Home › News ›

Apple, Samsung, Fitbit Join FDA Trial for Faster Health Device Approval

Article Comments

Sep 27, 2017, 9:29 AM by Rich Brome @rbrome.bsky.social

The U.S. Food and Drug Administration (FDA) this week announced the companies participating in a trial program designed to streamline government approval of health devices and software. Apple, Samsung, Fitbit, and Verily (an Alphabet company) are among the nine companies selected, out of over 100 that applied. The pilot program is called Pre-cert and will determine quality standards for a company's software design, validation, and maintenance. Companies that meet the new standards will become pre-certified, allowing them to submit less information to the FDA when submitting a health or medical device or app for approval. The pilot program includes site visits by FDA staff, and gathering feedback from the industry, stakeholders, and the public. The first public update on the pilot program will be shared in January 2018.

Engadget »

Related

Samsung Refines its Foldable Phones

Aug 10, 2022
Samsung has announced its newest generation of foldable phones: the Galaxy Z Fold4 and Galaxy Z Flip4. Both have similar designs and features compared to their predecessors, with a slew of small updates and refinements across the board.

iPhone 14 Plus Offers a Big Screen For Less

Sep 7, 2022
Apple has revealed the iPhone 14 series, with new features, improved specs, and new size options. In place of a Mini option, the iPhone 14 will come in the same 6.1-inch and 6.7-inch screen size options as the Pro models.

Snapdragon 8 Gen 2 Redefines AI in Flagship Phones

Nov 15, 2022
Qualcomm has announced its newest top-end chip, intended to power most flagship-level Android phones in 2023. As expected, the Snapdragon 8 Gen 2 is more powerful and power-efficient across the board (compared to Gen 1), but the most impressive improvements and new features involve AI.

Samsung S24 Series Adds More AI, Updates the Hardware

Jan 17, 2024
Samsung has unveiled its lineup of flagship phones for 2024, the Galaxy S24 series. The phones sport multiple upgrades in both hardware and software compared to last year's models.

Galaxy Ring Joins Samsung's New Wearable Lineup

Jul 10, 2024
Samsung has launched a new lineup of wearable devices, including the all-new Galaxy Ring, as well as the Samsung Galaxy Watch Ultra, Watch7, and Buds3 series. The Galaxy Ring is similar in concept the Oura Ring: a health-tracking device small enough fit into a ring on your finger.

more news about:

Comments

This forum is closed.

This forum is closed.

No messages

Page 1 of 1