The U.S. Health and Human Services Dept. and Defense Dept. announced a joint agreement with Novavax (NSDQ:NVAX) worth $1.6 billion to scale the manufacturing of its COVID-19 vaccine candidate. Gaithersburg, Md.-based Novavax’s commercial-scale manufacturing is expected to produce 100 million doses of the investigational vaccine that would become available for use in clinical trials or, should the […]
FDA warns of false positives with certain COVID-19 tests from BD
The FDA issued a statement today warning on an increased risk of false positive results with the BD Max System SARS-CoV-2 tests from Becton Dickinson (NYSE:BDX). The agency is alerting clinical laboratory staff and healthcare providers to the risk after a study in which the manufacturer found that approximately 3% of results from the BD SARS-CoV-2 […]
BD launches COVID-19 antigen test that can produce results in 15 minutes
Becton Dickinson (NYSE:BDX) announced today that it’s received an FDA emergency use authorization for its COVID-19 antigen test, which the company will start shipping this week. BD plans to ramp-up manufacturing capacity to 2 million tests per week by the end of September, with 10 million tests produced by the end of September. The tests run […]
Conformis expects 50% drop in Q2 product revenue
Joint replacement implant maker Conformis (NSDQ:CFMS) said today that it anticipates a COVID-19-influenced 50% year-over-year drop in second-quarter product revenue. Releasing its preliminary results for the quarter ended June 30, the Billerica, Mass.-based company projected total revenue of $19.5 million for the quarter, which is down -1% year-over-year on a reported and constant currency basis. About […]
Thermo Fisher projects 10% increase in Q2 sales
Thermo Fisher Scientific (NYSE:TMO) announced today that it estimates revenue growth for its recently ended second quarter to total approximately 10%. Waltham, Mass.-based Thermo Fisher said in a news release that its reported and organic sales growth for the quarter (ended June 27) was primarily driven by global sales of PCR-based tests and other products and services supporting […]
MedTech 100 roundup: Stocks tick back up to open July
After a solid start to July, the medtech industry continues to experience a stock market roller coaster amid the COVID-19 pandemic. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 84.25 points at the end of last week (July 3). That total represents a 2.9% increase from […]
Haemonetics’ blood-collection devices could leave particles in donors, report says
A consortium of news outlets is questioning the safety of Haemonetics (NYSE:HAE) blood-collection devices, claiming that particles have been detected in donors whose plasma was extracted by the machines. According to a report in the Miami Herald, whistleblower documents indicate that more than 150 Haemonetics customer reports have been made regarding the presence of particles by plasma […]
Smith College team wins ventilator design challenge
A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries. A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team […]
Eurofins launches 10-minute COVID-19 exposure testing device
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Eurofins’ CE-Marked INgezim dual-recognition immunochromatographic assays […]
Mayo Clinic needed to engineer its way through COVID-19: Here’s what they did.
The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination. As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier […]
Medical device litigation and COVID-19: What you need to know
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say, […]
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