Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

Shots: The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…

ByRidhi Rastogi16 hours ago

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ABANZA Secures US FDA 510(k) Clearance for QuadLock Fixation System for ACL Reconstruction

Shots: The US FDA has granted 510(k) clearance to ABANZA’s QuadLock Fixation System, a knotless, bidirectional, tension-adjustable device for anterior cruciate ligament (ACL) reconstruction In biomechanical testing under high-demand cyclic loading, QuadLock demonstrated <0.5 mm cyclic displacement representing a >500% reduction in cyclic displacement and >1,000 N pullout strength vs conventional fixation methods QuadLock is…

ByDipanshu DixitJanuary 28, 2026

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BlueOcean Global Receives US FDA 510(k) Clearance for Excelsior External Fixation System

Shots: The US FDA has granted 510(k) clearance to BlueOcean Global’s Excelsior External Fixation System, a circular external fixation platform designed to support both bone reconstruction and soft tissue management The system is cleared for commercial distribution in the US and will be rolled out initially through select centers, with broader availability planned in the…

ByPrince GiriJanuary 27, 2026

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HemoSonics Secures the US FDA’s 510(k) Clearance for Quantra Hemostasis System in Obstetric Procedures

Shots: The US FDA has granted 510(k) clearance to Quantra Hemostasis System with QStat Cartridge, expanding its use in peripartum obstetric procedures to help manage postpartum hemorrhage Quantra is a cartridge-based viscoelastic testing system that uses SEER Sonorheometry tech to provide fast, point-of-care whole-blood coagulation analysis in <15min., enabling individualized & evidence-based decisions, along with…

ByRidhi RastogiSeptember 26, 2025

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AliveDx Reports the US FDA’s 510(k) Submission for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

Shots: The US FDA has received 510(k) premarket notification for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture's) disease; available in IVDR CE-marking countries since Jul 2025 VAS assay diagnoses autoimmune vasculitis using just 10μL of sample in a single test, with 3 key autoantibody markers: MPO, PR3, & GBM…

ByRidhi RastogiSeptember 4, 2025

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TYBR Health’s B3 GEL System Receives the US FDA’s 510(k) Clearance to Protect Healing Tissue and Preserve Function

Shots: The US FDA has granted 510(k) clearance to the B3 GEL System to protect healing tissue planes and preserve mobility; launch is anticipated at the end of 2025 Preclinical studies supporting clearance showed that B3 GEL reduced tissue binding and improved range of motion, with greater flexion and extension in treated models compared to controls…

ByDipanshu DixitJune 10, 2025

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Ibex Medical Analytics Receives the US FDA’s 510(k) Clearance for Ibex Prostate Detect

Shots: The US FDA has granted 510(k) clearance to Ibex Prostate Detect, which generates heatmaps using AI to detect small & rare missed prostatic cancers In studies, the device showed 99.6% PPV for cancer heatmap accuracy & detected 13% rate of missed cancer in pts initially diagnosed as benign, where these false negatives were later confirmed…

ByRidhi RastogiFebruary 11, 2025

Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

ABANZA Secures US FDA 510(k) Clearance for QuadLock Fixation System for ACL Reconstruction

BlueOcean Global Receives US FDA 510(k) Clearance for Excelsior External Fixation System

HemoSonics Secures the US FDA’s 510(k) Clearance for Quantra Hemostasis System in Obstetric Procedures

AliveDx Reports the US FDA’s 510(k) Submission for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

TYBR Health’s B3 GEL System Receives the US FDA’s 510(k) Clearance to Protect Healing Tissue and Preserve Function

Ibex Medical Analytics Receives the US FDA’s 510(k) Clearance for Ibex Prostate Detect

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