Siemens Healthineers (ETR: SHL) announced today that it has secured an FDA emergency use authorization for its COVID-19 antibody test. The news comes nearly a week after the German medtech giant said it had started worldwide shipments of the test — a laboratory-based total antibody test that can detect SARS-CoV-2 antibodies including IgM and IgG in blood. […]
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 Abiomed Impella RP to treat COVID-19 heart failure
Abiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for use with COVID-19-related right heart failure. The Impella RP temporary heart pump provides circulatory support for patients with right side ventricular failure. It won FDA approval in September 2017 for such an indication and in October 2019 Abiomed reported real-world data […]
Poll: Patients want to return to the doctor
AdvaMed said polling data confirmed that nearly half of American adults surveyed said they or someone in their household postponed or skipped medical care as a result of COVID-19. The poll, released yesterday by the Kaiser Family Foundation showed that 48% of those adults or adults in their household had to put off medical care […]
ReWalk Robotics posts COVID-19-affected Q1 losses
ReWalk Robotics (NSDQ:RWLK) shares ticked up slightly today despite first-quarter results that came up short of the consensus forecast. The Yokneam Illit, Israel–based robotic walking assistance company posted losses of $3.8 million, or -37¢ per share, on sales of $760,000 for the three months ended March 31, 2020, for a 4% bottom-line gain on a sales […]
Vexos to manufacture 10,000 ventilators for Canadian COVID-19 patients
Electronics manufacturer Vexos said this week that it has signed an agreement with the government of Canada to manufacture 10,000 mechanical ventilators for COVID-19 patients in that country. The LaGrange, Ohio-based company said it will build the ventilators, known as Mechanical Ventilator Milano (MVM), under an exclusive license agreement with Elemaster Group for the Americas. […]
Siren raises $11.8m Series B
Siren, a developer of smart textiles with remote patient monitoring applications, announced today that it raised $11.8 million in a Series B financing. The San Francisco-based medical device company had its funding round led by Anathem Ventures, with participation from existing investors DCM, Khosla Ventures, 500 Startups and Peter Thiel’s Founders Fund. Additionally, DCM partner […]
MIT researchers may have invented a safer way of splitting ventilators
MIT and Brigham and Women’s Hospital researchers say they have a way of splitting ventilators which could address many of the safety concerns — potentially boosting the supply of ventilators amid the COVID-19 pandemic. They have demonstrated their concept’s effectiveness in the lab — but they still caution it should be used only as a last resort […]
Siemens Healthineers to produce 50m antibody tests per month against COVID-19
Siemens Healthineers (ETR: SHL) said today that it has started worldwide shipments of its COVID-19 antibody test, with a goal of producing 50 million tests per month as the pandemic evolves. The German medtech giant also announced that FDA has granted an emergency use authorization for its PCR Fast Track Diagnostics (FTD) SARS-CoV-2 Assay6 test kit. Both […]
New Jersey man charged in $45m PPE price-gouging scheme
A New Jersey man is facing charges of federal wire fraud for an alleged scheme to sell $45 million worth of personal protective equipment that prosecutors say he didn’t have. Ronald Romano, a Manalapan, N.J. used car salesman, was arrested for supposedly attempting to deceive and price gouge New York City into buying personal protective […]
Philips wins 510(k) for sensor to detect COVID-19 patient deterioration
Royal Philips (NYSE:PHG) announced that it has won FDA 510(k) clearance for a wearable biosensor to help manage confirmed and suspected COVID-19 patients in the hospital. The Amsterdam-based company described the BX100 biosensor as a wireless wearable sensor designed to help healthcare providers detect when COVID-19 patients in lower-acuity units are at risk for deterioration so […]
Varian launches remote care software for cancer patients
Varian Medical Systems (NYSE:VAR) announced that it launched new capabilities for its Noona software for monitoring cancer patients. Noona supports cancer care teams with patient screening, real-time symptom reporting, secure care team messaging, telephone triage automation and patient access to medical records, enabling continuous reporting and symptom monitoring for cancer patients. Palo Alto, Calif.-based Varian also […]