United States: Introduction of "RAPID" Program to Accelerate Medicare Coverage for Breakthrough Medical Devices
【Company/Organization】 U.S. Department of Health and Human Services (HHS) / CMS・FDA
【Category】 Regulatory Trends・Insurance 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" to ensure that innovative medical devices reach patients more quickly.
This program aims to significantly reduce the waiting period from FDA approval to insurance coverage, from the conventional average of over one year to as little as two months. It specifically targets "breakthrough devices" for life-threatening conditions, enabling the simultaneous generation of evidence required for regulatory approval and data needed for insurance coverage through collaboration between regulatory and insurance authorities from the early stages of development.
Japan: Panasonic HD Begins Automation Demonstration for iPS Cell Generation Process
【Company/Organization】 Panasonic Holdings Corporation
【Category】 Regenerative Medicine・Technological Innovation
Panasonic Holdings Corporation is developing a fully automated device for generating iPS cells from a patient's own blood and commenced full-scale demonstration experiments in April 2026.
For the widespread adoption of regenerative medicine, reducing cell production costs and stabilizing quality are essential. By automating processes that previously relied on skilled manual labor, a significant reduction in production costs is expected. In anticipation of future approval applications to Japan's PMDA (Pharmaceuticals and Medical Devices Agency), the company is strengthening its collaboration with the Kyoto University iPS Cell Research Foundation, aiming for product commercialization in fiscal year 2028.
Johnson & Johnson: Acquisition to Strengthen Cardiac Ablation Sector
【Company/Organization】 Johnson & Johnson (USA)
【Category】 M&A / Business Strategy
Johnson & Johnson (J&J) announced that it has agreed to acquire Atraverse Medical, a US company with expertise in left atrial access technology.
In the treatment of atrial fibrillation, safe and accurate access to the left atrium is a critical step. Atraverse's “HOTWIRE™” system is a guidewire that uses radiofrequency (RF) technology to enhance the safety and efficiency of procedures. J&J is accelerating the expansion of its portfolio to enable advanced treatments while minimizing the burden on the body in the cardiovascular field, similar to its minimally invasive treatments using gastrointestinal endoscopes.
Stryker: Overcoming Cyberattack Impact and Confident in 2026 Performance
【Company/Organization】 Stryker (USA)
【Category】 Corporate Trends / Cybersecurity
Stryker, a major medical device manufacturer, has overcome a temporary business disruption caused by a cyberattack in the first quarter and expressed strong confidence in its full-year 2026 performance outlook.
In parallel, the company continues to invest in growth areas, such as completing the acquisition of AVS, which possesses intravascular lithotripsy (IVL) technology. Strengthening cybersecurity measures is one of the top priorities for modern medical device manufacturers in an increasingly digital world, and the company's rapid recovery response has garnered attention within the industry.
※This report is based on publicly available information as of April 25, 2026. There is no overlap with news reported before the previous day regarding Omron Healthcare's approval or Medtronic's system operation.
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