Breakthrough Device Designation: Understanding Regulatory and Reimbursement Implications Webinar
ADVAMED EVENT — Join us for a timely webinar focused on the FDA breakthrough devices program and the implications for payment and coverage.
Regulatory Affairs
U.S. Health Care Enforcement: Priorities and Key Regulatory Developments Webinar
Join us for our webinar with Sidley Austin to better understand the current health care enforcement landscape with the new administration.
AdvaMed Encourages Administration to Prioritize Transport of Medical Supplies
AdvaMed, the world’s largest trade organization representing medical technology companies, released the following statement from President and CEO Scott Whitaker on the unveiling by U.S. Reps. Diana DeGette (D-Colo.) and…
Navigating China’s New Regulatory Policy: Order 739 Webinar
Join us for our webinar with Sidley Austin and China Med Device for a comprehensive overview of China’s new regulatory policies.
The Problems State Right-to-Repair Statutes Pose for Patients and Hospitals
The long-term implications of state right-to-repair laws could have devastating consequences for health care providers and their patients.
AdvaMed Encourages Administration to Consider Patient Needs as It Addresses Semiconductor Shortage
AdvaMed, the world’s largest trade organization representing medical technology companies, wrote a letter to U.S. Department of Commerce Secretary Gina Raimondo “to strongly encourage the implementation of policies that ensure…
38 House Democrats Join Call to Give Seniors Access to Life-Saving Medical Care
A large group of Democratic lawmakers is requesting that the Biden administration enact a finalized federal rule that would give seniors on Medicare access to life-saving medical treatments.
ICYMI: Medical Experts, Lawmakers, and Innovation Funders Urge Administration to Grant Medicare Beneficiaries Expanded Coverage of FDA-Designated “Breakthrough” Technologies Through MCIT Rule
Thought leaders across the country are urging the Administration to enact the Medicare Coverage of Innovative Technology (MCIT) rule that was set to go into effect March 15 before it…
Patient Groups Support Giving Seniors Access to Life-Saving Medical Technologies Through MCIT
A growing number of patient groups are expressing their support to the Centers for Medicare & Medicaid Services (CMS) of the Medicare Coverage of Innovative Technology (MCIT) rule.
MY01 Inc. Receives FDA Clearance for the MY01 Continuous Compartment Pressure Monitor as an Aid in Diagnosis of Compartment Syndrome
MY01’s device helps diagnose acute compartment syndrome (ACS), a relatively common and potentially lethal muscle condition notably suffered by Tiger Woods in his car accident last February.