Health was clearly on the minds of the designers behind the new Series 6 Apple Watch
Sleep motion sensors, hand-washing detection and a blood-oxygen sensor are all functions of the new model unveiled Tuesday, which has a $399 starting price tag.
âThe new health sensor in Series 6 shines red and infrared light onto your wrist and measures the amount of light reflected back. Advanced algorithms use this data to calculate the color of your blood, which indicates the amount of oxygen present,â Sumbul Desai, vice president of health at Apple and a practicing doctor, said atTuesdayâs event. âThe new blood oxygen app lets you take a measurement in just 15 seconds.â
Apple is not marketing the new function of the watch as a medical device, thatâs because it doesnât currently have the U.S. Food and Drug Administrationâs approval to do so.
âBlood Oxygen app measurements are not intended for medical use, including self-diagnosis or consultation with a doctor, and are only designed for general fitness and wellness purposes,â reads a product disclaimer for the Series 6 Watch.Â
For instance, the FDA previous said that electrocardiogram readings, or ECGs, that aim to notify users of irregular heart rhythms, should not replace traditional diagnostic methods.
The FDAâs role raises an important point for consumers. Some online reviews may say a blood-oxygen monitor is âFDA-approved,â but they likely mean that the product is âFDA registeredâ or received âFDA clearance. They are very different from being approved for the purpose of accurately detecting the amount of oxygen in your blood.
The highest-risk devices (Class III), such as mechanical heart valves, generally require FDA approval of a premarket approval application before marketing, according to the FDA. âManufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.â
The FDA âclearsâ rather than âapprovesâ Class II moderate-risk medical devices such as pulse oximeters âfor marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval.â
And Class I? These include non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves, and âare subject to general controls only, and most are exempt from premarket notification requirements,â according to the FDA.
For instance, in its review of the AccuMed CMS-50D1 Pulse Oximeter ($33 on Amazon), CNET noted that itâs âFDA-cleared, meaning it should work as advertised when it comes to monitoring your pulse rate and oxygen saturation level.â
The less expensive Apple Watch, the SE model, which was also unveiled on Tuesday, shares many of the same functions as the Series 6 watch, but does not have the blood oxygen sensor.
Typically a healthy range of oxygen levels is between 95% to 100%, according to the Mayo Clinic. Values below 90% are considered low and below 60% âusually indicate the need for supplemental oxygen.â
One of the many symptoms of coronavirus is shortness of breath or difficulty breathing which could be the result of low oxygen levels.Â
Typically a healthy range of oxygen levels is between 95% to 100%. Values below 90% are considered low and below 60% may indicate the need for supplemental oxygen.
But itâs not always the case that patients who have low oxygen levels feel shortness of breath or difficulty breathing.
âWhatâs been intriguing about COVID is people who have no symptoms show up in the emergency room with oxygen stats in the 80s,â said Thomas Russo, chief of the division of infectious disease at the University at Buffalo.
Thatâs particularly the case among the COVID pneumonia patients, according to Richard Levitan, an emergency room doctor, who volunteered for 10 days at the Bellevue Hospital hospital in New York in April.
âWhatâs been intriguing about COVID is people who have no symptoms show up in the emergency room with oxygen stats in the 80sâ
âAs the inflammation from COVID pneumonia starts, it causes the air sacs to collapse, and oxygen levels fall,â he said in a New York Times opinion piece published in April. âYet the lungs initially remain âcompliant,â not yet stiff or heavy with fluid. This means patients can still expel carbon dioxide â and without a buildup of carbon dioxide, patients do not feel short of breath.â
By the point, however, many these patients were admitted to the hospital their oxygen levels were so low they needed to be put on a ventilator, he wrote.
Thatâs why some doctors have recommended that more people purchase pulse oximeters so that they can keep tabs on oxygen levels.Â
These can be purchased for as little as $17 on Amazon
In other words, you donât necessarily need to pre-order the new Apple Watch if youâre interested in monitoring your oxygen levels.
But if more people who buy the new Apple Watch use the new technology, assuming itâs accurate,Â it could prompt more people to get properly tested for coronavirus or âtrigger a call to their doctorâ, said Russo.
What about the new Apple Watchâs accuracy? âAssuming it gives reasonable information with a 4% error rate, then it might be a useful tool to help monitor diseases,â said Timothy Connolly, a pulmonologist and medical director of Respiratory Care Services at Houston Methodist Hospital in Texas.
âWhat we donât want is for people to go, âOh sâ! Iâm looking at my oxygen levels and itâs low, it must be Covid.ââ he said. âIt has got to be taken with a grain of salt. I wouldnât encourage people to look at their oxygen level as a diagnostic tool.â
âIf someone gets an Apple Watch and they see theyâre at 86% oxygen levels, they need to be evaluated by a doctor because it could be a billion different things.â
âIf someone gets an Apple Watch and they see theyâre at 86% oxygen levels, they need to be evaluated by a doctor because it could be a billion different things,â he said.Â
However, once someone has tested positive for coronavirus, monitor oxygen levels to see if there is change over time, he added. Thatâs why Connolly encouraged a friend who tested positive for coronavirus to purchase a pulse oximeter.Â
âI told him, âIf that number shifts downward I need to know because thatâs when you might need to go to the hospital. If stays in the same range, I donât care how bad you feel, stay at home.’â
If oxygen levels continue to drop, a patient is mostly likely in better hands in the hospital than at home, but it does not necessarily mean that they need to be intubated, Connolly told MarketWatch.Â
Apple is partnering with the investigators of the Seattle Flu Study and faculty from the University of Washington School of Medicine âto learn more about COVID and understand the interplay with influenza,â Desai, Appleâs vice president of health, said.
âWe will explore how changes in blood oxygen and heart rate can be early signals of the onset of these respiratory conditions,â she said.
More than $30 billion â two-thirds of the FEMA disaster-relief funds being used to fund the extra benefits â has been distributed to make the $300-a-week payments across more than 20 states
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Oxygen saturation, Apple Watch, Coronavirus, Pulse oximetry
World news – US – Worried about COVID-19? New $399 Apple Watch tests blood-oxygen levels. Other products do this for $17 â but what does the FDA say?