Heart Test Laboratories Inc (HSCS)

[Whalatane]

In late September 2023, the FDA cleared an algorithm for low ejection fraction (less than 40%) under the 510(k)-pathway using the new product code. Accordingly, we now believe it is probable that we could submit the MyoVista algorithm for clearance under the 510(k) pathway. The 510(k) pathway is more common than De Novo and, on average, has a much quicker decision process than De Novo by the FDA.
We have formally filed the request with the FDA and expect a response in late Q4 2023.

Likely to be make or break for this Co
JMO
Kiwi