Regulatory Approvals

Aurie wins FDA nod for reusable intermittent catheter system

Aurie announced that it received FDA de novo clearance for its Aurie Reusable No-Touch Intermittent Catheter System. The Syracuse, New York-based company says the milestone...

FDA clears Bright Uro’s abdominal sensor for evaluating bladder dysfunction

Bright Uro’s Glean abdominal sensor has obtained US Food and Drug Administration (FDA) clearance, expanding the company’s broader Glean urodynamics system to include multi-channel...

Microsure announces CE Mark approval and CEO transition

Microsure, a medical robotics company developing high-precision robot-assisted systems for microsurgery, announced the CE mark approval of its MUSA-3 system and a leadership transition as...

FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent

US-based TaeWoong Medical has secured the US Food and Drug Administration (FDA) clearance to commercialise the Niti-S Spaxus Stent, expanding its range of endoscopic...

Agitated Solutions wins CE mark for cardiac microbubble generator device

Agitated Solutions announced that it received CE mark approval for its novel Orbis microbubble generator device. St. Paul, Minnesota-based Agitated Solutions designed Orbis to streamline...

Motif Neurotech wins FDA IDE to evaluate brain implant for treating depression

Motif Neurotech announced that it received FDA investigational device exemption (IDE) to evaluate its brain stimulation implant. Houston-based Motif plans for its RESONATE early feasibility...

BrioHealth gets conditional FDA nod for pediatric ventricular assist device study

BrioHealth announced that it received conditional FDA approval to conduct a clinical evaluation of its ventricular assist device (VAD) in pediatric patients. Burlington, Massachusetts–based BrioHealth...

Xeltis gains EU CE mark on positive trial data for vascular access graft

Xeltis has gained a European CE mark for aXess, with 12-month pivotal data of the vascular access graft for haemodialysis demonstrating strong and higher...

Corify Care picks up FDA nod for cardiac mapping tech

Corify Care announced that it received FDA clearance for its Acorys imageless, non-invasive cardiac mapping platform. Madrid-based Corify designed its platform to provide a global,...
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