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Regulation

By Emily Olsen | 07:20 pm | December 22, 2022
The U.S. International Trade Commission determined Apple Watches with ECG functionality violate AliveCor patents, but an import ban is on hold until appeals wrap up in a case before the U.S. Patent and Trademark Office's Patent Trial and Appeal Board.
By Emily Olsen | 11:54 am | December 13, 2022
The company said it plans to launch the latest model of its CGM in early 2023.
By Emily Olsen | 02:20 pm | December 12, 2022
The Mobile Health Apps tool aims to help developers determine which federal laws apply and which agencies oversee different aspects of mobile health technology.
By Emily Olsen | 01:11 pm | December 08, 2022
Former CEO Elizabeth Holmes was sentenced to more than 11 years in prison last month.
By Emily Olsen | 12:00 pm | December 08, 2022
The company pitches iQuest as a way for physicians to provide more precise cancer treatment and lessen the likelihood of negative side effects.
By Emily Olsen | 01:23 pm | December 07, 2022
The Patent Trial and Appeal Board determined three AliveCor patents regarding the detection of heart conditions like cardiac arrhythmias were unpatentable.
By Emily Olsen | 01:31 pm | December 06, 2022
EchoGo Heart Failure, developed in partnership with the Mayo Clinic, helps physicians detect heart failure with preserved ejection fraction.
By Emily Olsen | 02:17 pm | November 21, 2022
The Israeli startup said it's now focused on receiving clearance to use its AEYE-DS system with a portable camera.
By Emily Olsen | 07:14 pm | November 18, 2022
Elizabeth Holmes, founder of the scandal-ridden blood-testing startup, was found guilty on four of eleven charges in January.
By Jessica Hagen | 12:56 pm | October 21, 2022
When determining approval for Breakthrough Device designation, the FDA will consider whether the device addresses present health inequities.