It has been a blockbuster year for women’s health as the federal government and medtech place particular focus on the wellbeing of women.
At the start of the year, President Joe Biden announced the federal government would focus its health initiatives on improving women’s health outcomes. Since then, his administration has announced two other federal initiatives to improve the care continuum for women.
The medical device industry has also had many wins this year for women’s health. Several studies focused on women’s heart health and how TAVI affects them. Some companies launched improved breast cancer locator and imaging systems, and surgical robotics companies started using robots in gynecological procedures.
At DeviceTalks West in Santa Clara, California, Oct. 16–17, a wide range of women’s health technologies will be featured. (Learn more about the event and register at West.DeviceTalks.com.)
As we enter the last quarter of the year, here are ten women’s health stories that caught the attention of our MassDevice readers:
Jill Biden launches $100M initiative to transform women’s health research
First Lady Jill Biden and the White House in February announced that $100 million in federal funding will go toward research and development into women’s health.
The First Lady said the funding is part of a White House Initiative on Women’s Health Research that the White House announced in November 2023. The Federal Department of Health and Human Services set aside money from the Advanced Research Projects Agency for Health (ARPA-H) for this initiative.
ARPA-H’s $100 million funding will go toward early investment in “life-changing” work by women’s health researchers and startup companies. The “Sprint for Women’s Health” initiative will invest in discoveries early when private companies are less likely to take the investment risk.
Biden signs executive order for women’s health research and innovation
President Joe Biden signed an executive order in March that will direct funds and actions toward expanding and improving research on women’s health.
Biden’s executive order will create directives that will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, according to the White House. It will also motivate new research on a wide range of topics in women’s health.
It also intends to integrate women’s health across the federal research portfolio, prioritize investments in women’s health research, galvanize new research on women’s midlife health and assess unmet needs to support women’s health research.
Read more about the administration’s initiatives >>
Edwards reports ‘excellent’ outcomes for TAVI in women
Edwards Lifesciences announced positive results in August from its RHEIA trial, showing superior outcomes for women who received transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR). The findings involved female patients treated with Edwards’ Sapien 3 and Sapien 3 Ultra valves.
The independently-run RHEIA trial included 443 women, aged 73 on average, with severe symptomatic aortic stenosis. One year after treatment, 8.9% of TAVI patients experienced death, stroke, or rehospitalization, compared to 15.6% in the SAVR group, highlighting TAVI’s advantages for this demographic.
Edwards continues to focus on improving heart valve replacement outcomes for women. Dr. Hélène Eltchaninoff, a cardiology expert, noted that women are often underrepresented in severe aortic stenosis treatment, emphasizing the significance of this trial’s findings.
Melodi Health raises $10.75M, enrolls first patient in study of absorbable mesh for breast cancer patients
Melodi Health raised $10.75 million in an oversubscribed Series A round and launched a clinical trial for its Matrix mesh technology. The Minneapolis-based company began its ARIA FDA investigational device exemption (IDE) trial to improve outcomes for women undergoing breast reconstruction after mastectomy, enrolling the first patient at University of Utah Health.
Melodi has raised $15 million, with Series A funding led by HM Venture Partners, Engage Venture Partners, Southeast Minnesota Capital Fund, and Three Bridges Private Capital. The funds will support clinical activities and further product development for its innovative implantable medical device.
The Matrix mesh is an absorbable device that supports soft tissue while releasing antibiotics to reduce post-surgical infections. Co-founder and CEO Sarah Worrell said the device addresses a significant unmet need, as no FDA-approved soft tissue support products with antibiotic properties currently exist for breast surgery.
Read more about the fundraising >>
Cairn Surgical raises $4.5M for breast cancer locator system
Cairn Surgical announced it closed a $4.5 million Series A2 financing round to advance its Breast Cancer Locator (BCL) System.
The funds will support completing a U.S. pivotal trial and initiate a limited commercial launch in Europe. The BCL system aims to improve the accuracy of breast-conserving surgeries by providing surgeons with detailed information about the tumor’s size, shape, and precise location. Current tumor localization methods often fail to remove the entire tumor in 20% of cases, leading to additional surgeries.
Mick Sawka, investment advisor at Morningside Ventures, which led the funding round, highlighted the system’s promising results in European trials, noting its potential to improve patient care and reduce healthcare costs. Cairn Surgical’s approach is expected to transform the surgical experience for both patients and healthcare providers, he said.
GE HealthCare, UCSD to collab on female-specific imaging
GE HealthCare is collaborating with the University of California San Diego School of Medicine to advance imaging technology for female-specific pelvic disease.
The partnership focuses on developing new magnetic resonance imaging protocols and educational materials to improve diagnoses and access to care for women’s pelvic health.
The project, led by Dr. Rebecca Rakow-Penner at UCSD’s Center for Translational Imaging and Precision Medicine (CTIPM), covers conditions like endometriosis and ovarian cancer. It aims to enhance visualization using MRI in both clinical and academic research settings. GE HealthCare plans to distribute the protocols and educational materials globally to its MRI users.
Read more about the partnership >>
Virtual Incision announces first completed hysterectomy with MIRA surgical robot
Virtual Incision completed the first surgery in a study evaluating its MIRA robotic-assisted system for hysterectomy procedures.
The clinical study focused on the safety and efficacy of MIRA, a miniaturized robotic system the company designed to reduce hospital stays, blood loss and complications associated with open surgery for benign hysterectomies.
The study is part of Virtual Incision’s broader efforts to expand MIRA’s applications. Following its first clinical evaluation, which supported FDA authorization for colectomy procedures, the company continues to develop new versions of MIRA for general surgery, urology, and other specialties.
Read more about the procedure and the robot >>
FDA clears new cervical cytology AI tech from Hologic
Hologic won FDA 510(k) clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm in February.
The company said it is the first FDA-cleared digital cytology system that combines AI with volumetric imaging to detect pre-cancerous lesions and cervical cancer cells. It digitally images glass slides of cervical cells and applies AI to highlight areas of concern for cytologists and pathologists.
Hologic’s new process improves sensitivity without sacrificing specificity, reducing false negatives for high-grade squamous intraepithelial lesions by 28% compared to traditional microscopic review. The system enables faster, more effective treatment decisions and supports remote collaboration across healthcare settings.
Get more about the technology >>
Moon Surgical expands surgical robot indications to gynecological laparoscopy
Moon Surgical announced in April its Maestro surgical robot is being used clinically in gynecological laparoscopic procedures.
The recent gynecological use was for hysterectomy, cystectomy, adnexectomy and ovariectomy procedures.
Moon Surgical designed Maestro to provide an accessible, enhanced version of traditional laparoscopy. Maestro acts as a robotic surgical assistant to augment the precision and control of laparoscopic surgery. The small, adaptable system can integrate into existing clinical workflows. It features capabilities that bolster operating room efficiency and allow for alternative labor models.
Read more about the procedures >>
FDA approves Lumicell’s breast cancer visualization system
Lumicell announced in April it received FDA approval for its LumiSystem direct visualization system for breast cancer removal.
According to the company, the LumiSystem allows surgeons to scan the breast cavity post-lumpectomy in real time to detect and resect residual cancer that could have been missed with 84% diagnostic accuracy. The LumiSystem with the company’s LumiSight optical imaging agent is indicated for fluorescence imaging in adults with breast cancer as a supplement for the intraoperative detection of cancerous tissues within the resection cavity after removing primary specimens during lumpectomy surgery.
Lumicell used data from more than 700 breast cancer patients across five clinical studies to assess the safety of the system. The most common side effects of LumiSight are hypersensitivity and an abnormal color in urine.
