The Coala Heart Monitor is an FDA-cleared and CE Class IIa medical device system intended for remote cardiac and respiratory monitoring. This expanded functionality will enable healthcare providers to use the Coala and its integrated stethoscope to, besides remote cardiac monitoring previously available, remotely auscultate lungs and aid in the detection of pulmonary disease.

Jun 22, 2020 Through the US Food and Drug Administration's (FDA) Emergency Guidance, the Coala heart monitor has expanded indications of use 

The Coala Heart Monitor is an FDA-cleared and CE Class IIa medical device system intended for remote cardiac monitoring using advanced algorithms to detect arrythmias as Atrial Fibrillation (AF). The Coala has also recently been expanded to allow for remote respiratory monitoring with its integrated stethoscope. Coala Heart Monitor systemet är både FDA- och CE-godkänt och bygger på unik patenterad teknik, baserad på mer än 10 års svensk forskning och utveckling. Kompatibel med Apple HealthKit och CareKit The Coala is FDA cleared for adult only (ages 22 years or older). The arrhythmias of which the Coala can indicate for is more common among elderly people. The Coala Heart Monitor is tested on and developed through measurements on adults. "The Coala Heart Monitor was introduced in Scandinavia in 2017 for cardiac patients and only recently in the U.S. The FDA's new guidance has just enabled us to expand the use for respiratory Swedish health tech innovator Coala Life AB selected Innokas Medical to manufacture Coala Heart Monitor, which has global market potential.

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The FDA’s 510(k) clearance of the Coala Heart Monitor is an important performance validation of our unique technology and innovative digital solution. With its mobile and cloud-based solutions, together with its high-performance algorithms, Coala Life is now proud to be able to offer American physicians our Coala Heart Monitor. Coala Heart Monitor 2019-02-14 11:23 CET FDA clears the Coala Heart Monitor Stockholm, Sweden, February 14th, 2019 - Coala Life AB announced today Coala marknadsförs på två sätt: Coala Heart Monitor ó direkt till privatpersoner och óCoala för vården ó/Coala Pro som marknadsförs till vårdgivare. Produkten är CE-märkt (CE Klass IIa) och FDA godkänd (510(k)). Coala har fyra komponenter: 1. Registrering av EKG med elektroder från bröstet eller genom att man lägger fingrar Coala Life, a leading Swedish digital health company has, as supported by FDA’s Emergency Guidance, expanded the indication for use enabling physicians to remotely, in real-time, monitor patients’ hearts "The Coala Heart Monitor was introduced in Scandinavia in 2017 for cardiac patients and only recently in the U.S. The FDA's new guidance has just enabled us to expand the use for respiratory Additional functionalities will be added to the Coala Heart Monitor System under the FDA policy ’Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Coala Heart Monitor is an FDA cleared and CE approved medical device system that is developed and validated in Sweden. Coala Life AB is ISO 13485 certified.

Stockholm, 14 feb, 2019 - Coala Life har idag erhållit ett 510(k) godkännande av det amerikanska läkemedelsverket FDA. Godkännandet ger tillstånd att marknadsföra och sälja Coala Heart Monitor på den amerikanska marknaden. - FDA-godkännandet är en fantastisk milstolpe och en viktig kvalitets- och marknadsvalidering av vår unika teknologi.

The company has developed a portfolio of CE- and FDA-cleared medical products and services enabling user-centered remote monitoring and analysis of heart and lungs, powered by smart algorithms. The Coala Heart Monitor (Coala®) was introduced in Scandinavia in 2017 and further in the US and selected EU countries in 2019. Coala heart monitor and smartphone.

Apr 29, 2020 The Coala Heart Monitor is an FDA-cleared and CE Class IIa medical device system intended for remote cardiac monitoring using advanced 

The Coala Heart Monitor (Coala®) was introduced in Scandinavia in 2017 and further in the US and selected EU countries in 2019.

Coala har fyra komponenter: 1. Registrering av EKG med elektroder från bröstet eller genom att man lägger fingrar Coala Life, a leading Swedish digital health company has, as supported by FDA’s Emergency Guidance, expanded the indication for use enabling physicians to remotely, in real-time, monitor patients’ hearts "The Coala Heart Monitor was introduced in Scandinavia in 2017 for cardiac patients and only recently in the U.S. The FDA's new guidance has just enabled us to expand the use for respiratory Additional functionalities will be added to the Coala Heart Monitor System under the FDA policy ’Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Coala Heart Monitor is an FDA cleared and CE approved medical device system that is developed and validated in Sweden. Coala Life AB is ISO 13485 certified. Coala is a registered trademark and the company's products are protected by more than 20 different patents. Coala Life, a leading Swedish digital health company has, as supported by FDA's Emergency Guidance, expanded the indication for use enabling physicians to remotely, in real-time, monitor patients Coala Heart Monitor is an FDA cleared and CE approved medical device system that is developed and validated in Sweden. Coala Life AB is ISO 13485 certified.
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“A pioneer in digital heart diagnosis and individual focused medical innovations, Coala Life has recently secured 510(k) approval from the U.S. FDA, which opens the door to the huge American marketplace for company’s unique heart monitor system that helps predict and prevent heart disease,” said Anders Jacobson, co-founder and CEO of Blue. FDA cleared Coala Heart Monitor now enables virtual heart and lung exams from a patient's home IRVINE, Calif., April 15, 2020 /PRNewswire/ -- Coala Life, a leading Swedish digital health company has, as supported by FDA's Emergency Guidance, expanded the indication for use enabling physicians to remotely, in real-time, monitor patients' hearts and lung sounds.

Coala is a registered trademark and the company's products are protected by more than 20 different patents. The Coala Heart Monitor is an FDA-cleared and CE Class IIa medical device system intended for remote cardiac monitoring using advanced algorithms to detect arrythmias as Atrial Fibrillation (AF).
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Coala Heart Monitor är en trygghetslösning baserad på över 10 år av svensk forskning och utveckling. Följ ditt hjärta med Coala! Facebook: / 

Den innovativa produkten är utvecklad och godkänd i Sverige och är framtagen för att erbjuda en extra trygghet genom att du tidigt kan upptäcka tecken på flera olika hjärtsjukdomar. Coala Heart Monitor Stockholm, Sweden, February 14th, 2019 - Coala Life AB announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Coala Heart Coala Heart Monitor is an FDA cleared and CE approved medical device system that is developed and validated in Sweden. Coala Life AB is ISO 13485 certified. Coala is a registered trademark and the company's products are protected by more than 20 different patents.