MedGizmo - MedGizmo Overview: EKGs With Mobile Device – RUSSIA vs. USA‎
05.06.2016, 02:08   MedGizmo

MedGizmo Overview: EKGs With Mobile Device – RUSSIA vs. USA‎

A couple of days ago a leading Russian on-line news agency published a big story on medical gadgets -CardioQVARK a mobile solution to get a medical-grade EKG, analyze it and send it to physician. I have been using US product – AliveCor’s KARDIA  for about 9 months, and so I was curious – is CardioQVARK a clone of KARDIA, or it is a completely different story. As I have no chance for practical test of CardioQVARK, the only way is to judge – from media reports and corporate Web-site
First general impression is - these two devices are very similar:
CardioQVARK so far is a specially designed phone cover, while KARDIA is a stand-alone device, that can be placed in a similar cover.
However, KARDIA works with different types of smartphones and both with iOS and Android. I have been using KARDIA initially with my SAMSUNG smartphone and it was working perfect; now with new SONY EXPERIA – it is working – but not that good. CardioQVARK so far is designed for iPhone and iOS only. But the principle is the same: place your two thumbs on the sensors of cover and the device gives you electrocardiogram (EKG) almost instantly. In both cases results can then be sent to a doctor using a relevant app. KARDIA recently introduced an option of voice recording during the measurement procedure in addition to its typing text for each recording.
Recently MedGizmo reported a number of concerned media releases that are questioning the accuracy of wearables measurements. I am not a qualified cardiologist at all, and cannot provide any judgement on the quality and accuracy of both devices. However, I do feel that, hence KARDIA is FDA approved device – it MUST be accurate.
There is very little, if nothing reported on CardioQVARK outside Russia (mostly in Russian), so the goal of this post is to make English-speaking medical professionals aware of existence of different to KARDIA solution. Who knows, maybe the market (that is the ultimate judge) will accept it widely?
Little is known about Moscow-based L Kard LLC that is the legal owner of the project. However, we may find a very cryptic note in the Crunchbase (about Cardio Quark company):
"Company produces ECG monitoring devices in a phone case form factor. It also develops cloud software for health monitoring and communication." And this is all.
Usually behind a good project stands a great man. In our case – this is Alexander Ezhkov, the owner of Pirogovo Golf and Yacht Club  and one of the biggest retail Mytishchi Fair, who invested about 2 million USD in development and commercial production of CardioQVARK.
The scientific part of the program was supervised by experts from St.Petersburg State Electrotechnical University and Academician Petrovsky Russian Research Center of Surgery; while industrial production is running at one of the facilities of GS Group Holding in Kaliningrad. Initially 100 prototype devices were produced that went rigorous clinical trials at 7 hospitals in Moscow area. Since 2014 when the project started - 11,000 ECGs were processed. 

CardioQVARK provides for collection of the following data:
  • Standard ECG with duration from 30 seconds to 5 minutes
  • Mean cardiac cycle
  • 12 parameters of heart rate variability, their interpretation and graphics
  • Recognition of arrhythmia
  • Detection of atrial fibrillation
  • Recognition of pacemaker pulses
  • Analysis of cardiac cycle morphology
Here is how one of the screen looks:
According to the developers, the most important distinction of CardioQVARK form its peers is Doctor with Tablet technology. Patient self-registers the EKG, may look at major indicators in an intuitive form, than data is sent to server and made available to physician. The doctor has its own tool - tablet, which has advanced features for working with cardiogram; while serious attention is paid to personal data protection.

The physicians have ability now to download and install from iTunes Store  CardioQVARK Doctors  app (in Russian). Here is a screenshot from iPad:

Besides this feature, CardioQVARK allows to monitor patients with implantable antiarrhythmic devices (pacemakers). And an important thing – the software has an open interface for third-party API developer.
Summarizing our brief overview
According to the Russian news media, salient project metrics are:
  • Major customers: on-line shops, clinics and hospitals
  • 2016 production volume – 30,000 devices
  • Average cost - $100-150
  • Expert EKG Analysis Fee – around 30 Rub (approx.$1)
  • Projected annual sales volume -100,000 – 500,000 devices
  • Projected 2020 revenue from services and partnership programs: 1.6B Rub (approx.$24.4M)
  • Projected 2020 sales revenue (approx. $22.9M)

Major Project milestones since its initiation in 2014:
  • Commercial production of CardioQVARK for iPhone
  • Developed software for doctors and patients: applications and cloud service.
  • Developed and implemented algorithms and analysis of cardio data.
  • A total of 1,300 people, screened 11,000 cardiograms processed
  • Initiated procedures to obtain Apple MFI License and Russian Medical Device Registration Certificate

2016 :
  • Apple MFI License and Russian Medical Device Registration Certificate
  • Development of new devices, including for Android OS

  • Expansion into foreign markets (Eastern Europe)
  • Clinical trials (USA and West Europe)

  • Global expansion
  • IPO

And here is YouTube video
MedGizmo overview is based on the following resources
05.06.2016, 02:08   MedGizmo
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