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…
On October 3, 2023, the FDA issued a proposed rule1 aimed at helping to ensure the safety and effectiveness of in vitro diagnostic products (IVDs) offered as LDTs, due to concerns that without FDA oversight false test results or false…
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…
Medical devices that are placed inside a surgically or naturally formed cavity of the human body are considered implants by FDA.1 These can be permanent (e.g., knee implant) or temporary (e.g., chemotherapy ports), and are made from a wide variety…
