In Brief: Healthdyne
This article was originally published in The Gray Sheet
Executive Summary
Healthdyne: European launch of disposable, single-use probe for non-invasive fetal oximetry is slated for late 1997, President and CEO Craig Reynolds says June 18 at the Dillon, Read & Company medical technology conference in New York City. A U.S. launch will follow FDA clearance of a premarket approval application. The device gives a "direct measurement of oxygen, it gives...a quantitative number," the exec said. Reynolds originally predicted a 1997 U.S. launch for the system at a December 1995 investor's conference ("The Gray Sheet I&W-11)...
You may also be interested in...
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.