FLEX Vessel Prep system receives new indication to address in-stent restenosis

By NS Medical Staff Writer

22 Oct 20

Patients undergoing peripheral vascular interventions often receive a balloon-expandable or self-expanding stent to keep the artery open as…

RegulationApprovals

AppliedVR receives FDA breakthrough device designation to treat pain with digital therapeutic

By NS Medical Staff Writer

22 Oct 20

EaseVRx is now one of the first virtual reality (VR) digital therapeutics to get breakthrough designation to treat…

RegulationApprovals

Aidoc granted AI industry-first FDA clearance for triage of incidental pulmonary embolism

By NS Medical Staff Writer

22 Oct 20

Flagging incidental, critical findings is a huge technical challenge due to the varied imaging protocols used and lower…

RegulationApprovals

FDA approves Tyber Medical’s foot and ankle plating systems

By NS Medical Staff Writer

22 Oct 20

The plating systems are designed to treat a range of deformity, trauma, and degenerative conditions to the forefoot,…

RegulationApprovals

Spectrum Solutions gets FDA EUA status for SDNA-1000 saliva collection device

By NS Medical Staff Writer

21 Oct 20

Spectrum’s SDNA-1000 device is said to make both sample collection and transport for Covid-19 testing easy

RegulationApprovals

DxTerity secures FDA EUA status for at-home saliva-based Covid-19 test

By NS Medical Staff Writer

20 Oct 20

The EUA status enables to use the updated version of DxTerity’s SARS-CoV-2 RT-PCR test at home and workplace

RegulationApprovals

FDA approves Bracco Diagnostics’ CardioGen-82 infusion system

By NS Medical Staff Writer

19 Oct 20

CardioGen-82, a closed system, will enable to produce rubidium Rb 82 chloride injection for intravenous administration

RegulationApprovals

OSSIO awarded FDA 510(k) clearance for OSSIOfiber compression screw portfolio

By NS Medical Staff Writer

19 Oct 20

This is the third FDA clearance for the company’s OSSIOfiber Intelligent Bone Regeneration Technology, which uses proprietary bio-integrative…

RegulationApprovals

Genalyte gets FDA EUA status for rapid Covid-19 antibody test

By NS Medical Staff Writer

16 Oct 20

The multi-antigen serology panel will help identify IgG and IgM antibodies the body produces in response to the…

RegulationApprovals

FDA approves LIVMOR Halo atrial fibrillation detection system

By NS Medical Staff Writer

16 Oct 20

LIVMOR Halo is said to be the world's first prescriptible wearable device for continuous heart monitoring

RegulationApprovals