Substantially Equivalent....so what was the point of this clinical study late last year, https://hotcopper.com.au/threads/ann-positive-wheezo-clinical-study-results.5597003/#.YFSCu68zZPY, which caused the pps to increase from 15.5c to 18.5c (and the result weren't even that good). No wonder MM was so certain they would get FDA approval by the end of this month (and just before the important quarterly) because there wasn't any changes to the Class I product, effectively this was just a "re-brand" of wheezo.
"A total of 56 patients participated in the study (55 eligible for data analysis), with 114 recordings taken. A total of 11 physicians participated in the study, which was unblinded and non-randomised by design."
"The study data was reanalysed by the Company in this report and a new and improved proprietary algorithm developed. The wheezo device when compared to the physician assessment of the chest and trachea was able to correctly detect a true positive (sensitivity) in 81% of cases and correctly detect no wheeze (a true negative) in 79% of cases (specificity). It is recognised that Physician assessment of wheeze is subjective and when adjusted for two physicians that showed significant disagreement to retrospective breathing recordings wheeze assessment, the sensitivity of the device increased to 89%."
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