A new database on chronic urinary tract infections aims to help explain why millions of women and girls worldwide develop persistent infections that can defy treatment.

A growing body of research suggests persistent, antibiotic-resistant UTIs may be caused by bacteria that embed deep within the bladder wall, potentially evading both the immune system and conventional treatments.

This phenomenon, known as intracellular bacterial colonisation, means bacteria live inside cells rather than on their surface.

While it is not new, a medical case study of a child with chronic infections, led by University of Sydney researchers, suggests its long-term impact may be underestimated.

The case study found no antibiotic regimen, including aggressive long-term courses, could eliminate the infection because bacteria were embedded in the epithelium, the bladder’s inner lining.

Samples showed no improvement despite years of treatment, raising concerns about current approaches, which remain limited to antibiotic therapy and diathermy, a surgical technique using heat from an electrical current to cut or coagulate the bladder lining, and which carries an increased risk of cancer development if performed repeatedly.

Lead researcher Dr Arthika Manoharan, from the Charles Perkins Centre and the School of Medical Sciences, said some girls as young as five are treated with antibiotics for years, often relapsing as soon as treatment stops.

As a result of the published case study, children under 15 will be the focus of the new database built by Dr Manoharan, which aims to understand why some people develop chronic UTIs.

She said she hopes it will help remove the long-held assumption that UTIs are linked to sexual activity.

She said: “Often people think of UTIs only affecting adult women who are sexually active, which is not the case.

“There are many cases where this issue starts in childhood, with no clear cause.

“This can have a huge impact to their quality of life at a time when they should be enjoying school, playing sports and simply being kids.

“The longer consequences of persistent UTIs can be severe.

“Some women see their employment affected due to chronic incontinence; others are unable to maintain a sexual relationship.

“Many echo the same sentiment: One minute you’re fine, the next you’re in agony and can’t leave the house.”

The research team said it hopes the database will help explore whether immune system evasion or genetic predisposition could explain why some children develop chronic UTIs while others do not.

ShanX Medtech, a female-led AMR diagnostics startup, has secured €24m to scale its rapid antimicrobial susceptibility testing (AST) technology.

The Eindhoven-based company has closed a €15m seed round and been awarded an €8.85m European Commission contract developed by the Health Emergency Preparedness and Response Authority in collaboration with the European Health and Digital Executive Agency.

Founded in 2019, ShanX Medtech develops in-vitro diagnostic solutions for antimicrobial susceptibility testing, which determines which antibiotics will work against a specific infection.

The company says its technology can deliver results within an hour, compared to current methods which take longer.

The platform uses proprietary chemistry called FLORA to monitor pathogen metabolism in real time. According to the company, this requires limited user involvement and offers an improvement over approaches that need trained expertise.

Dr Sophia E. Shanko, founder and chief executive of ShanX Medtech, said: “We founded ShanX Medtech because of a single patient story, one that revealed how much is at stake when diagnostic results arrive too late.”

“Our vision is to equip every clinician with the ability to act decisively, guided by diagnostic evidence in real-time.

“This funding brings us significantly closer to delivering ultra-rapid AST directly to both laboratory and point-of-care environments; faster, simpler, and more accessible than ever before.”

The company’s initial market focus is on urinary tract infections, a common women’s health application, though the underlying platform has potential across wider clinical uses.

The oversubscribed seed round includes equity, grants and the Innovatiekrediet. The equity investment was led by Borski Fund, NextGen Ventures, CbusineZ, Brabantse Ontwikkelings Maatschappij, Invest-NL and a strategic angel fund.

Simone Brummelhuis, partner at Borski Fund, said: “Following an extensive market analysis of innovations addressing antimicrobial resistance, ShanX’s technology clearly emerged as best-in-class.

“While the company’s initial go-to-market strategy focuses on a well-defined women’s health application in urinary tract infections, the underlying platform offers substantial potential across a wide range of clinical indications.

“We are proud to support Sophia and her exceptional team in realising their ambitious vision.

“The oversubscribed financing round, together with multiple multi-million-euro commercial contracts, underscores both the strength of the technology and the founder’s proven commercial execution.”

By FinDBest IVF

The year 2025 will be remembered as a pivotal moment in reproductive medicine—a year when artificial intelligence moved from proof-of-concept to regulatory approval, when automation transformed from aspiration to clinical reality, and when genomic technologies began delivering on their promise of precision fertility care.

At FinDBest IVF, we’ve tracked these developments week by week through our Monday’s 5 news series, and as the year draws to a close, we’re taking stock of the innovations that defined 2025 and will shape the future of IVF/ART.

This review highlights the year’s most significant advancements across six key domains: AI-powered embryo selection, automation & robotics, male infertility solutions, non-invasive diagnostics & precision medicine, regulatory & industry milestones, and emerging research & clinical innovation.

Each represents not just technological progress, but tangible improvements in clinical outcomes, patient experience, and global access to fertility care.

• AI-Powered Embryo Selection: From Algorithms to Approvals

The Regulatory Breakthrough

2025 marked the transition of AI-powered embryo selection from research tool to clinically validated medical device.

The most significant milestone came in October when Alife Health, led by CEO Melissa Terán alongside Paxton Maeder-York and Dr. Emre Seli, received CE Mark approval under the EU Medical Device Regulation (MDR) for its Embryo Predict™ system.

This represented the first time an AI-based embryo selection platform achieved the stringent requirements of post-2021 European regulation, setting a new benchmark for transparency, clinical validation, and real-world performance.

The deep learning model, trained on thousands of time-lapse embryo videos, predicts implantation potential with precision that potentially reduces time to pregnancy and minimises failed transfers.

Federated Learning: Privacy Meets Performance

A groundbreaking study published in Nature Communications Medicine introduced federated task-adaptive learning for personalized embryo selection.

Led by Prof. Guangyu Wang, this approach allows AI models to learn across multiple IVF centers without centralising patient data—addressing one of the field’s most critical challenges: privacy-preserving collaboration.

The technology keeps data at individual clinics while building superior prediction models, achieving better live-birth prediction compared to centralised approaches while maintaining built-in data protection.

Metabolic Imaging: The Next Frontier

While morphology-based AI dominated headlines, Lumiris Technologies’ Metaphor™ system introduced a paradigm shift: using AI-driven hyperspectral imaging to assess embryo metabolic stress.

Unlike traditional time-lapse systems that evaluate visual development, Metaphor analyzes the metabolic “fingerprint” of embryos through hyperspectral microscopy combined with AI, offering insights into cellular health that are invisible to the human eye.

This metabolic stress assessment potentially identifies embryos with better implantation potential beyond what visual assessment can detect.

• Automation & Robotics: The Smart Lab Revolution

World’s First Robot-Born Babies

August 2025 brought a watershed moment: the birth of the world’s first babies conceived through AI-powered, robot-controlled IVF.

Columbia University Fertility Center, working with Conceivable Life Sciences under the leadership of Dr Zev Williams, CEO Alan Murray, and Chief Knowledge Officer Dr Stephanie Kuku, successfully delivered 19 healthy infants using an autonomous system that handled sperm selection, fertilization, and embryo culture with minimal human intervention.

The AI-driven robotic platform manages the full IVF workflow from sperm analysis to embryo culture, demonstrating that automated reproductive medicine can deliver clinical outcomes that match or exceed traditional approaches.

The 19 healthy live births validate that automation reduces variability, increases efficiency, and potentially democratizes access to expert-level IVF care.

Overture Life: Automation Reaches Critical Mass

Overture Life, founded by Martin Varsavsky and led by CEO Hans Gangeskar with scientific direction from Santiago Munné and contributions from Dr José A. Horcajadas, emerged as 2025’s automation leader.

The company’s DaVitri platform—the world’s first microfluidics-based automated vitrification system—launched European preorder waitlist in September and opened a Dallas clinical lab and robotics HQ in October.

DaVitri standardizes vitrification protocols for embryos and oocytes, reducing operator dependency and improving reproducibility across IVF labs.

Beyond DaVitri, Overture Life continues developing an integrated suite including automated sperm selection and ICSI modules toward a fully integrated smart lab.

AutoIVF Secures Major Investment

Vitrolife’s investment in AutoIVF signaled mainstream industry validation of automation technologies, positioning the Swedish giant to integrate automated solutions across its global distribution network.

The investment accelerates commercialization of AutoIVF’s automation platform, which enhances consistency and affordability while reducing outcome variability—making IVF more cost-accessible without sacrificing quality.

• Male Infertility: AI, Robotics & Precision Selection

AI Rescues 18-Year Infertility Journey

One of 2025’s most compelling stories came from Columbia University, where Dr Zev Williams and his team used the STAR system (Sperm Tracking and Recovery) to help a couple achieve pregnancy after 18 years of trying.

The AI identified 44 viable sperm in under 2 hours from an azoospermic sample—sperm that conventional methods had missed.

This technology transforms outcomes for severe male factor infertility by detecting sperm conventional analysis overlooks, developed over five years to address one of fertility’s most challenging clinical scenarios.

T’easy: AI Meets Testicular Biopsy

UZ Brussel introduced “T’easy,” an AI-powered system that detects sperm in testicular biopsies within minutes, dramatically reducing the time required for male infertility diagnosis and improving success rates in testicular sperm extraction procedures.

The real-time AI analysis of testicular biopsy samples completes in minutes instead of hours, improving TESE success rates while reducing patient time under anesthesia—a practical efficiency gain that directly benefits patient comfort and clinical workflow.

Research Debunks Antioxidant Myth

A major randomised clinical trial published in JAMA Network delivered important negative findings: antioxidant supplements (Impryl®) showed no benefit for male fertility in IVF cycles.

Led by researchers Wiep de Ligny and Jan-Peter de Bruin, the SUMMER trial found no statistically significant improvement in pregnancy or live birth rates, challenging widespread clinical practice and emphasising the need for evidence-based approaches over routine supplement prescription.

• Non-Invasive Diagnostics & Precision Medicine

First-Ever Footage of Human Embryo Implantation

Scientists achieved a historic first in August 2025: capturing real-time 3D video of a human embryo implanting in the uterus.

Published in The Guardian and detailed in Human Reproduction by Oxford University Press, this groundbreaking imaging revealed the embryo’s active, invasive role in implantation—offering unprecedented insights into one of reproduction’s most critical yet mysterious processes.

The advanced 3D imaging technology captured embryo-endometrial interaction dynamics that may inform new interventions to improve implantation rates.

Optical Genome Mapping for Pregnancy Loss

Optical Genome Mapping (OGM) emerged as a superior alternative to traditional cytogenetic methods for diagnosing chromosomal causes of recurrent pregnancy loss.

Highlighted in Contemporary OB/GYN, this high-resolution genome mapping technology detects structural chromosomal variants faster and with more detail than karyotyping or chromosomal microarray.

OGM outperforms traditional cytogenetics in identifying miscarriage-related genetic abnormalities, accelerating diagnosis in recurrent pregnancy loss cases and enabling earlier targeted interventions.

Spent Culture Media: The Non-Invasive Biomarker

A comprehensive review of 49 studies, published in EMJ Reproductive Health, highlighted spent embryo culture media as a promising source of non-invasive biomarkers for embryo viability.

Metabolomic analysis of culture media—examining glucose, amino acids, fatty acids, and other metabolites—offers embryo assessment without biopsy.

While the review emphasizes the need for unified methodologies to advance clinical application, the approach could reduce reliance on invasive PGT-A while providing complementary embryo viability insights.

• Regulatory & Industry Milestones

Australia Calls for National ART Regulation

A coalition of Australian researchers and legal experts issued a landmark call for national IVF/ART regulatory reform, recommending establishment of an independent commission, harmonised accreditation standards, and unified governance across fertility clinics.

The review, detailed in the Surrogacy & Fertility Bulletin by Sarah Jefford, highlighted system fragmentation as a key barrier to quality and safety.

The proposal reflects a global trend toward strengthened fertility clinic governance, addressing inconsistencies that currently exist across state-level regulation.

Monash IVF Leadership Transition

Monash IVF appointed Dr Victoria Atkinson, currently CMO at Healthscope, as its next MD & CEO effective May 2026.

The appointment reinforces Monash IVF’s commitment to clinical governance and patient-safety-led transformation as the group enters a new operational phase focused on quality outcomes and systematic improvement.

ASRM Framework for Embryo Testing Innovation

The American Society for Reproductive Medicine (ASRM) published a comprehensive framework in Fertility & Sterility outlining a staged pathway for embryo testing technologies from early innovation to validated clinical practice.

The framework emphasises evidence strength, reproducibility, and patient-centered outcomes—providing critical guidance for labs, regulators, and device manufacturers navigating the journey from innovation to clinical deployment.

Global Regulatory Tightening: MDR, FDA, NMPA

FinDBest IVF partnered with Femtech World to publish a comprehensive analysis of global regulatory shifts affecting IVF innovation in 2025.

The review examined how device and diagnostic regulation is tightening across major markets.

In the EU, MDR is in full effect with IVF consumables now classified as Class IIb or III, requiring stricter UDI compliance and post-market surveillance.

The FDA has increased scrutiny of AI/ML-based devices with updated premarket pathways. China’s NMPA now requires UDI cloud integration and cybersecurity risk reports for connected IVF devices.

These changes mean approval timelines have extended 6-12 months with significantly increased documentation requirements, affecting every manufacturer seeking global market access.

Professional Development & Industry Recognition

The ASRM Society of Reproductive Biologists & Technologists (SRBT) launched the Nexpring Health Diarmaid Douglas-Hamilton Memorial Scholarship, honouring a legendary figure in ART and supporting the next generation of embryologists and lab technicians.

The scholarship expands access to advanced reproductive technology education, ensuring continued innovation through professional development of emerging ART leaders.

• Emerging Research & Clinical Innovation

Organoids: Mini Placentas & Ovaries

Dr. Margherita Turco’s pioneering work with lab-grown reproductive tissues—including “mini placentas” and ovarian organoids—is reshaping fertility research.

Featured in Nature, these patient-derived cells grown into 3D placental and ovarian tissue models enable unprecedented study of implantation biology and early ovarian development.

The 3D cellular models allow research into implantation and ovarian biology previously impossible with traditional 2D cultures, potentially revealing new therapeutic targets for implantation failure and ovarian disorders.

Mitochondrial Replacement: Three-Person IVF

Research published in Science Daily reported successful live births using mitochondrial donation techniques (three-person IVF), preventing transmission of mitochondrial disorders.

The technology replaces mother’s mitochondria in eggs with healthy donor mitochondria, offering a reproductive option for women carrying mitochondrial disorders.

Early monitoring showed no adverse effects in infants, though long-term studies continue to track outcomes.

Polygenic Embryo Screening: The Ethical Frontier

Orchid’s embryo screening services gained attention—and ethical scrutiny—for offering polygenic risk score analysis for traits including IQ, heart disease risk, and longevity.

The Washington Post reported that high-profile individuals including Elon Musk are using the technology, raising significant bioethical concerns about embryo selection beyond medical disease prevention.

The multi-gene risk scoring for complex traits extends embryo screening from single-gene disorders to polygenic conditions, sparking urgent questions about trait selection, equity, and societal implications.

Cloud-Based EMR Revolution

eIVF, led by CEO Nimesh Shah, launched CloudFlex, a HIPAA-compliant cloud-based electronic medical record solution that eliminates onsite servers and large upfront investments.

The platform integrates EMR software with infrastructure management into a single hosted solution, reducing capital investment and IT maintenance burden for clinics while ensuring data security—accelerating digital transformation particularly for smaller fertility practices.

Next-Generation FSH Development

Granata Bio and Georgetown Equity Partners announced a joint venture to develop next-generation recombinant follicle-stimulating hormone (FSH) formulations.

Led by Ali Hussein, Mark De Ridder, CEO Evan Sussman, Dr. William Schoolcraft, and researcher Dr T. Rajendra Kumar, the initiative aims to improve ovarian stimulation efficiency and affordability across IVF protocols through novel recombinant FSH with improved pharmacokinetics.

Validating AI: Clinical Variables and Morphokinetics

A significant study in Reproductive BioMedicine Online examined how clinical variables affect embryo morphokinetics and AI quality scoring.

The research, led by Jorge Ten and colleagues including M. Carmen Tio, Pedro Pini, Andrea Bernabeu, Rafael Bernabeu, and Klaus Wiemer at Instituto Bernabeu, provides critical insights into factors that influence AI-based embryo assessment systems.

The analysis helps embryologists understand when AI predictions may need clinical context adjustment, informing appropriate use and interpretation of AI embryo selection tools.

Predicting Oocyte Retrieval Outcomes

Research by Julia K Bosdou, Christos A Venetis, Leonidas Zepiridis, Katerina Chatzimeletiou, Grigorios Grimbizis, and Efstratios M Kolibianakis investigated whether minimum oocyte yield could be estimated from follicle diameter on trigger day.

The cohort study, published in Reproductive BioMedicine Online, provides practical insights for clinicians counseling patients on expected outcomes, helping set realistic expectations and optimize trigger timing.

Looking Forward: Implications for 2026

As we move into 2026, several clear trends emerge from 2025’s innovations.

Regulatory maturity means the AI and automation technologies that struggled for regulatory approval in previous years have now successfully navigated MDR, FDA, and other frameworks.

This regulatory maturity will accelerate commercial deployment and clinical integration, making 2026 the year these technologies move from early adopters to mainstream practice.

Automation as standard of care is no longer aspirational.

With 19 healthy robot-IVF babies born and major platforms like Overture Life’s DaVitri reaching commercialisation, automation is transitioning from experimental to standard practice, particularly for high-volume processes like vitrification and sperm selection.

Privacy-preserving AI addresses one of the field’s most significant barriers through federated learning and other privacy-preserving techniques.

These approaches enable multi-center collaboration without centralizing sensitive patient data, solving both technical and regulatory challenges.

Evidence-based medicine remains essential.

Negative findings like the SUMMER trial’s antioxidant results remind us that rigorous clinical trials are critical, even for widely adopted practices. The field continues maturing through careful validation rather than assumption.

Ethical frameworks become urgent as technologies like polygenic screening demand development of ethical guidelines, professional standards, and potentially regulatory guardrails to ensure responsible innovation.

The industry must proactively address these questions rather than reacting to public concern.

Conclusion

2025 will be remembered as the year IVF innovation achieved critical mass—when AI earned regulatory approval, when robots assisted in live births, when non-invasive diagnostics began replacing invasive procedures, and when automation moved from aspiration to commercial reality.

But perhaps most importantly, 2025 demonstrated that technological innovation alone is insufficient.

Success requires regulatory navigation, clinical validation, ethical frameworks, and—crucially—the distribution partnerships that transform laboratory breakthroughs into global patient access.

At FinDBest IVF, we’re proud to have chronicled these innovations through our Monday’s 5 series throughout 2025, and we’re committed to connecting the innovators shaping reproductive medicine with the global network that will bring their solutions to the patients who need them.

The future of family building is being written today. Join us in making it accessible to all.

About FinDBest IVF

FinDBest IVF is the leading B2B marketplace connecting IVF medical device manufacturers with vetted distributors and market expansion service providers worldwide.

Our platform serves manufacturers, distributors, and fertility clinics across 150+ countries, facilitating partnerships that accelerate innovation and improve patient outcomes globally.

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