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

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

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

Stryker secures FDA nod for OptaBlate bone tumour ablation system

By NS Medical Staff Writer

21 Sep 22

OptaBlate, which is the company’s first interventional oncology technology, is said to optimise every aspect of the procedure,…

InnovationsApprovalsMotors & Motion Control

MagBio Receives 510(k) Clearance and CE Mark for MagXtract Collection Tube For COVID-19 Testing

By NS Medical Staff Writer

13 Sep 22

Now Launching in U.S. and Europe as the first FDA-cleared Guanidine-Free Molecular Transport Medium; Offers Improved Safety, Stability…

DevicesApprovalsDiagnostic Devices

Magnus’s SAINT Neuromodulation System secures FDA nod for MDD treatment

By NS Medical Staff Writer

07 Sep 22

The SAINT system integrates hardware, software, and cloud computing to identify the ideal anatomic target for focused neuromodulation…

DevicesApprovalsNeurological

Applied DNA seeks approval for monkeypox test from NYSDOH

By NS Medical Staff Writer

22 Aug 22

If approved, the firm will get permission to manufacture the diagnostic kit intended to identify the genetic signature…

RegulationApprovals

FDA grants IDE to Avenda Health’s AI-enabled prostate cancer therapy

By NS Medical Staff Writer

10 Aug 22

With the approval, the firm’s FocalPoint ablation system powered by iQuest can now be used in a randomised…

RegulationApprovals

Rapid Medical Gains FDA Clearance for the Smallest & Only Adjustable Thrombectomy Device

By NS Medical Staff Writer

27 Jul 22

TIGERTRIEVER 13 is designed to reduce vessel tension during ischemic stroke treatment, and is the only device that…

RegulationApprovalsSurgical and Supplies