Happy Holidays!Best wishes for Peace, Health, and Prosperity for you, your family, and your organization. David Barone, Zvi Ladin and the team at Boston MedTech Advisors Reimbursement Updates Important 2026 Update on RTM Billing Codes As of January…
BMTA News Recent Symposiums David Barone, Principal of BMTA, has recently participated as a panelist in two symposiums presenting innovative startups from Israel and Austria: “HealthTech Hub Bridges of Innovation: Connecting Israeli Ingenuity with U.S. Healthcare Impact”, including 20 presenting…
In Memory of Yossi Elaz We are deeply saddened to share the news of Yossi Elaz’s passing. Yossi was a valued member of our BMTA team for 10 years. His creativity, problem-solving skills, and dedication were invaluable to our projects…
The FDA's Center for Devices and Radiological Health (CDRH) is committed to ensuring the safety and effectiveness of medical devices throughout their lifecycle. A crucial aspect of this oversight is postmarket surveillance, which involves monitoring devices after they enter the…
Advancements in digital health technologies, including artificial intelligence/machine learning-enabled medical devices (MLMD), necessitate developing regulatory expectations that are aligned with best practices for development and change management to support the quality of such devices. The change management process helps to…
Updates – U.S. Reimbursement for Medical Technologies and Healthcare services David Barone, Principal of BMTA, will discuss U.S reimbursement during the September 24 meeting of the Life Science Collaborative (Boston). Copy of the presentation, which will include updates on recent…
Below is an update of the BMTA blog “CMS Proposal for Transitional Coverage for Emerging Technologies (TCET).” Obtaining nationwide coverage for novel medical devices takes an average of five years.1 In August 2024 CMS published a final notice for Transitional…
Update: FDA Rescinds Lab-Developed Test (LDT) Oversight Rule On September 19, 2025, the FDA announced it will rescind its 2024 rule that extended medical device oversight to laboratory-developed tests (LDTs), officially ending the initiative to regulate LDTs as medical devices…
Commercializing a new medical device involves navigating a complex landscape of regulatory, payer and provider considerations. For some devices, one critical component of this process is the review by the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), which can…
Understanding coding and coverage mechanisms are essential to developing a reimbursement strategy for a new medical technology. These Q&As address the differences between coding and coverage. My device has been cleared by the FDA. Does the regulatory approval guarantee coverage…
