After rising more than 31 points to heights never before reached, the medtech industry returned to normal this past week. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 23) at 115.54 points, a total that, had it not been for the previous week, would […]
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.
How COVID-19 changed medical device clinical trials forever
The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials. DeviceTalks Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on […]
Pfizer-BioNTech to provide U.S. with another 200M shots for kids, boosters
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine. Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In […]
COVID-19 testing boosts Abbott in Street-beating Q2
Abbott (NYSE:ABT) shares took a small dip despite second-quarter results that topped the consensus forecast. The Abbott Park, Ill.-based company posted profits of $1.2 billion, or 66¢ per share, on sales of $10.2 billion for the three months ended June 30, 2021, for a more-than doubled bottom-line on sales growth of 39.5%. Adjusted to exclude […]
J&J beats The Street in Q2, raises guidance
An accelerated rebound in medical device sales helped drive Johnson & Johnson (NYSE:JNJ) second-quarter results that topped the consensus forecast. The New Brunswick, N.J.-based company posted profits of $6.3 billion, or $2.35 per share, on sales of $23.3 billion for the three months ended June 30, 2021, for a 73.1% bottom-line gain on sales growth […]
Diversified Medical Healthcare acquires RapidRona and its COVID-19 diagnostic tests
Diversified Medical Healthcare today announced that it has acquired RapidRona and its home wellness testing portfolio. RapidRona received emergency use authorization in December last year for its SARS-CoV-2 diagnostic test. The home test uses a network of CLIA certified laboratories throughout the U.S. to deliver results to a patient in 48 hours or less. “We […]
Abbott laying off hundreds of workers as COVID-19 testing demand drops
Abbott (NYSE:ABT) is reportedly laying off as many as 400 workers in Maine as a result of a drop in demand for its COVID-19 diagnostics. WMTW-TV in Portland, Maine reported that about 300 Abbott employees will be laid off in Westbrook, as confirmed by the town’s mayor. Additionally, the station reported that about 100 workers […]
SEC claims Parallax Health Sciences, execs misled about COVID-19 tests, PPE
The SEC announced today that it levied a complaint against Parallax Health Sciences and two top executives for making allegedly misleading statements about COVID-19-related products. Without admitting or denying the allegations, Parallax, its CEO Paul Arena, and CTO Nathaniel Bradley consented to judgments permanently enjoining them from future violations of the charged provisions and requiring […]
Eurofins launches COVID-19 testing network to facilitate European travel
Eurofins announced today that it opened a network of about 500 COVID-19 testing centers across Europe to help facilitate summer travel. Luxembourg-based Eurofins’ network covers major traveling hubs to provide testing accessibility in locations ranging from supermarkets to business parks and residential areas, too. According to a news release, the company’s 500-center network is already […]
FDA revokes EUAs for certain respirators, decontamination systems after increased N95 access
The FDA issued a briefing confirming the revoking of emergency use authorizations (EUAs) for certain respirators and decontamination systems. EUAs for all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, including disposable respirators like KN95s, along with decontamination and bioburden reduction systems, were all revoked, having been issued amid the COVID-19 pandemic. According […]
PharmaJet begins enrollment for needle-free COVID-19 vaccine trial
PharmaJet announced today that it began enrollment for a Phase 1 clinical trial for its needle-free COVID-19 vaccine in Australia. Golden, Colo.-based PharmaJet’s needle-free injection systems will be studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. Get the full story at our sister site, Drug Delivery […]