Papcup has introduced a non-invasive, at-home device designed to screen for cancer-causing HPV strains using regular menstrual blood. This device, developed with support from the Venture Builder Incubator (VBI) at the University of Edinburgh, aims to provide an alternative to traditional smear tests, which many women find uncomfortable and inconvenient. The device offers a highly accurate, non-invasive method for testing, allowing women…
Clarius Mobile Health has received FDA clearance for its Clarius OB AI fetal biometric measurement tool, which aims to improve access to obstetrical prenatal monitoring and care, especially in resource-limited areas. The Clarius OB AI model, now available with the Clarius C3 HD3 wireless handheld ultrasound scanner in the United States and Canada, automates fetal biometry measurements to estimate fetal age, weight,…
Femasys, a biomedical company focused on women’s health, has announced receiving European Union Medical Device Regulation (EU MDR) and CE Mark certification for four of its products. The approved products—FemaSeed, FemVue, FemCerv, and FemCath—comply with the latest EU medical device regulations, marking a significant step for Femasys as it prepares to enter the European market. This achievement follows the recent completion of…
Raydiant Oximetry, a clinical-stage medical device company focused on improving outcomes for mothers and babies during childbirth has closed an oversubscribed $7.5 million Series A3 extension round. The round was led by Cross-Border Impact Ventures (CBIV), a VC fund focused on the health of women and children worldwide. The round also included participation from RH Capital, Global Health Impact Fund, VCapital, and…
Lunit, a provider of AI-powered cancer diagnostics and therapeutics, has acquired Volpara Health Technologies, a global leader in breast cancer screening software. Last year when the acquisition was first announced Lunit shared plans to acquire all Volpara shares at AUD 1.15 per share, amounting to a deal worth approximately AUD 292 million (USD 193 million). The acquisition merges Volpara’s advanced breast health…
Meditrina, a developer of gynecologic medical devices, announces the CE Mark and UKCA Mark approval for its Aveta Hysteroscopy System. This approval, aligned with Regulation (EU) 2017/745, marks a significant achievement for Meditrina, allowing the company to expand its international footprint and further its commitment to advancing women’s health worldwide. The Aveta Hysteroscopy System features a fully disposable 4.6mm resecting hysteroscope, designed…
The first successful IUD and transcervical procedures using Aspivix’s non-traumatic Carevix were performed in the U.S. This milestone underscores the potential of Carevix to offer a gentler alternative to traditional methods. The procedures were performed by Alissa M. Conklin, MD., Assistant Professor of Clinical Obstetrics and Gynecology at Indiana University School of Medicine. She shared: “The suction was perfectly adequate and easy…
Teal Health, headquartered in San Francisco (USA), has achieved a significant milestone in its mission to improve cervical cancer screening options. The company has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for its at-home self-collect cervical cancer screening device, the Teal Wand. This designation follows the successful completion of Teal Health’s clinical trial. The trial surpassed…
