Women’s health company Organon has received clearance by the U.S. Food and Drug Administration (FDA) of the Special 510(k) for technological updates to the JADA System, intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. The product updates include a new kit configuration with updated packaging, as well as a streamlined design to…
Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, has received FDA clearance for Sonata System 2.2, which provides new benefits for facilities, physicians and patients. These benefits include a 20% reduction in the smallest ablation size setting, which greatly increases the ability to treat fibroids in tighter anatomical locations, new software advances that…
Materna Medical, a clinical-stage medical device company, has announced the completion of a $10 million Series A2 financing round. The round was led by Wavemaker Three-Sixty Health (Wavemaker 360) with new investors including Kimera Limited, Women’s Venture Capital Fund, Golden Seeds, Black Capital, Shatter Fund, and Astia Angels. Key existing investors also joined the syndicate including Band of Angels, Texas Halo Fund,…
Meditrina announces the market release of their single-use Aveta Opal Hysteroscope and disposable Aveta Auto Resecting Device for removing soft endometrial tissue such as uterine polyps in an office setting, without the need for fluid management. The Aveta Opal HD Hysteroscope has the smallest insertion profile at 4.6mm featuring a 3.0mm working channel optimized for use with the 2.9 mm OD Aveta…
Pelvital, a privately held medical device company that has developed Flyte, a clinically proven, FDA-cleared, non-surgical treatment for female stress urinary incontinence (SUI), announced today that Ryan Willemsen has been appointed Chief Operations Officer. In this role, Willemsen will be responsible for leading the operations of Pelvital with a focus on market adoption of Flyte, building a global sales and distribution capability,…
Israeli femtech startup Ark Surgical has secured $2.1 million in funding for its LapBox containment system for secure removal of large internal organs during laparoscopic GYN surgery. The financing was raised from investors of the Together equity crowdfunding platform alongside the Israeli Innovation Authority and NGT. Ark Surgical has completed the first-in-human (FIH) study demonstrating the safety and effectiveness of the LapBox. Approximately 600,000 hysterectomies…
CooperCompanies has announced the acquisition of obp Medical by CooperSurgical, one of its business units. obp Medical is a U.S. based medical device company that develops and markets differentiated products including single-use vaginal speculums with integrated LED illumination. Commenting on the transaction, Al White, Cooper’s President and CEO said, “This acquisition is a great strategic fit that builds upon CooperSurgical‘s strong family of OB/GYN…
UroMems, developer and manufacturer of the electronic artificial urinary sphincter (eAUS), today announced that it has raised an additional €7 million in a second tranche of its previously announced Series B financing round completed in May 2020. The additional capital was provided by existing investors including Hil-Invent GmbH, Financière Arbevel, Wellington Partners, Bpifrance, via its FABS fund, Supernova Invest and btov Partners,…
