Spectral Medical Inc T.EDT

Alternate Symbol(s): EDTXF

Spectral develops devices for unmet medical needs. Sepsis occurs in 1.7M Americans/year causing 250K deaths, often caused by endotoxin. Our devices measure and remove endotoxin from the bloodstream. An FDA confirmatory trial is underway. Dialco, a Spectral sub, offers SAMI, a novel instrument for renal replacement, cleared by FDA. Dialco is seeking FDA approval for DIMI a unique home dialysis enabler. These devices have large commercial potential

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Spectral Medical Inc

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Post by smartsobon Jul 11, 2022 3:53pm

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Post# 34816072

not a slam dunk

6 benefits of FDA Breakthrough Devices program - StarFish Medical

Kiefa

June 1, 2020 at 12:22 am

Comapnies that are granted a Breakthrough through this program, do they stand a better change at being approved by the fda or do they product go on to get fda approval and is there a percentage rate of approvals
Virginia Anastassova

June 5, 2020 at 9:28 pm

The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. The Breakthrough Devices Program does not offer a better chance for approval as approval is based on evidence of device safety and effectiveness and the same criteria applies as for the regular approval pathways. Approval rates for 2019 are 40% based on 5 designations and 2 approvals out of 5.

Virginia