The Global Center for Medical Innovation (GCMI) announced this week that it is entering into a collaboration with multiple entities to address the shortage of personal protective equipment (PPE) during the coronavirus outbreak. Atlanta-based GCMI is collaborating with Dr. Joanna Newton, a pediatric hematologist/oncologist at the Aflac Cancer & Blood Disorders Center of Children’s Healthcare […]
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 says it’s open to EUAs for ventilators to treat coronavirus
Amid a shortage of ventilators for treating coronavirus, the FDA put out a statement confirming its stance on issuing emergency use authorizations for potential temporary fixes. The FDA said it is operating on the basis of a EUA determination that the U.S. Dept. of Health and Human Services issues on Feb. 4. Earlier this week, […]
Mologic starts validation of point-of-need coronavirus test
Mologic announced today that it initiated early validation of point-of-need COVID-19 diagnostic tests with two United Kingdom-based universities. The Bedfordshire, U.K.-based company is initiating its tests with the Liverpool School of Tropical Medicine and St. George’s University London, according to a news release. The accelerated development of the test is a product of funding from […]
Bardy Diagnostics’ patch could monitor coronavirus patients prescribed HCQ experimentally
Bardy Diagnostics says Seattle-area health providers are using its Carnation ambulatory monitor (CAM) patch to measure QT segments in COVID-19 patients prescribed hydroxychloroquine (HCQ) experimentally. Hospitals across the city in their protocals have slated the local company’s CAM patch for use monitoring cardiac rhythms after coronavirus patients on HCQ are discharged from the hospital, as […]
Canadian companies join COVID-19 fight
Two Canadian companies announced today that they are leveraging production and business to help the healthcare industry take on the coronavirus crisis. Luxury apparel maker Canada Goose said it will use its manufacturing facilities to begin production of medical gear for healthcare workers and patients across Canada. Canada Goose will begin making scrubs and patient […]
Ixlayer Launches COVID-19 testing platform
Ixlayer announced today that it is adapting its established testing platform for COVID-19-specific content and user flows to allow for quick connection in the delivery of coronavirus testing. The San Francisco-based company said its platform already encompasses complex security components and is now adapted to the coronavirus-related content and flows that allow physicians, health systems, […]
European Commission to ask for EU MDR enforcement delay
The European Commission is putting together a proposal to ask the European Parliament and Council to delay enforcement of the new Medical Device Regulation (EU MDR) by one year in light of the coronavirus pandemic. Medical device companies have been scrambling to meet the implementation of the new MDR, scheduled for May 26. (The in […]
Jefferies offers $10 million to jumpstart emergency drug packaging initiative
Jefferies Financial Group announced today that it is the first private-sector company to support a newly established public-private consortium launched by the U.S. Dept. of Health & Human Services (HHS). HHS launched the program last week, announcing that it joined with ApiJect Systems America to create a high-volume “surge” drug packaging solution in the U.S. by using […]
Thermo Fisher lines up financing for Qiagen buy
Thermo Fisher Scientific (NYSE:TMO) confirmed in a prospectus supplement that it is in part financing its $11.5 billion purchase of Qiagen (NYSE:QGEN) with an offering worth $2.2 billion. The offering includes $1.1 billion in 4.133% senior notes due in 2025 and another $1.1 billion in 4.497% senior notes due in 2030. Thermo Fisher said in its prospectus […]
FDA allows use of AliveCor’s Kardia device for COVID-19 patients
AliveCor announced that the FDA now allows the company’s KardiaMobile 6L electrocardiogram (ECG) for use in measuring QTc (a heart rhythm disorder that can potentially cause fast, chaotic heartbeats) in patients with COVID-19. The Mountain View, Calif.-based company touts its KardiaMobile 6L as the world’s only six-lead personal ECG. It is designed to detect potentially […]
PerkinElmer secures FDA emergency use authorizaiton for COVID-19 tests
PerkinElmer (NYSE:PKI) announced that the FDA granted it emergency use authorization (EUA) for its new coronavirus RT-PCR test. The Waltham, Mass.-based company said in a news release that clinical laboratories that are certified under the Clinical Laboratory Improvement Amendments (CLIA) can now immediately begin using the kit to detect the SARS-CoV-2 virus that causes COVID-19. PerkinElmer […]