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 […]
Diagnostics
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, […]
BD adds informatics option to its COVID testing platforms
Healthcare providers who use the Becton Dickinson (NYSE:BDX) BD Veritor Plus and BD Max COVID-19 testing platforms have a new informatics option. BD announced today that it has launched new reporting capabilities for COVID-19 data, enabling its BD Synapsys informatics to generate scheduled reports. BD Veritor Plus is a portable instrument designed to deliver SARS-CoV-2 antigen […]
Chong Kun Dang to sell SkyLabs heart-monitoring ring in Korea
Pharmaceutical company Chong Kun Dang next month will start selling a heart-monitoring ring made by startup SkyLabs, according to Korean media reports. Chong Kun Dang paid ₩2.5 billion ($2.2 million) to SkyLabs for the right to sell the CART-I cardio tracker to consumers in South Korea, The Korea Herald reported today. Worn on a finger, […]
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 […]
GE Healthcare acquires Prismatic Sensors and its advanced photon-counting CT sensors
GE Healthcare (NYSE:GE) said today that it has acquired Prismatic Sensors, a Swedish startup with deep silicon detector technology for photon-counting computed tomography (PCCT). The financial terms of the deal were not disclosed. GE Healthcare expects to close the deal in January 2021; its held a minority position in the company since 2017. Photon-counting CT technology, […]
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 […]
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 […]
Qiagen readies portable digital COVID-19 antigen test
Qiagen (NYSE: QGEN) and its partner Ellume are gearing up for the launch of the QIAreach SARS-CoV-2 antigen test, which can reportedly process samples in 2–15 minutes. Qiagen notes that the test can process up to 30 swab samples per hour while supporting parallel processing of antibody tests. The companies have submitted the test for […]
Canada to buy 7.6M BD rapid COVID-19 tests
Becton Dickinson (NYSE:BDX) announced that Health Canada authorized its rapid COVID-19 tests and will buy 7.6 million of them. Under interim order, Health Canada authorized BD’s rapid, point-of-care SARS-CoV-2 antigen test for use with the BD Veritor Plus system. The order for 7.6 million tests runs through March 2021 in an effort to support Canada’s planning […]
