The FDA has issued emergency use authorization (EUA) for a mobile COVID-19 test kit developed by handheld detection system maker DetectaChem. Stafford, Texas-based DetectaChem develops the MobileDetect Bio BCC19 test kit is designed to test for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal swabs, mid-turbinate nasal swabs and oropharyngeal swab specimens. […]
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.
T2 Biosystems wins EUA for COVID-19 molecular diagnostic test
T2 Biosystems (NSDQ:TTOO) announced that it received FDA emergency use authorization (EUA) for its COVID-19 test. Lexington, Mass.-based T2 Biosystems’ T2SARS-CoV-2 Panel is a molecular diagnostic test for detecting SARS-CoV-2, the virus causing COVID-19. The company said in a news release that the test is capable of providing results in under two hours using a nasopharyngeal […]
Smith & Nephew is using vibrating bracelets to encourage social distancing
Smith & Nephew (NYSE:SNN) is utilizing devices made by Tharsus to help with social distancing as the company returns to the office. A report in The Telegraph outlines how the London-based medtech company is being providing vibrating bracelets from Blythe, England-based Tharsus to keep the six-foot (two-meter) distance widely recommended for preventing the spread of COVID-19. Get the full story […]
Does plasma therapy work against COVID-19? NIH panel says data lacking
More than a week after the FDA granted an emergency use authorization (EUA) for the use of convalescent plasma against COVID-19, an NIH advisory panel is saying that there is insufficient data to recommend either for or against the treatment. The National Institutes of Health’s COVID-19 Treatment Guidelines Panel said in a statement released today: […]
Ventec, GM complete HHS ventilator contract
Ventec Life Systems and General Motors announced today that they completed their government contract to produce 30,000 ventilators. The two companies kicked off mass production of Ventec’s V+Pro critical care ventilator at GM’s Kokomo, Ind., plant in April, having received a $489.4 million contract from the U.S. Dept. of Health and Human Services to deliver […]
Philips ends ventilator distribution deal with HHS
Royal Philips (NYSE:PHG) announced today that the U.S. Dept. of Health and Human Servies partially terminated its ventilator manufacturing contract. Amsterdam-based Philips received the termination notice from HHS after agreeing to a contract in April to deliver 43,000 bundled EV300 ventilator configurations to HHS through December 2020 amid the COVID-19 pandemic. News of the contract termination […]
Thermo Fisher opens plant to make COVID-19 testing supplies
Thermo Fisher Scientific (NYSE:TMO) announced today that it has opened its $40 million manufacturing facility in Lenexa, Kan. The facility is dedicated to viral transport media (VTM) but will continue to expand to meet expected demand for COVID-19 testing, according to a news release. In May, Thermo Fisher received a U.S. government contract to provide a […]
Large study of rapid COVID-19 tests concludes with plea for more studies
A large review of the results from rapid point-of-care COVID-19 tests found inconclusive evidence of their accuracy and led to a plea for more studies. The researchers at Cochrane sought to determine if rapid point-of-care antigen and molecular tests for COVID-19 are accurate enough to replace RT-PCR tests, which require laboratory analysis to diagnose infection. […]
The top 5 MassDevice stories of the week — August 28, 2020
As earnings season concludes and the COVID-19 pandemic roars on, medtech companies continue to find new ways to make waves. This week’s top five MassDevice stories showcase how companies are operating in the “new normal,” as they look toward the post-pandemic future, whenever that may arrive. Strong quarterly earnings, big funding rounds and new innovations in […]
AstraZeneca denies it’s seeking an EUA for its COVID-19 vaccine candidate
AstraZeneca has denied news reports it’s involved in talks with U.S. authorities about an emergency use authorization for its COVID-19 vaccine candidate. The denial comes after recent news reports claiming the Trump administration is eyeing a plan to fast-track the vaccine candidate, AZD1222, before the upcoming Nov. 3 presidential election. “AstraZeneca has not discussed emergency […]
BREAKING: U.S. to reportedly pay Abbott $750M for new COVID-19 tests
Multiple reports have said President Trump will announce a $750 million deal with Abbott (NYSE:ABT) for 150 million of its rapid COVID-19 antigen tests. As first reported by Politico before being confirmed by other outlets, a White House official said that Trump will announce the deal tonight, using his speech at the Republican National Convention to […]