FDA grants breakthrough status to Noninvasix’s sepsis monitoring technology

By NS Medical Staff Writer

24 Feb 22

LIVOx is the first monitoring device to non-invasively monitor sepsis by detecting a key indicator of septic shock

ApprovalsRegulationDiagnostic Devices

Olympus gets FDA approval for CELERIS single-use sinus debrider

By NS Medical Staff Writer

23 Feb 22

The debrider is designed to simplify patient care in the clinic and allows less invasive procedures in any…

DevicesApprovalsDiagnostic Devices

FDA approves Medtronic’s cardiac cryoablation catheters to treat paediatric AVNRT

By NS Medical Staff Writer

21 Feb 22

The expanded approval for both catheters, which are designed to freeze cardiac tissue and block unnecessary electrical signals…

RegulationApprovals

FDA approves CloudCath PD at-home monitoring platform

By NS Medical Staff Writer

16 Feb 22

CloudCath system is claimed to be the world's first data-driven and cloud-based remote monitoring platform for PD patients

RegulationApprovals

Theradaptive Wins Additional FDA Breakthrough Designation for Spinal Fusion

By NS Medical Staff Writer

16 Feb 22

Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue…

RegulationApprovals

Dose Reduction Capability of CARESTREAM Smart Noise Cancellation Receives FDA 510(k) Clearance

By NS Medical Staff Writer

09 Feb 22

The artificial intelligence (AI)-based feature allows a user to reduce dose without loss of image quality. SNC provides…

RegulationApprovals

FDA approves BSI’s new magnesium-based bone void filler

By NS Medical Staff Writer

03 Feb 22

The new magnesium-based bone void filler, dubbed Mg OSTEOREVIVE, has been developed for use in posterolateral spine fusion…

RegulationApprovals

VySpine gets FDA nod for ClariVy cervical IBF system

By NS Medical Staff Writer

02 Feb 22

The ClariVy cervical IBF system, which consists of cervical interbody fusion devices, is suitable for use in anterior…

RegulationApprovals

FDA approves Chemence Medical’s new Exofin precision pen

By NS Medical Staff Writer

01 Feb 22

Exofin precision pen features an adjustable tip to help the user to control the adhesive width by supporting…

RegulationApprovals

Bedfont Scientific receives FDA clearance for NObreath FeNO monitor

By NS Medical Staff Writer

01 Feb 22

The NObreath, which conforms to ATS and ERS guidelines1, is a portable, non-invasive device for the measurement of…

RegulationApprovals