Category: CERTIFICATIONS

Beckman Coulter Diagnostics Receives U.S. FDA Clearance for Rapid Bacterial vs. Viral Assay Providing Results in as Little as 15 Minutes for Adults and Children

November 8, 2026

BREA, Calif., Nov. 3, 2026 /PRNewswire/ — Beckman Coulter Diagnostics, a Danaher company and a global leader in clinical diagnostics, today announced U.S. FDA clearance of the Access MeMed BV® assay, a rapid host-response blood test that helps clinicians distinguish bacterial from viral infections in adult and pediatric patients. Available on the DxI 9000 and Access 2 immunoassay analyzers already installed in hospital laboratories nationwide, the new assay provides timely information aiding treatment decisions without requiring new instrumentation or changes to existing testing workflows. On the DxI 9000 Analyzer, results are available in as little as 15 minutes.

Onkos Surgical Continues Expansion of NanoCept® Antibacterial Technology with Latest FDA Clearance

November 6, 2026

PARSIPPANY, N.J., Nov. 6, 2026 /PRNewswire/ — Onkos Surgical, Inc. today announced a new FDA 510(k) clearance for its NanoCept® Antibacterial Technology, expanding its application to a broader offering of titanium components in the ELEOS™ Limb Salvage System. This marks another milestone in the company’s continued investment in antibacterial innovation.

Evident Vascular Receives FDA Approval for High-Fidelity AI-Powered IVUS Imaging Platform

November 5, 2026

Evident Vascular has announced U.S. Food and Drug Administration 510(k) clearance for the Evident Vascular Guidance System and Evident peripheral imaging catheters. The Guidance System is intended for ultrasound examination of intravascular pathology during peripheral vascular interventions.

PulseAI Receives U.S. FDA 510(k) Clearance of AI-Powered Arrhythmia Analysis Model for Wearables

November 5, 2026

BELFAST, Northern Ireland, Nov. 5, 2026 /PRNewswire/ –PulseAI, a medical technology company developing artificial intelligence for cardiac diagnostics, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its AI-powered arrhythmia analysis model for wearables.

FX Shoulder Solutions Makes History with FDA Clearance of Easytech Reversed®, the First-and-Only Stemless Reverse Shoulder System in the United States

November 5, 2026

ADDISON, Texas, Nov. 5, 2026 /PRNewswire/ — FX Shoulder Solutions, Inc. (FX), a global innovator dedicated exclusively to shoulder arthroplasty, announces a historic and revolutionary breakthrough in shoulder replacement technology with the FDA 510(k) clearance of Easytech Reversed® — the first-and-only FDA-cleared stemless reverse shoulder arthroplasty system in the United States and a game-changer in how surgeons can care for their patients.

Roche lands FDA clearance for respiratory testing panel

November 3, 2026

This clearance adds another panel to Roche Diagnostics’ respiratory testing portfolio, which includes a range of diagnostic and laboratory-focused offerings.

Contrario Medical Receives FDA 510(k) Clearance for Cyperus Sperm Separation Device

November 2, 2026

Single-use device prepares motile sperm for IVF, ICSI and IUI, giving fertility labs the next evolution in sperm separation technology with advanced capabilities.

HistoSonics Receives Singapore HSA Approval for Edison Histotripsy System

November 2, 2026

HistoSonics has received market authorization from Singapore’s Health Sciences Authority (HSA) for its Edison Histotripsy System, registered as the HistoSonics Histotripsy System. The approval marks another significant milestone in the company’s continued international expansion and creates new opportunities to advance access to histotripsy throughout the Asia-Pacific region.

FDA expands approval of Instylla’s Embrace HES for arterial bleeds

October 30, 2026

Data supporting the expanded clearance came from the HALT study involving 130 patients.

CereVasc Receives FDA IDE Approval to Evaluate the eShunt® System in Patients with Alzheimer’s Disease

October 29, 2026

FDA authorization enables clinical investigation of a fundamentally different approach for patients with early symptomatic Alzheimer’s disease