Happy Holidays!Best wishes for Peace, Health, and Prosperity for you, your family, and your organization…
BMTA Newsletter, November 2025
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 companies. The event was organized by the New England-Israel Business Council (NEIBC) the Advanced Regenerative Manufacturing Institute (ARMI) and Mass General Brigham.
“Open Austria East”, supported by the Austrian government, with 4 presenting companies. BMTA has also hosted an event of the Life Science Collaborative (LSC) in which two of the Austrian companies presented to the Boston-based LSC.
Regulatory Updates
Pioneering Progress in Liver Disease: FDA Accepts First Non-Invasive Reasonably Likely Surrogate Endpoint Qualification Initiative
BMTA is excited to share that the FDA’s Center for Drug Evaluation and Research has recently accepted Echosens’s Letter of Intent to qualify Liver Stiffness Measurement by Vibration-Controlled Transient Elastography (FibroScan®) as a reasonably likely surrogate in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH). This milestone marks a major achievement for the company. and reflects years of rigorous scientific and regulatory work. The initiative is part of the FDA’s Drug Development Tool (DDT) qualification program, which enables biomarkers and other tools, once qualified, to be used within a defined context of use in clinical trials without repeated FDA review, reducing regulatory uncertainty and accelerating development timelines. We commend Echosens for leading this important effort to advance MASH research and help transform the future of liver disease therapeutics.
FDA Shares Regulatory Guidance Priorities for the Coming Year
FDA’s Center for Devices and Radiological Health (CDRH) released its proposed list of medical device guidance documents for fiscal year 2026 and is seeking public feedback through December 1. Key priorities include finalizing guidance on the use of real-world evidence (RWE) to support regulatory decisions and on predetermined change control plans (PCCPs) for medical devices. The agency also plans to advance guidance on artificial intelligence (AI)-enabled device software functions, incorporation of voluntary patient preference information throughout the total product lifecycle, and requirements for human factors information in medical device marketing submissions.
FDA Seeks Public Comment on Evaluating AI-Enabled Medical Device Performance
The FDA’s Digital Health Center of Excellence has issued a Request for Public Comment on methods to measure and evaluate the real-world performance of artificial intelligence (AI)-enabled medical devices. The agency is seeking input on strategies to monitor performance drift over time, including the effects of changes in data inputs, clinical practice, and user behavior. Comments are due by December 1, 2025. This initiative reflects FDA’s ongoing focus on ensuring safe, effective, and adaptive AI technologies in healthcare.
FDA Finalizes Guidance on Predetermined Change Control Plans (PCCPs) for AI-Enabled Devices
FDA is finalizing guidance on PCCPs for AI-enabled device software functions, outlining how manufacturers can proactively define, validate, and justify future modifications to AI-driven device software within their initial submissions. Once authorized, modifications covered under a PCCP may be implemented without a new submission, enabling faster iteration while maintaining safety and effectiveness. This guidance reflects FDA’s ongoing focus on managing the AI software lifecycle through robust validation and risk control.
BMTA supports wide range of regulatory activities for innovative technologies, including AI-based devices and qualification of DDTs, by helping design evidence generation strategies and preparing qualification submissions to the FDA.
Reimbursement Updates
Upcoming AMA Hybrid Meeting Regarding Coding and Payment for Algorithmic Services
The September 2025 CPT Editorial Panel meeting included discussion as to the consistent development of CPT codes for services using AI-technologies. The AMA will host a hybrid meeting on December 8 in Chicago to further discuss coding and payment for clinical AI and other algorithmic services. Registration information can be found on the AMA website.
BMTA closely monitors developments in reimbursement policy to advise companies on an optimal strategy for their technologies.
CMS Proposes 2026 Payment Policy Changes Impacting Device-Related Services
CMS released proposed rules for the 2026 Medicare Physician Fee Schedule (PFS) which could affect reimbursement for device-related procedures and clinician services. Among the proposed initiatives, CMS proposes to establish an ‘efficiency adjustment’ to RVUs currently determined through the RUC survey to better reflect the resources involved in furnishing services paid under the PFS, and. to review certain potentially misvalued CPT codes identified by the public including provision of antigens for allergen immunotherapy, excimer laser treatment for psoriasis, and fine needle aspiration biopsy.
CMS Transitional Coverage for Emerging Technologies (TCET) Update
The TCET pathway grants expedited coverage by Medicare for FDA breakthrough devices. During 2025 CMS has selected four products and is in process of developing National Coverage Determinations for the respective products, effective 2026. The four technologies accepted into the TCET pathway are
transcatheter tricuspid valve replacement (Edwards Lifesciences), renal denervation for uncontrolled hypertension (Medtronic), cardiac contractility modulation therapy (Impulse Dynamics), and
transcatheter edge-to-edge repair system for tricuspid valve regurgitation (Abbott).
The next deadline for applying for TCET is January 31, 2026.
BMTA helps manufacturers and providers to develop reimbursement strategies and subsequently, coverage by Medicare and commercial payers, for new technologies.
Society of Gastrointestinal and Endoscopic Surgeons (SAGES) Shark Tank competition
SAGES continues to showcase and finance promising startups through its annual Shark Tank competition. You can present both your idea and supporting business model to judges at https://www.judgify.me/sharktank2026 through December 5, 2025 for a chance to present in person and win $30,000. For more information, go to https:/www.sages2026.org or contact julie@sages.org.
Since 2004, BMTA’s multidisciplinary team of highly experienced consultants has supported more than 400 medical technologies and life sciences companies around the world to achieve their business goals. BMTA offers valuable, ethical, result-oriented, professional, and cost-effective insights that recognize the multi-faceted aspects of today’s healthcare markets and the client’s unique business needs.
- Market Analysis and Business Strategy
- Business Development
- Regulatory Affairs and Clinical Trial Management
- Reimbursement and Contracting Strategies
- Financing Support
- Other Services
Boston MedTech Advisors provides practical business services to:
- Established and growing medical technology companies
- Healthcare providers
- Startups and entrepreneurs
- Private and institutional investors
