selling exhausted, page-20

FYI - below is the actual device clearance from the FDA. It would appear to the doctor was originally intended to play a central role in the application and interpretation of results. However, as this was never intended as a final diagnostic tool, I share your confidence this will achieve OTC approval.

From the clearance:

Indications for the WIM-PCTM is intended for the analysis, interpretation and Use: documentation of lung sounds. The WIM-PCTM is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.

Of note is that Isonea haven't applied for FDA approval for AsthmaSense - only for SonoSentry. Yet in reading the FDA guidance it would appear that regulatory oversight is required.

From the guidance:

The following examples represent mobile apps FDA considers mobile medical apps and that will be subject to its regulatory oversight:

Mobile apps that allow the user to input patient-specific information and - using formulae or processing algorithms - output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.

I've tried to do some research as to why Isonea believe the AsthmaSense - operating on a mobile platform - is exempt from of FDA approval but it's not clear, other than it clearly doesn't fall into any of the 'Appendix A' examples of being a class I device(that the FDA are focused on at the moment). That said, I'm sure they wouldn't have left it to chance and pre-cleared with the FDA.

Otherwise I thought this was interesting. Supports the synergies with Qualcomm..

To further clarify, the following categories identify the types of mobile medical apps and their associated classifications.

Displaying, storing or transmitting patient-specific medical device datain its original format – Mobile medical apps with this functionality constitute an MDDS (21 CFR 880.6310) and are subject to class I requirements (general controls), which include adequate design controls, registration, device listing, adverse event reporting, and corrections and removals. The FDA believes that requiring general controls sufficiently manage the risks for mobile medical apps that are used as a secondary display to a regulated medical device and are not intended for providing primary diagnosis or treatment decisions (i.e. mobile medical apps that meet the MDDS definition).

So. All good. I think.

http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071955.pdf

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm