Hologic (NSDQ:HOLX) is spending $50 million — including $14 million during its most recent quarter — to boost its production of COVID-19 tests. The U.S. government is providing $7.6 million to support the effort. The investment, which CEO Stephen MacMillan outlined during a July 29 earnings call, includes installation of new high-speed filling lines and investment […]
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 issues EUA for Helix COVID-19 NGS test
Helix announced today that it received FDA emergency use authorization (EUA) for its Helix COVID-19 next-generation sequencing (NGS) test. San Mateo, Calif.-based Helix’s NGS test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 (the virus causing coronavirus) in upper respiratory specimens from individuals suspected of having COVID-19 by their healthcare provider, according […]
FDA revokes Autobio antibody test EUA
The FDA issued a letter announcing that it revoked the emergency use authorization (EUA) for a COVID-19 test from Autobio Diagnostics. Autobio’s SARS-CoV-2 rapid antibody test received EUA on April 24 for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood or serum. Authorization for the […]
MedTech 100 roundup: Another high as stocks tick up
For the third consecutive week, stocks in the medtech industry reached heights not yet seen since the COVID-19 pandemic began. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.65 points at the end of last week (Aug. 7). Overall, medtech stocks saw a 0.72% increase from […]
DTW Podcast: 10 ways medtech is finding its footing amid COVID-19
When COVID-19 set upon the U.S. in March, medtech executives had a month at most to tell Wall Street analysts how the pandemic had hit the industry’s largest companies. We heard about short-term hits in revenues, procedures and employee headcounts, but uncertainty clearly ruled the day. Over the past few weeks, medtech executives from several […]
Pfizer to make Gilead’s remdesivir COVID-19 treatment
Pfizer (NYSE:PFE) announced today that it entered into a multi-year agreement with Gilead Sciences (NSDQ:GILD) to manufacture and supply its antiviral remdesivir treatment. The investigational antiviral remdesivir will be manufactured by Pfizer under the agreement as the company becomes one of the multiple external manufacturing organizations supporting efforts to scale up the supply of the investigational treatment for […]
Cardinal Health dips on mixed bag Q4
Cardinal Health (NYSE:CAH) shares took a hit today on fourth-quarter results that came in mixed compared to the consensus forecast. The Dublin, Ohio-based company posted profits of $656 million, or $2.23 per share, on sales of $36.7 billion for the three months ended June 30, 2020, more than doubling its bottom line despite a sales decline […]
Axonics beats on Q2 earnings despite losses
Axonics Modulation Technologies (NSDQ:AXNX) shares dipped slightly today on second-quarter results that beat the consensus earnings forecast. The Irvine, Calif.-based sacral neuromodulation (SNM) device maker posted losses of -$19.8 million, or -54¢ per share, on sales of $15.1 million for the three months ended June 30, 2020, for a -3.8% bottom-line slide on massive sales growth […]
Insulet up on Street-beating Q2, raised guidance
Insulet (NSDQ:PODD) shares ticked up today on second-quarter results that topped the consensus forecast. The Acton, Mass.-based wearable insulin delivery system developer posted profits of $14.4 million, or 22¢ per share, on sales of $226.3 million for the three months ended June 30, 2020, for a bottom-line gain of nearly ten times as much as last […]
FDA issues EUA for Vela Diagnostics COVID-19 PCR test
Vela Diagnostics announced that it received FDA emergency use authorization (EUA) for the manual version of its coronavirus PCR test. Fairfield, N.J.-based Vela designed its COVID-19 diagnostic to target conserved regions of the viral genome so the probe-based reverse transcription PCR test detects SARS-CoV-2, the virus causing COVID-19. The ViroKey test is conducted through nasopharyngeal […]
Koru Medical slides on missed earnings forecast
Koru Medical Systems (NSDQ:KRMD) shares dipped today on second-quarter results that missed the consensus earnings forecast. The Chester, N.Y.-based infusion system developer posted losses of -$1.1 million, or -3¢ per share, on sales of $7.7 million for the three months ended June 30, 2020, for a bottom-line slide into the red despite sales growth of […]