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

SeaStar Medical Receives FDA Approval to Begin Study with Selective Cytopheretic Device to Reduce Hyperinflammation in Adults with Acute Kidney Injury

By NS Medical Staff Writer

10 Feb 23

Patient enrollment in pivotal clinical study expected to begin in March

DevicesApprovalsOrthopedic

Varian gets FDA nod, CE Mark for HyperSight-equipped Halcyon and Ethos systems

By NS Medical Staff Writer

03 Feb 23

The firm has also announced the first patient treatment with a Halcyon system equipped with HyperSight at Penn…

Diagnostic DevicesApprovalsDiagnostic Imaging

FDA classifies LivaNova’s recall of LifeSPARC system’s controller as Class I

By NS Medical Staff Writer

30 Jan 23

The US health regulator claimed that the device could reach critical failure mode due to a problem in…

RegulationRecalls

Etiometry gets FDA clearance for AI-based IDO2 Index risk algorithm

By NS Medical Staff Writer

25 Jan 23

Hospitals in the US can now use Etiometry’s IDO2 Index to quickly identify changes in the conditions of…

Patient Care DevicesApprovalsPatient Care Monitoring

icotec ag Receives FDA Clearance for the Ø 4.5mm VADER Pedicle Screws

By NS Medical Staff Writer

25 Jan 23

The extended VADER Pedicle System maintains its proven indication and versatility for open, MIS and cement-augmented surgical techniques…

ApprovalsPatient Care DevicesSurgical and Supplies