Are there any women’s health SaMD companies?
You need to look beyond the clinical categorization of Software as a Medical Device to see the full picture for innovation in women’s health technology.
Last month I wrote a 101 piece, What is Software as a Medical Device (SaMD)? For those new to the topic, I’d start there before diving into this article.
Earlier this spring I saw that Guidea published a blog post titled, The First 500 FDA-cleared SaMD. Orthogonal also started their own running list as well. As you know, I’m passionate about evidence-based digital health interventions for women. I was excited to see these lists and thought I might be able to take a quick glance to understand what was happening in the world of SaMD and women’s health.
Well, it wasn’t quite that easy.
Guidea’s list is sortable by clinical area and I found there were only two products tagged as “Obstetrics and Gynecology.” I thought that surely there were more than TWO companies out of 500 serving women’s health needs, RIGHT?! Then my wheels started turning.
Making sense of the full scope of SaMD serving women’s health needs required looking at each individual company’s product offerings. Ultimately I found a disconnect between the tagging system, which generally spoke to the clinical department procuring the SaMD or the FDA division reviewing the product, versus the patients or beneficiaries. The original ‘glanceable’ tags did not tell the full story of what was happening in women’s health SaMD innovation. I realized that the story changes when you convert data points to insights.
I decided to create a new list.
Methods:
Let’s take a moment to nerd out on how I went about compiling this list.
Definitions and Inclusion Criteria
I needed an inclusion criteria definition for SaMD serving women’s health needs. I referred to my prior post which dug into how the FDA and the International Medical Device Regulators Forum defined SaMD and used those definitions. Then, I focused on the intent of use of the product.
Common Intentions of SaMD:
To treat, diagnose, screen or detect a disease or condition
To drive clinical management: aid in treatment, aid in diagnosis, to triage or identify early signs of a disease or condition will be used to guide next diagnostics or next treatment interventions:
To inform clinical management
I even did a little exercise to outline the difference between a common consumer digital health tool and when it crosses the line into SaMD:
For example:
Product #1: A simple calendaring app for entering when menstrual cycles begin and end can be useful for tracking for women. It’s a digital health product but it’s not making predictions, providing advice, or powered by an algorithm. It doesn’t need a clinical trial. It is the digital version of using a paper planner. NOT SaMD.
Product #2: Now take a calendaring app that also incorporates biomarker data like temperature and combines it with calendar data and large datasets of women with similar cycles, stirs all that data together into an algorithmic soup, and then spits out ovulation predictions. There should be some research studies backing that the algorithm works and provides value to the patient. This product could now be classified as Software as a Medical Device, or SaMD.
Now that I had my inclusion criteria I used six sources to identify products:
Guidea’s The First 500 FDA-cleared SaMD
Orthogonal’s SaMD Cleared by the FDA: The Ultimate Running List
The FDA’s Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices database
The FDA’s 501k Premarket Notification database
The FDA’s De Novo database
My own personal FemTech company tracking database
I started by cross checking Guidea and Orthogonal’s lists of over 500 companies and then dug into the 882 companies in the FDA AI/ML database across 18 pages. I looked for products that focused on biologically female organs or health conditions. I know that women’s health is larger than just breasts and uteruses, but narrowing products down by these criteria helped to create a more specific list.
Finally, I joined the kickoff call for the Women’s Digital Health Network, and asked the panel (some of who had spent their careers working with the FDA) if they knew of an existing list like what I was working on, and was pointed to the aforementioned Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices database. So in short, a public list of women’s health SaMD did not exist. This validated the need to move forward with publishing this work.
When you look at the list, you’ll find the name of the product, a brief summary of what it does, links to the FDA review documents, and where I found the products. I conducted my research as methodically as possible to the best of my abilities, but please let me know if I missed something. I’d be glad to add it to keep the information relevant and timely.
Insights:
There are 16 products that I would consider to be Women’s Health Software as a Medical Device. Guidea states that out of their 500 companies, radiology has the highest number of FDA-cleared applications, coming in at over 300 companies. I found radiology products to be well represented in the Women’s Health list as well with innovations across ultrasound and mammography. The majority of these companies are targeted towards clinical practice, but Clue Birth Control, Fitbit, Leva, and Natural Cycles stand out as consumer-oriented products. I was surprised that I didn’t find Ava Fertility Tracker, Bloomlife, Baymatob, or iSono on any of the lists, but since they weren’t on Guidea, Orthogonal, or the FDA AI/ML lists I didn’t include them below. I think this speaks to the fact that while this list is one piece of the puzzle when it comes to determining evidence-based health technology for women’s health, there is still a lot of work to be done.
Women’s Health Related Software as a Medical Device (in alphabetical order)
ATUSA iSONO Automated 3D Breast Ultrasound System | ATUSA scanner automatically captures the entire breast volume allowing for repeatable breast ultrasound imaging at point of care without the need for a trained ultrasound operator | FDA 510(k) Premarket Notification (FDA)
Bladder AI | Accurate bladder volume measurement via probe + phone app | FDA 510(k) Premarket Notification (FDA + Guidea )
Breastscape by Olea Medical | (Unclear if this is still active based upon the website) |FDA 510(k) Premarket Notification (FDA + Guidea )
Clue Birth Control | Software application for contraception for women ages 18-45 to monitor fertility and prevent pregnancy | FDA 510(k) Premarket Notification (FDA + Guidea)
Fitbit body temperature sensing software | Software-only mobile medical application intended for over-the-counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages (NB: Use case has not been stated by Fitbit but there are assumptions it could be used for ovulation tracking) | FDA De Novo Review (FDA + Guidea)
HERA W9, HERA W10 Diagnostic Ultrasound System | Improved fetal and gynecological imaging| FDA 501(k) Premarket Notification (FDA)
KidScore D3 by Vitrolife | Embryo decision support tools to determine statistical viability | FDA Premarket notification (FDA)
Leva Pelvic Digital Health System by Renovia | Motion sensor wand combined with personal coaching to help women strengthen their pelvic floor and decrease the symptoms of stress, mixed and urgency incontinence, including overactive bladder | FDA 510(k) Premarket Notification (FDA + Guidea )
Lunit Insight MMG | Radiology | Improving diagnostic accuracy for dense and fatty breast tissue | FDA 510(k) Premarket Notification (FDA + Guidea )
M-Vu Breast Density (created by VuComp and sold to iCAD Inc.) | Software for calculating and assessing breast density on mammograms. | FDA 501k Premarket Notification (FDA + Guidea)
Mammoscreen | A 2D and 3D AI-based software for breast cancer screening that can compare to prior images | FDA 510 (k) Premarket Notification (FDA + Guidea )
Natural Cycles | Temperature based fertility awareness method software | FDA DeNovo Classification Review (FDA + Guidea)
PAPNET Testing System by Neuromedical Systems, Inc. developed in 2019, acquired by TriPath Imaging, which was then acquired by Becton, Dickinson, and Company. BD does not have specific details on their website about the cervical cancer screening solutions. Perhaps this still exists in some form? | FDA Premarket Notification
Sonio AI | Improved image quality, reporting, and and billing for maternal and fetal sonography | FDA 510(k) Premarket Notification (FDA + Guidea )
Sozo Digital Health Platform by Impedimed | Bioimpedance spectroscopy (BIS) solution for the clinical assessment of breast-cancer related lymphedema | FDA 510(k) Premarket Notification (FDA)
Visage Breast Density | Assesses breast density from mammography and provides a breast density category to aid radiologists in assessment of breast tissue composition | FDA 501(k) Premarket Notification (FDA + Guidea)
Additional Resources:
FDA Guide: How to Determine if Your Product is a Medical Device
The difference between Software as a Medical Device and Digital Therapeutics
Listen to my podcast interview on Digital Health Talks: Following the Money in Women’s Health - From Biden’s Executive Order, ARPA-H Sprint, to Oprah is Women’s Health Finally Going to Get the Attention it Needs Deserves?
