Apple's Q2 earnings call, smartphone-based retinopathy scans and more digital health news briefs

Also: uBiome's FBI investigation; Better Therapeutics' pivotal trial plans.
By Dave Muoio and Jonah Comstock
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Wearables, services perform well for Apple. While iPhone sales and overall Q2 revenue were down in 2019, the company was fairly optimistic on its most recent earnings report due to substantial growth among its wearables, iPads and services businesses.

In terms of healthcare, CEO Tim Cook noted during the investors’ call that the past quarter included the rollout of the Apple Watch Series 4’s ECG functionality to Hong Kong and 19 European countries. He also paid lip service to the release of the Apple Heart Study findings, as well as the adoption of Apple’s personal health records by Michigan Medicine, UT Health Austin, the Department of Veterans Affairs and others.

Just like when the ECG app launched in the United States, there's hardly a day that goes by that I don't get a letter or an e-mail from a customer in one of these countries talking about how [Watch ECG] has significantly changed their life,” Cook said during the call. “We believe we're really just beginning to tap into what we can do to help our users actively manage their health and well-being.”

Moving toward De Novo. Better Therapeutics will be launching a pivotal trial of its behavioral coaching app for Type 2 diabetes later this year, the company announced last week. Informed by a pre-submission meeting with the FDA, the trial enroll 500 adults with Type 2 diabetes into an open-label, multi-stie, randomized controlled design, with the results intended to support a De Novo submission as a class 2 medical device.

“These are important milestones on Better’s path to develop prescription digital therapeutics for treating cardiometabolic diseases,” Kevin Appelbaum, CEO of Better Therapeutics, said in a statement, ”and follow recent peer-reviewed publication of our clinical data in hypertension. With good news in hand and more on the way, we are ready to raise our next round of financing to accelerate growth.”

Smartphone eye scans. Researchers from the University of Michigan Kellogg Eye Center have debuted a smartphone-mounted device that takes and interprets high-quality retinal photos to quickly determine whether a patient should be referred for diabetic retinopathy. Described at the Association for Research in Vision and Ophthalmology’s annual meeting, the AI tool (called RetinaScope) demonstrated automated interpretation sensitivity of 86.8% and specificity of 73.3% among a sample of 69 adult patients.

“Traditional retinal cameras are expensive, large, immovable and require special training to operate, whereas RetinaScope is a smartphone-based platform that is cheap, hand-held, and easy to use with no required training" Paulus, an assistant professor of ophthalmology and visual sciences and an assistant professor of biomedical engineering, said in a statement. "To make screening truly accessible, we need to provide on-the-spot feedback, taking the photo and interpreting it while the patient is there to schedule an eye appointment if necessary.”

uBusted? uBiome, one of the pioneers of direct-to-consumer microbiome testing, is under investigation by the FBI. The company's San Francisco headquarters were raided Friday and employees were asked to hand over computers, according to reports from The Wall Street Journal and CNBC.

While neither the Bureau nor uBiome has disclosed the nature of the investigation, unnamed sources speaking to the Journal, CNBC and STAT News have suggested that the company is being investigated for fraudulent insurance billing practices, possibly including double-billing insurance for tests, using improper billing codes or compensating telemedicine physicians who refer patients to uBiome in an illegal way. uBiome, for its part, told the Journal and CNBC that it is cooperating with investigators.

Digital brush buddy. A study recently published in the British Dental Journal suggests short-term oral hygiene and plaque benefits among patients (n = 108) provided a smartphone device, sensor-equipped toothbrush attachment and its corresponding app. After periods of two and four weeks, the researchers saw a 70% plaque reduction among intervention participants versus a 30% reduction in the control group, with the former reporting enjoyment and easy use of the device.

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