FDA identifies Draeger’s recall of Seattle PAP Plus and other products as Class I

By NS Medical Staff Writer

25 May 23

Initiated by the medical equipment maker on 17 April 2023, the recall involves a total of 570,459 devices…

RegulationRecalls

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

Dutch medical supplier Philips to pay more than $62m to settle FCPA charges

By NS Medical Staff Writer

15 May 23

In April 2013 the Commission charged Philips in connection with similar misconduct in Poland that had occurred between 1999 and…

RegulationRegulatory Policy

US FDA finalises recommendations to evaluate blood donor eligibility

By NS Medical Staff Writer

12 May 23

The US FDA expects the new recommendations will potentially increase the number of people eligible to donate blood,…

Regulation

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

FDA classifies Avanos’ recall of BALLARD ACCESS Closed Suction Systems as Class I

By NS Medical Staff Writer

24 Apr 23

The US-based medical technology company is recalling its BALLARD ACCESS Closed Suction System for neonates and paediatrics distributed…

RegulationRecalls

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