Regulatory Approvals

Minneapolis-based Imricor Medical Systems said it won 510(k) clearance from the FDA for its Vision-MR Diagnostic Catheter. The 9 Fr. catheter is designed for use...

Siemens Healthineers announced that it received FDA clearance for its 70cm bore Magnetom Flow magnetic resonance imaging (MRI) platform. The 1.5T platform features a closed...

Naox Technologies has received FDA 501(k) clearance for its wired electroencephelography (EEG) earphones, Naox Link. Paris-based Naox Technologies says it is taking its EEG sensors...

Stereotaxis has won FDA approval for its robotically navigated MAGiC ablation catheter, offering a minimally invasive option for patients who otherwise might not be...

Spectrumedics Medical has obtained a CE mark for its coronary intravascular lithotripsy (IVL) system under the European Union’s Medical Device Regulation (EU MDR). Related: StimLabs...

StimLabs announces that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for Theracor, the first human umbilical cord-derived medical device to...

SleepRes announced that it received FDA 510(k) clearance for its Kricket PAP device for treating obstructive sleep apnea (OSA). Kricket PAP is powered by the...

CMR Surgical has secured US Food and Drug Administration (FDA) clearance for its Versius Plus minimally invasive robotic surgical system, priming the company to...

Medivis announced today that it received FDA 510(k) clearance for its augmented reality (AR)-powered Cranial Navigation platform. The company said clearance makes Cranial Navigation the...