Regulatory Approvals

Vitestro gains CE mark for autonomous blood drawing robot

An autonomous blood drawing device developed by Dutch company Vitestro has become the first machine of its kind to be granted a CE mark...

Renata Medical wins FDA nod for first-of-its-kind stent for young children

Renata Medical shared the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children. Newport Beach, California-based Renata designed the...

FDA grants breakthrough status to M.scio telemetric pressure measurement system

The US Food and Drug Administration (FDA) has granted breakthrough device designation for the M.scio system, a non-invasive, telemetric pressure measurement system aimed at...

FDA approves electrical nerve stim tech from Neuros Medical

Neuros Medical announced it received FDA approval for its Altius direct electrical nerve stimulation system. The FDA cleared Altius as an aid in the management...

CereVasc wins FDA breakthrough nod for eShunt system

CereVasc received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies...

US FDA approves Resivant Medical’s tissue adhesive products

The US Food and Drug Administration (FDA) has issued 510(k) clearance for Resivant Medical’s high-viscosity tissue adhesive products, Cutiva Topical Skin Adhesive and Cutiva...

Stimvia plans to enter US neuromodulation market after MDR certification

Stimvia is set to enter the multi-billion dollar neuromodulation market in the United States with its innovative URIS device. The Czech company says this...

Accuray wins CE mark for new helical radiation delivery system

Accuray received CE mark approval for its Helix CT-guided helical radiotherapy system. The Madison, Wisconsin-based company designed Helix to deliver high performance and high...

Obvius Robotics earns FDA breakthrough nod for Certa access system

Obvius Robotics announced the FDA granted breakthrough device designation for its Certa access system for central venous catheterisation (CVC). CVC procedures require access to one...
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