Neurophet receives FDA 510(k) Clearance for Neurophet AQUA

By NS Medical Staff Writer

19 May 23

Plans to cooperate with radiology AI solution platform companies to enter the U.S. market

RegulationApprovals

Ricoh gets expanded FDA clearance for 3D anatomic modelling of soft tissue

By NS Medical Staff Writer

04 May 23

The expanded clearance has been granted for creating patient-specific anatomic models for neurological, cardiovascular, gastrointestinal, genitourinary, and breast…

RegulationApprovals

Apyx Medical Receives FDA 510(k) Clearance for the Use of Renuvion for Coagulation of Subcutaneous Soft Tissues Following Liposuction for Aesthetic Body Contouring

By NS Medical Staff Writer

01 May 23

Apyx Medical is an advanced energy technology company that offers Helium Plasma Technology products sold as Renuvion in…

RegulationApprovals

3M Health Care secures FDA clearance for two Veraflo Therapy dressings

By NS Medical Staff Writer

28 Apr 23

The 3M Veraflo Therapy lowers the number of surgical debridements required and encourages granulation tissue formation to create…

BiomaterialsApprovalsWound Care

VySpine’s UniVy OsteoVy-Ti NanoVy-HA cervical IBF system gets FDA clearance

By NS Medical Staff Writer

26 Apr 23

The implant is indicated for intervertebral body fusion to be used at one level in the cervical spine,…

RegulationApprovals

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

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

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