Demise Ascension Archive Of Past

These conditions are linked to infertility in up to 30 and 40 of cases, respectively, and timely diagnosis is a major unmet need that could be improved by digital screening tools in the future.

Each issue of our digest profiles 3 key stories of the week with deep-dive commentary on broader implications for the industry, as well as MA and funding activity.

Demise Ascension Archive Of Past

See our archive of past issues and connect with our digital health team below: SUBSCRIBE Chris focuses on digital diagnostic, therapeutic, and remote patient monitoring technologies and their impact on personalized medicine and population health.

Chris has led market analysis and strategy engagements across the diagnostics and health tech spaces.

Connect with him on LinkedIn or reach out at email protected Fanny Anderson is a Senior Associate at DeciBio, with experience in strategy development across the healthcare IT space, including clinical decision support, real-world evidence and digital health.

Connect with her on LinkedIn to learn more about her expertise in health technology consulting.

Digital health newsletter Vol.

Digital biomarkers show promise in womens health Apple Womens Health Study releases initial results, finding similar period symptoms across demographics TLDR: Apple launched its Womens Health Study in 2019 alongside parallel studies in hearing health and heart health.

Apple just released preliminary results from the womens health study, which includes over 10,000 participants and intends to better understand menstrual cycles and gynecological conditions.

The study collects self-reported data around menstrual cycles through surveys or the cycle-tracking feature on iPhones and Apple Watches.

Initial results suggest that over 6,000 participants tracked at least one menstrual symptom, with abdominal cramps experienced by nearly 90 of symptomatic participants.

So what Apples study is one of the largest longitudinal studies in womens health and is expected to continue through 2029 as it aims to narrow the medical research gap between men and women.

Further data collection and analysis of symptom prevalence and severity may elucidate connections between self-reported data (e.g., cycle length, menstrual flow rate, pain level) and womens health conditions like PCOS, infertility and menopause.

Composite digital biomarkers could potentially be used for digital screening or diagnostics in the future, especially for conditions causing longer cycles, heavier blood flow andor severe pain (e.g., PCOS, endometriosis).

However, Apples study will likely be limited to discovering composite digital biomarkers, as its study protocol does not mention collection of biospecimens (e.g., peripheral blood, menstrual blood) needed for multi-omic data analysis (e.g., genomic, proteomic).

Alternatively, Google Verilys Project Baseline is an example of a longitudinal study collecting both digital and physiological biomarkers (e.g., continuous wearable use paired with genetic testing and routine bloodwork), though their research is not yet focused in womens health.

Clue joins digital contraceptive market with FDA approval TLDR: Womens health represents a fairly nascent but rapidly growing segment within the digital biomarker and therapeutics space.

The digital contraceptives market was incepted in 2018, when Natural Cycles became the first to officially garner FDA approval as a software application for contraception based on its smartphone app and thermometer.

Clue, a period-tracking app with 13 million users worldwide, recently received FDA approval as the second digital contraceptive cleared in the U.S.

Unlike Natural Cycles, Clue Birth Control is a completely digital product (e.g., app-only, no thermometer), with only slightly lower efficacy.

Under typical use, Clue is 92 effective while Natural Cycles is 93 effective, on par with oral contraceptives.

Clues ovulation prediction algorithm is based on an initial questionnaire and uses Bayesian modeling to personalize predictions over time, narrowing a users high risk window.

Digital contraceptives have yet to gain payor coverage beyond FSAHSA eligibility, though Natural Cycles is aiming toward reimbursement in the future.

So what Digital contraceptives represent just one of several potential applications for digital biomarkers in womens health.

Digital biomarkers that are passively collected (e.g., heart rate, body temperature, activity level) and actively self-reported (e.g., cycle length, flow rate, pain level) could potentially be used to develop screening tools for conditions like PCOS and endometriosis.

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