1-888-INFO-FDA (1-888-463-6332) Contact FDA 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. FDA Determined Cause 2: Software change control: Action AliveCor was recognized by Fast Company as one of 2017’s most innovative companies in health (#3).
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. The CE Mark entails making sure your design and manufacturing meet a specific set of ISO specifications for ECG devices and medical devices. 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. Photo: Courtesy of Siemens Healthcare Private Limited. About AliveCor. AliveCor expects to soon add a professional QTc monitoring service which will facilitate a more seamless workflow with no on-premise calculations required. What were some unique obstacles you faced in applying for the CE mark versus the FDA 510(k) approval? FDA Approves AliveCor Personal ECG Monitor for Apple Watch. The FDA-cleared KardiaMobile 6L device is the most clinically validated personal ECG solution in the world. 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. 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.. KardiaBand is the first FDA-cleared medical device accessory for Apple Watch. November 30, 2017. 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. 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 secured approval from the US Food and Drug Administration (FDA) for its KardiaMobile six-lead personal electrocardiogram (ECG) device.