FemPulse has received FDA Investigational Device Exemption (IDE) approval to begin its EVANESCE II pivotal clinical trial for its wearable bioelectronic device targeting overactive bladder (OAB) in women. The device, called the FemPulse Ring, is designed as a vaginally-inserted, removable treatment option. “We want to thank everyone at FDA for their thorough review and clear dedication to patient safety. This is an…
BrightHeart has received FDA 510(k) clearance for its artificial intelligence software designed for prenatal ultrasound evaluations of the fetal heart. The technology aims to support the detection of congenital heart defects (CHDs), which affect nearly 1 in 100 newborns. “Fetal heart assessments are among the most technically demanding aspects of prenatal ultrasound,” said Cécile Dupont, BrightHeart CEO and a Partner at Sofinnova…
AbbVie has received European Commission (EC) marketing authorization for ELAHERE (mirvetuximab soravtansine) for the treatment of platinum-resistant ovarian cancer. The approval marks the first folate receptor alpha (FRɑ)-directed antibody drug conjugate approved in the European Union, Iceland, Liechtenstein, Norway, and Northern Ireland. The treatment specifically targets adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or…
The U.S. Food and Drug Administration (FDA) has approved Genentech’s Itovebi (inavolisib) for the treatment of advanced hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with a PIK3CA mutation. Itovebi is to be used in combination with palbociclib (Ibrance) and fulvestrant. This approval is based on results from the Phase III INAVO120 study, which showed that the Itovebi-based…
Femasys, a biomedical company specializing in women’s health, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemChec, adiagnostic tool for checking the fallopian tubes. This new solution is designed for controlled delivery of contrast media, allowing for clearer confirmation of tubal status during ultrasound evaluations. Kathy Lee-Sepsick, founder and CEO of Femasys,…
Sunny, a self-care brand in menstrual care, has achieved another milestone with their Sunny Cup + Applicator, now the first menstrual cup and applicator to receive FDA 510(k) clearance. This Class II Medical Device addresses the primary barrier preventing tampon users from switching to more sustainable menstrual products, free from potentially harmful materials. Sunny is a queer, women, and BIPOC-owned self-care brand…
