07:57:35 EDT Mon 29 Apr 2024
Enter Symbol
or Name
USA
CA



Izotropic Corp
Symbol IZO
Shares Issued 54,896,346
Close 2024-01-29 C$ 0.13
Market Cap C$ 7,136,525
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Izotropic receives further questions from U.S. FDA

2024-01-30 12:38 ET - News Release

Mr. Robert Thast reports

IZOTROPIC RECEIVES RESPONSE FROM U.S. FDA

Further to its Jan. 8, 2024, disclosure, Izotropic Corp. has received a response from the U.S. Food and Drug Administration (FDA).

The FDA's mammogram and ultrasound team has responded to Izotropic with additional questions regarding its presubmission 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.

As of the date of this news announcement, there has been no material change to the company's regulatory plans and no definitive decision provided by the FDA.

We seek Safe Harbor.

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