Diagnostic device news

Clinical Utility of Objective Tests for Dry Eye Disease: Variability Over Time and Implications for Clinical Trials and Disease Management.

PURPOSE:
To evaluate the efficacy of commonly used biomarkers in dry eye disease management in a longitudinal observational case series study followed by an interventional study in a subset of subjects treated with cyclosporine A (0.05%).

METHODS:
Bilateral tear osmolarity, Schirmer, tear film breakup time (TBUT),

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Good news for TearLab - it's been reclassified such that it will be easier for drs. to adopt. Bet that will help with their marketing machine.

TearLab Gets FDA Approval for Wider Use of Eye Test

The FDA granted a Clinical Laboratory Improvement Amendments to TearLab to widen the use of its Osmolarity System, a test for dry eye, according to a Reuter's report.

The change came after the device was reclassified to "simple" instead of "moderately

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RPS Announces Health Canada Approval of RPS InflammaDry Detector™
(August 22, 2011)
Ten-minute test allows clinicians to detect inflammation in the tears of patients with Dry Eye disease

On August 11, Health Canada granted Rapid Pathogen Screening, Inc. a Medical Device License for the RPS InflammaDry Detector, the first and only rapid, in-office test to detect elevated levels of MMP-9 in tear fluid. Receiving a Medical Device License allows RPS to begin marketing the

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Edited since originally posting...

I had written some strong criticisms in this space and on my blogspot blog the other day of TearLab's website www.allaboutdryeye.com because of its somewhat anonymous character (no indications of who owned the site). The style overall brought back unpleasant memories of the heyday of LASIK and all the doctor-promoting sites that purported to be some kind of quality accreditation but failed to state who was financially behind them (and profiting from ...

Usefulness of Double Vital Staining With 1% Fluorescein and 1% Lissamine Green in Patients With Dry Eye Syndrome.

PURPOSE:
To determine the relative staining characteristics of the nasal and temporal conjunctiva as compared with other measures of dry eye and evaluate the qualitative clinical impression of the utility of the double vital staining with fluorescein and lissamine green.

METHODS:
Ocular surface staining was performed with a mixture of 1% fluorescein

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