Digital Health and Informatics | October Roundup

Highlights & Summary  

October 2024 saw several exciting updates, advancements, and partnerships in digital health and informatics.  

In addition to new funding, product launches, and partnerships across the ecosystem, the FDA published new guidance regarding AI use in healthcare, noting past digital health and telemedicine considerations to inform current guidance.  

Disease management saw several new product launches, with Otsuka Precision Health and Amalgam Rx launching Elevmi, an app supporting Alzheimer's caregivers, and Lenovo introducing a 3D avatar for dementia care. Amwell expanded its offerings by partnering with Hello Heart for cardiovascular health.  

In healthcare and IT, Cohere Health and MCG Health are streamlining prior authorization with AI, while Oshi Health raised $60M to grow its GI care platform, and Counsel Health secured $11M to expand virtual message-based care.  

Women’s health also saw several exciting updates. Maven raised $125M to further its digital health model in fertility and maternal care, and Weill Cornell Medicine’s BELA AI aims to improve IVF success rates without invasive procedures. Alife Health is also partnering with Inception Fertility to offer personalized IVF success predictions and digital embryo assessment tools, enhancing patient counseling and lab efficiency.  

Overarching Industry Updates 

1 | FDA releases perspective on the regulation of AI in healthcare and biomedicine, considering the past handling of digital health tools, devices, and telemedicine platforms

Disease Management / Digital Therapeutics 

1 | Otsuka Precision Health, Amalgam Rx unveil app for Alzheimer's caregivers

2 | Amwell adds Hello Heart's cardiovascular platform to clinical programs portfolio

3 | Lenovo launches photorealistic 3D avatar to converse with dementia patients

Informatics / Healthcare IT Solutions 

1 | Cohere Health, MCG Health partner to address prior authorization process

2 | Oshi Health raises $60M for virtual digestive care

3 | Counsel Health secures $11M in seed funding led by a16z

Women’s Health / Femtech 

1 | Maven, digital health company focused on women’s health, announces $125m fundraise at a $1.7 billion valuation

2 | Fully automated AI-based system developed for IVF embryo quality assessment

3 | Alife Health’s AI technology now adopted by Inception Fertility to optimize IVF treatment

Overarching Industry Updates 

1 | FDA perspective on the regulation of AI in healthcare and biomedicine

The guidance discusses the need for comprehensive regulation of artificial intelligence in healthcare and biomedicine, highlighting the FDA’s evolving role. As AI technologies advance, including nearly 1,000 FDA-authorized AI medical devices and numerous AI-driven drug development submissions, regulatory frameworks must adapt. Effective oversight requires transparent premarket development, local postmarket monitoring, and specific mechanisms for evaluating large language models in health contexts. A coordinated, flexible regulatory approach across industries and with international organizations is essential to address AI's impact on patient outcomes rather than solely financial gains. The FDA acknowledges its role in ensuring AI tools are safe, effective, and ultimately beneficial for both patients and clinicians.

Disease Management / Digital Therapeutics 

1 | Otsuka Precision Health, Amalgam Rx unveil app for Alzheimer's caregivers

Otsuka Precision Health, a precision digital therapeutics company, and Amalgam Rx, a digital health company, have launched Elevmi, an app that assists caregivers who support family members with Alzheimer’s Disease. Leveraging conversational AI, the platform offers features like medication tracking, symptom monitoring, and educational materials, helping caregivers navigate the challenges of supporting loved ones with Alzheimer's. The app is available on iOS and Android stores. 

2 | Amwell adds Hello Heart's cardiovascular platform to clinical programs portfolio

Hello Heart, a digital leader in preventative heart health, has partnered with Amwell to join the clinical programs portfolio on the Amwell Converge™ platform, allowing Amwell health plan clients to access the app. Hello Heart features tools for managing heart health, including personalized insights and coaching for patients with hypertension, high cholesterol, and other risk factors for cardiovascular disease. 

3 | Lenovo launches photorealistic 3D avatar to converse with dementia patients

Lenovo has launched Alzheimer’s Intelligence, a custom AI with a photorealistic 3D avatar designed to support patients and caregivers as they navigate a diagnosis of dementia. With 24-hour access to this conversational avatar, users can receive advice that prioritizes accuracy, privacy, and compassion. With personalized and accessible care, Lenovo offers a novel approach to navigating dementia care.

Informatics / Healthcare IT Solutions 

1 | Cohere Health, MCG Health partner to address prior authorization process

Cohere Health and MCG Health are joining forces to integrate MCG’s evidence-based guidelines into Cohere’s AI-driven Unify Decisioning platform, aiming to streamline prior authorizations. This partnership is designed to increase auto-approvals for relevant cases, reduce provider workload, and enhance decision-making with evidence-based best practices. The integrated platform will debut with a major regional insurer in early 2025, marking a step toward the goal of faster, more efficient care authorization.

2 | Oshi Health raises $60M for virtual GI platform

Oshi Health, a virtual gastrointestinal care provider, raised $60 million in Series C funding led by Oak HC/FT, with support from CVS Health Ventures, Takeda, and others. Oshi offers patients with GI conditions like Crohn’s Disease and IBS access to a team of specialists via telehealth, alongside tools for symptom tracking and messaging. Available nationwide, Oshi partners with employers, health systems, and insurers, and plans to expand into Medicare populations by 2025. The new funding will drive partnerships with provider groups and employers to broaden coverage and reach.

3 | Counsel Health secures $11M in seed funding led by a16z

Counsel Health, a virtual healthcare startup focused on 24/7 message-based care, launched with $11 million in seed funding led by a16z Bio + Health. Counsel offers AI-enabled, asynchronous consultations with clinicians for complex medical needs. Currently available in five states, it plans nationwide expansion over the next two years, using the funds to enhance its technology and scale growth.

Women’s Health / Femtech 

1 | Maven, digital health company focused on women’s health, announces $125m fundraise at a $1.7 billion valuation

Maven, a digital health platform focused on women’s and family health, recently raised $125 million to advance its virtual care model focused on fertility, maternity, and family health. Over the past decade, Maven has worked to improve maternal health and fertility outcomes through innovative, patient-centered care models and a commitment to value-based care. Looking forward, Maven aims to transform healthcare further by advancing payment models, leveraging technology for personalized care, and improving accessibility across diverse populations.

2 |  Fully automated AI-based system developed for IVF embryo quality assessment

Researchers at Weill Cornell Medicine have developed an AI platform called BELA to predict embryo chromosomal status, or ploidy, a key factor for IVF success, without relying on subjective embryologist assessments. Unlike traditional methods like preimplantation genetic testing for aneuploidy (PGT-A), which involves invasive procedures, BELA uses time-lapse images and maternal age to make predictions. Trained on nearly 2,000 embryo images, BELA demonstrated higher accuracy than previous AI models when tested on diverse datasets. Researchers are planning clinical trials to further validate BELA’s efficacy, with the aim of improving IVF accessibility and care equity globally.

3 | Alife Health’s AI technology now adopted by Inception Fertility to optimize IVF treatment

Alife Health has partnered with Inception Fertility, North America’s largest fertility services provider, to introduce AI tools that enhance the in-vitro fertilization (IVF) experience. This collaboration will pilot Alife’s IVF Success Predictor™, which provides patients with personalized IVF success probabilities, and Embryo Assist™ software, which helps embryologists create digital embryo records and identify the best embryos for transfer using AI-based clinical decision support. Through these tools, Inception aims to improve patient counseling and streamline laboratory processes with advanced technology. Alife Health, recognized for its innovative contributions to reproductive medicine, seeks to improve IVF outcomes and accessibility worldwide through strategic partnerships.