Rapid Medical announced today that it received FDA clearance for its Drivewire guidewire for aiding in treating vascular diseases. Yokneam, Israel-based Rapid Medical’s Drivewire (known as Columbus outside the U.S.) is designed to allow physicians to control the direction and shape of the guidewire’s tip while it is inside the vessel, allowing for navigation in […]
FDA
BREAKING: FDA grants emergency use authorization to Moderna COVID-19 vaccine
FDA has decided to permit emergency use of Moderna’s (NSDQ:MRNA) mRNA-1273 COVID-19 vaccine. A week ago, FDA granted the same designation for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). The U.S. government will collaborate with the company to distribute the vaccine. Although the EUA permits the vaccine to be used in individuals 18 and older, medical workers […]
FDA approves Abbott Heartmate 3 label update in pediatric patients
Abbott (NYSE:ABT) announced that the FDA approved updated labeling for its HeartMate 3 heart pump for pediatric patients. The heart pump can now be used in pediatric patients with advanced refractory left ventricular heart failure, giving physicians more options for treating the pediatric population awaiting a heart transplant or ineligible for receiving a transplant due to […]
Corvion gains FDA breakthrough nod for LVAD
Corvion announced that it received FDA breakthrough device designation for its left ventricular assist device (LVAD). Webster, Texas-based Corvion said in a news release that the breakthrough nod for the fully implanted LVAD device allows the company to move forward with the FDA in addressing topics that arise during development and testing ahead of an […]
FDA clears first torn-ACL implant
Connective tissue repair implant maker Miach Orthopaedics announced that it received FDA de novo clearance for its ACL repair implant. Westborough, Mass.-based Miach said today in a news release that its Bridge-Enhanced ACL repair — BEAR — implant received the de novo marketing approval for treating anterior cruciate ligament (ACL) tears. BEAR is touted as the […]
Spark Biomedical wins FDA breakthrough nod for newborn opioid withdrawal relief device
Spark Biomedical announced today that the FDA granted breakthrough device designation to its transcutaneous electrical nerve stimulator designed to reduce signs and symptoms of neonatal opioid withdrawal syndrome (NOWS). NOWS results from exposure to prescription or non-prescription opioids such as methadone or heroin during pregnancy. Currently, no nationwide standard of care exists for managing NOWS, although […]
Biotronik wins FDA clearance for cardiac monitor sensor
Biotronik today announced FDA clearance of its Vital Data Sensor, designed to identify body temperature increases potentially associated with fever, as part of its new Biomonitor IIIm injectable cardiac monitor (ICM). Biomonitor IIIm contains integrated sensors designed to measure patient activity, heart rate and body temperature. The new sensor gives physicians access to daily reports […]
Garwood Medical wins grant to prevent biofilm formation on ortho implants
Garwood Medical Devices recently announced that it and a University of Buffalo research team have won a $749,000 federal grant to evaluate a medical device to prevent, control, and eliminate bacterial biofilm infections associated with orthopedic implants. Garwood is licensing the technology behind the BioPrax device, a cathodic voltage-controlled electrical stimulation (CVCES) patented by the University […]
Exero Medical smart sensor gains FDA breakthrough nod
Startup company Exero Medical announced today that the FDA has granted breakthrough device designation for its wireless system designed for early detection of potentially lethal anastomotic leaks (AL) following gastrointestinal surgery. The FDA scrutinized the company’s pre-clinical data from its animal studies as well as clinical data collected in the first-in-human feasibility trial conducted at […]
Genetesis wins FDA breakthrough nod for imaging tech
Cardiac imaging technology developer Genetesis announced today that its flagship product received FDA breakthrough device designation. Mason, Ohio-based Genetesis’ CardioFlux magnetocardiograph (MCG) uses highly sensitive room temperature magnetometers to deliver non-invasive measurements of the heart’s naturally generated magnetic fields, according to a news release. The FDA granted breakthrough device designation for CardioFlux in the diagnosis of […]
BREAKING: FDA authorizes first over-the-counter, fully at-home COVID-19 test
FDA announced today that it has granted an EUA for the Ellume COVID-19 Home — the first fully at-home test for the novel coronavirus that the agency is authorizing for over-the-counter sales. FDA last month OK’d an at-home test from Lucira, but it needs a prescription. The first authorization for a non-prescription COVID test came […]