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.

Follow our Monday’s 5 news series: https://findbestivf.com/ivf-market_news/
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OTO Fertility  has launched what it claims is a world-first AI fertility prediction platform and wearable to forecast treatment outcomes.

The Toronto-based company says its system pairs a clinical-grade biosensor with an FDA-approved app to track more than 50 markers including heart rate variability (beat-to-beat changes), nervous system regulation and stress response.

The platform, now available across North America, is designed to identify when the body is in what the company calls an optimised “Fertility Zone”.

OTO also claims its Fertility Index is a more accurate indicator of pregnancy success than current standard measures including age, BMI or AMH (anti-Müllerian hormone, a marker used to assess ovarian reserve).

The technology draws on bioscience and space medicine research originally developed by NASA for astronauts and later adapted for elite athletes, according to the company.

Caleb Evans, chief executive and founder of OTO, said: “Until now, there’s been no accurate way to predict fertility outcomes based on what’s actually happening in the body in real time.

“Our solution gives patients a clear understanding of their body’s signals, restores agency, and peace of mind, and provides clinicians with a powerful new layer of insights to guide better outcomes. OTO doesn’t replace existing fertility protocols; it enhances them.

“And for the millions who have done everything right and still struggle to get pregnant, it can help unlock a path forward.”

The company cites figures suggesting one in six women experience infertility globally, while IVF success rates have remained largely static.

OTO Fertility is a division of OTO Coach, a biometric health intelligence company headquartered in Toronto with offices in Vancouver and Helsinki.

The company says clinical programmes are currently underway.

Femtech World explores the latest business developments in the world of women’s health.

FemHealth Ventures closes oversubscribed US$65m Fund II

FemHealth Ventures, a women’s health-focused venture capital firm, has closed on FemHealth Ventures Fund II at US$65m.

The oversubscribed raise brings the firm’s assets under management to US$100m across two funds and further solidifies FemHealth Ventures’ position as a category-defining investor in women’s health innovation.

The fund received significant support from existing limited partners alongside new investors aligned with the firm’s mission to transform women’s health.

“We are thrilled to announce the successful close of Fund II, more than doubling the size of our inaugural fund,” said Maneesha Ghiya, managing partner of FemHealth Ventures.

“This raise reflects growing recognition that women’s health innovation offers both substantial societal impact and compelling investment potential.

“We are grateful for the trust our limited partners continue to place in us.”

“The next generation of transformative women’s health companies will be led by visionary founders, and we are honored to support them,” added Sara Crown Star, Venture Partner at FemHealth Ventures.

Fund II will continue investing across drugs, devices, diagnostics, and digital / AI-enabled technologies that address unmet needs in women’s health.

FDA clearance for wearable supporting urinary incontinence

BlueWind Medical has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its enhanced Revi wearable designed to deliver therapy more effectively and seamlessly support long-term symptom relief for patients with urgency urinary incontinence (UUI).

The updated Revi wearable features a streamlined, easy-to-use design with a smarter, user-friendly interface, while retaining the same simple, three-button control.

Together, these enhancements are intended to make it easier for patients, giving them greater confidence, control, and convenience in managing their UUI.

The Revi System offers personalised therapy that adapts to each person’s unique and changing UUI symptoms with adjustable, wearable control; symptom relief, with 79 per cent of patients achieving a 50 per cent reduction in UUI; and a strong safety profile, with no device- or procedure-related serious adverse events, no device migrations, and no device revision procedures.

“We are proud to lead the next generation of technology for the treatment of urgency urinary incontinence,” said Kerry Nelson, CEO of BlueWind Medical.

“BlueWind has been at the forefront of the field, pioneering implantable tibial neuromodulation for UUI. Our strong clinical evidence and our focus on patient comfort and satisfaction show that when patients can personalize their therapy, outcomes improve.

“The enhanced wearable continues that philosophy by making therapy easy to use, adaptable to each patient’s lifestyle, and supportive of long-term use.

“All of this helps patients achieve durable symptom relief and overall satisfaction.”

CE Mark for treatment for women with PCOS-related Infertility

Medical device company May Health has announced that its novel technology to treat PCOS-related infertility, the Anavi System, has received CE Mark certification.

The CE Mark, granted under the European Union’s Medical Device Regulation (EU MDR) 2017/745, is a significant regulatory milestone that enables commercialization in the European Union.

The Anavi System is treatment offered as a one-time, office-based procedure intended to restore natural ovulation in women with PCOS-related infertility who do not respond to, are contraindicated for, or decline first-line medications.

Building on the established success of laparoscopic ovarian surgery to restore ovulation, this approach translates a laparoscopic procedure into a more accessible, ultrasound-guided in-office option.

The Anavi System delivers targeted radiofrequency (RF) energy to ablate a small fraction of ovarian tissue with the aim of re-initiating ovulatory cycles, offering an alternative for women who are not ready, willing, or able to advance to IVF.

“Approximately 80 per cent of women with PCOS have oligo-anovulatory infertility, a condition characterised by lack of ovulation,” said Dr Saad Amer, lead investigator of the ULTRA EU study, expert in PCOS, endometriosis, and infertility, and professor at the University of Nottingham.

“Moreover, 20–30 per cent of those women do not respond to first-line ovulation induction therapies.

“The Anavi System provides a compelling treatment option that restores ovulation in women with PCOS without the use of any hormonal therapy, and as a single, in-office procedure that can be efficiently incorporated into the care pathway for appropriate PCOS women.”

CE Mark certification for the Anavi System was supported by safety and feasibility data from the ULTRA clinical studies conducted in Europe and the United States.

Participants were women with PCOS who were anovulatory or oligo-ovulatory and had failed to respond to first-line pharmacologic treatments, or who were contraindicated for or declined such treatment.

A preliminary analysis from the ULTRA studies presented at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting in 2025 demonstrated that, in 26 of 32 women evaluable at 12 months, 77 per cent reported ovulation, with 13 women experiencing spontaneous ovulation and seven women ovulating after first-line medications were resumed.

At 12 months, a 46 per cent cumulative pregnancy rate was observed, including 10 spontaneous pregnancies (seven with and three without the restart of first-line medication) and two pregnancies with assisted reproductive technology (one intrauterine insemination (IUI), one IVF), resulting in six live births at the time of reporting.

The most common procedure-related adverse events were reported as mild and included vaginal bleeding, pain, and headache.

The CE Mark permits commercialization of the Anavi System in the European Union, with rollout planned on a country-by-country basis.

Partnership to to expand access to rapid STI testing

Testmate Health and Intermountain Health have announced a strategic partnership and investment to accelerate access to rapid, low-cost molecular tests for sexually transmitted infections (STIs) in the US.

The collaboration enables Intermountain Health and Testmate Health to bring lab-quality STI diagnostics to at-risk communities.

STIs remain a largely silent epidemic, with 80 per cent of chlamydia and gonorrhea infections going undiagnosed each year.

Populations most affected include college students, LGBTQ+ communities, and rural or low-resource clinics face significant barriers to timely testing and treatment.

This partnership and investment directly address that gap by bringing high-accuracy, low-cost diagnostics to the people and places that need them most.

“Our partnership and investment in Testmate reflects our commitment to solutions that make care faster, more accessible, and equitable,” said Karen Brownwell, vice president of Lab Services at Intermountain Health.

“When these STI tests become FDA-approved in the US, Testmate’s innovative approach to molecular diagnostics will allow us to deliver lab-quality results outside traditional lab settings, directly impacting communities that have historically lacked access to timely testing.”

Testmate’s single-use, reader-free molecular test for Chlamydia trachomatis and Neisseria gonorrhoeae, are able to deliver lab-quality results in under 30 minutes without central lab infrastructure.

The molecular tests are easy to use and compatible with both urine and swab samples, enabling rapid, private and stigma-free testing.

“This partnership and investment empowers people to take control of their sexual and reproductive health without barriers, stigma, or waiting,” said Dr Siew-Veena Sahi, CEO and founder of Testmate Health.

“By partnering with Intermountain Health, we could scale access to diagnostics in a way that changes outcomes for patients and communities alike.”

Through combining Testmate’s physician-built diagnostics with Intermountain’s infrastructure and clinical expertise, the programme aims to dramatically increase early detection, improve treatment, reduce loss to follow-up and lower healthcare costs.