Healthstats

HealthSTATS International operates from Singapore as a privately held technology company specializing in bio-monitoring devices for hypertension and related cardiovascular conditions. Founded in January 2000, the company has established a reputation for innovation through its BPro ambulatory blood pressure monitoring (ABPM) system based on wrist-worn arterial tonometry.

The company's technology has been recognized internationally through major awards including World Economic Forum Technology Pioneer (2006), Frost & Sullivan's Most Important Technology Development in BioSciences (2008), and Times Higher Education's Outstanding Contribution to Innovation & Technology (2011). Over 60 papers using HealthSTATS devices have been published in cardiovascular journals including JACC and the American Journal of Cardiology.

HealthSTATS has secured regulatory clearances across major markets: FDA 510(k) approval in the US (2006, 2018), CE marking (0197) across Europe, Health Canada approval, Australia TGA, Singapore HSA, and Colombia INVIMA. The company's business model centers on providing ABPM systems to healthcare providers and supporting clinical trials for major pharmaceutical companies including Novartis and Merck.

Modified Applanation Tonometry — HealthSTATS coined this approach as "Evidence-Based Blood Pressure technology." The BPro device positions a pressure transducer over the radial artery at the wrist, using the radius bone as structural support. The patented sensor plunger transfers arterial pressure forces to an internal sensor while a specialized strap system ensures consistent positioning over the artery.

The sensor samples at 60 Hz, capturing 8-second blocks of continuous pulse wave data every 15 minutes. This yields 96 measurements over 24 hours. Before each session, the device requires calibration using a conventional oscillometric blood pressure cuff (BPCalibrator MC3100+) applied to the upper arm. The calibration readings establish patient-specific parameters that the tonometric sensor uses to derive systolic pressure, diastolic pressure, pulse rate, and central aortic systolic pressure (CASP) from the radial pulse waveforms.

The system stores complete waveform data for each measurement along with time stamps. Data transfers via USB cable (original BPro) or Bluetooth wireless (BPro BT model). The BPro BT introduced in 2018 added wireless transmission, color display, and rechargeable battery while maintaining the same core sensor and measurement algorithms as the 2006 predicate device.

HealthSTATS validated the BPro against intra-arterial measurements at National University Hospital Singapore (2001-2002) in 15 subjects. The study demonstrated systolic accuracy of 0.1 ± 4.1 mmHg and diastolic accuracy of 0.5 ± 3.8 mmHg against the gold standard arterial line, meeting AAMI SP-10 criteria (mean ± 5 mmHg, SD ± 8 mmHg).

ESH protocol validation in 2004 with the Clinical Trials & Epidemiology Research Unit at National Heart Centre Singapore achieved systolic accuracy of 4.31 ± 4.0 mmHg and diastolic accuracy of 3.77 ± 3.48 mmHg in seated position. Phase 2.2 testing showed 23 of 33 subjects with systolic differences ≤5 mmHg and 29 of 33 subjects for diastolic. A subsequent AAMI validation in 88 subjects across seated, standing, and supine positions confirmed accuracy within AAMI standards across all body positions.

HealthSTATS targets clinical research organizations and pharmaceutical companies conducting cardiovascular drug trials. The company has supported 21+ clinical trials for Novartis across multiple geographic regions (US, Czech Republic, Russia, China) between 2007-2014, as well as trials for Merck. Academic partnerships include Queen Mary University London, University College London, National Heart Centre Singapore, multiple Japanese medical universities, and University of Cape Town.

The BPro differentiates from traditional arm-cuff ABPM devices through wrist placement and continuous pulse wave capture. This positioning addresses patient compliance issues associated with repeated arm cuff inflations during sleep. The device measures 44×51×19 mm and weighs approximately 50 grams, comparable to a sports watch. Wrist circumference compatibility ranges from 13 cm to >21 cm through interchangeable strap lengths.

The company faces competition from established ABPM manufacturers (Omron, Mobil-O-Graph, SpaceLabs, SunTech) using traditional oscillometric cuff technology, as well as newer wrist-based optical PPG approaches (Aktiia). HealthSTATS' validation against intra-arterial measurements and extensive pharmaceutical trial usage support clinical credibility, though the requirement for pre-session oscillometric calibration adds a procedural step relative to self-calibrating systems.