IZOTROPIC CORPORATION Izotropic Corporation announced that further to its January 8th disclosure, it has received a response from the U.S. FDA. The FDA's mammogram and ultrasound team has responded to Izotropic with additional questions regarding its pre-submission seeking definitive guidance on a Class II 510(k) pathway. The FDA had previously agreed in writing to provide a more definitive response to Izotropic within the month of January.
Izotropic's management, regulatory, and engineering teams will respond to the FDA's questions and will promptly report the outcomes of the FDA's response once it becomes available.
