BD secures FDA 510(k) approval for BD MiniDraw capillary blood collection system

By NS Medical Staff Writer

08 Dec 23

The BD MiniDraw capillary blood collection system is designed to provide lab-quality blood testing for the diagnosis of…

DevicesDiagnostic Devices

AngioDynamics concludes patient enrolment in AlphaVac F18 System trial in PE treatment

By NS Medical Staff Writer

08 Dec 23

The single-arm Investigational Device Exemption APEX-AV study is intended to assess the efficacy and safety of the AlphaVac…

DevicesCardiovascular

Ad Astra secures FDA 510(k) approval for QScout haematology analyser

By NS Medical Staff Writer

08 Dec 23

QScout system is designed to provide rapid, point-of-care (POC) white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiates…

DevicesDiagnostic Devices

BioPorto Receives FDA 510(k) Clearance for NGAL Test in the United States First Test to Aid in Assessing AKI Risk for Patients Aged 3 Months Through 21 Years

By NS Medical Staff Writer

08 Dec 23

BioPorto expects that US sales through its distribution agreement with Roche Diagnostics GmbH (Roche) will begin in the…

DevicesDiagnostic Devices

OSSIO secures FDA approval for OSSIOfiber bio-integrative fixation technology

By NS Medical Staff Writer

07 Dec 23

The OSSIOfiber intelligent bone regeneration technology is an implant material stronger than cortical bone that combines mechanical strength…

DevicesOrthopedic

US FDA approves Bering’s AI-based chest X-ray triage solution

By NS Medical Staff Writer

07 Dec 23

The solution, dubbed BraveCX, is a radiological computer-assisted triage and notification software designed to analyse adult chest X-ray…

Diagnostic DevicesDiagnostic Imaging

Dexcom integrates Dexcom G7 CGM with Tandem’s t:slim X2 insulin pump

By NS Medical Staff Writer

07 Dec 23

The integration will allow users of t:slim X2 insulin pump to spend more time in closed loop with…

DevicesDiabetes Care

OtoNexus Medical Technologies Selected for Elite FDA STeP Program

By NS Medical Staff Writer

07 Dec 23

FDA STeP Program awarded to OtoNexus Medical Technologies for ultrasound platform technology that evaluates middle ear infections

DevicesENT

Kaneka acquires Japan Medical Device Technology

By NS Medical Staff Writer

07 Dec 23

Kaneka manufactures and sells endovascular catheters, which are devices used in the treatment of cardiac, peripheral vascular, and…

DevicesCardiovascular

First Light Diagnostics secures FDA approval for rapid anthrax toxin test

By NS Medical Staff Writer

06 Dec 23

The SensiTox B. anthracis Toxin Test requires the patient’s blood sample, added directly to a test cartridge, and…

DevicesDiagnostic Devices