Memorandum

Philosys’ Gmate Smart glucose meter and app receive FDA 510(k) clearance – September 2, 2014

Executive Highlights

  • On August 4, Philosys received FDA 510(k) clearance for its Gmate Smart app and accompanying smartphone glucose monitor. Similar to the iHealth Align, the Gmate Smart operates only when plugged into the headphone jack of a smartphone.
  • A US launch is slated for late September 2014. The meter will retail from $8.95-$19.95; the Apple device-compatible Gmate app is free and is currently available on the app store.
  • The list of smartphone compatible meters grows by the day, now including Ambio, iHealth, J&J, LabStyle Innovations, Philosys, Roche, Sanofi, Telcare, and YOFi meter.

New York City-based Philosys recently announced that its smartphone-connected glucose meter, the Gmate Smart, received FDA 510(k) clearance, reflecting a lengthy 15-month Agency review. Similar to the iHealth Align (launched in June), the Gmate Smart plugs directly into the headphone jack of a user’s device and works via the complementary Gmate Smart app (currently only compatible with Apple iPhone, iPod touch, and iPad). The very small meter (see picture below) is approximately thumbnail-sized and about two US quarters in thickness. To test blood glucose, users plug the meter into the headphone hack, open the app, insert a test strip, apply a sample, and receive results on the app. We tried the product about a year ago and were impressed by its small size, though did not feel the app was as user friendly or well-designed as apps from J&J (VerioSync) and Sanofi (iBGStar). According to the company, the device meets both ISO 2013 and the stricter FDA 2014 proposed standards for SMBG home use.

A US launch of the device is slated for later this month. The free accompanying Gmate app is already available on the Apple app store, and the company is optimistic that an Android app will be “market-ready” by late fall. The meter will be marketed at various price points ranging from $8.95 to $19.95 in wholesale and retail outlets. The company told us that Gmate Smart will launch with US reimbursement, though it is unclear to what extent. In the EASD 2013 Exhibit Hall, the company (named “VPD” outside the US) told us that the CE-Marked meter was available in 12 countries in Europe and it had reimbursement. A sign advertised a “special exhibition price” of 45 euros for the small thumbnail-sized meter and 100 test strips.

Smartphone/cloud-connected blood glucose meters have come on the scene in a major way in the past several years, both from very established and smaller players (see below). We are fans of the move to greater connectivity, as it vastly improves data collection (a major unmet need), makes providers’ lives easier, and could help patients spend more time in zone by reducing the barriers to retrospective analysis. In the coming years, this trend will undoubtedly move to CGM and pumps, as we’ve covered recently with Dexcom’s Gen 5 platform (submission expected by end of 2014/early 2015) and several CGM-pump integration partnerships (Insulet/Dexcom, Asante/Dexcom). Medtronic also has cloud-connected devices in its pipeline, but has never revealed an official timeline on these products.

  • The Gmate Smart received a CE Mark in August 2012 and the company had originally expected FDA approval of the glucometer in 3Q12. The meter was not submitted to the FDA until April 2013 and was not cleared until August 4, reflecting a very length 15-month 510(k) review. Per our conversation with the rep at EASD, the FDA had lots of questions on the device that delayed clearance.
  • The Philosys Gmate Smart builds on a trend of smartphone/cloud-connected meters – below is a non-exhaustive list of those we are aware of (we acknowledge there are likely others in development). We believe much of the diabetes device industry is moving in this direction, and it will only be a matter of time before a large number of devices (BGM, CGM, pumps) are cloud connected.

Table 1: Smartphone/cloud-connected meter market

Company/
Product

Notes

Status

Closer Look/

diaTribe coverage

Ambio Remote Health Monitoring System

Wireless-enabled AgaMatrix Presto glucose meter

FDA 510(k) clearance

FDA clearance (July 2013)

iHealth Align

Plugs directly into headphone jack and wirelessly sends results to device

Launched in US on June 12, 2014; CE Marked

US launch (June 2014)

iHealth Smart Gluco-Monitoring System

Standalone meter; wireless Bluetooth sync to app on Apple devices

Launched in US on October 30, 2013; CE Marked

US launch (October 2013)

J&J LifeScan OneTouch VerioSync

Standalone meter; wireless Bluetooth sync to iPhone app

Available in US

FDA clearance (February 2013)

 

US launch (January 2014)

 

diaTribe test drive (March 2014)
 

LabStyle Innovations Dario

All-in-one meter, lancing device, strips; meter plugs into headphone jack of iPhone and Android

Soft launched in the UK, Italy, and New Zealand; FDA 510(k) application under review

CE Mark (October 2013)

 

NHS Reimbursement (June 2014)

Philosys Gmate Smart/ VPD 2in1 Smart

Meter plugs into headphone jack of Apple devices

Available in EU; FDA approved, with US launch in late September 2014

Enclosed

Roche Accu-Chek Connect

BGM with Bluetooth connectively to smart App and cloud

2014 EU Launch

Roche 2Q14

Sanofi iBGStar (diaTribe)

Standalone meter; plugs into iPhone charging port (iPhone 5 only with lightning adapter)

Available in US and EU

US Launch (May 2012)
 

diaTribe test drive (May 2012)

Telcare

Cellular-enabled standalone blood glucose meter

Available in US

ADA 2014 Exhibit Hall (June 2014)

 

diaTribe test drive (March 2012)

YOFi Meter

All-in-one meter, lancing device, strips; cellular chip; color touchscreen; built-in pedometer

As of January 2014, an FDA filing was expected in mid-2014; a US launch was expected in 4Q14

CES 2014 (January 2014)

Figure 1: Philosys Gmate Smart

 

-- by Varun Iyengar, Adam Brown, and Kelly Close