Body Vision Medical Forges Exclusive Distribution Agreements to Extend Global Access to LungVision AI Imaging System

By NS Medical Staff Writer

03 Aug 23

Body Vision Medical announces three strategic distribution agreements for Hong Kong, Macao and the entire Greater Bay Area…

Diagnostic DevicesDiagnostic Imaging

BD secures FDA 510(k) approval for Covid-19, Influenza, RSV combined molecular test

By NS Medical Staff Writer

02 Aug 23

BD RVP is a single molecular diagnostic combination test that can identify and distinguish SARS-CoV-2, influenza A, influenza…

Diagnostic DevicesIn vitro Diagnostic

Marylebone launches Mainz Biomed’s ColoAlert CRC test in UK

By NS Medical Staff Writer

02 Aug 23

Commercially available in select EU countries, the non-invasive test is based on real-time PCR-based multiplex detection of molecular-genetic…

Diagnostic Imaging

Terumo BCT’s Reveos system secures FDA clearance for commercial use

By NS Medical Staff Writer

02 Aug 23

Reveos system is said to be the first whole blood automation device available in the US that can…

Diagnostic DevicesIn vitro Diagnostic

Genesis MedTech announces FDA Breakthrough Device designation for the J-Valve Transfemoral System

By NS Medical Staff Writer

02 Aug 23

This innovative heart valve has been granted Breakthrough Device designation for the proposed indication of treatment of severe…

DevicesCardiovascular

Francis Medical Receives US FDA Breakthrough Device Designation for Vanquish Minimally Invasive Prostate Cancer Therapy

By NS Medical Staff Writer

02 Aug 23

The company is currently in the process of initiating their VAPOR 2 pivotal study in support of an…

DevicesDiagnostic Devices

Imeka receives FDA 510(k) clearance for ANDI imaging software

By NS Medical Staff Writer

01 Aug 23

The ANDI automated radiological image processing software generates white matter bundles that connect specific regions of the brain…

Diagnostic DevicesDiagnostic Imaging

SEKISUI Diagnostics unveils OSOM Covid-19 antigen home test

By NS Medical Staff Writer

01 Aug 23

OSOM Covid-19 antigen home test is a lateral flow immunoassay tool, designed for the qualitative identification of SARS-CoV-2…

DevicesDiagnostic Devices

Axial3D’s INSIGHT image segmentation platform gets FDA clearance

By NS Medical Staff Writer

01 Aug 23

The automated, AI-driven, cloud-based segmentation platform has been approved by the US regulator for orthopedic trauma, maxillofacial, orthopaedic,…

Diagnostic DevicesDiagnostic Imaging

Aidoc launches AI-based Full Brain Solution for stroke detection

By NS Medical Staff Writer

01 Aug 23

The new solution is intended to facilitate the identification and care coordination of patients with MeVOs, along with…

Diagnostic DevicesDiagnostic Imaging