AI-based electrocardiogram (ECG) technology developer AliveCor announced that it received FDA clearance for its next-gen ECG algorithms. Mountain View, Calif.-based AliveCor’s next-gen interpretive ECG algorithms, called Kardia AI V2, offers users a way to take a 30-second ECG and receive instant determinations of multiple cardiac conditions through the company’s KardiaMobile and KardiaMobile 6L devices and the […]
Food & Drug Administration (FDA)
FDA authorizes Kantaro’s ‘high performance’ COVID-19 antibody test
Kantaro Biosciences announced today that it received FDA emergency use authorization (EUA) for its COVID-SeroKlir antibody test. New York-based Kantaro, a joint venture between Mount Sinai Health System and RenalytixAI (NSDQ:RNLX), developed the semi-quantitative SARS-CoV-2 IgG antibody test kit to determine the presence and precise level of IgG antibodies related to COVID-19. A partnership with […]
Hologic gains FDA nod for HIV test
Hologic (NSDQ:HOLX) announced that it received FDA approval for a diagnostic claim for its HIV-1 viral load monitoring assay. Marlborough, Mass.-based Hologic’s Aptima HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the U.S., according to a news release. Initially approved in 2016 for viral load monitoring, […]
Baxter gains FDA clearance for home dialysis system
Baxter (NYSE:BAX) announced today that it received FDA clearance for its Homechoice Claria automated peritoneal dialysis (APD) system with Sharesource. Homechoice Claria is designed to combine its simple user interface with the Sharesource two-way remote patient management platform for patients on peritoneal dialysis, according to a news release. The system is cleared for both adult and […]
FDA clears Think Surgical’s second-gen robotic knee surgery system
Think Surgical announced today that FDA has granted 510(k) clearance for the second generation of its TSolution One total knee application. The TSolution One is an active robot for total knee replacement; it includes fully automated bone preparation and provides surgeons a choice of implant options. The newly-cleared version of the system features includes an […]
BREAKING: Pfizer, BioNTech submit FDA EUA request for COVID-19 vaccine
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with FDA for an EUA of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2. If all goes as planned, the companies predict that high-risk populations in the U.S. could start receiving the vaccine by mid- to late-December. Vaccine distribution could start within […]
Alaris remediation could cost BD up to $244M
Becton Dickinson (NYSE:BDX) in its most recent fiscal year set aside $244 million to cover future product remediation costs, including the company’s work to fix its problematic Alaris infusion pumps. The Franklin Lakes, N.J.–based company has had shipments of the pumps on hold since early this year, when FDA called for a comprehensive 510(k) submission to […]
FDA OKs first COVID-19 test that people can use on themselves at home
The FDA announced that it issued emergency use authorization (EUA) for the first at-home, rapid COVID-19 diagnostic test. A diagnostic designed for self-testing in the home, the Lucira COVID-19 all-in-one test kit is a molecular (real-time loop-mediated amplification reaction) single-use test designed to detect SARS-CoV-2, according to an FDA news release. Lucira’s test is authorized […]
Lantheus gains FDA clearance for bone scan AI
Lantheus Holdings (NSDQ:LNTH) announced today that it received FDA 510(k) clearance for its automated bone scan index (aBSI). The North Billerica, Mass.-based parent company of Lanthus Medical Imaging, Progenics Pharmaceuticals and Exini Diagnostics said in a news release that the clearance is for the artificial intelligence-enabled aBSI product for use on GE Healthcare’s Xeleris platform. In […]
SafKan Health wins FDA clearance for ear-cleaning headset
Tucson-based startup SafKan Health this week announced FDA clearance for its automated ear-cleaning device, OtoSet. Developed to clean impacted earways, OtoSet has irrigation and microsuction technology built into an automated and wearable device. According to the American Academy of Otolaryngology, excessive or impacted earwax is present in 1 in 10 children, 1 in 20 adults, and […]
FDA issues EUA for GenScript’s COVID-19 neutralizing antibody detection kit
GenScript announced today that it received FDA emergency use authorization (EUA) for its cPass SARS-CoV-2 neutralizing antibody detection kit. Piscataway, N.J.-based GenScript touts its test as the first commercially available diagnostic for specifically detecting neutralizing antibodies without the use of live virus. It measures the presence of neutralizing antibodies in any sample, both in patients […]
