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FDA clearance

  • Clinical & Regulatory,Digital & Data,Medical devices

    ThinkSono wins FDA clearance for AI-guided ultrasound software for suspected DVT

    ThinkSono has received US FDA 510(k) clearance for ThinkSono Guidance, [...]

    July 31, 2026
  • Advanced Therapies,Clinical & Regulatory,Manufacturing & Supply Chain

    FDA clears IND amendment for automated manufacturing of Cabaletta’s rese-cel using Cellares platforms

    Cellares has secured FDA clearance of an IND amendment allowing [...]

    May 5, 2026
  • Clinical & Regulatory,Medical devices,Opinion & Events,Pharmaceuticals and therapeutics

    Amber Implants secures FDA clearance for VCFix spinal system

    Amber Implants has received FDA 510(k) clearance for its VCFix [...]

    May 5, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics

    FoRx Therapeutics starts first-in-human trial of novel PARG inhibitor FORX-428 in advanced solid tumors

    FoRx Therapeutics has initiated a first-in-human clinical trial of FORX-428, [...]

    May 5, 2026
  • Uncategorised

    FDA clears Daxor’s next-generation blood volume analyzer for precise fluid management

    Daxor Corporation, a global leader in blood volume measurement technology, [...]

    August 8, 2025
  • Biotech & Pharma Business,Clinical & Regulatory,Digital & Data,Medical devices,Opinion & Events

    Magentiq Eye secures Series A funding to advance AI-powered colonoscopy solutions

    Investment led by aMoon will support US and EU commercialisation [...]

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory,Therapeutic Areas

    AAVB-039 Gains FDA clearance to advance treatment for Stargardt Disease

    AAVantgarde’s AAVB-039 gene therapy, targeting the root cause of Stargardt [...]

    May 5, 2026
  • Digital & Data,Drug Discovery & Development,Opinion & Events

    Rapid ED diagnostic linked to 39% drop in sepsis mortality, real-world study finds

    IntelliSep test from Cytovale shows potential to reshape emergency triage [...]

    May 5, 2026
  • Clinical & Regulatory,Digital & Data,Opinion & Events

    Viz.ai gains FDA clearance for AI tool measuring subdural hemorrhage volume

    First-of-its-kind software aims to improve treatment decisions for patients with [...]

    May 5, 2026
  • Biotech & Pharma Business,Clinical & Regulatory

    Genetically engineered pig liver enters first-in-human trial for patients with no transplant option

    OrganOx and eGenesis launch human trial of a genetically modified [...]

    May 5, 2026

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