Oxford researchers announced today that, following testing with thousands of patients, dexamethasone may improve patient survival in cases of COVID-19. Dexamethasone is a corticosteroid commonly used for treating arthritis and other cases of inflammation. In total, 2,104 patients were randomized in Oxford’s trial to receive dexamethasone in doses of 6 mg, once per day, either […]
FDA
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]
FDA clears video game Rx for kids with ADHD
Akili Interactive announced that it received FDA clearance for its EndeavorRx video game for children with attention deficit hyperactivity disorder (ADHD). Boston-based Akili’s prescription treatment is delivered through a video game experience to improve attention function as measured by computer-based testing in children between ages 8 and 12 with primarily inattentive or combined-type ADHD. EndeavorRx […]
Canon wins FDA clearance for speedy MRI
Canon (NYSE:CAJ) announced that it received FDA clearance for its compressed Speeder technology to speed up MRI scan times. The Speeder technology, run on Canon Medical Systems USA’s Vantage Orian 1.5T MR system allows for clinicians to reconstruct full-resolution images from under-sampled data through iterative reconstruction, improving throughput and offering substantial amounts of time in between […]
Abbott FreeStyle Libre 2 iCGM FDA cleared for use in adults and children
Abbott (NYSE:ABT) announced today that it received FDA clearance for its FreeStyle Libre 2 system for adults and children ages four and older with diabetes. The Abbott Park, Ill.-based company touts its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system as the only such system with optional real-time alarms that measure glucose levels every minute […]
Chinese company faces federal charges in ‘fake’ N95 respirator case
A Chinese manufacturer has been charged with producing and exporting to the United States nearly half a million misbranded and defective masks that falsely purported to be N95 respirators, the federal government reported. King Year Packaging and Printing Co. Ltd. (King Year) faces three counts of violating the Federal Food, Drug and Cosmetic Act (FDCA) […]
Support grows for return of medtech reps to hospitals
Twenty-six more medical and surgical societies and healthcare associations have endorsed guidelines for the safe return of medtech company representatives to healthcare facilities during the coronavirus pandemic. The guidance, released in May by AdvaMed, the Association of periOperative Registered Nurses (AORN) and the American Hospital Association (AHA), builds on the April 17 joint statement by AHA, […]
Former FDA chief scienctist faults agency over COVID-19 antibody test ‘chaos’
FDA allowed both qualified and unqualified entities to flood the market with COVID-19 antibody tests, and the result was “chaos,” FDA’s former chief scientist Jesse Goodman told a U.S. House subcommittee. A month after FDA tightened oversight of the tests and started withdrawing tests from the market, there is still enough concern about false results that the […]
Illumina gains FDA EUA for sequencing-based COVID-19 test
Illumina (NSDQ:ILMN) announced that it received FDA emergency use authorization (EUA) for its COVIDSeq sequencing-based COVID-19 diagnostic test. COVIDSeq uses upper respiratory specimens, such as a nasopharyngeal or oropharyngeal swab, and delivers sample receipt to result in 24 hours with the NovaSeq 6000 sequencing system, according to a news release. Illumina’s high-throughput, in vitro diagnostic test […]
FDA eases rules on remote patient monitoring devices during pandemic
The FDA has relaxed regulations on 21 different types of remote patient monitoring devices for the duration of the COVID-19 pandemic to protect healthcare workers from exposure to the virus. In a new guidance released on Friday, the agency said it will not object to limited modifications to the indications, claims, functionality, or hardware or […]
Nuvaira gains FDA breakthrough nod for lung denervation system
Obstructive lung disease treatment developer Nuvaira said today that the FDA has designated its lung denervation system a breakthrough device. The Nuvaira lung denervation system enables a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which causes airway hyper-responsiveness or “lung attacks” in both COPD […]