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

OptraSCAN secures CE-IVDR for OS-Ultra digital pathology system

By NS Medical Staff Writer

29 Jul 22

The OS Ultra scanners deliver high-resolution images that can be analysed further with the help of OptraSCAN's artificial…

DevicesCertificationsDiagnostic Devices

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

Renovia’s leva Pelvic Health System approved in US to treat chronic FI

By NS Medical Staff Writer

08 Jul 22

The leva Pelvic Health System is indicated as a prescription digital therapeutic (PDT), where it works by guiding…

RegulationApprovals

FDA Approves Sientra’s Low Plus Profile Projection Breast Implant

By NS Medical Staff Writer

07 Jul 22

New Implant Offers Surgeons and Their Patients More Options to Customize Their Surgical Outcomes

RegulationApprovals

US FDA classifies recall of GE’s ventilator batteries as Class I recall

By NS Medical Staff Writer

29 Jun 22

The CARESCAPE R860 ventilator's backup batteries and replacement backup batteries were recalled as they were draining fast and…

RegulationRecalls

UK to tighten regulation of medical devices for patient safety

By NS Medical Staff Writer

27 Jun 22

The reforms will cover medical devices like hearing aids, x-ray machines and insulin pumps; new technologies such as…

RegulationCertifications

FDA clears Thermo Scientific EliA RNA Pol III and EliA Rib-P Tests for use in US

By NS Medical Staff Writer

10 Jun 22

New blood tests aid in diagnosing systemic sclerosis and systemic lupus erythematosus

RegulationApprovals

Nalagenetics secures CE mark for PGx Core software module

By NS Medical Staff Writer

01 Jun 22

The CE mark will allow the firm to sell its software in Europe, as well as secure regulatory…

RegulationApprovals

MedAlliance secures FDA IDE approval for SELUTION SLR drug eluting balloon

By NS Medical Staff Writer

31 May 22

The device demonstrated positive results in the treatment of patients with chronic limb-threatening ischemia (CLTI) and below-the-knee artery…

RegulationApprovals