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Fairtility’s AI decision-support tool granted CE mark under new MDR

CHLOE EQ™ is the first AI-powered tool for embryo classification and selection to achieve CE MDR approval

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Fairtility’s AI decision-support tool CHLOE EQ™ has earned the CE Mark under the European Medical Devices Regulation (MDR) regulatory requirements and is now commercially available to fertility clinics across Europe.

CHLOE EQ™ is an AI decision-support tool that was developed to provide embryo viability assessment which supports the prediction of blastulation, the prediction of implantation and ploidy and ranks embryos in order of priority.

It provides automatic annotations for morphokinetic and PN count which support fertilisation assessment.

According to Dr. Cristina Hickman, Fairtility VP of Clinical Affairs and leading embryology expert, embryo evaluation and selection has traditionally been a manual process, limiting patient access to treatment while also opening the door for human error.

“One of the key advantages that CHLOE EQ™ was designed to offer is accuracy and consistency in assessment,” she adds. “CHLOE’s proprietary AI-based algorithms become more accurate the more data it gathers, leading to uniform and accurate embryo assessment.”

The information provided by CHLOE EQ™ can then assist embryologists and IVF professionals in the decision of prioritising the most viable embryo for treatment, especially when there are multiple embryos deemed suitable.

The tool is designed to add efficiency to embryologists’ workflow, automating manual steps, including annotation of each embryo and written daily observations into each patient’s electronic medical record (EMR).

Embryologists verify the system’s automatic annotations that are then immediately integrated from the Time Lapse Incubator (TLI) directly into the EMR.

Eran Eshed, CEO and Co-Founder of Fairtility, says that: “Having gained regulatory acknowledgement in Europe, under the more stringent directive that the CE MDR provides, we are now commercially launching CHLOE EQ™ in clinics across the EU while continuing to uphold the highest standard of this classification.

“With the EU IVF market size estimated to reach over $2 billion by 2027, we see tremendous opportunities to demonstrate the clinical efficacy and impact of CHLOE EQ™ ahead of US market entry.”

The European MDR came into effect in May 2021 and serves as the new European legal framework for medical devices. MDR has more stringent requirements for demonstrated compliance, vis a vis the obsolete Medical Device Directive (MDD), the previous industry standard.

Fairtility is showcasing CHLOE EQ™ at the 38th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE), taking place in Milan Italy from July 3-6, 2022 with five oral presentations and seven posters supporting the clinical impact of the product.

In vitro fertilisation (IVF) is the most effective form of assisted reproductive technology. Due to the complexity of the procedure, however, prediction of embryonic implantation prior to IVF is key in decision-making.

The Israeli software company Fairtility aims to maximise IVF outcomes by using AI and computer vision algorithms to provide early, data-driven embryo quality.

For more info, visit fairtility.com.

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Start-up raises US4.2m to address disparities in women’s mental health

LunaJoy Health seeks to address the complex needs of high-risk women

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LunaJoy Health co-founders Sipra Laddha, MD and Shama Rathi, MD

The US telehealth start-up LunaJoy Health has raised US$4.2m in funding to address disparities in women’s mental health.

LunaJoy aims to eliminate inequalities in mental health and “redesign” the way women access care.

The platform, which offers mental health therapy, counselling and medication management, is developing care models that cater to underserved populations, providing care that seeks to address the complex needs of high-risk women.

The funding round, supported by Y Combinator, FoundersX Fund, Goodwater Capital, Magic Fund, VentureSouq, Nurture Ventures and NorthSouth Ventures, is hoped to help the company expand its capabilities and close disparities in maternal health care.

“The support from our investors, coupled with the current focus on maternal health improvements through TMaH funding, sets the stage for the change we need to see so badly across the industry,” said Sipra Laddha, co-founder and CEO of LunaJoy Health.

Mental health is a lifetime pursuit, and we want to design a way to engage and support women with a variety of needs and varying degrees of risk.

“By using technology, we can measure and treat symptoms more effectively, delivering a better service model to meet rising demand and a shortage of therapists in the US.”

This financial and strategic support, Laddha said, will help LunaJoy roll out its “novel” integrated care programme, LunaCare, across select communities in need of maternal mental health.

The investment will also facilitate the integration of advanced technology solutions to enhance care coordination and patient monitoring.

Surbhi Sarna, partner at Y Combinator, said: “LunaJoy Health’s mission to bring a new standard to maternal health care for Medicaid mothers aligns perfectly with our goal of supporting scalable solutions to the world’s most pressing challenges.

“We are proud to back such a vital initiative that promises significant impact.”

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New survey to ‘amplify’ marginalised voices in healthcare decision-making

UK charities enter partnership to address gender gap and advocate for inclusive healthcare policies

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The gynaecological health charity Cysters and Endometriosis UK have announced a partnership to amplify women’s voice in healthcare decision-making.

Despite progress in healthcare data collection, there remains a gap in representing the experiences of marginalised groups, particularly for those impacted by conditions and diseases like endometriosis.

Decision-makers in Parliament and the NHS often rely on data and statistics to inform policy and resource allocation. However, these datasets may not accurately reflect the experiences of marginalised communities.

A recent report from Endometriosis UK that gathered data on the experiences of being diagnosed with endometriosis in the UK found that whilst the ethnicity of respondents who identified as ‘white’ was proportionate to the data collected in the Census 2021, the remaining data was not illustrative of the ethnic diversity of the UK, with 15 per cent of respondents choosing not to respond to the ethnicity question.

To address this gap and advocate for inclusive healthcare policies, Cysters and Endometriosis UK are launching a new survey initiative aimed at amplifying the voices of marginalised groups in healthcare decision-making.

“We know that the current statistics are not inclusive of all communities, particularly marginalised groups,” said Neelam Heera-Shergill, founder of Cysters.

“By encouraging those from marginalised communities to share their experiences through this survey, they will be helping us to advocate for the changes that are needed, backed by evidence from their communities.

“In addition to delving into the diagnosis journey for people of colour and the unique barriers they encounter. We aim for this research and findings to pave the way for additional funded research on all menstrual-related conditions affecting people of colour.”

The survey seeks to gather insights into the experiences of marginalised communities, particularly concerning conditions and diseases like endometriosis.

Participants are encouraged to share their experiences openly and honestly, knowing that their responses will contribute to shaping more inclusive healthcare policies.

Sarah Harris, a researcher at Cysters, said: “We urge everyone to participate in this survey and share it far and wide. Together, we can ensure that all voices are considered in the conversation surrounding healthcare policy and resource allocation.”

The survey is anonymous and takes approximately 15 minutes to complete. To participate, visit Delayed Diagnosis of Endometriosis Among People of Colour in the UK Survey.

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Menstrual care start-up launches period equity initiative across college campuses

The initiative is hoped to facilitate access to period care and educate students on the use of more sustainable products

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Cherie Hoeger, founder and CEO of Saalt

The US menstrual care start-up Saalt has launched a new initiative aimed at addressing period poverty and environmental sustainability.

The Period Equity Initiative aims to reduce 100 million tampons from the environment while combatting period poverty.

Institutions, including Harvard University, Vanderbilt University, Northwestern University, the University of Utah and the University of Nebraska, are already participating in the programme.

One in five female college students in the US have had to decide between buying period products and paying for other basic essentials like food and other bills according to a nationwide survey.

The initiative, a direct response to the demand for more units for student populations, underscores the issue of period poverty, which affects students across America, challenging the misconception that it is solely an “overseas problem”.

Saalt aims to make period care accessible and affordable through the subsidisation of reusable period products, such as cups, discs, and period underwear, to participating universities and their campus affiliates.

The project is hoped to not only facilitate access to period care, but also educate students on the use of more sustainable products, which are designed to be reused rather than discarded.

“Every day we hear from customers about how life-changing Saalt cups are for them,” said Cherie Hoeger, founder and CEO of Saalt.

“Creating period equity and managing the environmental impact created by disposables are pressing matters that demand urgent attention and innovative solutions.

“Through our Period Equity Initiative, we’re taking a proactive approach to tackle these challenges by leveraging our expertise and aligning with universities across America to make a big impact closer to home.”

The Period Equity Initiative, Hoeger added, furthers Saalt’s commitment to making period care more affordable, accessible and sustainable.

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