Regulation

The company had previously received FDA clearance to use its prescription wearable to treat migraines at onset.

Lucira's diagnostic is the first over-the-counter at-home combination test for COVID-19 and flu authorized by the FDA.

Rapid RV/LV uses AI to calculate the ratio between the right and left ventricles, an indicator of pulmonary embolism severity.

According to the state authorities, the online birth control company billed Medi-Cal for services it didn't provide and dispensed female condoms to beneficiaries who didn't request them.

The Oregon Health Authority said the deal is not likely to greatly reduce access to affordable care in the state, but it placed some conditions on its approval.

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.

The company said it plans to launch the latest model of its CGM in early 2023.

The Mobile Health Apps tool aims to help developers determine which federal laws apply and which agencies oversee different aspects of mobile health technology.

Former CEO Elizabeth Holmes was sentenced to more than 11 years in prison last month.

The company pitches iQuest as a way for physicians to provide more precise cancer treatment and lessen the likelihood of negative side effects.