Apple, Samsung, Fitbit Join FDA Trial for Faster Health Device Approval
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.
Feb 9, 2022
Samsung today announced its lineup of flagship phones for 2022: the Galaxy S22 series. The top-end S22 Ultra sees the biggest changes as it essentially absorbs Samsung's Note series with an integrated S Pen stylus and a more Note-like shape and design, instead of the Contour Cut design of the other models.
Mar 23, 2021
OnePlus today announced the OnePlus 9 and OnePlus 9 Pro, its newest flagship phones. The 9 Pro is a true flagship-class phone with a QHD AMOLED display with variable refresh from 1 to 120 Hz, and IP68 water rating, starting at $969.
Jan 14, 2021
Samsung today officially unveiled its Galaxy S21 series of flagship phones for 2021. All three models sport a distinctive new "Contour Cut Camera" design where the metal frame extends around one corner to surround the rear cameras.
Apr 14, 2020
OnePlus has revealed its new lineup for 2020 — the OnePlus 8 and OnePlus 8 Pro — both of which have 5G. They also manage to pack larger batteries into slightly thinner bodies compared to their predecessors.