Shineco, Inc Subsidiary, Granted USPTO Patent and FDA Marketing Approval for Its In-situ Fecal Specimen Sampling Device

By NS Medical Staff Writer

08 Dec 22

This product provides a massager-like fingertip swab, a collection tube and a lid with unidirectional sampling inlet

DevicesApprovalsDiagnostic Devices

AVAVA Receives FDA 510(k) Clearance for its First-in-Class High Energy Skin Renewal Platform – MIRIA Skin Treatment System

By NS Medical Staff Writer

08 Dec 22

The MIRIA system is the only FDA cleared laser product that more than doubles the current therapeutic energy…

InnovationsApprovalsCoatings & Surface Treatments

Health Canada approves Novocure’s Optune for treatment of glioblastoma

By NS Medical Staff Writer

30 Nov 22

The wearable and portable Optune device delivers TTFields therapy to the region of the tumour

RegulationApprovals

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

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