News & Updates

CardioMed will be attending EuroPCR 2026 Conference in Paris, France, March 18th – 22nd. We’ve been invited to present topics for medical device innovation:

Non-Clinical Testing of Structural Heart Devices to Support U.S. Market Approvals: Meeting Not-so-Obvious Regulatory Expectations. (Oral Presentation, May 19th)
Total Product Lifecycle Advisory Program (TAP) in U.S. Food & Drug Administration: Early opportunities for long-term impact in U.S. market. (e-Innovation)
The Bridge from Benchtop Testing to Clinical Studies – Simulated Use Testing . (e-Innovation)

Come visit us in Paris and stop by our affiliate’s booth (BDC Laboratories, Booth ##).

CardioMed Device Consultants are leading the Artificial Intelligence & Digital Health Session (March 9, 2026; 8:00 AM – 12:30 PM ET) at CRT 2026, bringing together leading clinicians, researchers, and innovators to explore the evolving role of artificial intelligence in cardiovascular medicine.
The session will highlight key advancements in AI-driven coronary and endovascular interventions, clinical decision-making and procedure planning, and the growing role of wearables, digital health technologies, and real-world data. Additional discussions will focus on emerging applications of predictive modeling, generative AI, and large language models, as well as regulatory considerations, including FDA perspectives on AI/ML-enabled medical technologies.
CardioMed will also participate in sessions discussing how to move from EFS to pivotal clinical studies and Tricuspid valve investigational studies.

After receiving Breakthrough Device Designation earlier in the year, a CardioMed client was accepted into the FDA program, TPLC Advisory Program Pilot (“TAP Pilot”).
The purpose of TAP Pilot is to “spur more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health” (Total Product Life Cycle Advisory Program (TAP) | FDA). This is a great opportunity for CardioMed and the client to work closely with FDA TAP Team to learn first-hand how Breakthrough Device Designation and TAP programs can expedite patent access to novel cardiovascular devices.