FDA classifies Baxter’s recall of WatchCare IMS systems as Class I

By NS Medical Staff Writer

24 Nov 22

The recall is based on reports of interference to other nearby critical medical devices by radiofrequency emissions from…

RegulationRecallsPatient Care Monitoring

Philips reports new safety issues in previously-replaced Trilogy ventilators

By NS Medical Staff Writer

22 Nov 22

The firm has notified the two issues to the appropriate authorities throughout the world and anticipates finishing its…

RegulationRecallsPatient Care Monitoring

Zimmer secures FDA clearance for Persona OsseoTi knee replacement system

By NS Medical Staff Writer

22 Nov 22

Persona OsseoTi is said to have a new porous version of the Persona anatomic tibia that uses the…

RegulationApprovalsOrthopedic

SafeSource Direct Receives FDA 510(k) Clearance on Chemo-Rated Nitrile Exam Gloves

By NS Medical Staff Writer

18 Nov 22

FDA Clearance Clears Way for American-Made PPE

ApprovalsPatient Care DevicesSurgical and Supplies

Allotrope Medical announces FDA Safer Technologies Program (STeP) designation for their surgical device StimSite

By NS Medical Staff Writer

08 Nov 22

For the past year, StimSite has been used by surgeons to help locate and identify ureters through electrical…

Patient Care DevicesCertificationsSurgical and Supplies

Philips to lay off 4,000 employees amid falling sales

By NS Medical Staff Writer

25 Oct 22

The Dutch health technology company has been hit with a loss of €1.5bn in Q3 2022, which was…

RegulationRecallsRespiratory and Anesthesia

XACT Robotics secures FDA nod for ACE Xtend Remote Control Unit

By NS Medical Staff Writer

12 Oct 22

The remote control unit enables the users to robotically insert and steer instruments by using the XACT ACE…

Patient Care DevicesApprovalsSurgical and Supplies

Becton, Dickinson recalls sterilisation containers for potential quality breach

By NS Medical Staff Writer

10 Oct 22

The recall list includes 17 versions of the reusable metal containers, sold under the Genesis Sterrad brand, which…

RegulationRecallsSurgical and Supplies

Thermo Fisher Scientific Announces FDA Approval of Oncomine Dx Target Test as the First NGS-Based Companion Diagnostic to Aid in Therapy Selection for Patients with RET Mutations/Fusions in Thyroid Cancers

By NS Medical Staff Writer

28 Sep 22

Approval also marks the second NGS-based companion diagnostic to identify RET-fusion positive locally advanced or metastatic non-small cell…

DevicesApprovalsDiagnostic Devices

ClearPoint announces FDA clearance for ClearPoint Prism Neuro Laser Therapy System

By NS Medical Staff Writer

26 Sep 22

The ClearPoint Prism Neuro Laser Therapy System is authorised for use to necrotise or coagulate soft tissue using…

DevicesApprovalsDiagnostic Devices