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Industry Landscape
The Medical Technology (MedTech) industry is experiencing rapid innovation, driven by advancements in minimally invasive procedures, digital health, and personalized medicine. Focused ultrasound technology, in particular, is a cutting-edge segment, expanding its applications beyond traditional surgeries. The industry is characterized by strong R&D investment, complex regulatory landscapes, and increasing demand for cost-effective, patient-centric solutions globally.
Total Assets Under Management (AUM)
Medical Device Market Size in United States
~590 Billion USD (2024 est.)
(5.4% CAGR)
- Driven by technological advancements and aging population.
- Increased demand for non-invasive treatments.
- Rising healthcare expenditure and chronic diseases.
Total Addressable Market
590 Billion USD
Market Growth Stage
Pace of Market Growth
Emerging Technologies
AI-Powered Image Guidance
Integration of artificial intelligence for enhanced real-time imaging and precise targeting during focused ultrasound procedures.
Personalized Focused Ultrasound
Development of adaptive focused ultrasound systems capable of tailoring treatment parameters to individual patient anatomy and pathology for optimized outcomes.
Theranostics with Focused Ultrasound
Combining diagnostic imaging with therapeutic focused ultrasound for real-time monitoring of treatment delivery and response at the cellular level.
Impactful Policy Frameworks
Medical Device User Fee Amendments of 2022 (MDUFA V)
MDUFA V, signed into law in September 2022, reauthorizes the FDA to collect user fees from medical device companies to fund the premarket review process, aiming to accelerate patient access to safe and effective medical devices.
This policy aims to expedite the FDA review process for new medical devices, potentially allowing Insightec to bring new indications and product advancements to market faster.
FDA's Digital Health Software Precertification (Pre-Cert) Program (Ongoing Pilot)
Although a pilot, the FDA's Pre-Cert program, initiated in 2017, aims to streamline the regulatory review for software as a medical device (SaMD) from companies demonstrating a commitment to quality and organizational excellence, rather than product-by-product review.
While still in pilot, a formalized Pre-Cert program could significantly simplify and accelerate regulatory approvals for software updates and AI enhancements to Insightec's Exablate Prime system.
Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for Magnetic Resonance Imaging (MRI)-Guided Focused Ultrasound (MRgFUS) (Updated 2022)
CMS updated its NCD for MRgFUS in 2022, expanding coverage for certain conditions, specifically essential tremor, under specific conditions and evidence requirements.
This NCD directly impacts Insightec by expanding reimbursement coverage for its key indication (Essential Tremor), potentially increasing patient access and adoption by healthcare institutions.
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