Gynecological Equipment News
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Raleigh’s UVision360 Gets FDA OK For Biopsy Sheath
A new biopsy sheath developed by Raleigh med tech startup UVision360 is ready to hit the market after landing federal approval this week. UVision360 announced it had received the greenlight from the U.S. Food and Drug Administration for its patented LUMINELLE 360° Bx Sheath. The device expands the startup’s “all-in-one” gynecological system LUMINELLE DTx, an endoscopic ...
By LUMINELLE
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Icecure Medical announces updated regulatory strategy in china for the icesense3 system to treat Cancerous Tumors with Cryoablation
IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” or the “Company”), developer of the next generation minimally invasive cryoablation technology that destroys tumors by freezing, today announced the advancement of its regulatory strategy in China with the submission of an amendment to the registration certificate for the IceSense3® system, which was granted ...
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Gynesonics Announces First Office-Based Sonata Procedure in the State of Texas
Redwood City, CA, October 5, 2021 – Gynesonics®, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that Dr. John Thoppil is the first physician in the state of Texas to offer its Sonata® Treatment to women with symptomatic uterine fibroids as an office-based procedure at his River Place ...
By Gynesonics
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Gynesonics Announces FDA Clearance of Next Generation Sonata System
Redwood City, CA, September 16, 2021 – Gynesonics®, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today the Food and Drug Administration (FDA) has given clearance of the Sonata® System 2.2 which provides important new benefits for facilities, physicians and patients. These benefits include: ...
By Gynesonics
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Gynesonics Announces Expert Group of European Gynecologic Surgeons Publishes Consensus on the Broad Use of the Sonata Technology in a New Treatment Strategy for Symptomatic Fibroids
Redwood City, CA, August 11, 2021 – Gynesonics®, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today a group of 12 surgeons from multiple fibroid treatment centers in Germany, Austria and Switzerland have published a review of symptomatic fibroid treatments, and recommended a treatment algorithm ...
By Gynesonics
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Boston Scientific Exercises Option to Acquire Farapulse, Inc.
Boston Scientific Corporation (NYSE: BSX) today announced it exercised its option to acquire the remaining shares of Farapulse, Inc. The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation (PFA) System – a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. ...
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Gynesonics Announces Positive Coverage Policy Decision Published by Cigna for Treatment of Uterine Fibroids with the Sonata System
Redwood City, CA, June 3, 2021 – Gynesonics®, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that Cigna has released a national coverage policy for treatment of uterine fibroids with the Sonata® System.1 Cigna is one of the largest commercial payers in the country with a significant ...
By Gynesonics
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Thermedical Announces FDA Breakthrough Device Designation
WALTHAM. Mass.. May 19,2020 - Thermedicak a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT): today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter. The FDA Breakthrough Devices Program is intended to help ...
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Thermedical Announces SERF VT Study Presented as Part of HRS 2020 Science Late-Breaking Clinical Trial Sessions May 2020
WALTHAM, Mass., May 8, 2020 - Thermedicak a developer of thermal-ablation systems to treat ventricular tachycardia (VT), announced that results from a First-in-Human Early Feasibility Study (EFS) using the new Durablate® catheter to treat VT were presented in the late-breaking clinical trial sessions at the Heart Rhythm Society (HRS) meeting today. Called the Saline Enhanced Radiofrequency ...
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Proa Medical Receives 510(k) Clearance from FDA for Brella-Spec Vaginal Speculum for Gynecological and Obstetrical Procedures
Proa Medical, Inc., developer of innovative and practical medical devices for women’s health, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its single-use device, the Brella-Spec™ Vaginal Speculum, for visualization and exposure of the interior of the vagina by a medical professional during gynecological and ...
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Proa Medical Receives Positive Reception for Brella Vaginal Retractor at American Congress of Obstetricians and Gynecologists (ACOG) Annual Meeting
Proa® Medical, Inc., developer of innovative and practical medical devices for women’s health, today announced that the company received significant positive feedback for its FDA-cleared Brella® Vaginal Retractor at the recent Annual Clinical Meeting of the American Congress of Obstetricians and Gynecologists (ACOG), the largest U.S. congress for women’s health, held April ...
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