Infectious Disease Diagnostics
Oct 16, 2025
Scanogen’s Bloodstream Infection Assay Earns FDA Breakthrough Device Status; Lapsi Health Launches Keikku 2.0; Medtronic BrainSense™ Adaptive DBS Earns 2025 TIME Best Inventions Honor; Photocure Partners with Intelligent Scopes Corporation to Advance AI Integration in Blue Light Cystoscopy; Conformal Medical Expands CONFORM Trial to Europe; Materna Medical Presents Study on At-Home Patient Outcomes: Experienced vs. Naïve Dilator Users
Scanogen Received FDA Breakthrough Device Designation for Rapid Bloodstream Infection Assay On October 15, 2025, Scanogen Inc., a molecular diagnostics innovator developing next-generation infectious disease detection technologies, announced that the U.S. Food and Drug Administration (FDA) granted Breakthr...
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Aug 28, 2025
Esaote’s MyLab™ A50 and A70 Ultrasound Systems Achieve FDA 510(k) Clearance; Health Canada Approves MedMira’s Reveal® TP Rapid Test for Syphilis; MolecuLight’s Transformative Effect on Wound Care Confirmed by Large Randomized Trial; Arctx Medical’s ACC Kit Receives FDA IDE Approval and Dr. Robert Kieval Appointed CEO; Quest’s Haystack MRD Test Awarded FDA Breakthrough Device Designation for Post-Surgical Colorectal Cancer Monitoring; Sonic Healthcare USA Strengthens Oncology Diagnostics with Acquisition of Cairo Diagnostics
FDA Granted Approval to Esaote’s MyLab™ A50 and MyLab™ A70 Ultrasound Systems On August 25, 2025, Esaote announced that its MyLab™ A50 and MyLab™ A70 ultrasound systems had received FDA approval, marking a significant milestone that confirmed the systems’ compliance with the highest standards of safety and clini...
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Apr 20, 2023
Bausch + Lomb and Heidelberg Engineering Introduced SeeLuma; Oxford Nanopore and bioMérieux Signs Partnership Agreement; Boomerang Medical’s Bioelectronic Device for Inflammatory Bowel Disease; Senseonics’s ENHANCE Clinical Trial Updates; RapidAI’s Non-Contrast CT Imaging Product; FDA Clearance for Neuspera Medical’s Peripheral Nerve Stimulation System
Bausch + Lomb and Heidelberg Engineering Introduced SeeLuma™ Fully Digital Surgical Visualization Platform On April 13, 2023, Bausch + Lomb, a leading global eye health company dedicated to helping people see better and to live better, and Heidelberg Engineering, announced the introduction of the Se...
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