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COVID-19

BD launches combination COVID-19, flu, RSV diagnostic test

June 30, 2022 By Danielle Kirsh

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, News Well Tagged With: BD, coronavirus, COVID-19

Dexcom focuses on early diabetes diagnosis as COVID links emerge

June 29, 2022 By Jim Hammerand

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 […]

Filed Under: Blog, Diabetes, Featured, News Well Tagged With: CGM, coronavirus, covid, COVID-19, Dexcom, diabetes

How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

June 22, 2022 By Jim Hammerand

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 […]

Filed Under: Blog, Clinical Trials, Dialysis, Featured, Food & Drug Administration (FDA), News Well, Pediatrics, Regulatory/Compliance, Research & Development Tagged With: covid, COVID-19, FDA, SeaStar Medical

Former SCWorx CEO indicted over alleged COVID-19 rapid tests scheme

June 2, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics, Legal News, News Well Tagged With: coronavirus, COVID-19, SCWorx

Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children

May 23, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Clinical Trials, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, Pfizer

Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says

May 18, 2022 By Jim Hammerand

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, […]

Filed Under: Blog, Cardiovascular, Featured, News Well, Patient Monitoring, Respiratory, Structural Heart, Transplants Tagged With: Abbott, covid, COVID-19, heart failure, lung failure

FDA authorizes Labcorp’s non-prescription COVID-19 test that also detects flu, RSV

May 17, 2022 By Sean Whooley

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. […]

Filed Under: Diagnostics, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, LabCorp

Lucira Health asks FDA for EUA on molecular at-home COVID/flu test

May 12, 2022 By Jim Hammerand

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 […]

Filed Under: Blog, Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, News Well, Regulatory/Compliance Tagged With: covid, COVID-19, FDA, influenza, Lucira, Lucira Health

Intuitive shares dive as first-quarter profits fall short

April 21, 2022 By Jim Hammerand

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 […]

Filed Under: Business/Financial News, Contract Manufacturing, Featured, MassDevice Earnings Roundup, News Well, Robotics, Surgical, Wall Street Beat Tagged With: coronavirus, COVID-19, Intuitive Surgical, Robotic Surgery

Takeda wins approval to distribute Novavax’s COVID-19 vaccine in Japan

April 20, 2022 By Brian Buntz

Takeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine. Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX). The approval covers the use of the vaccine as both a primary and booster immunization in adults at least […]

Filed Under: Featured, News Well, Pharmaceutical Tagged With: coronavirus, COVID-19, COVID-19 vaccine, Novavax, Nuvaxovid, NVX-CoV2373, Takeda

Moderna says bivalent COVID-19 boosters could offer more robust protection against variants

April 19, 2022 By Brian Buntz

Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine. A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine. […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, Moderna, mRNA-1273.211, SARS-CoV-2, variants of concern

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