Revenio Group Oyj: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.
Revenio Group Oyj's Icare Finland Oy Suspends FDA Trading License Process for Icare One Self-Tonometry Product
Revenio Group Oyj announced that Icare Finland Oy, a subsidiary of the Health Care segment of Revenio Group Corporation, has decided to suspend the FDA trading license process for the Icare One self-tonometry product, while further action is taken. The application is not deemed to have progressed in a way and at a speed that would justify the continuation of the current application process. The main reason for the slow progress is assumed to be the regulation related to obtaining a trading license for products in the FDA's so-called home use category. Part of this regulation is still in its draft stage and expected to be specified by the FDA at a later date. Icare One was previously granted trading licenses for other principal market areas where it continues to be sold as normal. The product features of the device are still being developed on the basis of medical research work related to self-tonometry. Icare Finland Oy will re-launch the FDA license process at a later date, utilizing the new product features and increased medical research evidence. In the United States, Icare Finland Oy currently sells its main product, the TA-01 tonometer, and sensors for professional use. The sale of these products continues as normal. The suspension of the licensing process will have no impact on the market situation of Icare Finland Oy's products or the Revenio Group Corporation's financial guidance for the fiscal year 2012.
Latest Key Developments in Advanced
- Nortal Investments AB acquires stake in Accelerator Nordic AB
- Deltex Medical Group PLC establishes joint venture with distributor
- dorsaVi Ltd announces ownership interests of Starfish Ventures Pty Ltd
- FDA advisory panel votes favorably on Boston Scientific Corp scientific WATCHMAN left atrial appendage closure device
- Share this
- Digg this