SeekIn secures CE Mark for LeukoPrint molecular karyotyping test

By NS Medical Staff Writer

08 Apr 22

SeekIn developed the kit to identify CNA patterns in leukaemia patients based on the shallow whole-genome sequencing

DevicesRegulationApprovals

OraSure Technologies’ subsidiary DNA Genotek launches the first device with De Novo authorization from the FDA for the preservation and stabilization of microbiome samples

By NS Medical Staff Writer

08 Apr 22

OMNIgene·GUT Dx allows for the non-invasive collection of human fecal samples and the stabilization of DNA from the…

RegulationApprovalsInnovations

C2i Genomics unveils C2inform minimal residual disease test in Europe

By NS Medical Staff Writer

07 Apr 22

C2inform will help to customise the treatment plan and support the development of more effective cancer treatments

RegulationApprovals

Venus Concept submits FDA 510(k) related to the use of its Aime next generation robotic technology for tissue excision and skin resurfacing

By NS Medical Staff Writer

04 Apr 22

Aime is a robotic platform designed to provide micro-coring for medical aesthetic applications

DevicesRegulationApprovals

Optellum wins CE mark for AI-based early lung cancer detection tool

By NS Medical Staff Writer

31 Mar 22

The AI-based tool is capable of identifying and tracking at-risk patients with suspicious lung nodules for the detection…

DevicesRegulationCertifications

Artio Medical gets FDA approval for Solus Gold Embolization Device

By NS Medical Staff Writer

23 Mar 22

Solus Gold Embolization Device can be used to stop or slow down blood flow in the peripheral vasculature

RegulationApprovals

Orthofix secures FDA nod for TrueLok EVO Ring Fixation system

By NS Medical Staff Writer

17 Mar 22

The system is said to be the first circular fixator in the market designed for complex limb reconstruction…

RegulationApprovalsOrthopedic

Guardant Health gets regulatory approval in Japan for Guardant360 CDx

By NS Medical Staff Writer

15 Mar 22

A liquid biopsy test, Guardant360 CDx analyses circulating tumour DNA (ctDNA) from the blood samples of patients with…

RegulationApprovalsDiagnostic Devices

Cionic secures FDA approval for Neural Sleeve

By NS Medical Staff Writer

09 Mar 22

Neural Sleeve is an algorithm-powered bionic, leg-worn, lightweight garment designed to help people with mobility issues

RegulationApprovals

Health Canada approves bioLytical’s iStatis Covid-19 antigen test

By NS Medical Staff Writer

08 Mar 22

The approval will enable bioLytical Laboratories to sell iStatis Covid-19 antigen test across Canada for professional use in…

DevicesRegulationApprovals