The story
Bunnell Incorporated was established in 1980 with the help of the University of Utah's Innovation Center, which is a project funded by the National Science Foundation. In 1982, the company began clinical trials for the Life Pulse Ventilator at five key medical centers in Utah, Arizona, Minnesota, Pennsylvania, and Florida.
In 1985, the company treated almost 100 infants, then submitted "12 copies of a nearly thousand-page application to the FDA for approval." The application was rejected and continued to be rejected for three years, the company was under a $2 million debt. On June 30, 1988, the FDA approval was granted.
From Wikipedia’s article on Bunnell Incorporated, shared under CC BY-SA 4.0.3