SEC Sues Imaging3 For Misleading Investors About FDA Device Review
This article was originally published in The Gray Sheet
Executive Summary
The Securities and Exchange Commission says the imaging equipment firm’s founder and CEO made misleading public statements about the contents of a 2010 “not substantially equivalent” letter from FDA for Imaging3’s investigational Dominion 3-D, real-time imaging system.
You may also be interested in...
The Omniscient Regulator: QRxPharma’s Unusual Take on FDA and Investor Calls
Investor calls routinely begin with a disclaimer that the call is being recorded. They don’t usually include a warning that “FDA is monitoring the call.” But that is how QRxPharma began a discussion of a bad news event for its MoxDuo application.
News In Brief
Ecolab buys O.R. Solutions
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”