FDA authorises marketing of MAGENTIQ-COLO gastrointestinal lesion software detection system

By NS Medical Staff Writer

01 Aug 23

The device, one of the only artificial intelligence solutions cleared for colonoscopy, will be updated in the future…

RegulationApprovals

Icotec gets FDA clearance for VADER Pedicle System Navigated Instruments

By NS Medical Staff Writer

28 Jul 23

The VADER Pedicle System Navigated Instruments combine standard surgical processes with advanced navigational tools to ensure that treatments…

RegulationApprovals

Urotronic Announces FDA Approval of Optilume BPH Catheter System, Pioneering the Next Generation of Minimally Invasive Solutions for Enlarged Prostate Symptom Relief

By NS Medical Staff Writer

12 Jul 23

Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal…

RegulationApprovals

Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

By NS Medical Staff Writer

22 Jun 23

BabySat is a step forward in solving some of these exact challenges by bringing real-time medical grade infant…

Patient Care DevicesApprovalsPatient Care Monitoring

Inspire Medical Systems Announces FDA Approval for Apnea Hypopnea Index Indication Expansion and Increased Body Mass Index Labeling

By NS Medical Staff Writer

12 Jun 23

The update includes an increase on the upper limit of the Apnea Hypopnea Index (AHI) to 100 events…

RegulationApprovals

FDA grants clearance to THINK Surgical’s TMINI Miniature Robotic System

By NS Medical Staff Writer

31 May 23

The TMINI Miniature Robotic System incorporates a wireless robotic handpiece, which assists surgeons in performing total knee replacement…

RegulationApprovals

Concept Medical’s fourth IDE approval for the MagicTouch Sirolimus Coated Balloon is granted for the treatment of Superficial Femoral Artery Disease

By NS Medical Staff Writer

30 May 23

The Company has already received three other pivotal IDE approvals for its SCB MagicTouch family of products for…

RegulationApprovals

DBI selects HTEC, Effectum Medical for IVDD compliance of DBI-EPIbreath

By NS Medical Staff Writer

29 May 23

DBI-EPIbreath is said to be an easy-to-apply breath test that can offer reliable estimates of circulating concentrations of…

RegulationApprovals

Neurophet receives FDA 510(k) Clearance for Neurophet AQUA

By NS Medical Staff Writer

19 May 23

Plans to cooperate with radiology AI solution platform companies to enter the U.S. market

RegulationApprovals

Ricoh gets expanded FDA clearance for 3D anatomic modelling of soft tissue

By NS Medical Staff Writer

04 May 23

The expanded clearance has been granted for creating patient-specific anatomic models for neurological, cardiovascular, gastrointestinal, genitourinary, and breast…

RegulationApprovals