Quidel Corp. (NSDW:QDEL) announced that it received FDA emergency use authorization (EUA) for its Solana SARS-CoV-2 assay. San Diego-based Quidel’s Solana SARS-CoV-2 assay is an isothermal reverse transcriptase-helicase-dependent amplification (RT-HDA) assay designed for the qualitative detection of nucleic acid from the virus causing COVID-19 in nasopharyngeal and nasal swab specimens, according to a news release. Testing […]
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.
FDA adds to pandemic-related shortage list
The FDA today announced new shortages of laboratory testing supplies needed for the COVID-19 pandemic and renewed its shortage listing for several types of personal protective equipment (PPE). Newly categorized as being in short supply are micro-pipettes and what the agency described as general-purpose lab equipment. Read the full list on our sister site, Medical […]
Philips wins $2.8M from DoD for early COVID-19 detection tech
The U.S Defense Department has selected Royal Philips (NYSE:PHG) and BioIntelliSense to receive nearly $2.8 million. Amsterdam-based Philips (which has its U.S. base in Cambridge, Mass.) was selected by the DoD through a Medical Technology Enterprise Consortium (MTEC) award to validate BioIntelliSense’s FDA-cleared BioSticker device for the early detection of COVID-19 symptoms, according to a news […]
Report: Higher error rate seen in use of pulse oximeters with Black patients
Pulse oximeters, a handy tool to measure oxygenation issues and elevated heart rates, are reportedly more error-prone with Black patients. The New York Times reported that, based on a study that had its findings shared with the New England Journal of Medicine, the devices can provide misleading results in more than one out of 10 […]
11 COVID-19 therapies you need to know
The pharmaceutical industry launched a herculean effort to battle the COVID-19 pandemic early in 2020, developing an array of vaccines and other therapeutics while also identifying existing drugs suitable for treating patients sick with severe coronavirus infections. FDA recently granted emergency authorization to two SARS-CoV-2 vaccines and several other treatments. Here are 11 of the […]
BREAKING: Pfizer’s COVID-19 vaccine receives European authorization
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they received conditional authorization from European regulators. The European Commission confirmed that it granted a conditional marketing authorization for the vaccine developed by the two companies, making it the first available COVID-19 vaccine in the European Union. The news follows an earlier announcement that the companies had received […]
How Dexcom CEO Kevin Sayer is leading the company forward
Like most companies in 2020, Dexcom (NSDQ:DXCM) faced a number of challenges brought on by COVID-19, public unrest and more. Dexcom chairman, president & CEO Kevin Sayer had to prioritize the health of his employees over all else, while also keeping patients safe and somehow managing to keep the diabetes giant rolling as a business. “Anybody who […]
House Dems subpoena Azar, Redfield on questions of political pressure at CDC
A Congressional committee subpoenaed top Trump administration officials today, demanding documents they allege could show “extensive” pandemic-related political interference at the CDC. In a letter to Health and Human Services secretary Alex Azar and Centers for Disease Control and Prevention director Dr. Robert Redfield, House Democrats said an investigation showed that efforts to interfere with […]
BREAKING: FDA grants emergency use authorization to Moderna COVID-19 vaccine
FDA has decided to permit emergency use of Moderna’s (NSDQ:MRNA) mRNA-1273 COVID-19 vaccine. A week ago, FDA granted the same designation for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). The U.S. government will collaborate with the company to distribute the vaccine. Although the EUA permits the vaccine to be used in individuals 18 and older, medical workers […]
SEC charges diagnostics company with fraud over COVID-19 test claims
The SEC announced charges against Decision Diagnostics (OTCMKTS:DECN) and its CEO, alleging false and misleading claims over a COVID-19 blood test. Westlake Village, Calif.-based Decision Diagnostics and its CEO Keith Berman are alleged to have made the claims in numerous press releases, saying that the company had developed a working, breakthrough technology for detecting COVID-19 […]
MedTech 100 roundup: Industry peaks again after new vaccine authorization
Recent news in the industry continues to drive its stocks forward, with COVID-19 vaccine developments driving further medtech growth last week. The FDA granted Moderna emergency use authorization for its vaccine candidate on Friday and its rollout to the U.S. is beginning today. Moderna’s vaccine joins the one made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), which […]