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 […]
Regulatory/Compliance
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, […]
Boston Scientific’s Lotus layoffs extend to Ireland
Boston Scientific (NYSE:BSX) has reportedly confirmed job losses at its Galway, Ireland, location, following the retirement of the Lotus Edge. Galway Bay FM reported today that the Marlborough, Mass.-based company confirmed the job losses at its Ireland location, adding that Boston Scientific confirmed the job loss will affect fewer than 30 employees. The report said that […]
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 […]
MedTech Europe gives proposed European Health Union a partial nod
MedTech Europe has endorsed a new plan to strengthen the EU’s response to future pandemics and public health emergencies, with a few caveats. European Commission President Ursula von der Leyen outlined the plan to create a European Health Union in her state of the union speech on Nov. 11. The plan is a response to lessons learned from […]
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 […]
BREAKING: Johnson & Johnson finally unveils its new robot-assisted surgery system
Johnson & Johnson (NYSE:JNJ) today shared details on its surgical robotic platform that it says offers unrivaled flexibility and control compared to the rest of the market. The new system is designed with six arms to provide more control and flexibility in surgery, while its arms will be integrated into the operating table. Additionally, the platform […]
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 […]
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 […]
