Gynesonics, a medical device company specializing in women’s healthcare, recently announced the creation of a new Category 1 CPT Code for its Sonata Transcervical RF Ablation Procedure, used in the treatment of uterine fibroids. The American Medical Association (AMA), in collaboration with the American College of Obstetrics and Gynecology (ACOG), has assigned code 58580 to this procedure, reflecting its integration into current…
Aspivix, a company specializing in women’s health technology, has recently received CE Mark approval for its Carevix device, indicating its compliance with European health, safety, and environmental protection standards. This approval allows for the commercial use of Carevix in European countries. Carevix is designed to reduce pain during transcervical procedures, such as the placement of Intrauterine Devices (IUDs). It operates using a…
Flow Medical, a pulmonary embolism treatment startup, recently secured $2M in a friends-and-family investment round. Based in Chicago, the company is spearheaded by CEO Jennifer Fried, former Head of Explorer Surgical, and Co-founders Dr. Jonathan Paul and Dr. Osman Ahmed, specialists in venous thromboembolism at The University of Chicago Medical Center. The connection between acute pulmonary embolism (PE) and maternal health is…
GE HealthCare has announced the release of MyBreastAI Suite, a new AI-powered platform for mammography, designed to aid clinicians in detecting breast cancer. This platform integrates AI applications from iCAD, focusing on breast density assessment and enhancing the efficiency of mammography workflows. Addressing the challenges posed by the global rise in breast cancer cases, MyBreastAI Suite aims to streamline breast cancer detection.…
Owlet, a frontrunner in smart infant monitoring technology, has recently obtained De Novo clearance from the U.S. Food and Drug Administration for its Dream Sock product. This marks a significant development in infant care technology as Dream Sock stands as the only over-the-counter, medical-grade pulse oximeter designed specifically for infants. The Dream Sock by Owlet is engineered to keep track of a…
Caldera Medical, a Los Angeles-based medical device company has announced the completion of its acquisition of Atlantic Therapeutics, an Ireland-based medical device provider specializing in non-invasive pelvic floor strengthening and nerve-stimulating solutions. Caldera Medical specializes in products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, Polyps, and Fibroids. The company is committed to improving the quality of life for women…
The management of menopausal symptoms, particularly hot flashes, has taken a significant step forward with the introduction of the Zera Cooling Crescent. Developed by Aphra Hallam, a 22-year-old Industrial Design and Technology student at Brunel University London, this innovative device offers discreet and effective relief for women experiencing this common discomfort. Historically, menopause has been a topic of limited discussion and understanding,…
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…
