Apple Watch Archives - Medical Design Sourcing

Apple reportedly pulling pulse oximetry from watches if Masimo appeal fails

The Apple Watch Series 9 [Image courtesy of Apple]Federal customs officials have reportedly approved Apple’s workaround to continue importing Series 9 and Ultra 2 watches if it fails in its appeal of an import ban in its patent dispute with Masimo.

The consumer tech giant has told U.S. Customs and Border Protection that redesigned watches “definitively do not contain pulse oximetry functionality,” according to a Masimo filing with the Federal Circuit that was recounted in media outlets. Masimo said the agency has signed off on Apple’s plan to get around the International Trade Commission import ban, though the decision has not yet been published in the Federal Register.

In a statement shared with MassDevice, Masimo said: “Apple’s claim that its redesigned watch does not contain pulse oximetry is a positive step toward accountability. It is especially important that one of the world’s largest and most powerful companies res…

Masimo trade secret suit against Apple ends in mistrial

Masimo’s W1 smartwatch [Image from Masimo]The ongoing patent spat between Masimo (Nasdaq:MASI) + and Apple has another twist as a federal judge declared a mistrial.

A federal judge in California made the ruling yesterday after jurors could not come to a unanimous verdict, according to a Reuters report.

A Masimo spokesperson issued the following statement following the ruling:

“While we are disappointed that the jury was unable to reach a verdict, we intend to retry the case and continue to pursue legal redress against Apple. As we begin that process, the United States Trade Commission is scheduled in the coming months to decide whether to ban the importation of certain models of the Apple Watch, following a ruling last year by an Administrative Law Judge that Apple infringed one of Masimo’s patents for pulse oximetry.”

Reuters reported that an Apple statement says the company …

President Biden upholds ITC ruling favoring AliveCor in Apple patent spat

A figure from AliveCor’s patent, included in the PTAB ruling

AliveCor announced today that the final determination ruled on its patent dispute with Apple cleared presidential review.

In December, the International Trade Commission (ITC) ruled that the Apple Watch infringed AliveCor’s patented technology.

Along with its final determination, the ITC issued a limited exclusion disorder (LEO) and a cease and desist order. It set a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during its review period. The LEO goes into effect upon the favorable resolution of appeals in the case. That includes AliveCor’s appeal of a U.S. Patent Trial and Appeal Board decision.

Mountain View, California-based AliveCor said in a news release that it marks the ITC’s first LEO against Apple to clear presidential review. The company believes it “sends a strong signal” to companies that AliveCor’s IP is prot…

ITC rules in favor of AliveCor in patent spat with Apple

A figure from AliveCor’s patent, included in the PTAB ruling

AliveCor announced today that the International Trade Commission (ITC) ruled that the Apple Watch infringed its patented technology.

Along with the final determination, the ITC issued a limited exclusion disorder (LEO) and a cease and desist order. It set a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during its review period.

In a news release, AliveCor said it could potentially impact sales of “millions of infringing Apple Watches.”

“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 l…

FDA clears Apple Watch app for tracking Parkinson’s from H2o Therapeutics

[Image from H2o Therapeutics]H2o Therapeutics announced recently that the FDA cleared its prescription mobile app, Parky, for monitoring Parkinson’s disease.

Ankara, Turkey–based H2o’s Parky app monitors symptoms including tremors and dyskinesia in real-time through the Apple Watch. In addition, the tool allows users and medical professionals to share meaningful and reliable data.

In a news release, the company said the app leverages the Apple-developed Movement Disorder API tool. As a result, the app helps medical professionals develop a clinical profile of the patient outside of the clinic.

H2o said its app strengthens the possibility of data-driven, tailored treatment procedures. The company noted that Parky bridges the gap between real-life and in-clinic settings.

“As a woman-founded, non-VC-backed company based in Turkey, receiving our first 510(k) clearance is a huge milestone for us. We believe Parky will bring great value to…

Mayo Clinic’s new Apple Watch app uses AI to detect left-ventricular dysfunction

The Mayo Clinic developed a new app that transmits ECG signals from Apple Watches for AI analysis to identify heart disease.

The application transmits ECG (electrocardiograms) signals recorded in non-clinical environments seamlessly and securely to a medical center so that the AI analysis can identify left-ventricular dysfunction, a life-threatening, asymptomatic heart disease.

According to a news release, a study — for which results were presented as late-breaking clinical science during Heart Rhythm 2022 — observed 2,454 subjects from 46 states and 11 countries who downloaded the study app for their Apple Watch. The average age was 53±15 years and 56% were female.

Mayo Clinic’s app sent all previously recorded ECGs for clinician review and AI analyzed ECGs acquired within one month of a clinically ordered ECG. They were evaluated for the presence of ejection fraction ≤40% using a model adapted for single lead use.

“We have seen how artific…

FDA clears AFib notification on Apple Watch

An FDA letter confirms that Apple (NSDQ:AAPL) received 510(k) clearance for an irregular heart rhythm notification on the Apple Watch.

The letter, dated Oct. 22, stated that, after reviewing Apple’s 510(k) premarket notification of intent to market the device, the FDA determined that the device is substantially equivalent to legally marketed predicate devices for the indications Apple sought.

Get the full story at our sister site, MassDevice.

Apple debuts software for people with disabilities

[Image from Apple]Apple yesterday unveiled next-generation software features designed for people with mobility, vision, hearing and cognitive disabilities.

Cupertino, Calif.-based Apple’s operating systems are set to undergo software updates later this year that would allow people with limb differences to navigate the Apple Watch using AssistiveTouch, while the iPad will support third-party eye-tracking hardware for easier control and low-vision communities, according to a news release.

Get the full story at our sister site, Medical Design & Outsourcing.

Apple Watch may someday detect blood sugar, blood pressure levels

Rockley Photonics indicated in an SEC filing that it may work with Apple in the future to introduce new monitoring functions to the Apple Watch.

The Telegraph first reported on the filing, which indicated that the company’s operating financial results will depend on revenue that is attributable to a few of its large customers, including Apple — its largest.

“Rockley has a master supply and development agreement with this customer, which provides a general framework for Rockley’s transactions with it,” the filing said. “This agreement continues until either party terminates for material breach. Under this agreement, Rockley has agreed to develop and deliver new products to this customer at its request, provided it also meets Rockley’s business purposes, and has agreed to indemnify it for intellectual property infringement or any injury or damages caused by Rockley’s products.”

The filing details the United Kingdom-based compa…