Tag Archive : Approval

/ Approval

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

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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.

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FILE PHOTO: The Huawei logo is seen at the IFA consumer technology fair, amid the coronavirus disease (COVID-19) outbreak, in Berlin, Germany September 3, 2020. REUTERS/Michele Tantussi/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

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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

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  • Google is expected to win EU approval for its $2.1 billion Fitbit deal after it addressed competition and data concerns, Reuters reported.
  • The internet giant has promised it will not use Fitbit data to personalize adverts for 10 years, according to a Financial Times report.
  • It will also ensure competitors can use its Android and Cloud platforms, according to people familiar with the matter.
  • The EU opened a four-month long investigation into Google’s acquisition of Fitbit in August. The deal was first announced in November 2019.
  • Visit Business Insider’s homepage for more stories.

Google’s $2.1 billion acquisition of wearables company Fitbit appears to have cleared a major hurdle.

It will be cleared by EU antitrust regulators after the tech giant agreed Tuesday to restrict how it uses customer data, according to multiple reports.

Google promised regulators that it would not personalize adverts based on user data for 10 years, up

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a close up of a sign: Google first announced the Fitbit acquisition in November 2019. Reuters


© Reuters
Google first announced the Fitbit acquisition in November 2019. Reuters

  • Google is expected to win EU approval for its $2.1 billion Fitbit deal after it addressed competition and data concerns, Reuters reported.
  • The internet giant has promised it will not use Fitbit data to personalize adverts for 10 years, according to a Financial Times report.
  • It will also ensure competitors can use its Android and Cloud platforms, according to people familiar with the matter.
  • The EU opened a four-month long investigation into Google’s acquisition of Fitbit in August. The deal was first announced in November 2019.
  • Visit Business Insider’s homepage for more stories.

Google’s $2.1 billion acquisition of wearables company Fitbit appears to have cleared a major hurdle.

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It will be cleared by EU antitrust regulators after the tech giant agreed Tuesday to restrict how it uses customer data, according to multiple reports.

Google promised regulators

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On Monday, J.P. Morgan and Morgan Stanley reiterated their Overweight ratings on Abbott Laboratories (ABT). The company’s newest continuous glucose monitor (CGM), the Freestyle Libre 3, recently received a CE mark of approval. The system has shown to be a major evolutionary improvement over the current Libre 2 which leads analysts to believe that there are multiple long-term growth opportunities for Abbott.

The next-gen Libre CGM, Libre 3 will leverage Bluetooth technology to have continuous, real-time glucose readings automatically delivered to your smartphone every-minute (vs user scanning required in the past) allowing for unsurpassed 14-day accuracy and a ~70% size reduction from the Libre 1 & 2, becoming the world’s smallest and thinnest sensor.

The FreeStyle Libre 3 system was designed to fit perfectly into people’s everyday lives, allowing users to check their glucose as often as they like by just looking on their phones. This innovation allows the users

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