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Endoscopic AI: AI Medical Service Inc. Has Obtained Regulatory Approval from Thailand’s FDA for Its Gastric AI-based Endoscopic Diagnosis Support System

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Endoscopic AI: AI Medical Service Inc. Has Obtained Regulatory Approval from Thailand’s FDA for Its Gastric AI-based Endoscopic Diagnosis Support System
News

News

Endoscopic AI: AI Medical Service Inc. Has Obtained Regulatory Approval from Thailand’s FDA for Its Gastric AI-based Endoscopic Diagnosis Support System

2025-07-25 18:01 Last Updated At:18:11

TOKYO--(BUSINESS WIRE)--Jul 25, 2025--

AI MEDICAL SERVICE INC. (hereinafter AIM), a medical start-up specializing in the development of diagnostic endoscopic AI, is excited to announce that it has received medical device approval from the Thai Food and Drug Administration (Thai FDA) on June 26, 2025. The approval is for its endoscopic image diagnosis support software, the "gastroAI-model G." This system utilizes artificial intelligence to assist physicians in differentiating between neoplastic and non-neoplastic gastric lesions within endoscopic images. This marks the first time in Thailand that an AI-powered diagnostic support system for the upper gastrointestinal tract, equipped with lesion differentiation 1 capabilities, has received regulatory approval 2.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250724574631/en/

Background of our efforts to complete regulatory review and device registration in Thai
Gastric cancer is the fifth most common cancer in the world, with more than 1 million people contracting gastric cancer and approximately 600,000 people dying from the disease each year 3. Gastric cancer is characterized by a mortality rate that increases significantly with disease progression. However, gastric cancer is very often treatable if detected at an early stage; the 5-year relative survival rate is approximately 95% if detected at stage I, but less than 50% if detected at stage III or later 4. Nevertheless, early-stage gastric cancer is difficult to detect and is said to be missed in 4.5 to 25.8% of cases 5.

In Thailand, the high mortality rate for gastric cancer (approximately 75% 6 of diagnosed individuals die from the disease) suggests that many cases are detected at an advanced stage. This healthcare challenge is compounded by significant demographic trends; as a member of the Global South, Thailand is experiencing economic growth and a rising life expectancy. For example, the current average life expectancy of around 76 years 7 is one factor that contributes to Thailand having one of the most rapidly aging populations in the ASEAN region. According to the United Nations' World Population Prospects (2024), Thailand's population has peaked and is expected to decline in the future. Consequently, the need for effective cancer countermeasures, including for gastric cancer, is expected to rise concurrent to aging demographics. By delivering our gastric cancer diagnostic support AI leveraging Japan's world-leading endoscopic medical technology to the clinical frontline in Thailand, we aim to address the anticipated shortage of endoscopy specialists and ultimately contribute to reducing the number of deaths from gastric cancer.

About gastric cancer differentiation AI “Endoscopic image diagnosis support software - gastroAI-model G”
The gastric cancer differentiation AI, brand-named “Endoscopic image diagnosis support software - gastroAI-model G,” is a diagnosis support system for determining the neoplastic or non-neoplastic nature of gastric lesions. The system analyzes endoscopic still images acquired during endoscopic examination and provides near-instant feedback to the physician. The software indicates whether the candidate lesion featured in the image is likely neoplastic (“Adenoma or Adenocarcinoma”), likely non-neoplastic, or unlikely to be neoplastic (“Low Confidence”) 8. If the lesion in the image is neoplastic, the degree of visual similarity between it and historical neoplastic lesions (confidence level) is displayed, and a rectangle indicating the location of the lesion is superimposed onto the image.

Brand name: Endoscopic image diagnosis support software - gastroAI-model G
Approval Number: 68-2-2-2-0006282

About AI Medical Service Inc.
AI Medical Service is a med-tech company and healthcare startup guided by the mission to "Save Lives All Over the World." Japan is a world leader in the field of endoscopy, with an accumulation of world-class data in both quality and quantity. We are engaged in product research and development that leverages this data, and we aim to save patients worldwide by swiftly delivering the results of these efforts to clinical settings.

Company
Company: AI Medical Service Inc.
Address: Hareza Tower 11F, 1-18-1 Higashi-ikebukuro, Toshima-ku, Tokyo 170-0013, Japan
Executive Leadership: Tomohiro Tada, Yasushi Takigawa
Founding: September 1, 2017
Business: Development of endoscopic AI (artificial intelligence) to support diagnostic imaging and related activities

 

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Iran's top judge hinted at fast trials and executions for those who were detained in nationwide protests against the country's theocracy, even as activists said Wednesday that the death toll rose to levels unseen in decades, with at least 2,571 people killed so far.

Iran’s judiciary chief Gholamhossein Mohseni-Ejei, made the comments about trials and executions in a video Tuesday, despite a warning from U.S. President Donald Trump that he would “take very strong action” if executions take place.

The U.S.-based Human Rights Activists News Agency said the number of dead climbed to at least 2,571 early Wednesday. The figure dwarfs the death toll from any other round of protest or unrest in Iran in decades and recalls the chaos surrounding the country’s 1979 Islamic Revolution.

After Trump was informed of the number of deaths, he warned Iran's leaders that he was terminating any negotiations and would “act accordingly.”

Details of the crackdown began emerging Tuesday as Iranians made phone calls abroad for the first time in days after authorities severed communications countrywide when the protests broke out.

Here is the latest:

Tens of thousands of mourners thronged the streets near Tehran University for the funeral of more than 300 security forces and civilians on Wednesday.

Many held Iranian flags and identical photos of Ayatollah Ali Khamenei and their relatives. The caskets, covered in Iranian flags, were stacked at least three high in the backs of trucks and covered with red and white roses and framed photographs of people who were killed. The crowd chanted and beat their chests in response to an emcee speaking from a stage.

One man in the crowd held up a photo of U.S. President Donald Trump during the Pennsylvania assassination attempt, emblazoned with: “The arrow doesn’t always miss!”

India's Embassy in Tehran urged Wednesday all Indian nationals to leave Iran, citing what it called an “evolving situation” in the Islamic Republic.

The statement, posted on X, also advised Indian citizens to remain highly vigilant and avoid areas where protests are taking place.

German police said Wednesday the two climbed over a fence into embassy grounds and tore down an Iranian flag. Both wanted to hoist two pre-Islamic Republic flags but failed, German news agency dpa reported.

They left the grounds when guards used pepper spray and were detained on the sidewalk outside.

The incident happened late Tuesday.

Major Middle East governments were discouraging the Trump administration from waging a war with Iran, fearing “unprecedented consequences” in the volatile region, an Arab Gulf diplomat said Wednesday.

The Cairo-based diplomat, who was given anonymity because he wasn't authorized to speak to the media, said major governments in the region, including Turkey, Egypt, Saudi Arabia and Pakistan, have been “in constant contact” with the U.S. administration over a potential American strike on Iran that could explode into a “full-blown war.”

Such a war will “certainly” have dire repercussions “not only on the Middle East but also on the global economy," he said.

Iranian state television said Wednesday’s mass funeral in Tehran would include 300 bodies of security force members and civilians. The funeral is expected to take place at Tehran University under heavy security.

The U.S.-based Human Rights Activists News Agency said the crackdown killed at least 2,571 people. It said 2,403 of the dead were protesters and 147 were government-affiliated. Twelve children were killed, along with nine civilians it said were not taking part in protests. More than 18,100 people have been detained, the group said.

Gauging the demonstrations and the death toll from abroad has grown more difficult. The Associated Press has been unable to independently assess the toll, given the communications being disrupted in the country.

Melanie Lidman contributed from Jerusalem.

Trump’s decision to impose a 25% tariff on countries that trade with Iran could impact India, an expert said, as New Delhi already faces existing 50% U.S. trade levies due to its purchases of Russian oil.

Abhijit Mukhopadhyay, a senior economist at the Chintan Research Foundation in New Delhi, said the bigger risk is not India-Iran trade, but India’s access to the U.S. market, as its exports to Iran are modest.

India mainly exports rice, tea, sugar, pharmaceuticals and electrical machinery to Iran, while importing dry fruits and chemical products. Textiles and garments, gems and jewelry and engineering goods are likely to be the most vulnerable sectors, he said.

Trump’s latest move also could affect India’s investments in Iran, including the strategically important Chabahar port, which gives India a trade route to Afghanistan, Central Asia and Europe while bypassing Pakistan, Mukhopadhyay said.

Iran’s judiciary chief signals fast trials and executions for those detained in nationwide protests.

Gholamhossein Mohseni-Ejei made the comment in a video shared by Iranian state television on Wednesday.

He emphasized the need for swift action, saying delays would lessen the impact.

His remarks challenge Trump, who warned Iran about executions in an interview aired Tuesday.

Trump stated the U.S. would take strong action if Iran proceeded with executions. The situation highlights escalating tensions between the two countries over the handling of the protests.

Dozens of Pakistani students studying in Iran have returned home through a remote southwestern border crossing, a Pakistani immigration official said Wednesday.

Federal Investigation Agency spokesperson in Quetta city, Samina Raisani, said about 60 students crossed into Pakistan on Tuesday through Gabd border in Balochistan province with valid travel documents.

More students were expected to return through the same crossing later Wednesday, she said.

Mudassir Tipu, Pakistan’s ambassador to Iran, said Tuesday that Iranian universities had rescheduled exams and permitted international students to leave the country.

The satellite internet provider Starlink now offers free service to people in Iran who have access to the company's receivers, activists said Wednesday.

Mehdi Yahyanejad, a Los Angeles-based activist who helped get the units into Iran, told The Associated Press that the free service had started. Other activists also confirmed in messages online that the service was free.

Starlink has been the only way for Iranians to communicate with the outside world since authorities shut down the internet Thursday night as nationwide protests swelled and they began a bloody crackdown against demonstrators.

Starlink did not immediately acknowledge the decision.

This frame grab from videos taken between Jan. 9 and Jan. 11, 2026, and circulating on social media purportedly shows images from a morgue with dozens of bodies and mourners after crackdown on the outskirts of Iran's capital, in Kahrizak, Tehran Province. (UGC via AP)

This frame grab from videos taken between Jan. 9 and Jan. 11, 2026, and circulating on social media purportedly shows images from a morgue with dozens of bodies and mourners after crackdown on the outskirts of Iran's capital, in Kahrizak, Tehran Province. (UGC via AP)

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