Regulation

The Agency has qualified Apple's atrial fibrillation history feature as a medical device development tool, allowing it to be used in clinical trials.

The Agency alleges the company's CT and ultrasonography systems are noncompliant with good manufacturing requirements.

They had been designated as innovative medical devices.

Epitel received 510(k) clearance for two remote monitoring offerings and Curio Digital Therapeutics received clearance for its postpartum prescription digital therapeutic.

Patricia MacTaggart, program director and teaching instructor at George Washington University and 2024 Changemaker Award winner, discusses how Medicaid’s innovative use of telehealth as a care modality influenced Medicare and other payers.  

Ernie Crawford, CEO at Crawford Technologies, discusses how the 2024 CMS Final Rule pertaining to materials and content is bringing health equity to payer market communications.  

1upHealth CEO Joe Gagnon talks about how healthcare organizations can use data to meet the needs of new CMS prior authorization rules.  

The Eko Low Ejection Fraction Tool will be added to the company's cardiac early detection platform, which already includes various algorithms to inspect heart health.

Tom Leary, SVP and head of government relations at HIMSS, discusses anticipated U.S. health IT advancements, including EHR modernization for the VA and the Indian Health Service, as well as ARPA-H's $2.5 billion healthcare technology initiative.

J29's Tracy Mills and Nick Vass discuss providing clinical and data analysis support, and bridging gaps between the public and private health sectors.