This article was originally published in The Gray Sheet
Gains FDA permission to resume normal distribution of the Life Pulse high frequency jet ventilator. The firm's activities previously had been limited by FDA to shipments to existing customers of supplies and, in emergency situations, ventilators. The shipment restrictions were part of a September 1992 order/agreement with FDA that required Bunnell to recall and retrofit its existing Life Pulse devices ("The Gray Sheet" Sept. 21, p. 28). Bunnell President and CEO Bert Bunnell said in an April 6 press release that "the effect of the FDA enforcement action has been mixed. We have sustained heavy losses in personnel and sales, but our customer base has remained largely intact".
You may also be interested in...
Data show Opdivo/Cabometyx combo bests Sutent for overall and progression-free survival and response endpoints in first-line RCC. Exelixis CEO says comparison to Sutent is standard control and allows better comparison to other combo regimens.
ES: Public Company Edition: Fifty biopharma companies launched initial public offerings in the US last year and there have been 52 so far in 2020, including Metacrine, Dyne, Athira and COMPASS.
In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.