Nanowear, a remote diagnostics and smart clothing company, has added another Food and Drug Administration (FDA) 510(k) clearance to its SimpleSense system.

The SimpleSense system includes a noninvasive wearable vest that remotely monitors patient vitals such as heart rate, blood pressure, respiration rate and physical activity. The device collects and shares this information with the SimpleSense web platform, which generates artificial intelligence-enabled, real-time analytics to support clinicians’ decision-making.

Providers can use SimpleSense to remotely triage cardio, pulmonary and upper vascular patients, the company said.

WHAT’S THE IMPACT?

As the company’s first software-only clearance, this 510(k) will enable it to “implement standalone AI and deep learning algorithms that will inform remote diagnoses,” according to the announcement.

Specifically, Nanowear says the clearance establishes its core data assets, secures its data architecture and unifies its 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),” Venk Varadan, cofounder and CEO of Nanowear, said in a statement.

“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.”

This clearance paves the way for Nanowear to move into other clinical verticals such as hypertension, COPD, sleep apnea, worsening heart failure and post-surgical recovery.

THE LARGER TREND

Nanowear now has three FDA 510(k) clearances. Its first came in 2016 and was for its SimpliECG wearable undergarment. The second is from 2020 and cleared the SimpleSense diagnostic undergarment and machine learning digital platform.

The company lent its services to the New York City-Metro Health Systems during COVID-19 through a research collaboration focused on remote detection of COVID-19.

Athos is another company developing smart clothing. In 2015, the company scored $35.5 million in funding for its clothing line with embedded sensors. 

An early player in the space, OMsignal closed its doors in 2019 after declaring bankruptcy and selling its patents to Honeywell Safety Products.

There’s also Siren, which makes smart socks to help podiatrists keep a lookout for diabetic foot ulcers. The company landed $20.8 billion in Series B funding last year.

Owlet, a baby tech company, also makes smart socks that use pulse oximetry to track a baby's oxygen levels and heart rate during sleep. Earlier this year, Owlet went public through a SPAC merger with Sandbridge Acquisition Corporation.

Digital health and fitness company WHOOP has begun adapting its wearable into smart clothing. Users can place their WHOOP 4.0 device in the company’s Body collection to track their heart rate, skin temperature, blood oxygen saturation, resting heart rate, heart rate variability and respiratory rate.