Regulatory Approvals

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 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...

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...

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

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