Galen gets FDA De Novo grant and clearance for Galen ES Robotic System

By NS Medical Staff Writer

27 Sep 23

The world’s first such robotic platform is intended to ease ear, nose, and throat surgical procedures, including instrument…

RegulationApprovals

Profound Medical wins FDA 510(k) clearance for TULSA-PRO Thermal Boost

By NS Medical Staff Writer

26 Sep 23

Thermal Boost is the firm’s first FDA-cleared TULSA AI module which enables predictable, tailored ablation at the prostate…

RegulationApprovals

Quantum Surgical receives NMPA market authorization for its Epione robot to treat abdominal cancers in China

By NS Medical Staff Writer

22 Sep 23

Epione allows physicians to treat inoperable tumors that are particularly difficult to reach, due to their size or…

RegulationApprovals

Tyber Medical Gains FDA and MDR Clearance For Its Implantable K-wires And Steinmann Pins In Stainless Steel And Titanium Alloy

By NS Medical Staff Writer

22 Sep 23

These critical approvals pave the way for significant expansion and greater product availability for patients and Tyber's private-label…

RegulationApprovals

Moon Surgical Announces CE Mark for Its Commercial Maestro System

By NS Medical Staff Writer

20 Sep 23

Easy to Use and Scalable: The Maestro System’s Approach to Laparoscopy

RegulationApprovals

Tasso Receives CE Mark Certification for Tasso+, Latest Generation Whole Blood Collection Lancet Device

By NS Medical Staff Writer

20 Sep 23

Designation expands the availability of Tasso’s patient-centric blood collection solution for decentralized clinical trials, home diagnostic testing, wellness…

RegulationCertifications

B. Braun Receives FDA Clearance for AQUAbase nX Reverse Osmosis System

By NS Medical Staff Writer

19 Sep 23

B. Braun Medical Inc. (B. Braun) is a leader in smart infusion therapy and safe and effective pharmacy…

RegulationApprovals

CereVasc Receives FDA IDE Approval to Expand its Clinical Study of Patients with Normal Pressure Hydrocephalus Utilizing the Generation 2 eShunt System

By NS Medical Staff Writer

19 Sep 23

The Gen2 eShunt System has been designed to simplify the device preparation process, enhance the overall ease of…

RegulationApprovals

Venus Concept Receives 510(k) Clearance for the Venus Versa Pro System, Its New Multi-Application Platform

By NS Medical Staff Writer

15 Sep 23

Venus Versa is customizable and upgradable and offers the most in-demand aesthetic treatments by supporting 10 optional applicators

RegulationApprovals

FDA classifies Abbott’s recall of Proclaim and Infinity IPGs as Class 1

By NS Medical Staff Writer

14 Sep 23

The Proclaim and Infinity IPGs were recalled due to their inability to exit magnetic resonance imaging (MRI) mode…

RegulationRecalls