Welcome!

News Feed Item

Cardiac Insight Announces FDA Clearance of “CARDEA SOLO™” – The First Wearable (ECG) Sensor Giving Physicians Immediate Access to Complete Cardiac Arrhythmia Data and Analysis

Cardiac Insight, a U.S. developer of body worn sensing devices and computational software, announced today, the FDA has cleared the company’s wearable electrocardiogram (ECG) sensor, CARDEA SOLO™. The device offers physicians immediate access to improved reporting and analysis of heartbeat-to-heartbeat data. The design and ease of use also encourage better patient compliance for the acquisition and recording of complete patient data. CARDEA SOLO will be used to assist with the diagnosis of a variety of arrhythmias, including the most common, atrial fibrillation (AFib).

The company expects the capabilities of CARDEA SOLO to enhance efficiencies in mean time to cardiac diagnosis and treatment, which can contribute to improved conditions for patients and reduce health care system costs.

“CARDEA SOLO is an affordable, patient friendly and nonintrusive device designed to improve health care for the millions of patients who suffer from arrhythmia,” said Brad Harlow, Co-Founder and Chief Executive Officer of Cardiac Insight, Inc. “The timely retrieval of cardiac patient data can contribute to improved diagnosis and treatment and lower health care costs.”

Physicians can now use CARDEA SOLO in their offices to retrieve full-disclosure cardiac data for immediate review and action - a process that previously required days or weeks. For the first time, the sensor technology eliminates the need for outsourcing to costly and time-consuming third-party service centers and puts control of the patient data, analysis and processing in the hands of physicians and their staff. Global service billing is streamlined and the need to track and reprocess in-house capital equipment is eliminated.

The device is small, lightweight (approximately 25 grams), lead-less, water-resistant and single-use disposable. Patients can wear CARDEA SOLO comfortably under their clothing for up to seven days and maintain their normal daily activities.

The CARDEA SOLO sensor records ECG data and patient symptoms. The physician office software analyzes the recorded cardiac data to provide physicians with full-disclosure of all data, ECG trace review tools and a summary report of heart rhythms.

The American Heart Association journal, Circulation, reported that 33.5 million people around the globe have AFib. According to the National Stroke Association, AFib raises a person's risk for stroke by 500 percent and most AFib-related strokes can be prevented.

CARDEA SOLO is available by contacting [email protected].

About Cardiac Insight:

Cardiac Insight, Inc. (www.cardiacinsightinc.com) is a U.S. developer of advanced body-worn digital health care information devices for cardiology, respiratory and other complex disease states. The company’s technologies and systems are created using advanced algorithms and software that provide improvements in mean time to diagnosis. Cardiac Insight’s mission is to invent complete and progressive solutions for unmet clinical needs on behalf of physicians, clients and payers. Cardiac Insight was founded in 2008 and is based in Kirkland, WA.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...