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Results For "FDA-clearance"

62 News Found

Samsung Receives FDA clearance for AI algorithms detecting lung nodules in X-rays
Digitisation | November 01, 2021

Samsung Receives FDA clearance for AI algorithms detecting lung nodules in X-rays

It provides an option to automatically perform nodule detection immediately after chest X-ray imaging


Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV
Biotech | September 18, 2021

Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV

Initiation of EBT-101 Phase 1/2 clinical trial expected later this year


Abbott receives FDA clearance for its imaging tech using AI
Digitisation | August 04, 2021

Abbott receives FDA clearance for its imaging tech using AI

Ultreon 1.0 Software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using AI -


FDA clears Dexcom’s Stelo as first OTC Continuous Glucose Monitor for kids
Medical Device | June 16, 2026

FDA clears Dexcom’s Stelo as first OTC Continuous Glucose Monitor for kids

Expanded indication makes Stelo the first FDA-cleared OTC CGM for children aged two years and older with diabetes or prediabetes


FDA clears Wave Neuroscience’s AI-guided brain stimulation platform for PTSD treatment
Medical Device | June 13, 2026

FDA clears Wave Neuroscience’s AI-guided brain stimulation platform for PTSD treatment

MeRT becomes one of the few FDA-cleared neuromodulation therapies for PTSD, using EEG biomarkers and AI to personalize treatment for patients with treatment-resistant symptoms


FDA clears Cercare Medical’s CBCT perfusion technology for real-time stroke imaging
Medical Device | June 01, 2026

FDA clears Cercare Medical’s CBCT perfusion technology for real-time stroke imaging

The technology enables clinicians to assess brain tissue and microvascular reperfusion directly in the angiography suite, potentially improving stroke treatment decisions and patient outcomes


Clariant bags FDA nod for bio-based PVC additives
R&D | June 01, 2026

Clariant bags FDA nod for bio-based PVC additives

Derived from rice bran wax, Licocare RBW products offer a renewable solution with a substantially lower carbon footprint than conventional montan waxes


FDA okays RIVANNA’s AI-powered Accuro XV ultrasound system
Medical Device | May 12, 2026

FDA okays RIVANNA’s AI-powered Accuro XV ultrasound system

The clearance marks a pivotal step forward for the company as it pushes deeper into AI-driven diagnostics and expands its clinical footprint in point-of-care imaging


FDA clears Rivanna’s Accuro XV AI-powered 3D ultrasound system
Medical Device | May 11, 2026

FDA clears Rivanna’s Accuro XV AI-powered 3D ultrasound system

The ultrasound-based AI imaging platform is designed to support rapid fracture detection and soft tissue injury assessment in emergency care settings


Co-Diagnostics JV leases manufacturing facility in Saudi Arabia
Medical Device | May 11, 2026

Co-Diagnostics JV leases manufacturing facility in Saudi Arabia

CoMira Diagnostics will manufacture PCR diagnostic instruments and medical consumables in Sudair Industrial City