Here’s a roundup of companies announcing regulatory clearances from the Food & Drug Administration and foreign regulatory agencies:
- Boston Scientific wins expanded CE Mark for WallFlex biliary stent
Boston Scientific Corp. (NYSE:BSX) announced that its WallFlex Biliary RX Fully Covered Stent has received CE Mark approval for the treatment of benign biliary strictures.
- Medtronic announces new inflatable bone tamp for treatment of vertebral compression fractures
Medtronic Inc. (NYSE:MDT) today announced Food & Drug Administration clearance of the Kyphon Xpander II Inflatable Bone Tamp for the treatment of vertebral compression fractures with minimally invasive Kyphon Balloon Kyphoplasty.
- Burton Medical receives FDA clearance for its AIM-200 OR light source for surgical operating rooms
Burton Medical Inc. received FDA clearance for its AIM-200 O.R. light for surgical lighting applications in operating rooms for ambulatory surgical centers as well as acute care facilities.
- Devon Medical Products receives FDA 510(k) clearance for CircuFlow sequential compression pump models
Devon Medical Products, a manufacturer and distributor of creative, safe, and cost-effective medical devices, announced it has received Food & Drug Administration 510(k) clearance to market its CircuFlow 5100 and 5200 sequential pump models that treat venous insufficiency and lymphedema.
- Mirador Biomedical announces 510(k) clearance of the Compass vascular access and Compass lumbar puncture devices
Mirador Biomedical, a medical device company developing the innovative Compass family of disposable medical devices, announced FDA 510(k) clearance of its two leading products, the Compass Vascular Access and the Compass Lumbar Puncture.
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- Successful Pre-IND FDA filing for STB’s FAST dressing
STB Lifesaving Technologies announced that is has completed a successful pre-Investigational New Drug (pre-IND) submission to the Food & Drug Administration for its lead product, the Fibrin Adhesive STat, or FAST, dressing.
- PneumRx Inc. announces CE Mark approval for its RePneu lung volume reduction coil system
PneumRx Inc. announced that it has received CE Mark approval for its RePneu Lung Volume Reduction Coil (LVRC) System to treat the later stages of emphysema.
- Synapse Biomedical receives FDA Humanitarian Use Device Designation for amyotrophic lateral sclerosis
Synapse Biomedical Inc. received Food & Drug Administration designation of the NeuRx diaphragm pacing system as a Humanitarian Use Device for amyotrophic lateral sclerosis patients with a stimulatable diaphragm who are experiencing chronic hypoventilation and has now submitted for Humanitarian Device Exemption approval.