Johnson & Johnson (NYSE:JNJ) announced today that its Janssen Pharmaceutical subsidiary has moved up first-in-human clinical trials of its COVID-19 vaccine candidate to late July, versus the previously planned start in September. “Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to […]
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.
DOJ charges medtech exec with fraud over COVID-19 tests
The U.S. Dept. of Justice announced that it charged Arrayit president March Schena for alleged involvement with fraudulent claims for allergy and COVID-19 testing. In a news release, the DOJ alleged that Schena participated in schemes to mislead investors, manipulate Arrayit’s stock price and conspired to commit health care fraud in connection with the submission […]
Hologic says its Q3 financial outlook has improved
Hologic (NSDQ:HOLX) announced that the financial outlook for its current fiscal third quarter has improved since it reported its second-quarter results. In April, Hologic reported profits of $94.8 million, or 36¢ per share, on sales of $756.1 million for the three months ended March 28, falling in line with Wall Street projections. In the company’s report, […]
Illumina gains FDA EUA for sequencing-based COVID-19 test
Illumina (NSDQ:ILMN) announced that it received FDA emergency use authorization (EUA) for its COVIDSeq sequencing-based COVID-19 diagnostic test. COVIDSeq uses upper respiratory specimens, such as a nasopharyngeal or oropharyngeal swab, and delivers sample receipt to result in 24 hours with the NovaSeq 6000 sequencing system, according to a news release. Illumina’s high-throughput, in vitro diagnostic test […]
DOD chooses ExThera blood filter for COVID-19 trial
ExThera Medical announced today that the U.S. Defense Dept. selected its Seraph 100 Microbind affinity blood filter for a U.S.-based clinical trial. The randomized, controlled, multi-center trial will be funded by the DoD and run by investigators at the Uniformed Services University in Bethesda, Md. It comes on the back of encouraging preliminary results in […]
3M sues seller of fake and damaged N95 respirators
3M (NYSE:MMM) announced that it filed a legal action in federal court alleging that a seller on Amazon inflated prices of fake, defective and damaged N95 masks. N95 masks have been in high demand as the COVID-19 pandemic roars on. In April, the U.S. Defense Dept. awarded a $76 million contract to 3M to produce the respirators […]
BioMedInnovations gains EUA for ventilator
BioMedInnovations announced today that it received FDA emergency use authorization (EUA) for its SuppleVent ventilator technology. With the EUA, the SuppleVent system becomes the latest alternative ventilator to gain some form of authorization to assist during the COVID-19 pandemic. Denver, N.C.-based BioMedInnovations’ proprietary back-pressure regulator (BPR) technology was designed in collaboration with Lawrence Livermore National […]
Harvard’s Wyss Institute wants to create a COVID-19 antibody test strip
The iQ Group Global announced today that it has inked a collaboration with Harvard’s Wyss Institute to develop a printable point-of-care SARS-CoV-2 antibody test with real-time results. Life Science Biosensor Diagnostics, the iQ Group’s development company, has been working on the Australian-invented Biosensor Platform, a printable organic thin-film transistor “strip” that has the potential to provide a variety […]
Phosphorus wins FDA EUA for at-home COVID-19 saliva test
Phosphorus today announced it received FDA emergency use authorization for its COVID-19 saliva test for at-home sample collection. The test is the second at-home unsupervised saliva test approved by the FDA so far, according to the company. It is available by ordering online and is available through healthcare and employer partnerships. Saliva tests are simple […]
Sherlock Biosciences announces manufacturing partnership for CRISPR-based COVID-19 test
Sherlock Biosciences announced today that it will collaborate with Integrated DNA Technologies (IDT) to enable large-scale manufacturing of the Sherlock CRISPR SARS-CoV-2 kit for COVID-19 detection. Officials at Cambridge, Mass.–based Sherlock Biosciences think the company’s CRISPR-based diagnostic test, which recently received an FDA emergency use authorization, will increase testing capacity and decreasing time to result […]
MedTech 100 roundup: Stocks stand pat in June’s first week
While the markets experienced some growth over the past week, stocks in the medtech industry remained practically unchanged over seven days. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.15 points at the end of last week (June 5). That total represents just a -0.02-point decrease […]