Medical Device

Gynesonics Receives FDA Clearance for its Next Generation Sonata System

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…

Medical Device Company Materna Medical Raises $10M to Accelerate Growth

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 Expands Its Hysteroscopic Tissue Resection Product Portfolio with the Release of the New Aveta Office Suite

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 Appoints Ryan Willemsen as New COO to Support the Commercialization of Flyte, the Company’s Non-Surgical Treatment for Female Stress Urinary Incontinence

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,…

Ark Surgical Raises $2.1M for its LapBox Tissue Containment System for Laparoscopic GYN Surgery

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…

Cooper Acquires obp Medical, a Medical Device Company Known for its Single-Use Vaginal Speculums with Integrated LED Illumination

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 Raises a $23M Series B to Fund Final Development of its Implantable Medical Device for Those Suffering from Urinary Incontinence

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,…

LabReady GBS, an Innovative Women’s Health Diagnostic Device to Improve the Maternal Group B Strep Testing Processes, Is Now Available in Europe

Earlier this week Vax-Immune Diagnostics annoucned that it has received CE Mark approval for its first-in-class medical device, LabReady GBS. LabReady’s Group B Strep product is the first in Vax-Immune Diagnostics’ lineup of women’s health solutions that helps avoid life-threatening complications and expensive consequences for mothers and their babies. With CE Mark approval, LabReady is now available to European physicians, patients, and hospital systems. The brainchild…