BMTA Newsletter, October 1, 2024
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 and the companies we serve. Prior to joining BMTA, Yossi had a long career, including serving as VP R&D at Mennen Medical, Siemens Medical Systems, and Draeger Medical Systems. As noted by one of his colleagues “Yossi and his team focused on developing so many exciting breakthrough innovations in the field of computer-based monitoring and diagnostic systems for cardiology and intensive care. Yossi’s contribution to this field was significant, and his fingerprint can be found in every patient monitor used in ICUs across the world today.”
In honor of Yossi, donations can be made to Dana Farber: http://danafarber.jimmyfund.org/goto/Shiri
New BMTA Blogs
Active post market surveillance
The FDA is developing a post market surveillance system to monitor the safety of medical devices after they are approved for use (See BMTA blog). The system will analyze data from electronic health records and other sources to identify potential safety problems. The FDA has started monitoring two specific devices in 2024, with an eventual goal of expanding the program. To learn more about compliance with FDA post marketing guidelines call BMTA.
Predetermined Change Control Plans (PCCPs)
The FDA has released draft guidelines for PCCPs in medical device submissions, including those for Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD), with or without AI/ML-enabled software functions (See BMTA blog). These PCCPs outline planned device modifications, validation, and impact assessment. The FDA reviews PCCPs to ensure device safety and effectiveness without requiring additional submissions for approved changes. For assistance in determining and drafting PCCPs for a marketing submission, please contact BMTA.
The SINC venture capital fund In support of SAGES‘ mission to invest in and accelerate innovation, SAGES Ingenuity has sponsored the venture capital SINC Fund. Medical device manufacturers currently fundraising can submit a pitch deck through https://www.sages-ingenuity.com/application-for-investment/. SAGES also continues to finance promising startups through its annual Shark Tank competition. Entrepreneurs can present their ideas at https://www.judgify.me/sharktank2025 through November 20, 2024 for a chance to present in person and win $30,000.
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
Industry News
AI-enabled medical devices lack of clinical validation data:
A recent study found that nearly half of all AI-enabled medical devices cleared or approved by FDA between 1995 and 2022 lacked adequate clinical validation data. Most AI medical devices have been cleared through the FDA’s 510(k) process, based on evidence of safety and efficacy collected from a similar predicate device and validation data may not necessarily be required. However, lack of published clinical validation information has raised concerns about their real-world effectiveness, market adoption, and payer coverage. As the FDA is continuously proposing new strategies to ensure the safety and efficacy of AI-enabled medical devices, BMTA works with developers of such devices to address market authorization requirements as well as the clinical evidence supporting coverage by payers and faster market adoption.
Apple’s Hearing Aid Feature (HAF) clearance
The FDA has established policies prioritizing innovation that fosters health equity by expanding access of effective medical technologies to patients. A recent authorization via the De Novo pathway of Apple’s HAF received broad media coverage, being the first over-the-counter (OTC) hearing aid device approved by the FDA for marketing in the U.S, following the recently established OTC category for hearing aids indicated for adults with mild to moderate hearing loss. Companies interested in exploring new initiatives undertaken by the FDA may contact BMTA.
Updated CPTs, 2025
The CPT 2025 published by the American Medical Association (AMA) features 420 overall updates, including new codes, deletions, and revisions of CPT codes. Key updates include:
● Revisions to Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM) codes.
● Introduction of the AI Taxonomy to classify AI-based medical procedures.. BMTA is working with medical device manufacturers to assess optional reimbursement strategies, applying for new CPT and HCPCS codes and supporting efforts to expanding coverage policies by Medicare and commercial payers.
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