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 […]
Regulatory/Compliance
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 izing 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, […]
BREAKING: Moderna is filing for a COVID-19 vaccine EUA
Moderna (NSDQ:MRNA) announced today that it will apply for emergency ization from U.S. FDA and the European Medicines Agency for its COVID-19 vaccine candidate. The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and […]
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 izes Kantaro’s ‘high performance’ COVID-19 antibody test
Kantaro Biosciences announced today that it received FDA emergency use ization (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 真人百家家乐app下载home dialysis system
Baxter (NYSE:BAX) announced today that it received FDA clearance for its 真人百家家乐app下载homechoice Claria automated peritoneal dialysis (APD) system with Sharesource. 真人百家家乐app下载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 […]
