United States: New “RAPID” Program Announced to Accelerate Reimbursement for Breakthrough Medical Devices
【Company/Organization】 U.S. Department of Health and Human Services (HHS) / CMS・FDA
【Category】 Regulatory Trends・Reimbursement
The Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA), both under the U.S. Department of Health and Human Services (HHS), have announced a new reimbursement pathway called “RAPID” (Regulatory Alignment for Predictable and Immediate Device) to accelerate the delivery of innovative medical devices to patients.
Under the previous system, there was an average waiting period of over one year from FDA approval to Medicare coverage. With the introduction of this new system, this period is expected to be shortened to as little as two months. This program specifically targets products designated as “Breakthrough Devices” that contribute to the treatment or diagnosis of life-threatening conditions. By fostering collaboration between both authorities from the development stage, the program also aims to streamline evidence generation.
This change in the system is a noteworthy development for Japanese medical device manufacturers, particularly from the perspective of accelerating the market introduction of innovative medical devices. Companies considering entry into the U.S. market may significantly shorten the period from approval to reimbursement by strategically utilizing the Breakthrough Device designation.
Japan: Omron Healthcare Obtains Regulatory Approval for Atrial Fibrillation Detection Program
【Company/Organization】 Omron Healthcare Co., Ltd.
【Category】 Regulatory Approval・SaMD
Omron Healthcare Co., Ltd. announced that it has obtained regulatory approval as a Medical Device Program (SaMD) for a program that detects the possibility of atrial fibrillation.
This program is designed to detect early signs of atrial fibrillation, a type of arrhythmia, during at-home vital data management and notify the user. Approved after rigorous review by Japan's PMDA (Pharmaceuticals and Medical Devices Agency), this technology is expected to significantly contribute to the early detection and treatment of atrial fibrillation, which can be a cause of cerebral infarction.
The acquisition of regulatory approval for SaMD (Software as a Medical Device) indicates progress in the development of Japan's regulatory environment for the digital health sector. With an increasing number of approved diagnostic support software utilizing AI and algorithms, compliance with software regulations will become even more crucial in future medical device development.
Medtronic: AI-powered Spinal Surgery Assistance System "Stealth AXiS" Makes Clinical Debut
【Company/Organization】 Medtronic (Ireland)
【Category】 New Products/Technological Innovations
Medtronic announced that the world's first spinal surgery using its next-generation surgical navigation system, "Stealth AXiS Autopilot," which received FDA approval, has been performed.
This system integrates AI-powered preoperative planning with real-time navigation, simultaneously improving surgical precision and optimizing the physician's workflow. Digital integration with GE Healthcare's "bkActiv" ultrasound diagnostic device is also underway, significantly enhancing the convenience of diagnostic imaging in the operating room.
The practical application of AI-powered surgical assistance systems significantly contributes to improving the accuracy of surgical procedures and reducing the burden on physicians. In Japan, applications for regulatory approval of surgical assistance robots and AI navigation systems are also increasing, and utilizing the early consultation system with the regulatory authority (PMDA) is key to obtaining approval.
Johnson & Johnson: Introduces AI-powered Imaging Tool to Support Arrhythmia Treatment
【Company/Organization】 Johnson & Johnson (USA)
【Category】 New Products/Technological Innovations
Johnson & Johnson (J&J) unveiled "CARTOSOUND SONATA," a new AI-powered tool to support cardiac disease treatment, at HRS 2026 (Heart Rhythm Society).
This system uses AI to analyze images inside the heart, assisting with high-precision mapping essential for treating complex arrhythmias. Amidst the growing demand for minimally invasive treatments, this technology is attracting attention as it enables a less burdensome and more precise approach, similar to procedures performed under gastrointestinal endoscopy.
The evolution of AI-powered imaging tools contributes to improving the success rate of complex arrhythmia treatments and reducing surgical times. In the Japanese market, regulatory applications for AI-powered medical devices are also increasing, and pre-consultation with the PMDA regarding algorithm performance evaluation and clinical data collection methods is becoming increasingly important.
Reference Information
This report is based on publicly available information as of April 24, 2026. There is no overlap with the information reported on GE Healthcare's Venue Fit and Intuitive Surgical's financial results from the previous day (April 23rd edition).
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