A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Dune Medical Devices announced results of a study published in the journal Nature.com demonstrating the utility of the MarginProbe technology in prostate cancer surgery. The prototype device, developed by Dune, was designed to enable use of Dune’s patented radiofrequency spectroscopy technology in radical prostatectomy procedures, to aid surgeons in complete removal of the prostate gland while achieving negative surgical margins. MELODIKA