Femasys Inc. checked off a box on the way to launch of its Fembloc non-surgical birth control method with U.S. FDA clearance of Femchec. An enhanced version of the Femvue product used to diagnose fallopian tube abnormalities, Femchec enables confirmation of successful blockage of the fallopian tubes to prevent pregnancy without use of radiation.
Germitec SA received U.S. FDA de novo clearance for Chronos, its chemical-free, ultraviolet-C-based disinfection device for endocavitary and external ultrasound probes. The technology will help to protect patients and aid health care professionals in tackling cross-contaminations in U.S. hospitals, Vincent Gardès, CEO of Germitec, told BioWorld.
In what represents the first patenting from Munich, Germany-based Meliodys Medical UG, its co-founder and chief executive officer Simone Sabbione describes their development of a hormone-free, local pain management approach for treating dysmenorrhea, which aims to address the condition while minimizing the occurrence of side effects.
In Ciconia Medical Inc.’s first patenting, the company’s founder and CEO, Roni Cantor-Balan, describes the development of a cervical measurement device for childbirth progress monitoring that replaces the manual vaginal examinations undertaken during labor.
Recurrent spontaneous abortion (RSA), also known as recurrent miscarriage, is a disorder related to pregnancy defined as two or more pregnancy losses during the first trimester. It affects about 2%-5% of couples trying to conceive. Chinese researchers have investigated the potential involvement of Cbl proto-oncogene like 1 (CBLL1) in RSA, since CBLL1 has been reported to vary with the menstrual cycle in the endometrium.
After decades of being woefully under-diagnosed and all but ignored by the biotech and pharma industry, recent advances in understanding its complex etiology could be opening the way to new treatments for endometriosis. Impetus is coming from (modest) increases in funding for basic research, such as the Biden administration’s $200 million for women’s health research and NIH grants under an ‘Advancing cures and therapies and ending endometriosis diagnostic delays’ call announced in March of this year.
Swiss scientists developed hydrogel implants that could help prevent and treat endometriosis by blocking the fallopian tubes and stopping the passage of endometrial cells. The implants, though in their early stage of development, bode well for the millions of women suffering from the chronic condition.
Novocuff Inc. closed an oversubscribed $26 million series A funding round to support further development of the Novocuff cervical control system, which is designed to reduce preterm births by closing the cervix in high-risk pregnancies. The funds will enable the company to undertake a U.S. multi-center pivotal clinical trial, pursue marketing authorization, expand its team and begin early-stage commercialization of the device.
Clarius Mobile Health Corp. received U.S. FDA clearance for the Clarius OB artificial intelligence biometric measurement tool, which is designed to improve access to accurate prenatal monitoring in low-resource regions. The system automatically estimates fetal age, weight and growth intervals critical to assessing fetal health and early identification of potential issues and multiple pregnancies.
Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU.
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