Remote diagnostics company Nanowear announced on Thursday that its nanotechnology-enabled wearable remote monitoring device and its SimpleSense platform received FDA 510(k) clearance as a continuous blood pressure monitor. SimpleSense-BP is a novel Softwear-as-a-Medical Device (SaMD) platform that combines the company’s proprietary cloth-embedded nanotechnology sensors and its artificial intelligence (AI) and machine learning (ML) to provide clinical-grade decision support as a cardiopulmonary clinical decision support tool.
“This FDA clearance represents an exciting and differentiating moment for Nanowear. Accelerated by the pandemic, the market has been eagerly searching for reliable, clinical-grade wearable, and data service solutions that find product market fit with the following three attributes: at-home, utilizing AI, and a proven team that executes,” says Venk Varadan, CEO and co-founder of Nanowear. “This SaMD is just the first example of what our nanotechnology and AI is capable of, in understanding the individualized risk signatures and cardiopulmonary care pathways of each patient, materially enabling precision medicine.”
The FDA clearance is the fourth received by the company, founded in 2014, that has more than a dozen patents, most of which cover the manufacturing of cloth embedded with nanosensors developed for continuous monitoring of patients’ cardiopulmonary health.
SimpleSense uses the company’s patent-protect nanosensor-embedded cloth to produce a gender-neutral sash that is worn as an undergarment to monitor 85 distinct biomarkers related to cardiopulmonary function. These data points—upwards of 100 million per day from continuous monitoring—are fed into a closed-loop AI- and ML- enabled software platform that remotely provides healthcare providers with actionable information on their patients.
According to Varadan, the integrity of the data from the nanosensors fuels its diagnostic algorithms and fast analysis.
“The largest bottleneck for any AI deployment is data preparation, which can take 70% to 80% of the time in any given application,” he said in a press release in September 2021 following the company’s FDA clearance as the first software-only an end-to-end digital platform. “Unlike wrist or armband device-enabled hospital-at-home platforms that do not yield high-fidelity longitudinal data, our SimpleSense platform utilizes clinical-grade biomarkers with a high SNR (signal-to-noise ratio). The time required to see results with our neural network is significantly shorter, meaning we have the profound ability to scale the capabilities of our platform immediately. SimpleSense already reduces provider workflow and patient time by approximately 60%; but the long-term value is that SimpleSense truly does get smarter with each patient.”
The current approval from the FDA was based on the company’s four-decision tree algorithm SimpleSense-BP, which was tested in three study arms with both training and validation conducted in different geographies and demographic populations aimed to replicating the diversity of the US population, generalized tot the entire hypertensive population. It is validated to track changes of > +/- 15mmHg systolic and +/- 10mmHg diastolic blood pressures over a continuous recording period across all classes of hypertension.
Ken Ouriel, chief medical officer of NAMSA, a MedTech clinical research organization, notes that a technology such as SimpleSense is important to get a reliable measure of person’s real-life vital statistics versus readings that are often skewed by so-called white coat syndrome which can cause patients to show higher blood pressure readings. Continuous blood pressure monitoring has high value not just in the healthcare setting but as a tool in clinical trials.
“Just as a patient’s blood pressure may be high in a 30 second reading due to white coat syndrome, the same patient may reduce their blood pressure by breathing calmly for five minutes before the 30 second reading. So, what are we actually learning about that individual patient or the therapeutic applied?” Ouriel noted. “To date, existing healthcare wearables and software platforms are either restricted in scope and time; or are unreliable and unvalidated for what they can diagnose during ‘real-world’ conditions. Nanowear’s continuous device, software platform, and AI algorithms, can transform the way clinical research platforms operate. Importantly, sponsors would be able to receive clinically reliable and trended data driven insights; data from the real world; their patients’ homes, their workplace, and a myriad of other settings that comprise everyday life.”
