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Tag: U.S. FDA

Why Apple Watch Series 6’s blood oxygen monitor didn’t require FDA approval

Thursday, October 8, 2020 4:32 pmThursday, October 8, 20206 Comments

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

Tuesday, July 7, 2020 12:53 pmTuesday, July 7, 202069 Comments

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

Thursday, May 7, 2020 8:54 amThursday, May 7, 20201 Comment

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

Wednesday, March 6, 2019 8:28 amTuesday, March 5, 20196 Comments

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

Wednesday, November 28, 2018 3:00 pmWednesday, November 28, 20185 Comments

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

Monday, October 29, 2018 4:28 pmMonday, October 29, 20181 Comment

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

Thursday, September 20, 2018 3:07 pm4 Comments

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

Wednesday, September 19, 2018 8:57 am4 Comments

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

Tuesday, September 18, 2018 4:37 pm8 Comments

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

Friday, September 14, 2018 11:28 amFriday, September 14, 201811 Comments

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

Tuesday, September 26, 2017 2:25 pmTuesday, September 26, 20174 Comments

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

Friday, August 4, 2017 4:51 pm21 Comments

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

Friday, July 21, 2017 10:28 amFriday, July 21, 201712 Comments

Apple Watch Series 3 could offer a glass-film touchscreen…

Apple Watch 3 rumor, er… watch

Wednesday, July 5, 2017 3:32 pmWednesday, July 5, 201712 Comments

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

Monday, June 19, 2017 2:33 pm14 Comments

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

Wednesday, March 16, 2016 2:55 pmWednesday, March 16, 20166 Comments

AliveCor is building sensors the Apple Watch…

Apple invention turns Apple Watch into a full-fledged medical device

Thursday, March 10, 2016 8:29 am19 Comments

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

Tuesday, May 26, 2015 3:25 pmTuesday, May 26, 20158 Comments

Apple Watch features hardware capable of measuring blood oxygen saturation levels…

Apple Watch teardown reveals pulse oximeter, suggesting future measurement of blood oxygen

Friday, April 24, 2015 12:00 pmFriday, April 24, 201519 Comments

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

Monday, March 30, 2015 9:33 am8 Comments

With Apple Inc. and fellow Silicon Valley companies edging further into health care…

Apple Watch not ready for full health tracking mode, yet

Tuesday, February 17, 2015 3:26 pmTuesday, February 17, 20156 Comments

When the highly-anticipated Apple Watch finally hits shelves in April…

Apple Watch to support DexCom’s glucose monitor at launch

Monday, February 9, 2015 9:56 amMonday, February 9, 201516 Comments

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

Tuesday, January 20, 2015 12:58 pmTuesday, January 20, 201511 Comments

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

Monday, September 8, 2014 1:58 pmMonday, September 8, 20148 Comments

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

Wednesday, June 11, 2014 8:29 amWednesday, June 11, 201418 Comments

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

Monday, June 9, 2014 4:08 pm32 Comments

Apple believes there is the opportunity to do more with devices…

Wanted: a watchdog for the mobile medical app explosion

Thursday, June 5, 2014 2:57 pmThursday, June 5, 201415 Comments

Seventy-five percent of smartphone apps that claim to assess malignancy are wrongly diagnosing..

Will Apple’s HealthBook app draw government regulation?

Friday, March 21, 2014 10:19 pm156 Comments

With the “Affordable Care Act” suffering from a lack of enrollment…

With Healthbook, Apple will asserts itself as the platform for digital health

Wednesday, March 19, 2014 12:33 pm3 Comments

Emerging details about Apple’s forthcoming Healthbook app suggest the tech giant…

Apple’s looming Healthbook app is the start of something huge

Tuesday, March 18, 2014 5:30 pmTuesday, March 18, 201412 Comments

Apple is poised to launch a body-monitoring app known as Healthbook…

Healthbook: Apple’s major first step into health and fitness tracking revealed

Monday, March 17, 2014 10:50 am12 Comments

Seven years out from the original iPhone’s introduction…

7 billion reasons Apple gets health

Tuesday, February 11, 2014 1:25 pmTuesday, February 11, 201425 Comments

The personal medical devices gold rush has begun…

Over 200 people working on Apple’s iWatch peripheral device; no FDA regulation, sources say

Monday, February 10, 2014 4:52 pm22 Comments

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

Friday, February 7, 2014 9:26 amFriday, February 7, 201411 Comments

Industrial design, blood-reading sensors, medical devices, hardware engineering, software vision, fitness…

Apple’s iWatch: Think healthcare, not health clubs

Tuesday, February 4, 2014 6:34 pm20 Comments

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

Tuesday, February 4, 2014 12:26 pmTuesday, February 4, 201424 Comments

Apple CEO Tim Cook hinted at a new product category…

iWatch + iOS 8: Apple sets out to redefine mobile health, fitness tracking

Saturday, February 1, 2014 10:01 am18 Comments

Apple currently plans to release a new version of the iPhone operating system…

FDA approves software for iPhone-based vision test

Friday, April 12, 2013 2:33 pm4 Comments

The FDA recently gave clearance to Vital Art and Science Inc…

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