FDA announced today that it has expanded the previous EUA it granted for the saliva-based COVID-19 test out of Rutgers University — allowing people to collect samples at home and return the samples to the Rutgers Clinical Genomics Laboratory in a sealed package for testing. The news comes just weeks after FDA authorized an at-home COVID-19 […]
FDA
FDA warns of color-coding problem when sterilizing N95 masks
The FDA is warning that a problem is cropping up as health providers use hydrogen peroxide sterilization to reuse N95 respirators amid the COVID-19 pandemic: There’s no standard color to show the process worked. Specifically, staff at hospitals are facing a pink versus blue problem. The 3M Comply Hydrogen Peroxide Chemical Indicator 1248 uses blue […]
FDA yanks 60 Chinese companies’ respirators from emergency use list
The FDA has removed respirators made by 60 companies in China from its emergency use authorization (EUA) list for COVID-19 over concerns that they may be “sub-standard.” The list, which had totaled 74 manufacturers when issued April 24, still includes 15 models of N95 respirators made in China by 3M (NYSE:MMM), plus a number of models […]
NuVasive lands 2 510(k)s, launches spinal surgery device
NuVasive (NSDQ:NUVA) announced that it received FDA 510(k) clearance for its Modulus ALIF and Cohere TLIF-O offerings for thoracolumbar procedures. The San Diego-based company expanded its Advanced Materials Science (AMS) implant portfolio with the clearances, along with the commercial launch of the Modulus extreme lateral interbody fusion (XLIF) dual-sided plate. NuVasive’s Modulus anterior lumbar interbody fusion (ALIF) […]
Control Medical wins 510(k) for blood clot removal device
Control Medical Technology (Park City, Utah) announced today that the FDA has cleared its Aspire MAX 7 – 11F mechanical thrombectomy device to remove blood clots from peripheral vessels. Peripheral thrombectomy is associated with peripheral arterial disease (PAD), acute limb ischemia (ALI), critical limb ischemia (CLI), chronic total occlusion (CTO), deep vein thrombosis (DVT), pulmonary […]
How can we keep our medtech community connected?
Everyone has had to rethink some priorities since the COVID-19 pandemic began circling the world. We’re working hard to make and renew connections in this critical industry with an eye toward personal safety and good health. Tom Salemi, Editorial Director, DeviceTalks Organizing conferences during the COVID-19 pandemic certainly creates new challenges. Most of us can’t […]
FDA tightens oversight of serological tests for COVID-19
Manufacturers of antibody tests for the COVID-19 virus must now prove the tests’ accuracy to the FDA before they can begin marketing them. And those who do not submit their validation information to the FDA within 10 days may have those tests pulled from the market. The policy reversal follows criticism of the agency’s March […]
Liberate Medical wins EUA for VentFree muscle stimulator
Liberate Medical announced today that it received FDA emergency use authorization (EUA) for its VentFree respiratory muscle stimulator. Crestwood, Ky.-based Liberate’s VentFree system is designed to reduce disuse atrophy of the abdominal wall muscles, which could reduce the number of days that adult patients require mechanical ventilation. It could also be used for patients with […]
Pavmed completes $4.1m offering
Pavmed (NSDQ:PAVM) filed an SEC Form D to confirm the sale of more than $4 million in debt, options, warrants and other rights to acquire securities. The medical device company completed its total offering of approximately $4.1 million, having made its first sale on April 30, according to the filing. It took just one investor to […]
BREAKING: FDA grants emergency use of drug to treat COVID-19
The FDA this afternoon issued an emergency use authorization for the investigational antiviral drug remdesivir to treat severely ill COVID-19 patients. The authorization for the drug, made by Gilead Sciences’ (NSDQ:GILD), will allow both adults and children to be treated with the remdesivir, the first drug believed to have any effect on the virus that has […]
BD’s CME America suspends distribution of recalled infusion pumps
Becton Dickinson (NYSE:BDX) subsidiary CME America notified customers that it is suspending distribution of its recalled BodyGuard infusion pump system. In March, the FDA designated the CME America BodyGuard microset infusion sets recall as Class I — its most serious level — after complaints of under-infusion related to the sets. CME America initiated the U.S. recall […]