mHealth Boost In Q3 2010: Increased Venture Backing & 4 Major FDA Regulatory Clearances

2010 has been a big year in the area of mHealth, with the market finally beginning to emerge from its “wait-and-see” attitude of the last several years.  Q3 2010 was particularly productive for the industry as venture backing in mHealth-related startups began to accelerate, while the FDA made four important regulatory clearances. Focusing on the latter, …   Read More

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2010 has been a big year in the area of mHealth, with the market finally beginning to emerge from its “wait-and-see” attitude of the last several years.  Q3 2010 was particularly productive for the industry as venture backing in mHealth-related startups began to accelerate, while the FDA made four important regulatory clearances.

Focusing on the latter, the first of four major movements by the FDA was the clearance of WellDoc’s “Diabetes Manager System” for care providers and adult patients with type 2 diabetes.  Five years in the making, WellDoc’s offering is a mobile health system built on automated clinical coaching and behavioral algorithms driven by real-time patient data, according to the company.  WellDoc’s software aims to enable care providers to extend their care beyond traditional office visits by utilizing mobile phones and the Internet.

The second relates to AirStrip Technologies, which is best known as the creators of “AirStrip OB” — one of the first FDA approved medical applications in Apple’s AppStore.  The company announced in Q3 that the FDA had cleared its AirStrip “Remote Patient Monitoring (RPM)” suite of applications, which includes the “AirStrip RPM Critical Care” and “AirStrip Cardiology” apps.

The third milestone was Calgary Scientific’s “Resolution MD app,” which got clearance by both the FDA and Health Canada.  The Resolution MD app acts a viewer for diagnostic image files, which users can see instantly on their smartphones.  Since the app doesn’t actually transfer diagnostic image files to the user’s device, they can still be protected and stored behind the care provider’s firewall because the images themselves aren’t resident on the device.  This is a big deal because it’s a major step forward in securing mobile communication of healthcare information — something that’s been a major barrier to mHealth innovation in general.

The fourth milestone was Honolulu, Hawaii-based Kai Medical receiving 510(k) clearance for an updated version of its wireless respiratory rate monitor called “Noncontact Respiratory Spot Rate Check 200.”  The app aims to overcome barriers facing other approaches for measuring respiratory rates, which usually leads to it being inaccurately measured, infrequently measured or not measured at all.  These milestones and other findings are covered in a recent report published by MobiHealthNews.com entitled “Mobile Health Q3 2010: State of the Industry,” which can be found here.

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