The FDA has released a new reference panel to evaluate diagnostic tests for COVID-19. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration and monitoring of assay performance, according to the agency. Nucleic acid tests identify infection by confirming the presence of a virus’ genetic […]
COVID-19
Quest lands FDA nod for at-home COVID-19 test
Quest Diagnostics (NYSE:DGX) has received an FDA emergency use authorization (EUA) for an at-home diagnostic test for COVID-19. The Secaucus, N.J.-based testing giant said the test kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider. It allows an individual to […]
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 […]