The FDA today announced new shortages of laboratory testing supplies needed for the COVID-19 pandemic and renewed its shortage listing for several types of personal protective equipment (PPE). Newly categorized as being in short supply are micro-pipettes and what the agency described as general-purpose lab equipment. Read the full list on our sister site, Medical […]
BREAKING: Elizabeth Holmes’ trial postponed due to California COVID surge
Ex-Theranos CEO Elizabeth Holmes’ federal fraud trial will now start in July 2021 due to another COVID-19-related delay, according to published reports. A new surge of coronavirus cases in California led Judge Edward Davila to postpone jury selection to July 13, the San Jose Mercury News and CNBC reported. Davila previously postponed the trial to […]
House Dems subpoena Azar, Redfield on questions of political pressure at CDC
A Congressional committee subpoenaed top Trump administration officials today, demanding documents they allege could show “extensive” pandemic-related political interference at the CDC. In a letter to Health and Human Services secretary Alex Azar and Centers for Disease Control and Prevention director Dr. Robert Redfield, House Democrats said an investigation showed that efforts to interfere with […]
Health Canada gives Edwards’ Sapien 3 TAVR expanded use nod
Edwards Lifesciences (NYSE:EW) today announced that Health Canada has approved the expanded use of the company’s Sapien 3 and Sapien 3 Ultra transcatheter heart valves to treat patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 valves are the first transcatheter aortic valve replacement (TAVR) systems to […]
HHS to supply vulnerable populations with 30M more Abbott rapid antigen tests
The U.S. Department of Health and Human Services announced it will purchase an additional 30 million Abbott (NYSE:ABT) BinaxNOW tests for a variety of groups vulnerable to COVID-19. Recipients will include nursing homes, assisted living facilities, home healthcare, hospice organizations, historically black colleges and universities, Native American tribes and other vulnerable groups, the agency announced. 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 […]
Supremes turn back Cochlear IP appeal
The U.S. Supreme Court has declined to hear a $268 million patent case appeal filed by Cochlear Ltd. (ASX:COH) against two competitors. The Australia-based hearing implant company had appealed a March 2020 federal appeals court decision upholding a U.S. District Court decision that awarded $268 million in damages to those competitors, the Alfred Mann Foundation and Advanced Bionics, the […]
Nevro, Boston Scientific bury the hatchet in one IP case
Boston Scientific (NYSE:BSX) and Nevro (NYSE:NVRO) announced today that they have agreed to end Nevro’s patent infringement lawsuit against the larger company. Nevro had filed suit in the Northern District of California relating to high frequency paresthesia-free spinal cord stimulation (SCS) therapy. The official dismissal of the case is subject to the approval of the court. Boston […]