Ann: CardieX Submits FDA Application for CONNEQT Pulse, page-69

This article has been published in the Journal of Personalised Medicine on the 10th September :

Factors That May Impact the Noninvasive Measurement of Central Blood Pressure Compared to Invasive Measurement: The MATCHY Study

https://www.mdpi.com/2075-4426/12/9/1482
It is worth reading a couple of times. I found it difficult to read without an Atcor Sphygmocor bias, but here is my summary. Suggest you download the PDF and read the entire document ... not just the abstract !

Essentially, a study conducted by various Chinese Departments of Cardiology to understand if current methods for non-invasive measurement of central BP was acceptable versus invasive. There was acknowledgment in the paper that CBP was a better predictor of heart disease than BP, but concern over accuracy of non-invasive devices measuring CBP prompted the study..They tested 3 devices, Atcor SphygmoCor, Pulse Pen & Mobil-O-Graph

Jumping to the conclusion ....

5. Conclusions

Our study demonstrated that noninvasive central BP measurement tended to be slightly lower than invasive BP, though without statistical significance. SphygmoCor and PulsePen devices allow for good accuracy in central BP measurement. Additionally,calibration methods, specifically SBP/DBP and MBP/DBP methods, are acceptable.

But there is richness in the detail. A couple of things I noted :

......
Pulse Pen ( which does not have FDA approval that I can see) uses carotid tonometry. This has been addressed directly by Atcor in the past

O’Rourke et al. proposed that there was a systematic error in the carotid tonometry methoddue to the “Popeye” phenomenon, that is, low amplification of pulse between brachialand aortic arteries and high amplification between radial and aortic arteries (similar toPopeye, whose forearms are extremely hypertrophied).However, in this study the Pulse Pen performed to an acceptable level.
......

Also, some argue there is still work required around the accuracy of radial BP vs brachial BP ( see below ). I'm guessing this is something the Atcor team constantly work towards improving, particularly as better sensors become available and our algorithms continue to be refined.

Another commonly discussed issue in central BP measurement is the site of peripheral BP measurement. The most commonly used method in central BP measurement is the generalized transfer function method. In this method, central BP is estimated in two parts,correctly measured waveforms and transfer function models. Normally, waveforms are recorded at the radial site, and the calibrated noninvasive peripheral BP measurementis obtained at the brachial site (e.g., SphygmoCor device). The question of whether the peripheral BP measured in daily practice (brachial BP) is well matched to the peripheral BP needed in the transfer function (radial BP) is currently an ongoing concern for researchers in the field. In the 1950s and 1960s, Kroeker et al. [21] and Rowell et al. [22] showed that the brachial BP value was similar to the radial BP value. This finding was confirmed byKelly et al. with the application of nitroglycerin in 1990 [23]. These results constitute the basis for the use of brachial BP in noninvasive central BP estimation with radial tonometry. However, in recent years, some authors have argued that amplification from the brachial to the radial artery was non-negligible [24]; thus, the use of calibrated brachial BP may cause inaccuracy in noninvasive central BP measurement.

.....

My take out from all of this is that the Chinese researchers are satisfied that Atcor SphygmoCor does the job for which it is designed.
While the FDA and several major pharmaceutical companies have long been satisfied with our device & technology, it's always re-assuring as an investor to have this confirmed independently once again.

Bodes well for Conneqt Pulse sales into China as well !