ClearMask announced today that it received FDA 510(k) clearance for its ClearMask fully transparent surgical mask for use in a number of settings. Baltimore-based ClearMask touts its surgical mask as the first FDA-cleared fully transparent surgical mask for use in hospitals, clinics, schools, retail, hospitality and other settings. The company said in a news release […]
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.
Report: Chinese government grants COVID-19 vaccine patent
Chinese pharmaceutical company CanSino Biologics‘ COVID-19 vaccine candidate has received a patent from the Chinese government — the first such patent granted in the country. Chinese state media outlet People’s Daily reported Sunday that the country’s National Intellectual Property Administration granted the patent for Ad5-nCoV, which uses a weakened human common cold virus to deliver […]
FDA warns on false results for Thermo Fisher TaqPath COVID-19 testing kit
The FDA today issued a warning for labs and healthcare providers due to a risk of false results with a Thermo Fisher Scientific (NYSE:TMO) COVID-19 test kit. Results from the Thermo Fisher TaqPath COVID-19 Combo Kit may be false, based on two issues related to the test kit and the associated Applied Biosystems COVID-19 interpretive software, […]
Feds ink COVID-19 vaccine distro deal with McKesson
The U.S. Dept. of Health and Human Services (HHS) and Defense Dept. (DoD) announced a COVID-19 vaccine distribution deal with McKesson. Under Operation Warp Speed, McKesson will become a central distributor of future COVID-19 vaccines and related supplies needed to administer the pandemic vaccinations, according to a news release. Get the full story at our sister […]
CureVac stock soars after $213.3M IPO
Shares of CureVac (NSDQ:CVAC) continue to rise after the company reportedly raised $213.3 million in its initial public offering on Friday. According to a report from MarketWatch, the Germany-based biotech outfit priced its IPO at $16 per share and sold more than 13.3 million shares to raise the $213.3 million. Currently, shares of CVAC are […]
FDA releases first pandemic supply shortage list
Months into the coronavirus pandemic, the FDA has released its first official list of shortages of items needed by healthcare workers. The list ranges from personal protective equipment (PPE) such as gowns and gloves to testing supplies and ventilation-related products for the sickest patients. The list also includes Becton Dickinson (NYSE:BDX) BodyGuard infusion pump and syringe […]
PerkinElmer launches high-volume COVID-19 test workstations
PerkinElmer (NYSE:PKI) announced today that it launched a series of Explorer workstations for increasing COVID-19 testing capabilities. Waltham, Mass.-based PerkinElmer touts its Explorer workstations as capable of preparing and running up to 10,000 COVID-19 tests per day, enabling laboratories to ramp up their testing for the SARS-CoV-2 virus causing coronavirus and generate quick results. Get the […]
FDA approves saliva test for COVID-19
Over the weekend, the FDA issued emergency use authorization (EUA) for the Yale School of Public Health’s SalivaDirect COVID-19 test. Yale’s diagnostic test uses a new method of processing saliva samples when testing for COVID-19 infection without requiring a special swab or collection device, as the saliva can be collected in any sterile container. The […]
MedTech 100 roundup: Up-and-down week for industry
Medtech stocks highlighted the topsy-turvy nature of the market last week, but ultimately finished the seven days nearly unchanged. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.77 points at the end of last week (Aug. 14). Overall, medtech stocks saw a 0.13% increase from the […]
Vietnam’s Vingroup to supply ventilator parts to Medtronic
When Medtronic (NYSE:MDT) announced in April that it had tapped Foxconn to manufacture ventilators at the Chinese company’s Wisconsin plant, then-Medtronic CEO Omar Ishrak said that Medtronic is also working with “major players” in Asia to expedite ventilator production. This week, Vietnam’s largest conglomerate, Vingroup, announced that it had inked a deal for two of its companies — […]
HHS puts $6.5M more toward COVID-19 testing
The U.S. Department of Health and Human Services (HHS) said today it will provide a total of $6.5 million to help two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional diagnostic tests for COVID-19 per month. The investments in Aegis Sciences (Nashville, Tenn.) and in Sonic Healthcare USA (Austin, Texas) […]