PerkinElmer (NYSE:PKI) said today that it anticipates sales growth of approximately 12% for the second quarter, fueled by demand for COVID-19 tests and related products. The Waltham, Mass.-based diagnostic and scientific instrument company said demand for its RT-PCR and serology tests, RNA extraction systems and kits and automated liquid handling instrumentation was particularly robust. COVID-19 related […]
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.
What kinds of COVID-19 tests are out there?
Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it. To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing […]
FDA plans to resume onsite inspections later this month
FDA has a goal of restarting on-site inspections during the week of July 20 — four months after it temporarily halted them — though there will be changes due to the COVID-19 pandemic. The agency today said that it will pre-announce inspections to FDA-regulated businesses. Said FDA: “This will help assure the safety of the […]
Philips launches new face scanning tech, partners with BioIntelliSense on telehealth
Royal Philips (NYSE:PHG) today announced two separate steps toward helping patients receive remote care as telehealth’s importance continues to grow. Amsterdam-based Philips said today that it launched its Philips Respironics mask selector 3D facial scanning system for fitting masks and formed a strategic collaboration with BioIntelliSense to monitor at-risk patients from the hospital into the home. […]
3M resolves N95 fraud case in Indiana
3M (NYSE:MMM) announced today that it has resolved a federal court lawsuit in Indiana against an entity called ZeroAqua, halting a fraudulent N95 scheme involving the promise of billions of nonexistent N95 respirators. The lawsuit was among a handful that 3M filed nationwide more than two months ago — part of a larger legal effort in […]
Boston researchers have created a potential N95 mask alternative
Brigham & Women’s Hospital says it is developing a new, sustainable alternative to N95 respirator masks that are in demand during the COVID-19 pandemic. A team of bioengineers and clinical experts at the Boston-based hospital and the Massachusetts Institute of Technology (MIT) are working on the “injection molded autoclavable, scalable, conformable” iMASC system for providing […]
U.S. investing $42m to boost BD syringe and needle production
HHS’s Biomedical Advanced Research and Development Authority is helping BD expand operations and manufacturing capacity in Nebraska to boost syringe and needle supplies for an eventual COVID-19 vaccine. Becton Dickinson (NYSE:BDX) said today that the total project will cost $70 million, with BARDA providing $42 million. The company expects the new capacity to be online within […]
U.S. paying Novavax $1.6b to ramp up COVID-19 vaccine manufacturing
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 […]