Diagnosis
Artera receives FDA Clearance for breast cancer platform
Artera has won FDA clearance for ArteraAI Breast, its breast cancer platform for patients with early-stage HR-positive, HER2-negative invasive breast cancer.
ArteraAI Breast is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer.
These FDA milestones come alongside recent CE marking for both the ArteraAI Prostate Biopsy Assay and the ArteraAI Breast Cancer Assay in the US and Europe.
“FDA clearance for ArteraAI Breast represents a significant expansion of our FDA-cleared AI platform in oncology,” said Andre Esteva, chief executive and co-founder of Artera.
“This milestone reflects the growing role of our technology across multiple cancer types. Breast cancer care is highly nuanced, with treatment decisions that depend on individualised risk.
“Our goal remains consistent across prostate and breast cancer, and beyond: to help clinicians translate complex data into more precise, personalised treatment decisions across the cancer journey.”
ArteraAI Breast generates an AI-derived risk score showing the likelihood of distant metastasis, meaning cancer spreading to another part of the body, in patients with early-stage HR-positive, HER2-negative breast cancer.
Using digitised histopathology images, which are scanned tissue sample images, alongside patient clinical variables, the model sorts patients into low-risk and high-risk groups based on a predefined risk score cut-off.
In early-stage HR-positive, HER2-negative breast cancer, deciding the right intensity of treatment can be complex because clinical and pathological factors vary. Artera said the tool is designed to support clinicians within established decision-making frameworks.
Data presented at the 2025 San Antonio Breast Cancer Symposium evaluated the model in early-stage breast cancer and demonstrated the potential to inform chemotherapy benefit in certain patient populations.
“This clearance represents an important advance on the road to personalising treatments for patients with early-stage breast cancer,” said Eric Winer, medical oncologist and director of the Yale Cancer Center.
“Using AI and digital pathology has the potential to streamline operational workflows, while creating a strong interdisciplinary linkage between oncology and pathology. This approach may further improve the clinicians’ ability to help patients make the best treatment decisions.”
ArteraAI Breast is designed to integrate directly into standard pathology workflows using routine surgical resection samples, without requiring additional tissue or separate specimen collection.
This approach allows the software to provide same-day results, enabling pathology laboratories to give clinicians patient-specific prognostic risk information alongside standard histopathology reports.
Female sex may not raise stroke risk across all atrial fibrillation (AF) patients, with higher risk mainly seen in women aged 75 and older, a study suggests.
Researchers said stroke prevention for women with the condition should be more personalised, especially for patients under 75.
Dr Amitabh C Pandey, director of cardiovascular translational research at Tulane University School of Medicine, said: “For years, female sex has been included as a risk factor along with other factors such as high blood pressure and diabetes, meaning women were more likely to be prescribed anticoagulants.
“Our study shows younger women may not have as much added stroke risk as previously thought, while older women, particularly those over 75, appear to have a higher risk that deserves close attention.”
The new Tulane University study challenges a long-standing assumption in heart care that being female automatically increases stroke risk for patients with atrial fibrillation.
Atrial fibrillation, often called AF, is a common heart rhythm disorder that causes the heart to beat irregularly.
It is associated with a higher risk of stroke and is often treated with anticoagulants, also known as blood thinners.
The study found that stroke risk did not increase equally across all female patients with AF.
Instead, researchers said being female may act more as a risk modifier, with increased stroke risk seen primarily among women aged 75 and older or those with a greater burden of other health conditions.
Clinicians often use a scoring system to decide whether people with AF should be prescribed blood thinners.
The system gives points for factors including age, heart failure, diabetes, previous stroke, vascular disease and high blood pressure.
Women also receive one point for sex alone.
Researchers said this can mean women with AF become eligible for blood thinners earlier or more often than men with otherwise similar risk profiles.
While blood thinners can help prevent clot-related strokes, they can also increase the risk of bruising, prolonged bleeding, gastrointestinal bleeding and other serious complications.
The researchers analysed approximately 950,000 patients with AF using TriNetX, a large anonymised electronic health record database.
They compared stroke outcomes between male and female patients across three age groups: younger than 65, 65 to 74, and 75 and older.
Male and female patients were matched based on age, other health problems and whether they had been prescribed anticoagulation medicine.
Among patients younger than 75, the study found no significant difference in one-year stroke risk between men and women.
However, among patients aged 75 and older, women had a modest but statistically significant increase in stroke risk compared with men.
In patients aged 75 and older with no additional risk factors beyond age, women had about one additional stroke per 629 patients compared with their male counterparts.
The findings support growing interest in a newer AF risk score, known as CHA2DS2-VA, which removes sex as a standalone risk factor.
However, researchers said more studies are needed and medical guidance remains inconsistent.
Han Feng, assistant professor at Tulane University School of Medicine, said: “This general approach came from women being underrepresented in AFib trials and studies comprising only about one-third of study populations.
“Our study shows not all women with AFib have the same risk profile, and these decisions should be individualised.
Pandey said: “These findings highlight the need for modern tools and approaches that can personalise risk profiles to individuals.
“The goal is not to undertreat patients who need stroke prevention, but to better identify who is most likely to benefit from anticoagulation and who may be exposed to unnecessary risk.”
AI may help speed breast cancer diagnosis for high-risk women after abnormal mammograms, a study suggests.
Women with abnormal mammograms often wait weeks to learn whether they have breast cancer.
Researchers at UC San Francisco and UC Berkeley said an AI-guided workflow could help reduce that wait by quickly identifying those most likely to have the disease. Some women could move from imaging to evaluation, and sometimes biopsy, in a single day.
Dr Maggie Chung, first author of the study, said: “This is a really an exciting time.
“This moves us closer to personalised care, where we can tailor a plan so that each patient gets the right intervention at the right time.”
The study used an open-source AI model called Mirai.
The model was trained on hundreds of thousands of mammograms linked to patients’ cancer outcomes.
A mammogram is an X-ray scan of the breast used to look for signs of cancer. A biopsy involves taking a small tissue sample to test for disease.
The AI tool is designed to detect subtle patterns in screening mammograms and predict a woman’s cancer risk.
Researchers at UC San Francisco and UC Berkeley applied the model to more than 4,100 screening mammograms at Zuckerberg San Francisco General Hospital and Trauma Center.
Mirai identified 525 women, about 12.7 per cent of screened patients, as high risk.
Those patients could receive an interpretation of their mammograms immediately after the scan and have additional diagnostic imaging for suspicious areas on the same day.
Some women who needed biopsies were also able to have them on the same day.
The researchers said Mirai reduced the wait time for diagnostic evaluation from several weeks to about an hour.
For women who were ultimately diagnosed with breast cancer, it reduced the average wait for biopsy from more than two months to fewer than 10 days.
The researchers stressed that Mirai does not replace radiologists or make diagnoses on its own.
Instead, it acts as a triage tool to help physicians identify the patients who can benefit most from accelerated care.
The team analysed more than 114,000 archival mammograms before launching the programme, to ensure the model would capture enough high-risk patients without overloading the clinic with too many expedited evaluations.
The researchers said they hope AI will support a more personalised approach to breast cancer screening tailored to each patient’s breast cancer risk.
Chung said: “Right now, many women follow the same screening schedule but their individual risk can be very different.
“AI risk assessment gives us the chance to identify the women most likely to benefit from expedited care and get them what they need.”
Adam Yala, senior author of the study and a data scientist at UC Berkeley, said: “This is a powerful example of how AI can be a collaborative partner for physicians.
“It shows how we can improve care when we bring clinicians and data scientists together to design these systems.”
Type 2 diabetes diagnoses are rising twice as fast in women under 40 as in women over 40, new data shows.
Type 2 diabetes is a serious condition and can lead to complications such as heart attacks and strokes. When it develops in younger people, it can be more aggressive and have more severe and acute effects.
Diagnoses in women under 40 rose by 47 per cent between 2017/18 and 2023/24. By comparison, diagnoses rose by 22 per cent in women aged 40 to 79.
During the same period, type 2 diabetes diagnoses in men under 40 increased by 34 per cent.
Diabetes UK said it is concerned about the follow-up care offered to women who have had gestational diabetes, also known as GDM, which increases the risk of developing type 2 diabetes after pregnancy.
Gestational diabetes is high blood sugar that develops during pregnancy and usually goes away after birth, but it raises the risk of type 2 diabetes later.
Colette Marshall, chief executive at Diabetes UK, said: “These figures should be a wake-up call. Type 2 diabetes is rising twice as fast in younger women compared to older women, and a crucial opportunity for prevention is being missed. Every diagnosis is life-changing, but when it develops in younger people, type 2 diabetes is even more aggressive.
“Pregnancy shouldn’t be a pathway to ill health. Yet despite facing a much higher risk of type 2 diabetes, too many women with GDM receive little or no follow-up care after pregnancy.
“As the Government turns its Strategy into action, support for women who have had gestational diabetes must not be overlooked.”
Last year, the NHS published the first national GDM audit for England in 2024/25, which revealed inconsistencies in follow-up care.
Only 57 per cent of women with GDM received an annual HbA1c test, which should be offered to every woman with GDM.
An HbA1c test measures average blood sugar levels over the previous two to three months.
Only 4.5 per cent of women had received support through the NHS Diabetes Prevention Programme.
The report also found that 11 per cent of women developed prediabetes within five years of having GDM, while 15 per cent developed type 2 diabetes within 10 years.
Prediabetes means blood sugar levels are higher than normal and a person has a higher risk of developing type 2 diabetes.
A recent survey funded by Diabetes UK also found that more than a third of women with GDM felt abandoned by healthcare services after giving birth.
If you live in England and have had gestational diabetes, you can self-refer to the NHS Diabetes Prevention Programme, which supports people at risk of developing type 2 diabetes. If you live in Northern Ireland, Scotland or Wales, you can speak to your GP about support.
Diabetes UK has written to women’s health minister Baroness Merron calling for urgent improvements to postnatal support for those diagnosed with GDM during pregnancy.
GDM affects between 10 and 20 per cent of pregnant women, but Diabetes UK said cases have long been underreported and UK-wide data on the condition has not been readily available.
The charity said poor follow-up care for women who have had GDM may be contributing to rising rates of type 2 diabetes in younger women.
It is calling for consistent postnatal follow-ups for women after GDM, more referrals to the NHS Diabetes Prevention Programme, greater accountability for improvements in postnatal care, and action on inequalities affecting women from deprived and minority ethnic communities.
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