Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s left atrial pressure (LAP) monitoring device. The V-LAP system is the first digital, wireless, battery-free device that can communicate from deep within the body using high-resolution waveform morphology, according to the Tel Aviv-based startup. Because the pressure of the […]
FDA
FDA allows dry heat treatment for single-user mask reuse
The FDA has announced that it will allow the use of dry heat to lower the bioburden on masks used by healthcare workers treating COVID-19 patients. While not authorizing equipment made by a particular company, guidance released last week said healthcare providers may use dry heat to reprocess NIOSH-approved filtering facepiece respirators, such as N95s, […]
Alivecor wins FDA clearance for next-gen interpretive ECG algorithms
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 […]
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 […]
B. Braun halts certain Aesculap knee implants
B. Braun is notifying customers who purchased certain Aesculap knee systems to temporarily cease implanting them while the company addresses a “possible malfunction.” In a Nov. 16 letter sent to customers worldwide, the company said a “locally accumulated number of aseptic loosenings have been reported to us in connection with the univation X system. ln […]
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 clears PTSD nightmare-reduction app
The FDA has cleared a smartwatch app that delivers digital therapy to alleviate the effects of nightmares associated with post-traumatic stress disorder (PTSD). The machine-learning application by Minneapolis-based startup NightWare offers treatment without pharmaceuticals and runs on the Apple Watch. The company’s app can collect high-resolution biometric data, analyze sleep patterns, pinpoint the onset of a nightmare […]
