Morgan Stanley: Apple’s mHealth play could triple entire mobile market

Apple Watch

Though Apple (NSDQ:AAPL) has only begun to step into the healthcare market, a group of Morgan Stanley analysts estimate the company’s opportunity in the U.S. healthcare market to be three times larger than the global smartphone market, according to a Bloomberg report.

The analysts estimated that Apple’s healthcare market opportunities could be worth between $15 billion up to a massive $313 billion by 2027, according to the report.

The Cupertino, Calif.-based tech giant’s massive ecosystem built around the iPad and iPhone, other iOS devices and its App Store could allow Apple to disrupt “various processes in the healthcare industry,” according to Bloomberg.

While other companies, including Google and Amazon, may have an edge on artificial intelligence capabilities, the massive number of users of Apple devices “is a clear advantage that cannot be underestimated,” analysts said.

“Healthcare is a market where Apple has the potential to lead digital disruption – much like what iTunes did for music or the App Store for mobile services. Based on what it has done over the last five years, we see Apple creating the building blocks of another ecosystem,” analysts wrote, according to the Bloomberg report.

Analysts speculated that new medical-grade devices, including wearables or hearing aids, and integration of medical data into devices like the Apple Watch could “grab investors’ attention,” according to the report. Other opportunities include acquiring a healthcare company to accelerate its entrance into the market.

Last year, Apple reported total sales of $265.5 billion, with its iPhone device accounting for 60% of revenue, according to Bloomberg.

Last month, Apple released data from its 419,297-patient Apple Heart Study, showing that the device is capable of aiding in the detection of atrial fibrillation using its light-sensor based technology.

Apple touts results from massive AF-detection Apple Watch study

Apple Watch Series 4

Apple (NSDQ:AAPL) today released data from its 419,297-patient Apple Heart Study, showing that the device is capable of aiding in the detection of atrial fibrillation using its light-sensor based technology.

Results from the study were released today at the American College of Cardiology’s 68th Annual Scientific Session in New Orleans.

The study was designed to test how well Apple’s Watch could identify and prompt clinical evaluations for atrial fibrillation, the Cupertino, Calif.-based company said.

In the study, data was collected from a mobile application using Apple Watch’s photoplethysmography technology to intermittently measure blood flow activity and detect changes that could indicate an irregular contraction or heartbeat. That data, in the form of a tachogram, was then analyzed by an algorithm designed to detect irregular heart rhythms.

If the algorithm detected an irregularity, the Watch and its associated application then sent a notification to the study participant.

Researchers compared the notifications to subsequent results from a seven-day worn ECG patch, analyzing how well the algorithm on the watch matched the ECG findings, as well as the percentage of notified patients who  sought medical help through the application.

“The app continuously gathers data in the background without the wearer of the device doing anything, so it’s very opportunistic in this way. [Overall], this study improves our understanding of how this wearable technology and app works in the real-world setting and how well the technology can detect long periods of AFib,” co-principal investigator Dr. Mintu Turakhia of the Stanford School of Medicine said in a press release.

Only 0.5%, or approximately 2,100 individuals, received an irregular pulse notification. In total, 658 patients were sent a patch, of which 450 returned the patch and were included in the analysis.

Data indicates that 34% of the trial participants who were both sent a notification and had data collected via ECG patch were diagnosed as having atrial fibrillation.

“AFib can come and go, particularly early on in the course of the disease. It’s not surprising for it to go undetected in subsequent ECG patch monitoring. So while only 34 percent of people who were still having [signs of] AFib on the ambulatory ECG, that doesn’t mean that 66 percent didn’t have AFib. It just means that AFib may not have been there at the time,” Turakhia said in a prepared release.

Of the patients who received irregular pulse notifications, approximately half ended up contacting the study doctors, though others were assumed to have sought help elsewhere. Post-study surveys indicated that approximately 57% of individuals who received alerts said they sought medical attention outside the study.

Data from the trial also indicated a low rate of notifications for individuals under 40 years of age, at 0.16%, compared to just over 3% in patients over 65.

“Notifications of heart rhythm irregularities were low, an important finding given concerns about over notification, and we were able to see what happened downstream after participants received a notification,” Turakhia said in a prepared statement.

Limitations of the study included a reliance on self-reported data from participants and the failure to reach target enrollment of 500,000 participants, with a hoped for population of 75,000 individuals age 65 and over, researchers said.

Researchers said they are hopeful that the trial will serve as groundwork for future studies that look to leverage wearable technologies, and added that the next step for the study will be to explore how the monitoring tech can be used alongside other technologies, including real-time ECG, to manage heart rhythm problems.

“It really represents a paradigm shift for how clinical studies can be conducted. We don’t have to bring people into a brick and mortar clinic and give the study intervention,” Turakhia said in a prepared release.

In January, Johnson & Johnsons (NYSE:JNJJanssen and Apple said that they inked a deal to study if a mobile application from J&J, in combination with the Apple Watch’s ECG app and irregular rhythm notifications, can improve outcomes for people living with atrial fibrillation.

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Johnson & Johnson, Apple ink collab for AFib study

Johnson & Johnson‘s (NYSE:JNJJanssen and Apple (NSDQ:AAPL) said today that the two companies inked a deal to study if an app from J&J in combination with the Apple Watch’s ECG app and irregular rhythm notifications can improve outcomes for people living with atrial fibrillation.

The study is slated to measure the impact of the Apple Watch on the early detection and diagnosis of AFib, as well as the efficacy of a medication adherence program.

Get the full story at our sister site, Drug Delivery Business News.

 

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5 top stories that mattered for medtech in 2018

medtech medical devices 2018

[Image by managing editor Chris Newmarker]

The medical device industry faced some major challenges over the past year, from increased media scrutiny to regulatory uncertainty in both the U.S. and E.U.

It’s worth noting, though, that many things have been going right for medtech.

More than half of the roughly 100 largest medical device companies in the world saw their stock prices increase during 2018 – not a bad record considering the slumping Dow Jones Industrial Average and S&P 500.

Medical device companies spending a large amount on R&D compared to revenue – including Dexcom, Abiomed, Atricure, Edwards Lifesciences and Insulet – saw their stock prices skyrocket as they marketed innovative devices in fields including diabetes management and cardiology.

Artificial intelligence is playing a larger role in medtech innovation, medical device companies are increasingly forging partnerships with high tech companies, and there’s even a chance that the device industry might help combat the opioid epidemic.

Here are five trends that mattered for medtech in 2018 – and are bound to influence the future of the industry this year.

Next>>

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Report: Apple hiring dozens of MDs, solidifies venture into healthcare

Apple Health

Apple (NSDQ:AAPL) has hired dozens of medical doctors for positions with various teams at the company, confirming its plans to move into the healthcare biz, according to a recent CNBC report.

Many of the hires have been under the radar, according to the report, which estimates the company has more than 40 and up to 50 doctors on its roster.

The move suggests that Apple may be looking to integrate more health technologies into its platforms, and that it could be looking to branch out into applications for people with specific serious medical conditions and not focus as much on general wellness, CNBC reports.

The medical professionals are influential, according to the report, and are scattered across a number of teams to guide strategy as the tech giant continues to develop for the healthcare market.

Apple hired orthopedic surgeon Sharat Kusuma to manage its partnership with Zimmer Biomet (NYSE:ZBH) as the company explores whether its tech platform can help patients recover from hip and knee surgeries, according to CNBC.

The hires may also help the company deflect criticism, such as the scathing New York Times article criticizing the company’s electrocardiogram-equipped next-gen Apple Watch, and win over the medical community, according to the report.

While many of the doctors the company has hired are working on the Apple Watch, others are working with the health records group and some are employed to treat employees at the company’s headquarters, according to CNBC.

Many of the doctors also have connections to execs at the company, the report indicates. Former Stanford Medicine doctor Sumbul Desai works closely with Apple COO Jeff Williams, according to the report, while Dr. Bud Tribble is a software VP at the tech giant and an original member of the Macintosh design team.

Other notable medical members include family medicine doctor Mike Evans and anesthesiologist Michael O’Reilly, who’s been at the Cupertino, Calif.-based company for six years, CNBC said.

Many of the doctors employed by Apple are still seeing patients, according to the report, which CNBC theorizes could “give Apple an edge by emphasizing the patient experience.”

In November, an atrial fibrillation screening study using Apple’s next-gen Apple Watch enrolled 400,000 subjects, making it the largest study of its kind to date.

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Report: VA in talks with Apple to move EHRs to iOS devices

US Dept. of Veterans Affairs, Apple

The U.S. Department of Veterans Affairs could be partnering with Apple (NSDQ:AAPL) to bring electronic health records to iOS-based smartphones for military veterans across the country, according to a Wall Street Journal report.

Through the deal, Apple would build out software that would allow the approximately nine million veterans in the country to transfer their health records to their iPhone devices, according to the report. Apple would also be positioned to supply engineering support to the agency.

The information comes from a number of emails between top VA officials and associates of President Donald Trump’s Mar-a-Lago club, reviewed by the Wall Street Journal, according to the report. Apple has not yet officially commented on the matter.

The move is yet another step from the Cupertino, Calif.-based tech giant as it looks to pry its way into the healthcare market. Earlier this month, an atrial fibrillation screening study using Apple’s next-gen Apple Watch enrolled 400,000 subjects, making it the largest study of its kind to date.

In June, Apple opened up its Health Records application to developers, allowing digital health companies to use electronic health record data to power applications on Apple’s iOS devices.

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Apple Watch study enrolls 400k participants

Apple Watch

An atrial fibrillation screening study using Apple‘s (NSDQ:AAPL) next-gen Apple Watch has enrolled 400,000 subjects, making it the largest study of its kind to date.

Enrollment for the Apple Heart trial has been completed by Stanford University’s School of Medicine, and the study rationale and design has already been published in the American Heart Journal.

“The advantage of the app that uses the optical sensor is that it can check for an irregular pulse multiple times throughout the day in the background, without needing the user to actively engage the application,” study principal investigator Marco Perez of Stanford’s Cardiovascular Medicine said in a prepared statement.

Investigators in the trial aim to explore whether wearable technology can successfully identify pulse irregularity, in hopes that it may be able to identify previously unknown atrial fibrillation. The watch analyzes pulse-rate data with an optical sensor, using LED lights and light-sensitive photodiodes to measure changes in the volume of blood flowing through the users wrist.

If atrial fibrillation is detected, participants will be alerted through a notification system on the Apple Watch or Apple Heart application. Subjects will then proceed through a telehealth video visit with a doctor and receive an electrocardiogram monitoring patch to confirm the AF diagnosis.

Any participants who experience urgent symptoms will be directed to their local urgent care or emergency room facilities.

“We now have access to high-quality sensors that can measure and detect changes in our bodies in entirely new and insightful ways without even needing to go to the doctor, but we need to rigorously evaluate them,” study principal investigator Mintu Turakhia of Stanford’s Cardiovascular Medicine said in a press release.

Last month, Zimmer Biomet (NYSE:ZBH) said that it launched a clinical trial using the Apple Watch to help hip and knee replacement patients that could enroll as many as 10,000 patients.

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NYT Report: Apple Watch ‘should not be considered a medical device’

The new electrocardiogram-equipped Apple (NSDQ:AAPL) Watch should not be considered a medical device, according to a new report from the New York Times.

The article, written by Indiana University School of Medicine pediatrics professor Aaron Carroll, calls into question the downsides of the newly released device and the potential for both false positives and false negatives.

Carroll acknowledged the possible positives of the device, including the ability for physicians to monitor patients from a distance and diagnosing heart problems in individuals that would possibly go undetected, but said that “just because something seems like a good idea doesn’t mean it is.”

“No screening test is perfect,” Carroll wrote in the Times article. “In general, we would like people who are sick to have a positive screening result, and people who are well to have a negative result. Unfortunately, people who are sick sometimes have a negative result. Those are false negatives. People who are well sometimes have a positive result. Those are false positives.”

Both outcomes are worrisome, Carroll suggested in the report. He added the false negatives may cause someone who needs medical help to not seek it, but said that because “relatively few people have serious, undiagnosed arrhythmias with no symptoms” that it wasn’t a major concern.

False positives, however, end up costing time time, money and emotional distress, according to the Times report.

“The health care system is already busy, if not overloaded. No physician wants to field calls from patients who have no problems. Such patients will require visits and further testing, and will potentially receive interventions. They’ll generate bills and harms without benefits,” Carroll wrote.

Carroll said that the watch’s “irregular rhythm” notification feature is likely to generate “many false positives.” He added that before the watch won clearance, the FDA reviewed data collected by the Stanford Heart study for 266 individuals who received irregular rhythm notifications, and said that most of them had been wrong.

“The study wasn’t peer reviewed, so we don’t know for sure, but this was also a population for whom atrial fibrillation might be more common than in those who might use the watch. People who buy the latest Apple watch will most likely be younger, healthier, wealthier and more plugged into the health care system – and less likely to remain undiagnosed,” he wrote for the Times.

He went on to suggest that one of the major problems with the device is that the people who would benefit most are least likely to get it, according to the report.

“If we truly believed this was a medical test beneficial to the general population, insurance should pay for it. No one is suggesting that should happen,” Carroll wrote for the Times.

He went on to suggest that experts generally aren’t in support of universal cardiac monitoring, and that the US Preventive Services Task Force issued a “D” recommendation for screening asymptomatic adults at low risk, according to the report.

The suggestions were based on good research, Carroll said in the Times article. He added that a randomized controlled trial of ECG screening for heart problems “did not demonstrate that such screening offered any benefits in reducing desk or the risk of heart attacks or stroke in middle-aged people,” and that the ECG scans were “much more robust” than the Apple Watch will provide.

“I happen to own an Apple Watch. I find the other functions useful and fun. I even enjoy aspects of the activity monitoring. But I’m under no illusion they will help me lose weight or exercise more or improve my heart health. I own one because I want it, not because I need it. That’s the same criterion you should use, too,” Carroll wrote.

Last month, Apple unveiled the Series 4 Watch, which features on-board electrocardiogram scanning technology.

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Report: Apple is exploring custom health sensor tech

Apple (NSDQ:AAPL) may be looking to develop its own health sensor chip technology, according to a new report from CNBC.

The tech giant posted a job opening in mid July looking for “sensor ASIC architects to develop ASICs for new sensors and sensing systems for future Apple products,” according to the report.

A separate posting from August showed that Apple is looking for someone to “help develop health, wellness, and fitness sensors,” according to CNBC. An additional earlier posting from June mentioned that the company was also looking to continue working with optical sensors, which the company currently uses to measure heart rate.

Currently, Apple uses sensor-connected technology from Broadcom in its Apple Watch product, but may be looking to develop its own chip as a way to protect its IP from third-party developers, according to the report.

The hires don’t absolutely point to new tech, however, and could be related to the company’s existing biosensor technology, according to CNBC.

Apple has not officially commented on the matter.

In June, Reports emerged showing that Apple had submitted a patent application for a wearable blood pressure monitoring cuff.

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Apple opens EHR data to iOS app developers

Apple (NSDQ:AAPL) this week opened up its Health Records application to developers, allowing digital health companies to use electronic health record data to power applications on Apple’s iOS devices.

The Cupertino, Calif.-based tech giant originally opened the Health Records application for general use in March, allowing users of certain cooperating healthcare systems direct access to their electronic health records.

With the new Health Records API release, developers will now be able to use that electronic health data – with an individual’s consent – to create applications that aid in disease management, medical research and other purposes, the company said.

Medisafe, a medication management application, will use integrated EHR data to allow users to import their prescription list without the need for manual entry, identify problematic drug-drug interactions, set reminders and view applicable medication data.

“Medical information may be the most important personal information to a consumer, and offering access to Health Records was the first step in empowering them. Now, with the potential of Health Records information paired with HealthKit data, patients are on the path to receiving a holistic view of their health. With the Health Records API open to our incredible community of developers and researchers, consumers can personalize their health needs with the apps they use every day,” COO Jeff Williams said in a press release.

Health Records data is encrypted on iOS devices, Apple specified, and allows users to share data directly with selected trusted applications, without the data leaving the device.

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