AliveCor

AliveCor is a medical device and AI company that develops ECG hardware and software compatible with consumer mobile devices to enable remote heart rhythm monitoring and detection of abnormal heart rhythms, or arrhythmias. AliveCor was founded in 2011¹ and is headquartered in Mountain View, California, the United States.

AliveCor is a medical device and AI company that develops ECG hardware and software compatible with consumer mobile devices to enable remote heart rhythm monitoring and detection of abnormal heart rhythms, or arrhythmias. AliveCor was founded in 2011 and is headquartered in Mountain View, California, the United States.

Lawsuits involving Apple

In December 2020, AliveCor sued Apple, alleging that Apple Watch Series 4, 5, and 6 infringed three of its patents by copying technologies used in the KardiaBand ECG reader. Then in April 2021, AliveCor filed a complaint with the U.S. International Trade Commission (ITC), alleging infringement of the same three patents, and asked the ITC to block Apple from importing Apple Watches manufactured overseas. The following month, AliveCor filed a federal antitrust lawsuit against Apple, claiming Apple sought to monopolize the heartrate analysis market by changing the watch's operating system to be incompatible with rival technologies. On December 2, 2022, Apple sued AliveCor, claiming AliveCor copied technologies Apple had developed in 2008, two years before AliveCor was founded, and therefore its patent rights had been violated. On December 6, the U.S. Patent and Trademark Office (USPTO) invalidated the three AliveCor patents in response to an earlier request by Apple. On December 22, the ITC ruled that Apple Watch infringed two of the three patents, and that their import should be banned. The Biden administration was given 60 days to decide whether to veto the ruling, and a $2.00 per unit bond for was set for watches imported or sold during the review period. However, the ITC suspended enforcement of both the import ban and bond assessment pending the outcome of appeals challenging the USPTO decision. President Biden upheld the ITC ruling in February 2023 – the first ITC ruling against Apple to clear presidential review. In June '24 US Customs and Border Protection found that the newly designed Apple Watch does not infringe any of the AliveCor patents in the original ITC case. In June 2023, a U.S. district court judge ruled against AliveCor in its 2021 antitrust lawsuit against Apple, but AliveCor's unfair competition claim against Apple is ongoing as of September 2023. Both parties were scheduled to return to court in October 2023 for dispositive motions. In February 2024, the federal judge ruled in Apple’s favor and dismissed the antitrust lawsuit. AliveCor said it plans to appeal the ruling.

Products

KardiaMobile – KardiaMobile is a smartphone-connected ECG recorder for personal use The user places their fingertips on a device the size of a stick of chewing gum for about 30 seconds to record an ECG on their smartphone. The results can be read by the user or sent to a physician for analysis. KardiaMobile was cleared by the FDA in 2012 for detecting atrial fibrillation and normal sinus rhythm. The KardiaMobile does not use Bluetooth or any form of radio signal to communicate with the smartphone. Rather, it transmits the data as ultrasound (high frequency audio), which is then detected by the microphone on the smartphone. KardiaMobile 6L – In 2019, AliveCor received FDA clearance for KardiaMobile 6L, the first six-lead personal ECG device. In 2021, KardiaMobile 6L was cleared by the FDA for healthcare professionals to use to calculate patients’ QTc interval, a heart rate corrected interval that reflects the integrity of the heart's electrical recharging system. KardiaMobile Card – In late 2021, AliveCor received FDA clearance for the KardiaMobile Card, a personal ECG device with the size and dimensions of a credit card. KardiaCare – KardiaCare is a digital health subscription service that AliveCor introduced in 2020, to provide ECG evaluations and other related services that can be shared with caregivers. KardiaComplete – In 2022, AliveCor introduced KardiaComplete, a cardiovascular enterprise service for employers and health insurers to offer to employees and members. The service provides customers with AliveCor's KardiaMobile 6L and Omron’s Evolv blood pressure cuff to monitor their heart health, and includes heart data analyses, health coaching and a virtual assistant. KardiaPro – KardiaPro is a platform for doctors to monitor their patients using Kardia devices. The platform alerts doctors when a patient's device detects an abnormality. KardiaPro also tracks patient risk factors, including weight, activity and blood pressure and analyzes them with AI to alert doctors to potential issues. AliveCor Labs – In 2021, AliveCor introduced AliveCor Labs, an independent diagnostic testing facility that offers reimbursed cardiac monitoring services to U.S. healthcare providers. Kardia 12L – In 2024, AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

Financing

In 2017, AliveCor raised $30 million in series D funding from medical-device maker Omron and the Mayo Clinic, bringing the total raised to date to $43.5 million. In 2020, the company raised $65 million in series E funding, led by Omron with Khosla Ventures, WP Global Partners, Qualcomm Ventures and Bold Capital Partners. In 2022, the company announced that it had completed a Series F financing round for an undisclosed amount, led by GE Healthcare with participation from Khosla Ventures, Bold Capital Partners, Qualcomm Ventures, WP Global Partners and Pegasus Tech Ventures.

References

Text derived from https://en.wikipedia.org/w/index.php?oldid=1368338867 under CC BY-SA 4.0; modifications have been made.