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 […]
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.
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 […]
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 […]
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. […]
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 […]
Takeda wins approval to distribute Novavax’s COVID-19 vaccine in Japan
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 […]
Moderna says bivalent COVID-19 boosters could offer more robust protection against variants
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. […]
Johnson & Johnson rises on mixed bag Q1, increased 2022 guidance
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 […]
FDA grants EUA for breathalyzer that detects COVID-19
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 […]
