Meridian Bioscience secures FDA clearance for Curian Shiga Toxin assay

By NS Medical Staff Writer

20 Apr 23

The assay is said to be a rapid, qualitative, fluorescent immunoassay designed to simultaneously detect and differentiate Shiga…

DevicesApprovalsDiagnostic Devices

Reach Neuro gets FDA breakthrough status for Avantis platform

By NS Medical Staff Writer

11 Apr 23

Avantis platform uses small electrical impulses and delivers them to the spinal cord to help restore arm, shoulder,…

RegulationCertificationsMotors & Motion Control

FDA identifies recall of Philips’ DreamStation devices as Class I

By NS Medical Staff Writer

10 Apr 23

The Dutch medical devices maker recalled 1,088 devices in the US in February this year over the risk…

RegulationRecalls

Icentia gets FDA 510(k) clearance for CardioSTAT ECG monitoring solution

By NS Medical Staff Writer

07 Apr 23

By using the cardiac monitoring solution, medical practitioners can identify heart anomalies such as atrial fibrillation and others…

RegulationApprovals

FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS

By NS Medical Staff Writer

30 Mar 23

Speech Vitals - ALS is a software application used in the collection and analysis of speech recordings to…

DevicesApprovalsNeurological

FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products

By NS Medical Staff Writer

20 Mar 23

Company Must Stop Marketing Unauthorized Products

RegulationRegulatory Policy

Haemonetics Introduces Next Generation “Intelligent Control” Software for Cell Saver Elite+ Autotransfusion System

By NS Medical Staff Writer

03 Mar 23

This software upgrade, named Intelligent Control, offers customers key enhancements to help simplify operations, supporting enhanced efficiency and…

Patient Care DevicesApprovalsSurgical and Supplies

Bioelectronic Medicine Company Boomerang Medical Earns FDA Breakthrough Device Designation

By NS Medical Staff Writer

02 Mar 23

Boomerang Medical is currently enrolling a clinical trial studying a bioelectronic device for people living with Crohn’s disease…

Patient Care DevicesApprovalsSurgical and Supplies

Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion to Coagulate and Contract Soft Tissues, Including Subcutaneous Tissue, Where Needed

By NS Medical Staff Writer

28 Feb 23

Apyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative…

Patient Care DevicesApprovalsSurgical and Supplies

HistoSonics Announces FDA Approval of its Pivotal IDE #HOPE4KIDNEY Trial

By NS Medical Staff Writer

14 Feb 23

Company to Utilize its New Edison System with Advanced Imaging Features for Use in Kidney Tumors

InnovationsApprovalsFiltration & Fluid Control