related to an alleged COVID-19 test scheme. Schessel, the former CEO of the New York-based company, was charged with two counts of securities fraud for his alleged participation in a scheme to mislead investors about SCWorx’s procurement of COVID-19 rapid […]
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data support a three-dose primary series of their COVID-19 vaccine in young children Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong immune response and […]
Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body. What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection, […]
FDA authorizes Labcorp’s non-prescription COVID-19 test that also detects flu, RSV
The FDA authorized Labcorp’s seasonal respiratory virus RT-PCR DTC test for use without a prescription. Individuals with symptoms of respiratory viral infection consistent with COVID-19 can use the seasonal respiratory virus test that can identify and differentiate multiple respiratory viruses at the same time, which marks the first direct-to-consumer, multi-analyte COVID-19 test authorized by FDA. […]
Lucira Health asks FDA for EUA on molecular at-home COVID/flu test
Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test. Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a […]
Intuitive shares dive as first-quarter profits fall short
Intuitive (Nasdaq: ISRG) posted first-quarter financial results that fell short of the consensus forecast on Wall Street for earnings, but exceeded analysts’ expectations for sales. CEO Gary Guthart and CFO Jamie Samath discussed their efforts to address inflationary and supply chain challenges, with sole-source suppliers on their minds as they ramp up manufacturing capacity. (Go […]