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TEL AVIV, Israel, June 18, 2025 /PRNewswire/ -- MedHub-AI, a global leader in AI-powered cardiovascular diagnostics, announced today that the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved AutocathFFR®, the company's non-invasive, AI-driven software solution for evaluating coronary physiology.
AutocathFFR® is the first fully automated Software as a Medical Device (SaMD) that calculates Fractional Flow Reserve (FFR) values directly from standard X-ray coronary angiograms without the need for guidewires or vasodilatory agents. Generating results in just 37 seconds, the system provides interventional cardiologists with fast, reproducible, and operator-independent decision support in the cath lab.
Fractional Flow Reserve (FFR) is a commonly used technique in cardiac catheterization for assessing the extent of blood flow reduction in narrowed coronary arteries.
Traditionally, this procedure involves administering a vasodilatory drug to dilate the blood vessels, followed by the insertion of a guidewire equipped with a pressure sensor into the coronary artery. The sensor measures intravascular pressure changes to determine the FFR value, enabling physicians to assess the severity of arterial blockages.
AutocathFFR® revolutionizes this standard of care by calculating precise FFR values, fully automatically, directly from routine X-ray coronary angiograms using advanced AI algorithms, eliminating the need for invasive guidewires with a pressure sensor or drug-induced vessel dilation. AutocathFFR® delivers fast, hands-free consistent FFR results in just 37 seconds, empowering cardiologists with precise, reproducible values that minimize operator variability and enhance overall workflow reliability.
AI-FFR Pivotal Study
The PMDA approval is supported by a multicenter pivotal study that included 504 vessels from patients across six leading hospitals in the United States and Israel. Each patient underwent invasive FFR measurement, which was then compared to AutocathFFR® results analyzed at an independent core laboratory at MedStar Health in Washington, D.C., led by Dr. Hector Garcia.
The findings demonstrated a sensitivity of 90.2 percent, specificity of 94.9 percent, and overall diagnostic accuracy of 93.7 percent, validating the system's clinical performance and reliability.
Milestone for Japan and for AI in Cardiology
The approval coincides with MedHub-AI's strategic partnership with Terumo Corporation, Japan's leading cardiovascular device company. Together the companies will deliver this breakthrough platform across Japan and accelerate adoption of AI driven clinical tools.
"This PMDA approval is not only a historic achievement for MedHub AI," said Or Bruch El, CEO of MedHub-AI, "but also a turning point for how AI will shape cardiovascular care moving forward. AutocathFFR® delivers real time, reproducible insights through a fully automated pipeline, enabling physicians to make faster and more confident decisions at the point of care. It is the first end to end AI system in its class to be approved, and we are proud to set this new standard."
He added, "The results from our pivotal study give physicians the confidence they need in high stakes and time critical procedures. Our goal is clear. We intend to lead this category without compromise."
Next in Pipeline: iFR Pullback and Beyond
At the upcoming CVIT conference this July, MedHub-AI will unveil its non invasive iFR pullback solution, expanding its real time physiology suite and moving one step closer to fully wire free coronary assessment. This new capability will allow physicians to visualize pressure gradients along the vessel without the need for invasive tools, enhancing procedural planning and accuracy.
In parallel, the company will debut advanced features powered by vision language large models, also known as VLLMs. These AI systems are designed to interpret angiographic images, procedural cues, and patient specific data in real time and offline. By introducing deep contextual understanding directly into the cath lab, VLLMs will support interventional cardiologists with intelligent and dynamic recommendations both during procedures and in post procedural review. This groundbreaking technology is expected to captivate audiences by revealing the full power and potential of the AI powerhouse MedHub-AI is integrating into the heart of interventional cardiology.
Toward Global Expansion
With PMDA approval now secured in Japan, MedHub-AI is progressing rapidly toward regulatory clearance in the United States. The company is in the final stages of its FDA 510k process and expects approval in the very near future. This next milestone will further accelerate the company's global rollout, bringing its AI powered diagnostic platform to physicians across major healthcare markets worldwide.
About MedHub-AI
MedHub-AI is redefining the diagnosis of coronary artery disease with AutocathFFR®, the world's leading AI powered, image based FFR solution. By providing fast, reproducible, and non invasive coronary assessments, MedHub-AI enables clinicians to make better informed decisions and is advancing the global shift toward precision medicine in cardiology.
AutocathFFR® is built on a proprietary AI framework that allows the platform to continuously improve performance, adapt to new clinical needs, and deliver updated software with greater precision and speed. With regulatory approvals expanding, MedHub-AI is preparing for broad clinical adoption and global commercialization.
Contacts:
Yarden Bruch-El, COO
Email: Yarden@medhub-ai.com
Photo - https://mma.prnasia.com/media2/2714191/MedHub_AutocathFFR.jpg?p=medium600
Logo - https://mma.prnasia.com/media2/2147486/5377302/MedHub_logo.jpg?p=medium600
TEL AVIV, Israel, June 18, 2025 /PRNewswire/ -- MedHub-AI, a global leader in AI-powered cardiovascular diagnostics, announced today that the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved AutocathFFR®, the company's non-invasive, AI-driven software solution for evaluating coronary physiology.
AutocathFFR® is the first fully automated Software as a Medical Device (SaMD) that calculates Fractional Flow Reserve (FFR) values directly from standard X-ray coronary angiograms without the need for guidewires or vasodilatory agents. Generating results in just 37 seconds, the system provides interventional cardiologists with fast, reproducible, and operator-independent decision support in the cath lab.
Fractional Flow Reserve (FFR) is a commonly used technique in cardiac catheterization for assessing the extent of blood flow reduction in narrowed coronary arteries.
Traditionally, this procedure involves administering a vasodilatory drug to dilate the blood vessels, followed by the insertion of a guidewire equipped with a pressure sensor into the coronary artery. The sensor measures intravascular pressure changes to determine the FFR value, enabling physicians to assess the severity of arterial blockages.
AutocathFFR® revolutionizes this standard of care by calculating precise FFR values, fully automatically, directly from routine X-ray coronary angiograms using advanced AI algorithms, eliminating the need for invasive guidewires with a pressure sensor or drug-induced vessel dilation. AutocathFFR® delivers fast, hands-free consistent FFR results in just 37 seconds, empowering cardiologists with precise, reproducible values that minimize operator variability and enhance overall workflow reliability.
AI-FFR Pivotal Study
The PMDA approval is supported by a multicenter pivotal study that included 504 vessels from patients across six leading hospitals in the United States and Israel. Each patient underwent invasive FFR measurement, which was then compared to AutocathFFR® results analyzed at an independent core laboratory at MedStar Health in Washington, D.C., led by Dr. Hector Garcia.
The findings demonstrated a sensitivity of 90.2 percent, specificity of 94.9 percent, and overall diagnostic accuracy of 93.7 percent, validating the system's clinical performance and reliability.
Milestone for Japan and for AI in Cardiology
The approval coincides with MedHub-AI's strategic partnership with Terumo Corporation, Japan's leading cardiovascular device company. Together the companies will deliver this breakthrough platform across Japan and accelerate adoption of AI driven clinical tools.
"This PMDA approval is not only a historic achievement for MedHub AI," said Or Bruch El, CEO of MedHub-AI, "but also a turning point for how AI will shape cardiovascular care moving forward. AutocathFFR® delivers real time, reproducible insights through a fully automated pipeline, enabling physicians to make faster and more confident decisions at the point of care. It is the first end to end AI system in its class to be approved, and we are proud to set this new standard."
He added, "The results from our pivotal study give physicians the confidence they need in high stakes and time critical procedures. Our goal is clear. We intend to lead this category without compromise."
Next in Pipeline: iFR Pullback and Beyond
At the upcoming CVIT conference this July, MedHub-AI will unveil its non invasive iFR pullback solution, expanding its real time physiology suite and moving one step closer to fully wire free coronary assessment. This new capability will allow physicians to visualize pressure gradients along the vessel without the need for invasive tools, enhancing procedural planning and accuracy.
In parallel, the company will debut advanced features powered by vision language large models, also known as VLLMs. These AI systems are designed to interpret angiographic images, procedural cues, and patient specific data in real time and offline. By introducing deep contextual understanding directly into the cath lab, VLLMs will support interventional cardiologists with intelligent and dynamic recommendations both during procedures and in post procedural review. This groundbreaking technology is expected to captivate audiences by revealing the full power and potential of the AI powerhouse MedHub-AI is integrating into the heart of interventional cardiology.
Toward Global Expansion
With PMDA approval now secured in Japan, MedHub-AI is progressing rapidly toward regulatory clearance in the United States. The company is in the final stages of its FDA 510k process and expects approval in the very near future. This next milestone will further accelerate the company's global rollout, bringing its AI powered diagnostic platform to physicians across major healthcare markets worldwide.
About MedHub-AI
MedHub-AI is redefining the diagnosis of coronary artery disease with AutocathFFR®, the world's leading AI powered, image based FFR solution. By providing fast, reproducible, and non invasive coronary assessments, MedHub-AI enables clinicians to make better informed decisions and is advancing the global shift toward precision medicine in cardiology.
AutocathFFR® is built on a proprietary AI framework that allows the platform to continuously improve performance, adapt to new clinical needs, and deliver updated software with greater precision and speed. With regulatory approvals expanding, MedHub-AI is preparing for broad clinical adoption and global commercialization.
Contacts:
Yarden Bruch-El, COO
Email: Yarden@medhub-ai.com
Photo - https://mma.prnasia.com/media2/2714191/MedHub_AutocathFFR.jpg?p=medium600
Logo - https://mma.prnasia.com/media2/2147486/5377302/MedHub_logo.jpg?p=medium600
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
MedHub-AI Receives PMDA Approval in Japan for AutocathFFR®
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HO CHI MINH CITY, Vietnam, Jan. 12, 2026 /PRNewswire/ -- Digital travel platform Agoda reveals that Vietnam is becoming an increasingly popular year-end travel choice for families in the region and beyond. Based on searches made between September and November 2025 for stays during December 2025 and January 2026, Agoda recorded a 30% increase in family travel interest to Vietnam compared with the same period the previous year.
Agoda data shows that Vietnam is attracting more international families than ever this winter holiday season. South Koreans take the lead as the top market interested in traveling to Vietnam in December and January, with families from India, Singapore, Australia, and Malaysia rounding out the top five. Notably, Agoda reported that Indian families showcased the highest growth in travel interest to Vietnam during this period, with a 186% increase in searches. Malaysians also, are expressing strong growth in interest, with a 74% increase in searches, highlighting Vietnam's appeal as a family destination in Southeast Asia and beyond.
Families are choosing Vietnam for its storied culture and cuisine, diverse landscapes, and abundance of family-friendly resorts and attractions.
Phu Quoc Island leads as the most sought-after destination among international family travelers with a 47% increase in searches, popular for its sandy beaches, calm waters, and nature parks ideal for multi-generation vacations. Da Nang follows with 42% growth in travel interest, noted for its beaches, soft adventure activities, and access to Ba Na Hills theme park. Nha Trang comes in third place, remaining a favorite for its long coastline, family-oriented resorts, and island experiences. In fourth place, Ho Chi Minh City appeals with its vibrant food scene, entertainment complexes, and day trips to the Mekong Delta. In the north, Hanoi continues to draw families with its cultural landmarks, museums, and festive atmosphere, rounding out the top five most family-friendly year-end destinations in Vietnam.
Meanwhile, although Vietnamese families traditionally travel less internationally at the end of the year – typically preferring to wait for the Lunar New Year - China is becoming a noticeable exception. Among the top 20 outbound destinations preferred by Vietnamese families during the December-January period, searches for Shanghai increased 58%, while Beijing increased 59%. This shift is supported by the launch of new direct routes between Hanoi and selected Chinese cities earlier this year, making end-of-year overseas trips more accessible than ever.
Vu Ngoc Lam, Country Director at Agoda, said: "It is wonderful to see Vietnam increasingly chosen as an end-of-year holiday destination for families from across Asia and beyond. Agoda's data shows that travelers are recognizing Vietnam's family-friendly appeal, which further strengthen its position on the global travel map. As more families plan their festive-season or year-end getaways, we are delighted to support them through Agoda's simple, intuitive platform and our wide range of stays, flights, and activities."
With over 6 million properties, 130,000 flight routes, and 300,000 activities, all bookable in one seamless itinerary, Agoda helps families plan memorable year-end holidays, whether they choose a peaceful beach break, a cultural city escape, or an international exploration to mark the close of the year.
HO CHI MINH CITY, Vietnam, Jan. 12, 2026 /PRNewswire/ -- Digital travel platform Agoda reveals that Vietnam is becoming an increasingly popular year-end travel choice for families in the region and beyond. Based on searches made between September and November 2025 for stays during December 2025 and January 2026, Agoda recorded a 30% increase in family travel interest to Vietnam compared with the same period the previous year.
Agoda data shows that Vietnam is attracting more international families than ever this winter holiday season. South Koreans take the lead as the top market interested in traveling to Vietnam in December and January, with families from India, Singapore, Australia, and Malaysia rounding out the top five. Notably, Agoda reported that Indian families showcased the highest growth in travel interest to Vietnam during this period, with a 186% increase in searches. Malaysians also, are expressing strong growth in interest, with a 74% increase in searches, highlighting Vietnam's appeal as a family destination in Southeast Asia and beyond.
Families are choosing Vietnam for its storied culture and cuisine, diverse landscapes, and abundance of family-friendly resorts and attractions.
Phu Quoc Island leads as the most sought-after destination among international family travelers with a 47% increase in searches, popular for its sandy beaches, calm waters, and nature parks ideal for multi-generation vacations. Da Nang follows with 42% growth in travel interest, noted for its beaches, soft adventure activities, and access to Ba Na Hills theme park. Nha Trang comes in third place, remaining a favorite for its long coastline, family-oriented resorts, and island experiences. In fourth place, Ho Chi Minh City appeals with its vibrant food scene, entertainment complexes, and day trips to the Mekong Delta. In the north, Hanoi continues to draw families with its cultural landmarks, museums, and festive atmosphere, rounding out the top five most family-friendly year-end destinations in Vietnam.
Meanwhile, although Vietnamese families traditionally travel less internationally at the end of the year – typically preferring to wait for the Lunar New Year - China is becoming a noticeable exception. Among the top 20 outbound destinations preferred by Vietnamese families during the December-January period, searches for Shanghai increased 58%, while Beijing increased 59%. This shift is supported by the launch of new direct routes between Hanoi and selected Chinese cities earlier this year, making end-of-year overseas trips more accessible than ever.
Vu Ngoc Lam, Country Director at Agoda, said: "It is wonderful to see Vietnam increasingly chosen as an end-of-year holiday destination for families from across Asia and beyond. Agoda's data shows that travelers are recognizing Vietnam's family-friendly appeal, which further strengthen its position on the global travel map. As more families plan their festive-season or year-end getaways, we are delighted to support them through Agoda's simple, intuitive platform and our wide range of stays, flights, and activities."
With over 6 million properties, 130,000 flight routes, and 300,000 activities, all bookable in one seamless itinerary, Agoda helps families plan memorable year-end holidays, whether they choose a peaceful beach break, a cultural city escape, or an international exploration to mark the close of the year.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Agoda Data Shows Vietnam Rising as a Favorite End-of-Year Destination for Families Across Asia and Beyond
