Rune Labs has received clearance from the U.S. FDA to use the Apple Watch to monitor tremors and other symptoms in Parkinson’s patients…
Tag: U.S. FDA
Apple Watch new ‘Afib History Feature’ approved by U.S. FDA ahead of WWDC
Apple received U.S. FDA approval for a new “Afib History Feature” that is likely coming to your Apple Watch this fall (or sooner…
Apple urges, but doesn’t mandate, all employees to get COVID-19 vaccine
Apple is strengthening its push for employees to get the COVID-19 vaccine, but stops short of issuing a mandate …
Why Apple Watch Series 6’s blood oxygen monitor didn’t require FDA approval
Apple Watch Series 6 expands the health capabilities of previous Apple Watch models with a new blood oxygen feature that conveniently…
Study: Treatment with hydroxychloroquine cut death rate significantly in COVID-19 patients
A new study published recently by Henry Ford Health System shows that treatment with hydroxychloroquine cut the COVID-19 death rate significantly…
Apple awards $10 million to COPAN Diagnostics for COVID-19 tests
Apple today announced it is awarding $10 million from its Advanced Manufacturing Fund to COPAN Diagnostics, a market leader in sample collection kits…
Departure of Scott Gottlieb from the U.S. FDA is a potential blow to Apple, healthcare innovation
The departure of Scott Gottlieb from the U.S. Food and Drug Administration on Tuesday is a potential blow to Silicon Valley…
Apple’s watchOS 5.1.2 will enable electrocardiogram feature on Apple Watch Series 4
Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram…
With Apple Watch Series 4, Apple started the revolution in wearable healthcare
With the recent announcement of FDA approval for the first-ever consumer wearable health device…
Apple Watch Series 4 ECG should pave way for more medical gadgets, U.S. FDA says
The nation’s top medical-device regulator wants to make it easier…
Apple Watch Series 4’s electrocardiogram feature received FDA clearance just one day before ‘Gather Round’ event
Some on the Apple Watch team may have felt their hearts pounding in the days leading up to…
The Apple Watch is inching toward becoming a medical device
Apple Watch adds features that allow it to take high-quality heart readings and detect falls…
What the Apple Watch Series 4’s FDA clearance actually means
Apple announced that the US Food and Drug Administration cleared two new features for the Apple Watch Series 4…
U.S. FDA selects participants, including Apple, for new digital health software precertification pilot program
Today, the U.S. Food and Drug Administration announced the names of the companies selected to participate…
Apple plans to release a cellular-capable Apple Watch later this year
Apple Inc. is planning to release a version of its smartwatch later this year…
Apple Watch Series 3 could sport MicroLED display, cellular connectivity, Apple Smartbands
Apple Watch Series 3 could offer a glass-film touchscreen…
Apple Watch 3 rumor, er… watch
The Apple Watch Series 3 rumors we’ve heard suggest Cupertino plans on sticking with…
Apple Watch sales could soar with new U.S. FDA plan
Apple Inc.’s Apple Watch has been what is probably best described as a modest success…
AliveCor has FDA-approved heart tracker for Apple Watch
AliveCor is building sensors the Apple Watch…
Apple invention turns Apple Watch into a full-fledged medical device
A patent application published Thursday suggests Apple is working to turn Apple Watch into…
Current Apple Watch may also measure blood oxygen saturation with software update
Apple Watch features hardware capable of measuring blood oxygen saturation levels…
Apple Watch teardown reveals pulse oximeter, suggesting future measurement of blood oxygen
iFixit’s teardown of the Apple Watch has revealed that the sophisticated heart-rate monitor…
FDA ‘taking a very light touch’ on regulating the Apple Watch
With Apple Inc. and fellow Silicon Valley companies edging further into health care…
Apple Watch not ready for full health tracking mode, yet
When the highly-anticipated Apple Watch finally hits shelves in April…
Apple Watch to support DexCom’s glucose monitor at launch
Apple Watch gets an early foothold in the health-care market at a time when…
As Apple Watch looms, U.S. FDA clarifies regulatory stance on health-tracking wearables
The U.S. Food and Drug Administration has issued preliminary guidance…
Cedars-Sinai-backed app for Apple iPad, iPod touch receives U.S. FDA approval
The FDA clearance is for the whole system: the software, the earbuds, and the Apple devices…
Apple’s new health focus comes at propitious time
Hospitals are under federal regulatory pressure to improve how they treat patients…
U.S. FDA details high-level meeting with Apple: ‘Moral obligation to do more’ with health, innovative sensors
Apple believes there is the opportunity to do more with devices…
Wanted: a watchdog for the mobile medical app explosion
Seventy-five percent of smartphone apps that claim to assess malignancy are wrongly diagnosing..
Will Apple’s HealthBook app draw government regulation?
With the “Affordable Care Act” suffering from a lack of enrollment…
With Healthbook, Apple will asserts itself as the platform for digital health
Emerging details about Apple’s forthcoming Healthbook app suggest the tech giant…
Apple’s looming Healthbook app is the start of something huge
Apple is poised to launch a body-monitoring app known as Healthbook…
Healthbook: Apple’s major first step into health and fitness tracking revealed
Seven years out from the original iPhone’s introduction…
7 billion reasons Apple gets health
The personal medical devices gold rush has begun…
Over 200 people working on Apple’s iWatch peripheral device; no FDA regulation, sources say
Apple has been on a hiring spree of digital health engineers and scientists…
Apple assembles expert team for sensor-laden, fitness- and medical-focused wearable computer
Industrial design, blood-reading sensors, medical devices, hardware engineering, software vision, fitness…
Apple’s iWatch: Think healthcare, not health clubs
We might be looking at Apple’s so-called iWatch project from the wrong angle…
Morgan Stanley: Apple iWatch could spark sales as high as $17.5 billion in first year
Apple CEO Tim Cook hinted at a new product category…
iWatch + iOS 8: Apple sets out to redefine mobile health, fitness tracking
Apple currently plans to release a new version of the iPhone operating system…
FDA approves software for iPhone-based vision test
The FDA recently gave clearance to Vital Art and Science Inc…
