by UserName | Jan 30, 2025 | Insight
In May 2024, the decades-long debate between the FDA and CLIA program over regulation of LDTs, seemingly came to an end with the publication of an FDA final rule, making it explicit that IVDs are classified as devices under the FD&C Act, including when the...
by UserName | Oct 29, 2024 | Insight
Private payers are having to think outside the box to prioritize cost-savings for laboratory services, especially with the delayed implementation of the Protecting Access to Medicare Act (PAMA) proposed payment rate cuts to 2026, jeopardizing the integrity and...
by UserName | Oct 14, 2024 | Announcement
We are thrilled to welcome Bridget Manning to the growing Boston-based team at BeaconOne Healthcare Partners. Bridget is joining as a Manager with experience developing global market access and reimbursement strategies for medical device and in vitro diagnostic...
by UserName | Oct 7, 2024 | Insight
Robotic-assisted surgery continues to grow and today is used in many types of procedures, including general surgery, urology, gynecology, thoracic, and other specialties. However, large-scale adoption of robotic-assisted procedures remains closely tied to the...
by UserName | Sep 16, 2024 | Insight
In August 2024, the Centers for Medicare and Medicaid Services (CMS) established the Transitional Coverage for Emerging Technologies (TCET) pathway. TCET is intended to expedite national coverage for certain new technologies designated by the FDA as Breakthrough...
