Doctors: If you have a patient who had canaliculitis or another complication from a SmartPlug, for goodness' sakes report it to the FDA on the MAUDE database. Here's the link to MAUDE. And while you're at it, make sure you report it to Medennium too on their Contact page. Device manufacturers are required to notify the FDA of post market complications they become aware of. I just had a look and there are 14 reports of SmartPlug complications ...
This is the sort of thing that makes me wish I'd ever learned something about statistics. I don't know how to translate this. To someone as ignorant as me it could be anything from validating the usefulness of the tool to politely saying it's just a marketing gimmick stupid. Somebody with a mathematical bone in their body care to comment on what 33 means here? Reproducibility and repeatability of the OcuSense TearLab™ osmometer. BACKGROUND: Some studies report ...
...on February 1st. Yikes, I'm behinder than I thought I was. Sorry about that.
Morrisville company gets clearance to sell dry eye product MORRISVILLE, N.C. — A Morrisville-based company has gotten clearance from the U.S. Food and Drug Administration to market and sell a technology used to help people with dry eyes. TearScience announced Monday that it has received FDA clearance for its LipiFlow Thermal Pulsation System, which is designed for the treatment of meibomian gland dysfunction (MGD), also known as evaporative dry eye. The ...
TearScience's Lipiflow is all the rage right now and for good reason. We have several people on the board who have undergone the procedure either in Europe, Canada or as part of a clinical trial in the US (where it is not yet approved) Thus far it is available in Toronto and in Abbotsford BC. YouTube video on Lipiflow at Herzig Eye in Toronto June 9 press release: TearScience Launches Breakthrough Technology in Canada to Address the Root Cause of Evaporative Dry Eye ...