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…
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,…
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…
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…
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 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…
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…
Gynecological imaging startup Illumigyn has raised $33M from investors including Yozma Group Korea and Ubicom Holdings Japan to fund its global expansion. The company’s vision is to disrupt the medical field of gynecology with a complete platform solution featuring the Gynescope System, a new and FDA cleared “gynecology endoscope” and cloud platform service. Illumigyn was founded in Israel by Ran Poliakine and…
