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LifeSignals Announces FDA Clearance of Health Care Vital Sign Wireless Monitoring Biosensor and ECG Application

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FDA Approval Paves Way for Next Generation of Remote Patient Diagnostics

Fremont (California) – July 24, 2018 — LifeSignals announced today that it received FDA clearance for its wireless LP1100 LifeSignals Biosensor for enabling the next generation of wearable, healthcare monitoring devices. It is built on two solid technology foundations to provide unprecedented attributes unachieved by another ECG biosensor product to date. It deploys the company’s recently launched LC100 LifeSignals Processor (LSP) Platform and a patented, integrated multi-electrode architecture.

It opens the door for OEMS using the LifeSignals Processor to develop ECG and other vital sign monitoring wearables with wireless connection to the cloud. The approval also provides a needed biosensor 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 (NYSE: MMM) and STMicroelectronics (NYSE: STM) to develop and industrialize the LifeSignals 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.

LifeSignals Processor Innovations
Until now, traditional wireless ECG biosensors 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 biosensor family change all that.

LP1100 LS Biosensor is a clinical-grade, two-lead ECG (extendable to three leads) and heart rate monitoring biosensor, providing three days of monitoring with continuous wireless data transmission using two zinc-air batteries

The LS Biosensor has attributes previously unachieved by any other biosensor 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 biosensors while transmitting, and low cost.

LS Biosensor 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 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 Biosensor.

LS Biosensor is in high volume production at LifeSignals contract manufacturing partner – Dreamtech of Korea.

Developer Support Items for OEMs:
LifeSignals 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 biosensors, smart clothing-based designs, and receiver devices. Various apps are available for iOS and Android devices.

About LifeSignals, Inc.

LifeSignals (formerly HMicro Inc.) is the Silicon Valley-based creator and producer of the patented LifeSignals Processor (LSP), a semiconductor platform designed to faithfully capture and communicate vital life signals from humans and animals to the cloud. LifeSignals works together with its growing ecosystem of technology and services partners, to serve established OEMs and early-stage innovators in human and animal healthcare, senior living, worker safety, and other life-critical markets. LifeSignals is a venture capital-backed, a fabless semiconductor company, enabled by equity investments from Flex, Uniquest, Dreamtech, Renew Group, Seraph Capital, Xseed Capital, and Reddy Capital. Further information can be found at www.lifesignals.com.

Media Contacts for LifeSignals

PRxDigital

Jennifer Spoerri – 415-577-0171

Brenna Bolger – 408-838-6673

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