PharmaJet announced today that its partner, Technovalia, reported positive interim safety results from a needle-free COVID-19 vaccine trial. Golden, Colorado–based PharmaJet’s needle-free injection systems are being studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. Enrollment for the trial began in June 2021. Get the full story […]
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 resumes inspections in U.S. as omicron cases decline
The FDA announced that it is set to resume conducting domestic surveillance inspections after a brief postponement. In December, the agency confirmed temporary changes to inspectional activities due to COVID-19 as the omicron variant of the virus led to surges across the world. The FDA implemented the changes in the U.S. on Dec. 29, 2021, […]
Thermo Fisher launches PCR testing platform that detects COVID-19 pathogens in the air
Thermo Fisher Scientific (NYSE:TMO) announced today that it launched a new rapid environmental COVID-19 diagnostic platform. Waltham, Massachusetts-based Thermo Fisher designed its Renvo rapid in-air pathogen PCR test for detecting the virus on air samples collected through the company’s Thermo Scientific AerosolSense Sampler. According to a news release, the company designed the test for environmental […]
Labcorp launches on-demand platform for purchasing diagnostics
Labcorp (NYSE:LH) announced today that it launched Labcorp OnDemand to ease the experience of using the company’s diagnostics. Burlington, North Carolina-based Labcorp’s Labcorp OnDemand provides a platform on which individuals can purchase tests online, collect samples in their own home or schedule test appointments at one of Labcorp’s 2,000 patient service centers. The OnDemand platform […]
Could nasal vaccines be the next big weapon against COVID-19?
Because of the way they provide protection, nasal vaccines could be the best long-term way to prevent COVID-19 infection, according to experts cited in The New York Times. The Times reported that India-based Bharat Biotech, which has the Covaxin COVID-19 vaccine authorized in India and elsewhere, has an experimental COVID-19 nasal vaccine that may offer […]
Study bolsters case that vaccines protect against long-COVID
It may be too soon to know how often the omicron variant is associated with so-called long-COVID, but research from the Leavitt Partners’ COVID-19 Patient Recovery Alliance confirms that vaccination protects against the condition. Those who received at least one authorized COVID-19 vaccine dose before diagnosis were between seven and 10 times less likely to […]
FDA fully approves Moderna’s COVID-19 vaccine
Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine. FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second […]
Super bright X-rays offer insights into how COVID-19 damages the lungs
An international team has used super-bright X-rays to capture intricate details of COVID-19 lung damage — and much more. Their technique — called Hierarchical Phase-Contrast Tomography (HiP-CT) — relies on X-rays from the European Synchrotron Research Facility particle accelerator in Grenoble, France. Following its Extremely Brilliant Source upgrade (ESRF-EBS), European Synchrotron can produce X-rays 100 […]
How Phillips-Medisize helped Sotech Health develop a breath analyzer for COVID-19
Medtech contract manufacturing giant Phillips-Medisize used its human-factors product design expertise to help startup Sotech Health create what the companies claim is a breath sensor system that can detect COVID-19 in less than 30 seconds. Dallas-based Sotech Health has submitted the device to the FDA for an emergency use authorization. It’s also seeking regulatory nods in Canada, […]
Intuitive posts Street-beating Q4 despite COVID-19-related procedure disruptions
Intuitive (Nasdaq: ISRG) shares are down today despite fourth-quarter results that topped the consensus forecast. Despite Street-beating results, the Sunnyvale, California–based robotic surgery technology developer also reported that COVID’s omicron wave is affecting procedure volumes. Intuitive posted profits of $380.6 million, or $1.04 per share, on sales of $1.6 billion for the three months ended […]
Markey wants COVID-19 test-makers to lower prices
Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece. In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can […]
