The U.S. FDA granted Edap Tms SA breakthrough device designation for its Focal One system to treat deep infiltrating rectal endometriosis. The company believes that the Focal One high intensity focused ultrasound technology can offer relief to the thousands of women suffering from the debilitating condition.
Researchers from Oregon Health and Science University (OHSU) are seeking patent protection for a transcervical delivery device that may provide clinicians with a simple, inexpensive office-based procedure for the assessment of tubal patency or delivery of a permanent contraceptive agent to the fallopian tube.
Pearsanta Inc., a subsidiary of Aditxt Inc. formed in Feb. 2023, acquired MDNA Life Sciences Inc. for $25 million in stock, marking Aditxt’s second deal announced in a month. The company moved into the women’s health market with the $100 million planned acquisition of Evofem Biosciences Inc., maker of the contraceptive gel Phexxi, which it reported on Dec. 12. The deals show boldness on the part of Aditxt’s management team as the company just announced it regained compliance with Nasdaq’s continued listing rule for minimum stockholder’s equity on Jan. 2.
Invitae Corp. continued its aggressive cost-cutting initiative with the sale of its reproductive health assets to Natera Inc. for $10 million in upfront cash and an additional $42.5 million in potential milestone payments and litigation credits. The assets include screening tests for carrier status and non-invasive prenatal screening.
In a boon to older women worldwide, Bone Health Technologies Inc. received U.S. FDA clearance for its Osteoboost device, which reduces loss of bone strength in postmenopausal women. It is the first device cleared for intervention to slow loss of bone density or osteopenia before it advances to osteoporosis.
In a potential godsend for women struggling with infertility and painful periods, Hera Biotech Inc. acquired the endometriosis diagnostic assets of Scailyte AG, consolidating the two leading tissue-based diagnostic programs for the disease. The combination of the companies’ non-surgical diagnostic options could significantly speed time to treatment for millions of women, who on average spend 10 years in search of the cause of chronic pelvic pain before being diagnosed with endometriosis.
Listening to conversations between a mother and her unborn child on the cellular level could inform how the pregnancy is going and prevent complications. Three scientific groups from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in collaboration with Wayne State University and Michigan State University, have used single-cell RNA sequencing techniques to decipher these words, identify the cellular language of these interactions in the placenta and establish a cellular atlas.
With the use of 3D printing and microfluidics, Fertilis Pty Ltd. hopes to triple the success rates of in vitro fertilization (IVF) by improving embryo quality and quantity.
Abbott Laboratories received U.S. FDA approval for its molecular human papillomavirus (HPV) screening test, expanding the company’s cancer screening tools. The new member of the Alinity M family of diagnostic assays can be used for screening, as recommended by current guidelines, as well as diagnosis and provide detailed information on the potentially cancer-causing genotypes of the virus.