AMIC files de novo submission with FDA for Y-90 RadioGel device.
The recent decline in the Firm's share price, the FDA's rejection of the Firm's request for advertising clearance through the 510 procedure for the Y-90 RadioGel gadget, a reduced amount of the Company's level of activities arising from a lack of funds, the Company's outstanding debt, payables and conversion features of its debt have managed to get more difficult for the ongoing organization to secure capital. Nonetheless, the business continues its efforts to address the foregoing weaknesses, to seek capital and to reduce its debts and payables.. AMIC files de novo submission with FDA for Y-90 RadioGel device, seeks Course II reclassification Advanced Medical Isotope Corporation , a late stage development company involved primarily in the development of brachytherapy gadgets and medical isotopes for diagnostic and therapeutic applications, today announced that this provides filed a de novo submission with the Food and Drug Administration for marketing clearance because of its patented Y-90 RadioGel gadget pursuant to Section 513 of the U.S.What’s following: This is actually the first study to demonstrate that metabolomic profiling of the egg can generate important information about the resulting embryo. More studies are needed to confirm the results also to test in higher numbers. Implications: If long term studies confirm these results, the test could someday be utilized to predict the achievement of IVF and help determine which eggs ought to be selected for fertilization or even to end up being frozen, Behr said.