Radiotherapy solutions company CIVCO Radiotherapy and POLL Medical on Thursday jointly announced the receipt of US Food and Drug Administration (FDA) 510(k) clearance to market GrayDuck Stents.
The new product provides custom oral positioning with repeatable tongue deviation during radiotherapy.
GrayDuck Stents are designed to improve patient treatment and outcomes by sparing the tongue, taste buds and salivary glands from unnecessary dose. The stent can position the tongue in one of several positions: laterally (left or right), depressing (downward) or a combination thereof.
According to the company's director John Steffen, the ability to offer a custom device that can be formed in less than 15 minutes is very meaningful for the patient and clinical workflow, while still providing high quality positioning necessary for treatment.
GrayDuck stents were issued the US Patent 9,504,537 with additional patents pending worldwide. The stents are available in Europe with CE Mark and now in the US with FDA 510(k) clearance.
Philips launches InkSpace Imaging Snuggle coil for 3.0T MRI systems
Realheart secures European patent for artificial heart technology
Median Technologies secures FDA clearance for AI lung cancer screening software
Eli Lilly to invest over USD3.5bn in new Pennsylvania plant
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval
Apiject to open new generic injectable drug manufacturing facility in Apex, NC
Zylox-Tonbridge agrees staged acquisition of Germany's Optimed
Kestra partners with Biobeat to add cuffless blood pressure monitoring to wearable defibrillator
Boston Scientific to acquire Valencia Technologies to expand overactive bladder portfolio
EQT Life Sciences exits Vivasure Medical in EUR185m sale to Haemonetics