It opens the door for OEMS using the Life Signal Processor to develop ECG and other vital sign monitoring wearables with wireless connection to the cloud. The approval also provides a needed biosensor patch for companies looking to deliver certain health applications in the low acuity patient monitoring space, consumer wellness, senior care and animal health.
“This FDA approval is not only a great milestone for our company but also an indicator of what’s to come: a new era focused on the Internet of me, my body data, my life, wellness and health captured and faithfully delivered by products enabled by LifeSignals technology,” said Surendar Magar, co-founder and CEO of LifeSignals. “Using our LSP technology, data can be captured inexpensively with clinical grade accuracy, and faithfully transmitted wirelessly to existing medical monitoring systems in current hospitals or via new cloud-based systems for analysis,” he explained.
LifeSignals worked with 3M and STMicroelectronics to develop and industrialize the Life Signal Processor product family, targeting high-volume markets. LifeSignals’ LC1100 chip enables continuous scaling of products to incorporate new features. The integrated multi-electrode ECG sensor architecture, which was proven in the company’s previous FDA clearance in 2014, enables multi-lead ECG monitoring in a small form factor.
Until now, traditional wireless ECG biosensor patches have been too expensive in both cost and power consumption, have not been fully disposable (single-use), and not reliable enough for the mission-critical applications healthcare demands. The LSP technology and LP1100 patch family changes all that.
- LP1100 LS Patch is a clinical-grade, two-lead ECG (extendable to three leads) and heart rate monitoring patch, providing three days of monitoring with continuous wireless data transmission using two zinc-air batteries.
- The LS Patch has attributes previously unachieved by any other patch product—fully disposable, a small form factor, comfortable to wear under regular daily clothing, continuous data transmission on a Wi-Fi network, reliable coexistence of multiple patches while transmitting, and low cost.
- LS Patch is intended to be a baseline reference design for OEMs addressing various markets such as healthcare, consumer wellness, senior care and animal health, accelerating time to market of their diagnostic and monitoring systems. It can also be adapted as-is by OEMs under their private label to create their own end-products based on LS Patch.
- LS Patch is in high volume production at LifeSignals contract manufacturing partner—Dreamtech of Korea.
Life Signals product family supports a full suite of hardware and software development tools, including a development board and a software development kit (SDK) to design customized devices based on LSP. In addition, production-ready reference designs are available for multiple product types—including patches, smart clothing-based designs and receiver devices. Various apps are available for iOS and Android devices.