Clew Medical recently received FDA emergency use authorization for its ClewICU System for use in intensive care units. The EUA covers the company’s ClewICUServer and ClewICUnitor. The system is a standalone software that is designated as a medical device. It uses commonly recorded vital signs, nursing assessments, flowsheet data, medications and lab data to compute […]
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.
Cantel Medical up on Street-beating Q3
Cantel Medical (NYSE:CMD) shares ticked up today on third-quarter financial results that came in ahead of the consensus forecast. The Little Falls, N.J.-based infection prevention products and services company posted profits of $15.8 million, or 37¢ per share, on sales of $236.9 million for the three months ended April 30, 2020, for a 93.1% bottom-line gain […]
NASA, Fitbit gain EUAs for COVID-19 devices
The FDA granted emergency use authorization (EUA) for emergency COVID-19 ventilator devices developed by Nasa and Fitbit (NYSE:FIT). According to the FDA’s ongoing list of devices granted EUAs, both devices were authorized on June 1. NASA’s VITAL (ventilator intervention technology accessible locally) compressor and the Fitbit Flow are the latest of a few ventilator alternatives to […]
Canada orders 37 million syringes from BD in anticipation of COVID-19 vaccine
Canada reportedly signed a contract to purchase 37 million syringes from Becton Dickinson (NYSE:BDX) in preparation for a potential COVID-19 vaccine. A report in The Record revealed that Public Services & Procurement Minister Anita Anand said the country made a purchase order from the Canadian branch of BD in an effort to make sure Canada is […]
U of M releases Coventor ventilator design as open-source
The University of Minnesota recently announced that it released the design for its Coventor alternative ventilator as open-source. Minnesota’s Coventor low-cost device gained notoriety in March after researchers touted the design made from various parts totaling just $150. In April, it became the first ventilator of its kind authorized for use under the FDA’s EUA […]
Philips wins EUA for acute-care patient monitoring
Royal Philips (NYSE:PHG) announced today that it received FDA emergency use authorization (EUA) for its IntelliVue patient monitors and active displays. The Amsterdam-based company’s IntelliVue monitors MX750/MX850 and active displays AD75/D85 received authorization to support infection-control protocols and provide caregivers information remotely during the ongoing COVID-19 pandemic. Both sets of IntelliVue products received CE Mark approval […]
BD furloughs 160 employees at Nebraska plant
Becton Dickinson (NYSE:BDX) reportedly furloughed 160 employees at its Broken Bow, Neb. plant amid the COVID-19-induced dip in demand for certain healthcare products and procedures. A report in the Sandhills Express said BD’s PR associate director of reputation management Gwen Gordon confirmed that operations will resume as soon as possible in Broken Bow, but the furlough […]
Medtronic is making its ‘artificial lung’ therapy available for COVID-19 treatment
Medtronic (NYSE:MDT) is temporarily modifying product indications so that health providers can use its extracorporeal membrane oxygenation (ECMO) technology to treat people with severe cases of COVID-19. ECMO could be described as a type of “artificial lung” technology that pumps blood from a person’s body to an oxygenator that provides long-term oxygen and carbon-dioxide transfer. Medtronic […]
FDA wants to streamline development of at-home COVID-19 diagnostic tests
The FDA announced that it took steps in an effort to support the development of COVID-19 tests for at-home self-collection. Creating a voluntary emergency use authorization (EUA) template outlining the guidelines for at-home sample collection kits is among the steps the agency has taken, according to a news release. The template includes recommendations for laboratories […]
Gallup has a new poll that medtech should care about
Fewer Americans are worried about going to the doctor amid the COVID-19 pandemic, according to a new online poll from Gallup. The poll provides good news for the medical device industry as it seeks to recover from a dropoff in elective procedures — and even procedures that people need — as hospitals focus on treating […]
MedTech 100 roundup: Stocks peak to end May
Medtech stocks closed May at their highest point since before the COVID-19 pandemic rocked the markets. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.17 points at the end of last week (May 29). That total represents a 2.3% gain from the 85.22-point total at the […]