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

Philips recalls Respironics BiPAP machines due to plastic issue

By NS Medical Staff Writer

30 Aug 22

The US FDA said that the machines may contain plastic contaminated with a non-compatible material that could leak…

RegulationRecalls

FDA classifies recall of Medtronic’s HeartWare HVAD batteries as Class I

By NS Medical Staff Writer

26 Aug 22

The firm recalled the HeartWare Ventricular Assist Device (HVAD) system batteries due to risks of electrical faults that…

Patient Care DevicesRecallsPatient Care Monitoring

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

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