Healthcare Industry News:  FDA 

Devices Cardiology Litigation

 News Release - December 22, 2022

ITC Rules Apple Violated AliveCor's Patents

Limited Exclusion Order would bar Apple from importing infringing Apple Watches

MOUNTAIN VIEW, Calif., Dec. 22, 2022 -- (Healthcare Sales & Marketing Network) -- AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology, today announced that the International Trade Commission (ITC) has issued its Final Determination ruling that Apple Watch infringed AliveCor's patented technology. The ITC issued a Limited Exclusion Order (LEO), a cease and desist order and set a bond in the amount of $2.00 per unit of infringing Apple Watches imported or sold during the Presidential review period, potentially impacting sales of millions of infringing Apple Watches.

The ITC has suspended enforcement of its orders pending resolution of AliveCor's appeal of the U.S. Patent and Trademark Office, Patent Trial and Appeal Board's ("PTAB") decision finding the asserted patents unpatentable. Today's ruling marks a victory for AliveCor and affirms the Initial Determination issued in June by Administrative Law Judge (ALJ) Cameron Elliot of the ITC. The Final Determination will now undergo a 60-day review by President Biden.

In addition to fighting Apple on patent infringement in the ITC, AliveCor continues to seek relief in the Northern District of California from Apple's anticompetitive behavior. That case is expected to go to trial in early 2024.

"Today's ITC ruling is a win for innovation and consumer choice," said Priya Abani, CEO of AliveCor. "The ruling underscores the importance of upholding intellectual property rights for companies like AliveCor and scores of others whose innovations are at risk of being suppressed by a Goliath like Apple. We look forward to continuing to build and innovate on our cardiac solutions to improve people's lives."

AliveCor has introduced a series of game-changing innovations in AI-powered cardiac care, including the first-ever FDA-cleared wireless, patchless, six-lead ECG sensor, the first and only personal ECGs to detect six of the most common arrhythmias, and the first FDA-cleared credit-card-sized personal ECG. With more than 170 patents issued and pending worldwide, AliveCor continues to protect its strong portfolio of innovations in accordance with established patent law.

About AliveCor

AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS, and Normal Sinus Rhythm in an ECG. Kardia is the first AI-enabled platform to aid patients and clinicians in the efficient detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. AliveCor's enterprise platform allows third-party providers to manage their patients' and customers' heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor protects its customers with stringent data security and compliance practices, achieving ISO 27001 Certification, SOC 2 Type 2 Certification and HIPAA compliance attestation. AliveCor is a privately-held company headquartered in Mountain View, Calif. "Consumer" or "Personal" ECGs are ECG devices available for direct sale to consumers. For more information, visit alivecor.com.


Source: AliveCor

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