Month: March 2025

The state government has strengthened its healthcare and medical research collaboration with Cuba following discussions held in New Delhi. Health Minister Veena George met with Cuban First Deputy Health Minister Tania Margarita Cruz Hernández and a Cuban delegation on Thursday to advance the partnership.

According to Veena, the collaboration is set to bring significant advancements to the state’s health sector. Cuban expertise in research will be integrated with the approval of the Centre, ICMR, and DCGA. A memorandum of understanding (MoU) in this regard is expected to be signed by April.

The decision to partner with Cuba’s research sector in four key health areas was made after Chief Minister Pinarayi Vijayan’s visit to the country in 2023. The collaboration will focus on developing a triple-negative breast cancer vaccine, a lung cancer vaccine, treatment for diabetic foot ulcers, a dengue vaccine, and therapies for neurodegenerative diseases like Alzheimer’s.

The Institute of Advanced Virology in Thonnakkal, Thiruvanathapuram, will lead the vaccine development using Cuban technology. Research on cancer will be conducted in collaboration with Malabar Cancer Centre, diabetic foot treatment with Thrissur and Kozhikode Medical Colleges, and Alzheimer’s treatment with Thiruvananthapuram Medical College. The New Indian Express

President Donald Trump has said that he believes India will lower its tariffs on American goods, even as he reiterated his threat to impose reciprocal US tariffs on the country starting April 2.

In an interview with Breitbart News, an American news, opinion, and commentary website, Trump discussed the US’ relationship with India.

Asked about his summit with Prime Minister Narendra Modi last month, Trump said he has a “very good relationship with India.

“But the only problem I have with India is they’re one of the highest tariffing nations in the world, the website quoted Trump as saying believe they’re…probably going to be lowering those tariffs substantially, but on April 2, we will be charging them the same tariffs they charge us.

When asked about the India-Middle East-Europe-Economic Corridor (IMEC), a deal he signed the US onto during Modi’s visit to the US, Trump did not mention China in particular but said it was a “group of wonderful nations banding together countering other countries that look to hurt us on trade.

We have a powerful group of partners in trade, Trump said.

Again, we can’t let those partners treat us badly, however. We do better in many ways frankly with our foes than we do with our friends,” Trump was quoted as saying by the website.

“The ones that wouldn’t be as friendly to us in some cases treat us better than the ones that are supposed to be friendly, like the European Union, which treats us terribly on trade,” Trump said.

“India and everybody would think of them as an ally. I can say the same for others. But this is a group of wonderful nations that is countering other countries that look to hurt us on trade,” he added.

Trump earlier this month said that India has agreed to cut its tariffs “way down” as he reiterated his claim that the country charges America massive tariffs that make it difficult to sell products there.

Commerce Secretary Sunil Barthwal, however told a Parliamentary panel in New Delhi on March 10 that negotiations are still on and no agreement on trade tariffs has been reached so far between India and the US.

Trump has been criticising the high tariffs charged by India.

In his address to the joint session of Congress on March 4, the first of his second term in the White House, Trump criticised the high tariffs charged by India and other countries and termed them “very unfair.

In the past, Trump has called India a “tariff king” and a “big abuser.

India had said it was looking at deepening trade ties with the US, including by reducing tariff and non-tariff barriers, under a bilateral trade agreement.

During Prime Minister Modi’s visit to the US last month, both sides announced plans to negotiate a mutually beneficial, multi-sector Bilateral Trade Agreement (BTA). PTI

The findings are being presented at the American College of Cardiology’s Annual Scientific Session (ACC.25). They highlight how these important cancer screening tools can also be used to assess the amount of calcium buildup in the arteries within breast tissue—an indicator of cardiovascular health.

The U.S. Centers for Disease Control and Prevention recommends that middle-aged and older women get a mammogram—an X-ray of the breast—to screen for breast cancer every one or two years. About 40 million mammograms are performed in the United States each year. While breast artery calcifications can be seen on the resulting images, radiologists do not typically quantify or report this information to women or their clinicians. The new study, which used an AI image analysis technique not previously used on mammograms, demonstrates how AI can help fill this gap by automatically analyzing breast arterial calcification and translating the results into a cardiovascular risk score.

“We see an opportunity for women to get screened for cancer and also additionally get a cardiovascular screen from their mammograms,” said Theo Dapamede, MD, PhD, a postdoctoral fellow at Emory University in Atlanta and the study’s lead author. “Our study showed that breast arterial calcification is a good predictor for cardiovascular disease, especially in patients younger than age 60. If we are able to screen and identify these patients early, we can refer them to a cardiologist for further risk assessment.”

Heart disease is the leading cause of death in the United States but remains underdiagnosed in women and there is also lagging awareness. Researchers said the use of AI-enabled mammogram screening tools could help identify more women with early signs of cardiovascular disease by taking better advantage of screening tests that many women routinely receive. A buildup of calcium in blood vessels is a sign of cardiovascular damage associated with early-stage heart disease or aging. Previous studies have shown that women with calcium buildup in the arteries face a 51% higher risk of heart disease and stroke.

To develop the screening tool used for this study, researchers trained a deep-learning AI model to segment calcified vessels in mammogram images—which appear as bright pixels on X-rays—and calculate the future risk of cardiovascular events based on data obtained from the electronic health record data. The segmentation approach is what separates this model from previous AI models developed for analyzing breast artery calcifications. Researchers said the model is also strengthened by its use of a large dataset for training and testing, which included images and health records from over 56,000 patients who had a mammogram at Emory Healthcare between 2013 and 2020 and had at least five years of follow-up electronic health records data. “Advances in deep learning and AI have made it much more feasible to extract and use more information from images to inform opportunistic screening,” Dapamede said.

Overall findings showed the new model performed well at characterizing patients’ cardiovascular risk as low, moderate or severe based on mammogram images. After calculating the risk of dying from any cause or suffering an acute heart attack, stroke or heart failure at two years and five years, the model showed that the rate of these serious cardiovascular events increased with breast arterial calcification level in two of the three age categories assessed—women younger than age 60 and age 60-80, but not in those over age 80. This makes the tool particularly well suited for providing early warning of heart disease risk in younger women, who can benefit more from early interventions, researchers said.

The results also showed that women with the highest level of breast arterial calcification (above 40 mm²) had a significantly lower five-year rate of event-free survival than those with the lowest level (below 10 mm²). For example, 86.4% of those with the highest breast arterial calcification survived for five years compared with 95.3% of those with the lowest level of calcification. This translates to approximately 2.8 times the risk of death within five years in patients with severe breast arterial calcification compared to those with little to no breast arterial calcification.

The AI model was developed as a collaboration between Emory Healthcare and Mayo Clinic and is not currently available for use. If it passes external validation and gains approval from the U.S. Food and Drug Administration, researchers said the tool could be made commercially available for other health care systems to incorporate into routine mammogram processing and follow-up care. The researchers also plan to explore how similar AI models could be used for assessing biomarkers for other conditions, such as peripheral artery disease and kidney disease, that might be extracted from mammograms. American College of Cardiology

Medical device manufacturers should use a risk pyramid to determine whether their products are classified as high-risk and require conformity assessments by notified bodies under the EU’s Artificial Intelligence Act, according to Sebastian Fischer, regulatory strategy principal at TÜV SÜD Product Service GmbH.

Fischer and other experts discussed what manufacturers must do to comply with upcoming requirements under the act at DIA Europe 2025 on Wednesday.

The AI Act came into force on 1 August 2024. It will apply to products with high-risk applications on 2 August 2026, which includes medical devices placed in the Class IIa category or higher. It will then apply more broadly on 2 August 2027, with full implementation anticipated by 31 December 2030.

Fischer stated that the EU AI Act introduces a risk-based system for classifying AI applications. This system ranges from minimal-risk devices at the bottom of the pyramid to unacceptable-risk systems at the top. Fischer said that any system that uses harmful AI-based manipulation or deception, or a system that uses social scoring is an unacceptable risk and is prohibited.

Medical devices are classified as high risk if they use AI-embedded software used to diagnose or detect abnormalities and would require assessment by a notified body.

Devices with limited-risk include those that are not used to diagnose or detect abnormalities, which are subject to specific transparency obligations under the AI Act. At the bottom of the pyramid are those minimal-risk devices, and these are unregulated. This category is not explicitly mentioned in the AI regulations.

Fischer noted that while AI regulation may be new, the use of AI in medical devices is not.

Fischer recommended that manufacturers review a position paper from Team-NB and the German Notified Bodies Alliance for Medical Devices entitled Questionnaire: Artificial Intelligence in Medical Devices.

Thorsten Stumpf, project lead for regulatory affairs at Metecon GmbH elaborated on some of the requirements for providers for high-risk AI systems in addition to needing to undergo a conformity assessment before placing the product on the market or putting it into service.

Manufacturers must adhere to labeling requirements, which includes providing identification on the packaging. This should include the manufacturer’s name, registered trade name, trademarks, contact address, and CE marking.

In addition, risk management teams should be in place to assess the AI system. Lastly, manufacturers must also have technical documentation which includes keeping record-keeping logs over the lifetime of the AI system.

Fischer said that implementing the AI regulations is mostly an administrative exercise in getting the documentation in order.

Rajarshi Banerjee, CEO of Perspectum Ltd, emphasized the need to prepare for a new wave of applications utilizing advanced AI tools in medical devices. Many of these devices herald a future focused on the use of non-invasive technology to diagnose diseases.

His company has received FDA clearance and EU CE marking for its LiverMultiScan software application, which is a non-invasive test used to detect liver disease. He explained how the use of algorithms in the technology can be used to replace liver biopsies, which he said are often inaccurate.

The technology can determine whether the whole liver or only a part or it is diseased through an MRI scan. Scans from the MRI are sent to a laboratory that employs a proprietary algorithm. The result is a summary of images that detail the health of the liver. RAPS.org