Gynecological Health

Daye and Lindus Health Launch Clinical Trial to Develop Diagnostic Tampon for At-home STI and HPV Testing

Gynae Health startup Daye and clinical trial company Lindus Health have launched a clinical trial for a Diagnostic Tampon designed to allow women and assigned female at birth (AFAB) individuals to conduct HPV and STI tests in their homes. Supporting Daye’s mission to close the gender health gap, its Diagnostic Tampon has the potential to transform women’s experience when being screened for…

Nesa Medtech’s Fibroid Mapping Reviewer Application Gains FDA Approval

Indian femtech company Nesa Medtech has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fibroid Mapping Reviewer Application (FMRA). The Software as a Medical Device (SaMD) creates a 3D model of the uterus from ultrasound images, helping physicians diagnose and plan treatments for patients with symptomatic uterine fibroids. Uterine fibroids, also known as leiomyomas, are non-cancerous growths…

Ovarian Cancer Treatment: FDA Approves Clinical Trials for Leads Biolabs’ LBL-033

In a stride towards the development of innovative treatments for cancer, the U.S. Food and Drug Administration (FDA) has granted approval for the Phase I/II clinical trials of LBL-033, an anti-MUC16/CD3 bispecific antibody developed by Leads Biolabs. The biotech company is set to investigate the safety, efficacy, and pharmacokinetics of LBL-033 in combating advanced solid tumors, including ovarian cancer. This bispecific antibody,…

Ceek Women’s Health Launches Nella, A New Single-Use Vaginal Speculum Designed for Patient Comfort

Founded in 2018 by Fahti Khosrowshahi following her personal experiences with infertility treatments, Ceek Women’s Health aims to revolutionize gynecological care. Recognizing the need for more modern, patient-friendly tools in this sector, Khosrowshahi’s company is dedicated to developing innovative solutions that elevate the standard of care women receive. With the launch of the Nella Single-Use Vaginal Speculum the company is not taking…

Organon Invests $8M in Claria Medical to Support the Development of an Investigational Medical Device for Minimally Invasive Hysterectomy

Women’s health focused pharma company Organon has made a $8M strategic investment in Claria Medical, a privately-held company developing an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy. The agreement also grants Organon the option to acquire Claria Medical in the future. “Hysterectomy is one of the most commonly performed surgeries for women, which is why it is critical…

Daye Raises £10M in Series A Funding to Launch New Gynae Health Products and Kickstart Expansion to the U.S.

UK-based gynaecological health startup Daye, which is known for having invented the CBD tampon that is now used by over 60,000 women in the UK, has raised a £10M Series A from London-based Hambro Perks. Other participants in the round also include MassMutual Ventures, Cross Border Impact Ventures as well as leading UK health solutions provider, Simplyhealth, who will collaborate with Daye…

Bayer Teams Up with MyEndosis and DoctorOnCall to Launch a Telehealth Platform for Endometriosis in Malaysia

Bayer Malaysia has teamed up with the MyEndosis, the Endometriosis Association of Malaysia and DoctorOnCall, a digital health platform by Health Digital Technologies, to launch a new telehealth platform dedicated to endometriosis. The new service will provide online consultations with OB/GYNs from DoctorOnCall, which will be free of charge for a three-month period starting this June. Bayer’s Country Division head for Singapore, Malaysia…

Women’s Health Biotech Company ObsEva Is Added to the NASDAQ Biotechnology Index

ObsEva has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective as of market open on Monday, December 20, 2021. The biotech company develops and commercializes novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment…