Mr. Thomas Braun reports
VERISANTE TECHNOLOGY, INC. ANNOUNCES SUBMISSION TO THE FDA FOR AURA(TM), A SKIN CANCER DETECTION DEVICE
Verisante Technology Inc. has initiated communications with the Food and Drug Administration in the United States for the approval of Aura, a device for the detection of skin cancer.
"Verisante has now submitted documents to the FDA as we begin the formal application process for approval to market and sell Aura in the United States," said Thomas Braun. "We look forward to working closely with the FDA to receive further guidance and feedback on our regulatory pathway."
According to the Skin Cancer Foundation, skin cancer is the most common form of cancer in the United States, with more than 3.5 million skin cancers in over two million people diagnosed annually. Every year the new cases of skin cancer are greater than the incidences of breast, prostate, lung and colon cancer combined.
Melanoma, the deadliest form of skin cancer, accounts for one death every 57 minutes in the United States. The overall five-year survival rate for a patient whose melanoma is detected early, before the tumour has spread, is about 98 per cent but falls to 62 per cent when the disease reaches the lymph nodes, and 16 per cent when the disease metastasizes to distant organs.
We seek Safe Harbor.
© 2024 Canjex Publishing Ltd. All rights reserved.