Tag: Approval

07
Oct
2020
Posted in technology

Why Apple Didn’t Need FDA Approval for the Blood Oxygen Tracking Feature in the Apple Watch Series 6

Prior to releasing ECG functionality in the Apple Watch Series 4, Apple needed FDA approval for the feature, but the same isn’t true of Blood Oxygen monitoring in the Apple Watch Series 6 because Apple doesn’t see it as a medical feature.


As outlined by The Verge, pulse oximeters like the blood oxygen tracking feature in the Apple Watch are considered Class II Medical devices and documentation is generally required, but there’s a way around that. If a pulse oximeter is marketed as being for general wellness or fun rather than for a medical purpose, FDA documentation is not required.

That’s the reason why the blood oxygen tracking feature is not being marketed by Apple as a medical feature, and an Apple Support document clearly states that measurements taken using blood oxygen tracking are “not intended for medical use” and are designed for “general fitness and wellness purposes.”

The ‌Apple Watch Series 6‌ Blood Oxygen app provides no insight into blood oxygen readings, nor does it send alerts when a lower than normal blood oxygen level is detected, because that would be a medical feature.

Apple is prohibited from using the blood oxygen tracking feature from impacting the medical care that someone receives, which is a deviation from how the ECG functionality works. ECG readings from the watch are used to alert users of an abnormal heart rhythm (atrial fibrillation) and thus required greater oversight. Apple was required to provide the FDA with data proving that the feature can detect atrial fibrillation, which could be examined by experts.

Avoiding regulatory approval in the United States and in other countries permitted Apple to launch the blood oxygen feature in more than 100 countries. ECG availability is still limited because it requires medical approval in each country it launches in.


Michael

03
Oct
2020
Posted in technology

Japan’s Sony and Kioxia seeking U.S. approval to supply to Huawei – Nikkei

FILE PHOTO: A Huawei company logo is pictured at the Shenzhen International Airport in Shenzhen, Guangdong province, China, July 22, 2019. REUTERS/Aly Song/File Photo

TOKYO (Reuters) – Japan’s Sony Corp and memory chipmaker Kioxia Holdings Corp have applied for U.S. approval to continue supplying Huawei Technologies Co Ltd, Nikkei reported on Sunday.

If confirmed, the move follows other tech companies such as Intel Corp that recently received licences from U.S. authorities.

With U.S.-China ties at their worst in decades, Washington has been pushing governments around to world to squeeze out Huawei, arguing that the telecoms giant would transfer data to the Chinese government for espionage.

Huawei is one of the top customers for Sony’s image sensors for smartphones. Kioxia Holdings Corp is the world’s No. 2 maker of flash memory chips and a Huawei supplier.

Nikkei here said without U.S. licenses, Sony and Kioxia would face risk to their earnings.

Kioxia warned that U.S. curbs on Huawei could trigger memory chip oversupply and lower prices. It recently shelved a plan for a multi-billion dollar listing as U.S-China tensions cloud the global chip market.

A Sony spokeswoman said the company was in compliance with all regulations, but could not comment on particular clients.

A Kioxia spokesman also declined to comment.

Reporting by Makiko Yamazaki, Ju-min Park; Editing by Dan Grebler

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03
Oct
2020
Posted in technology

Japan’s Sony and Kioxia seeking U.S. approval to supply to Huawei: Nikkei

TOKYO (Reuters) – Japan’s Sony Corp and memory chipmaker Kioxia Holdings Corp have applied for U.S. approval to continue supplying Huawei Technologies Co Ltd, Nikkei reported on Sunday.

If confirmed, the move follows other tech companies such as Intel Corp that recently received licences from U.S. authorities.

With U.S.-China ties at their worst in decades, Washington has been pushing governments around to world to squeeze out Huawei, arguing that the telecoms giant would transfer data to the Chinese government for espionage.

Huawei is one of the top customers for Sony’s image sensors for smartphones. Kioxia Holdings Corp is the world’s No. 2 maker of flash memory chips and a Huawei supplier.

Nikkei https://asia.nikkei.com/Spotlight/Huawei-crackdown/Sony-and-Kioxia-seek-US-approval-to-bypass-Huawei-ban said without U.S. licenses, Sony and Kioxia would face risk to their earnings.

Kioxia warned that U.S. curbs on Huawei could trigger memory chip oversupply and lower prices. It recently shelved a plan for a multi-billion dollar listing as U.S-China tensions cloud the global chip market.

A Sony spokeswoman said the company was in compliance with all regulations, but could not comment on particular clients.

A Kioxia spokesman also declined to comment.

(Reporting by Makiko Yamazaki, Ju-min Park; Editing by Dan Grebler)

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30
Sep
2020
Posted in technology

Energous Receives FCC Approval, Extending Charging Zone to Up to 1 Meter for Groundbreaking Over-the-Air, Power-at-a-Distance Wireless Charging

Class II permissive change allows for expansion of Energous’ new, non-beamforming wireless charging technology announced earlier this year

Today Energous Corporation (Nasdaq: WATT), the developer of WattUp®, a revolutionary wireless charging 2.0 technology, announced that it has received a Class II permissive change to the existing MS-550 FCC Grant, extending the charging zone up to one meter. This change, under the FCC’s Part 18 rules, allows Energous and its partners to develop and market wireless charging products that may be charged within one meter of the transmitter. It is believed to be the first time that a non-beamforming transmitter has been permitted under the FCC’s rules with a charging zone of up to one meter under the FCC’s Part 18 guidelines.

“We continue to make advances that will enable over-the air, wireless charging at-a-distance to become a reality. This permissive change from the FCC substantially expands the allowable non-beamforming footprint and broadens the wireless power transfer (WPT) applications that can be supported by this patent-pending technology. While beamforming remains a key Energous technology, having pioneered the industry’s first FCC part 18 certification, non-beamforming technology represents a less costly, less complicated path to commercialization which is being well received by our customers interested in implementing distance charging solutions,” said Stephen R. Rizzone, president and CEO of Energous Corporation. “As Energous continues to set in place the building blocks required to enable a global wireless power 2.0 solution, the ongoing pandemic has temporarily impacted our ability to put the necessary engineering and application resources on customer sites, slowing the advance of multiple product and sales cycles expected to generate revenues for the third quarter. Interest in WattUp technology remains very strong, but pandemic-related delays have had a meaningful impact causing third quarter revenues to fall significantly on a percentage basis below revenues

29
Sep
2020
Posted in technology

Google Set to Win EU Approval for Fitbit Purchase

Alphabet’s Google  (GOOGL) – Get Report reportedly is set to win antitrust approval from the European Union for its $2.1 billion purchase of fitness tracker maker Fitbit  (FIT) – Get Report.

Reuters reported that Google offered fresh concessions to the European Commission in a bid to address concerns the deal could entrench Google’s power in online advertising and boost its trove of data.

The company said it had offered to restrict the use of Fitbit data for Google ads and would also tighten the monitoring of that process.

“We’re also formalizing our longstanding commitment to supporting other wearable manufacturers on Android and to continue to allow Fitbit users to connect to third party services via APIs (application programming interfaces) if they want to,” Google told Reuters in a statement.

The concessions are set to clear the way for the deal to be approved, Reuters said, citing people familiar with the matter.

The EU competition enforcer will now seek feedback from rivals and customers before deciding whether to accept Google’s concessions, demand more, or either clear or block the detail.

Last month, it rejected Google’s pledge not to use the fitness tracker’s data for advertising purposes in a bid to address competition concerns, saying that it was insufficient.

Fitbit had a 3% share of the global wearables market as of the first quarter of 2020, lagging behind Apple’s 29.3% share, as well as Xiaomi, Samsung and Huawei, Reuters said, citing data from market research firm International Data Corp.

In August, Amazon  (AMZN) – Get Report introduced the Amazon Halo, a health and fitness-tracking wristband paired with a subscription service and smartphone app.

The commission recently asked Google’s rivals and customers about interoperability issues, what technical steps Google could take to foreclose competition to Fitbit