AliveCor Receives Approval to Launch KardiaMobile in Mexico The company expands its personalized, mobile ECG now to over 25 countries around the world Thomson says the FDA approval was based in part on the experience of the 6000 or so people who use AliveCor’s device and app. Photo: Courtesy of Siemens Healthcare Private Limited. Thomson says the FDA approval was based in part on the experience of the 6000 or so people who use AliveCor’s device and app. Mexico City and Mountain View, Calif., Feb 19, 2020 — AliveCor, the leader in AI-based, personal ECG technology, and provider of enterprise cardiology solutions, announced approval from the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), to launch KardiaMobile in Mexico. AliveCor, Inc. is pioneering the creation of FDA-cleared machine learning techniques to enable proactive heart care and is recognized around the world for transforming cardiac care. The FDA-cleared KardiaMobile 6L device is the most clinically validated personal ECG solution in the world. AliveCor ran two clinical trials to test the hardware and the app. Steve Stiles. Alivecor received its first $3 million in financing in 2011. | We're powering the future of healthcare. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Alivecor, Inc. Albert Boniske Director of Regulatory Affairs 30 Maiden Lane, 6th Floor San Francisco, California 94108 Re: K140933 But, as AliveCor CEO Vic Gundotra points out, it’s one thing to be able to detect and another thing to get FDA approval to use your sensor as a medical device.

AliveCor expects to soon add a professional QTc monitoring service which will facilitate a more seamless workflow with no on-premise calculations required. The KardiaMobile 6L should better detect cardiovascular diseases, is available in June. AliveCor, Inc. is pioneering the creation of FDA-cleared machine learning techniques to enable proactive heart care and is recognized around the world for transforming cardiac care. About AliveCor. The AliveCor Heart Monitor also received a CE mark for Conformity in the EU. KardiaBand is the first FDA-cleared medical device accessory for Apple Watch. Alivecor SFO 30 Maiden Ln Suite 600 San Francisco CA 94108-5429: For Additional Information Contact: Albert Boniske 855-338-8800 Manufacturer Reason for Recall: Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application. Date Received: 09/24/2014: Decision Date: 01/27/2015: Decision: substantially equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel The app is set to launch for consumers in September. AliveCor beat the Apple Watch to market with an iPhone-connected gadget with FDA approval to detect AFib – and has now been given clearance to report two more heart conditions to consumers.. New FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVID-19 Patients ... and over 100 FDA-approved medications that have the potential for unwanted QT prolongation. November 30, 2017. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Rock Health is a seed and early-stage venture fund that supports startups building the next generation of technologies transforming healthcare. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Alivecor, Inc. Albert Boniske Director of Regulatory Affairs 30 Maiden Lane, 6th Floor San Francisco, California 94108 Re: K140933

AliveCor has received an additional FDA 510(k) clearance, this time for an algorithm that allows its smartphone ECG to detect atrial fibrillation -- an abnormal heart rhythm that isn't always detectable to the patient, but if left untreated can lead to stroke or congestive heart failure -- with high accuracy.

AliveCor, Inc. is transforming cardiological care using deep learning. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. AliveCor’s FDA-cleared 6-lead ECG aims to detect more than the Apple Watch.


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