Techno Trends
The most recent inventions, innovations, and ground-breaking technologies that are revolutionizing the healthcare landscape are presented to you in this section.
Atreon Orthopedics Launches First-of-Its-Kind BioCharge® Autobiologic Matrix for Rotator Cuff Repair
Atreon Orthopaedics has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its BioCharge® Autobiologic Matrix. The product is now being launched for full market availability. BioCharge is a bioresorbable synthetic implant designed to improve...
QuantalX Neuroscience Introduces Groundbreaking Delphi-MD Device for Brain Health Assessment in Europe
QuantalX Neuroscience has achieved a significant milestone with the CE MDR approval for its Delphi-MD device, a groundbreaking solution for brain health assessment. This certification, granted under the European Union’s Medical Device Regulation (MDR), establishes high standards for safety...
FDA Grants Onc.AI Breakthrough Device Designation for "Serial CTRS" in Early Mortality Risk Assessment
Onc.AI, a digital health company specialising in AI-driven oncology clinical management solutions, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Serial CT Response Score (Serial CTRS) AI model....
FDA Approves Roche's First-of-its-Kind Tina-quant® Lipoprotein (a) Gen.2 for measuring Lp(a) in molar units
Roche has announced that its Tina-quant® Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug Administration (FDA)....
US FDA Approves Werfen's New Aptiva® Reagents for Antiphospholipid Syndrome
Werfen has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Aptiva® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents....
FDA Grants Breakthrough Device Designation to AccurKardia's AK+ Guard™ for AI-powered Hyperkalemia Detection
AccurKardia has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Breakthrough Device Designation for its AK+ Guard™ hyperkalemia detection software. This innovative, AI-driven solution leverages Lead I ECG data to assist in identifying moderate to severe episodes...
FDA Approves Ventris Medical's First-of-Its-Kind 510(k) Clearance for Backpack® Bone Graft System.
Ventris Medical has announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for its Backpack® Porous Biologic Scaffold (K240765). Backpack® introduces a novel category of biomaterials aimed at enhancing cell proliferation and bone formation, specifically designed for use in orthopaedic and spinal fusion procedures. ...
Dexcom Innovates Groundbreaking First Generative AI Platform in Glucose Biosensing
Dexcom has announced the launch of its new GenAI platform, making it the first continuous glucose monitoring (CGM) company to integrate Generative AI into glucose biosensing technology....
FDA Approves R3 Vascular's Novel MAGNITUDE® Bioresorbable Scaffold for Below-the-Knee PAD
R3 Vascular has received approval from the U.S. Food and Drug Administration to start its ELITE-BTK pivotal trial. This trial will test the next generation of the company’s drug-eluting bioresorbable scaffold...
FDA Approves GT Metabolic's First-of-Its-Kind MagDI™ System for Duodeno-Ileal Anastomosis
GT Metabolic Solutions has announced that the U.S. Food and Drug Administration has cleared its MagDI™ System for side-to-side duodeno-ileal (DI) anastomosis....
