trending Market Intelligence /marketintelligence/en/news-insights/trending/fvvojqog2n8mgwwsbkj9tg2 content esgSubNav
Log in to other products

Login to Market Intelligence Platform


Looking for more?

Contact Us
In This List

Spectral septic shock treatment approval delayed by US FDA

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry


IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

Spectral septic shock treatment approval delayed by US FDA

Toronto-based Spectral Medical Inc. said the U.S. Food and Drug Administration asked for more data before it could approve the company's Toraymyxin.

Toraymyxin is a medical device that filters blood and removes an endotoxin from the bloodstream that can cause sepsis, a potentially life-threatening complication of an infection.

The FDA has requested that Spectral conduct further studies and submit data from outside the U.S. and real-world registries.

The premarket approval application was accepted for review by the FDA in July 2017 and was supported by a phase 3 clinical trial.

The company said it would meet with the regulator and discuss a path forward.