In Memory of Yossi Elaz We are deeply saddened to share the news of Yossi…
BMTA Newsletter, February 2025
BMTA is Celebrating 20 Years
During this period, BMTA has worked with over 400 companies worldwide. Among its activities during 2024, BMTA:
- Met with the FDA in Pre-Submission sessions to review regulatory strategies and clinical study
designs and submitted multiple applications for clearances of new devices. - Participated in the first round of CMS Transitional Coverage for Emerging Technologies (TCET) program intended to support coverage by Medicare for FDA designated ‘Breakthrough Devices’.
- Pursued insurance coverage for new technologies and procedures.
- Supported multiple clinical studies, including design of study protocols, identifying PIs and clinical sites, overseeing multi-site clinical studies, and conducting a large post-market study.
BMTA News
As part of the Japanese program to expand innovation of medical technologies, BMTA hosted a delegation from the Japan Agency for Medical Research and Development last month to discuss challenges of Japanese start-ups seeking to enter the U.S. market.
Development of Digital Health is Rapidly Accelerating
Technological advancements, clinical needs and economic forces accelerate the adoption of digital technologies and their influence on patient care.
- A recent IQVIA Institute report suggests that the number of digital health tools is now exceeding 330,000.
- Regulatory approvals and coverage of digital health products, including AI-enabled devices, are increasingly helping providers to monitor disease progression and treatment effectiveness, as well as predicting future health changes.
- A report from the Office of Inspector General (OIG), recommends that CMS enhance oversight of remote patient monitoring (RPM) services to ensure proper use and billing, and advises the agency to develop methods to track specific health data being monitored and types of devices used (requiring the creation of new HCPCS codes).
- Since the first approval of an AI-enabled medical device in 1995, the FDA has approved over 1,000 AI-enabled medical devices, with their most common use being in radiology (accounting for over 70% of devices), followed by cardiology.
- The FDA has released a draft guidance for “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” offering recommendations for companies seeking clearances for devices using AI-enabled functions.
Contact BMTA for help with meeting FDA requirements for AI enabled medical devices.
The Health Tech Hub Accelerator Program (HTH), a strategic collaboration between the U.S. Department of Health and Human Services (HSS) and Israel’s Ministry of Health, exists to fuel health technology innovation and strengthen bilateral readiness for health emergencies.
In partnership with Mass General Brigham (MGB), the HealthTech Hub (HTH) helps Israeli startups that develop solutions supporting health preparedness, response, and recovery to navigate U.S. regulatory pathways, validate clinical and commercial adoption strategies, and build key industry connections. March 3rd, 2025 is the deadline for applying for the next group of companies. Online application is available at https://www.armiusa.org/nextfab/armihealthtech-hub/.
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
