Regulatory Approvals

Reach Surgical receives CE Mark approval for SOUND REACH Swift

Reach Surgical, the surgical solutions division of Genesis MedTech, has received CE Mark approval for SOUND REACHTM Swift, ultrasonic shears designed for open surgical...

Genesee BioMedical receives FDA 510(k) clearance for ATLAAS device

Genesee BioMedical, Inc., a medical device company with decades of experience designing, manufacturing, and commercializing technologies for cardiac surgery, announced today the U.S. Food...

MannKind wins FDA approval for inhaled insulin for children

MannKind announced that it received FDA approval for its Afrezza inhaled insulin powder for children. FDA approval covers use in children and adolescents aged 6...

Neurovalens earns FDA nod for neuromod for PTSD

Neurovalens announced that it received FDA de novo approval for Modius Spero, a post-traumatic stress disorder (PTSD) therapy. Belfast, Northern Ireland-based Neurovalens designed its Modius...

Cornerstone Robotics wins CE mark for Sentire endoscopic surgical robot

Cornerstone Robotics announced that it received CE mark approval for its Sentire endoscopic surgical robotic platform. European approval covers minimally invasive surgical procedures in general...

Epineuron receives FDA 510(k) clearance for Evala Nerve Stimulator

Epineuron, a medical device company pioneering bioelectronic medicine, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Evala®...

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...
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