MedTech News
FDA clears new radiotherapy systems from Siemens Healthineers’ Varian
Varian announced today that it received FDA 510(k) clearance for its TrueBeam and Edge radiotherapy systems with HyperSight imaging.
New Soldier® High Flow Microcatheter Granted FDA Clearance
FDA Clears Soldier Microcatheter for Localized Drug Delivery in Vascular Interventions
Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface
Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology.
FDA Clears AIOMEGA’s AIO Breathe, for Treatment of Obstructive Sleep Apnea
TYLER, Texas–(BUSINESS WIRE)– AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and Drug Administration.
Nevro Receives FDA 510(k) Clearance to Use SI Fixation System Without Need to Include Lateral Screw
Nevro1™ Proven to Immediately Transfix Sacroiliac (SI) Joint to Allow for Long-term SI Joint Fusion
Sonus Microsystems unveils latest ultrasound tech
Sonus Microsystems has unveiled its latest ultrasound technology, delivering remote diagnostic imaging, without the need to go to a clinic or hospital
New Models of PENTAX Medical i20c Video Endoscope Series Obtain CE Marks
TOKYO, Feb. 27, 2024 /PRNewswire/ — PENTAX Medical, a division of HOYA Group, have obtained CE marks for new models of PENTAX Medical i20c Video Endoscope Series – PENTAX Medical Video Colonoscope EC34-i20c, PENTAX Medical Video Upper GI Scope EG27-i20c and R/L Knob Adaptor OE-B17.
Virtual Incision wins FDA nod for miniature MIRA surgical robot for use in colectomies
Virtual Incision announced that the FDA granted marketing authorization to its MIRA miniaturized surgical robotic system.