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coronavirus

Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.

Masimo’s SafetyNet monitoring reduced length of COVID-19 hospital stays, study says

July 5, 2022 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Digital Health, Featured, Health Technology, News Well, Patient Monitoring, Software / IT Tagged With: coronavirus, COVID-19, Masimo

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

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

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

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

Johnson & Johnson rises on mixed bag Q1, increased 2022 guidance

April 19, 2022 By Sean Whooley

Johnson & Johnson (NYSE:JNJ) shares ticked up today on first-quarter results that were mixed compared to the consensus forecast. The New Brunswick, New Jersey-based company posted profits of $5.1 billion, or $1.93 per share, on sales of $23.4 billion in the first quarter for a 16.9% bottom-line slide on sales growth of nearly 5%. Adjusted […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, News Well, Pharmaceutical, Wall Street Beat Tagged With: coronavirus, COVID-19, Johnson & Johnson

FDA grants EUA for breathalyzer that detects COVID-19

April 15, 2022 By Chris Newmarker

The FDA has authorized the first COVID-19 diagnostic test that detects chemicals associated with an infection in a person’s breath. The company’s maker InspectIR (Frisco, Texas) expects to manufacture roughly 100 instruments per week, the FDA said in an announcement posted yesterday. The devices can each evaluate roughly 160 samples per day. Someone taking the […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: coronavirus, COVID-19, InspectIR

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