Ambient Clinical Analytics Achieves ISO 13485:2016 Certification & their DART™ Solution is Now Part of the Patient Safety Movement‘s Actionable Patient Safety Solutions

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Ambient Clinical Analytics announces today that it achieved ISO 13485:2016 certification and the Company’s DART™ solution was included in the Patient Safety Movement’s Actionable Patient Safety Solutions (APSS) #9 for Sepsis.

ISO certification communicates a message to all potential provider healthcare partners that certified companies are world-class businesses capable of delivering value and long-lasting support.

Ambient Clinical Analytics announces today that it achieved ISO 13485:2016 certification and the Company’s DART™ solution was included in the Patient Safety Movement’s Actionable Patient Safety Solutions (APSS) #9 for Sepsis. They are also partnering with the Patient Safety Movement Foundation by signing their Open Data Pledge in order to help eliminate preventable deaths in hospitals. Ambient’s AWARE™ software is an FDA Class II cleared product for point of care use and was built by clinicians for clinicians. The solution uses detection and support rules to indicate if clinical issues are present or developing and to maintain a complete view of a patient’s condition to help prevent medical errors. According to the Institute of Medicine, medical errors are quickly becoming a leading cause of death and injury to people across the globe. Preventable harm is ranked as the third leading cause of death in the United States and the fourteenth worldwide.
Ambient Clinical Analytics is pleased to announce that it has achieved ISO 13485:2016 certification, an internationally recognized quality standard specific to the medical device industry. The ISO 13485 standard is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical device industry. “ISO certification communicates a message to all potential provider healthcare partners that certified companies are world-class businesses capable of delivering value and long-lasting support, said Deb Sutherland, Vice President Software Development, Quality & Regulatory at Ambient Clinical Analytics. “By becoming ISO certified, a company is able to demonstrate through time they have met the objectives of a rigorous standard of excellence which is extremely important to health systems and will enhance their competitive advantage.”

Ambient Clinical Analytics is also proud to announce today that Ambient’s Sepsis DART™ product has been accepted into the Patient Safety Movement’s Actionable Patient Safety Solutions (APSS) #9 for Sepsis. “Ambient’s Sepsis DART™ solution is focused on both the customizable automated detection of potential sepsis, as well as graphically tracking the delivery of the process of care to improve timeliness of response and to eliminate errors in treating sepsis patients.”, said Al Berning CEO of Ambient Clinical Analytics. “We believe Ambient’s Sepsis DART™ product is a great fit to better address sepsis in healthcare provider organizations across the world.” Ambient’s ISO certification demonstrates the consistent quality of our solutions, and our solutions themselves, are a great fit towards furthering patient safety, and we are looking forward to working closely with the Patient Safety Movement Foundation in its goal of eliminating preventable patient deaths.

As an industry leader in healthcare analytics, Ambient will feature the Ambient AWARE™ family of solutions, including Sepsis DART™ and DART™ iOS at our Booth 888-95 in the Personalized Health Experience at the HIMSS19 conference. The conference takes place on February 11th-15th, 2019 at the Orange County Convention Center in Orlando, FL. For more information stop by our Booth 888-95 at HIMSS19 or visit our website http://www.ambientclinical.com.

Ambient’s AWARE™ family of products collect data, present, manage, store, and deliver patient information that address important clinical problems. Ambient is an exceptionally secure, high-performance Software as a Medical Device (SaMD) platform that has achieved FDA Class II clearance. Ambient’s software uses licensed Mayo Clinic technologies, which include over 1,000 rules and algorithms, to give providers real-time access to vital process-of-care information and analytics. Our solutions are designed to deliver data visualization, communication, and analytics based clinical decision support. We change the way acute and critical care providers operate through providing situational awareness of a patient’s total condition through “smart” bedside-based notifications for patient degradation, Sepsis and other clinical conditions.

More than 4.8 million people worldwide and 200,000 people in U.S. hospitals die every year from errors that could have been prevented. Medical errors are now the third leading cause of death in the United States, behind only heart disease and cancer, and cost close to $1.44 Trillion in the US alone. The Patient Safety Movement Foundation is a global non-profit that is working with all stakeholders, including patients, healthcare providers, medical technology companies, government, employers, and private payers such as insurance companies. Their vision and public commitment is to eliminate preventable dealths in hospitals. Their annual World Patient Safety, Science & Technology Summit presents specific, actionable solutions to meet patient safety challenges and highlights the hospitals’ commitments to implement Actionable Patient Safety Solutions and medical technology companies that have pledged to share data. Through commitments from over 4,700 hospitals and over 80 companies like Ambient Clinical Analytics, the Patient Safety Movement Foundation has saved over 90,000 lives in 2018 alone.

About Ambient Clinical Analytics

Ambient Clinical Analytics is supporting leading healthcare systems and has done so since its founding in 2013. Ambient is an exceptionally secure, high-performance, FDA Class II approved Software as a Medical Device platform. Our solution is designed by clinicians to be easy-to-use by every caregiver in your organization, and it is configured to be up and running rapidly. We are trusted by a community of high-performing healthcare providers across the United States. Our solutions are powerful real-time point-of-care healthcare solutions designed to deliver data visualization, communication, and analytics based clinical decision support solutions.

Ambient’s platform stands alone in its ability to help customers gain the instant actionable insights necessary to improving vital clinical processes and the care they deliver to patients. With a strong and experienced team focused on innovation, Ambient provides a scalable and sustainable method to deliver high reliability healthcare to any health system. Additional information about Ambient Clinical Analytics AWARE™ family of solutions can be found by visiting https://ambientclinical.com.

Mayo Clinic has a financial interest in the technology referenced in this news release. Revenue Mayo Clinic receives is used to support its not-for-profit mission in patient care, education and research.
@AmbientClinical @0x2020 #patientsafety #0x2020

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