All articles by Vishnu Priyan
QuidelOrtho gets FDA authorisation for Sofia 2 antigen test
Intended for prescription use only, the rapid antigen test helps identify Covid-19 infection.
Methinks gets CE mark for AI-based stroke triage software
The imaging software deploys AI algorithms to detect suspected LVO on NCCT images and computed tomography angiography.
Maternova and MedMira sign rapid diagnostics distribution deal
Maternova will exclusively distribute MedMira’s Reveal, Multiplo and Miriad brands across Latin America.
Rhein Laser introduces UroFiber 150Q system to treat stone lithotripsy
UroFiber 150Q will help provide better treatment for stone lithotripsy and benign prostatic hyperplasia enucleation.
CurvaFix introduces new intramedullary device for small-boned patients
The new CurvaFix device can be used for both left and right rami nonunions.
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Hologic secures approval for NovaSure V5 GEA device in Canada and Europe
The new version of the device integrates improved features to help treat several cervical and uterine anatomies.
FDA grants EUA for Cepheid’s Xpert Mpox test
Designed to operate on Cepheid’s GeneXpert systems, the test has received authorisation for use in moderately complex settings.
FDA grants EUA for Anavasi’s AscencioDx Covid-19 Test
The test can detect SARS-CoV-2 RNA within 20 minutes and uses assay chemistry to target multiple viral genome locations.
FDA grants IDE approval for Concept Medical’s Coated Balloon
The IDE approval will enable data on the safety and efficacy of the Magic Touch PTA Sirolimus Coated Balloon to be collected.
Ibex gets CE mark for Galen Prostate diagnostics platform
The new diagnostics platform will help pathologists conduct a primary diagnosis of prostate biopsies.