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Gynesonics

Gynesonics lands FDA clearance for fibroid-removal system

May 29, 2020 By Sean Whooley

Gynesonics announced that it received FDA 510(k) clearance for its next-generation Sonata System 2.1 for transcervical fibroid ablation (TFA). Redwood City, Calif.-based Gynesonics’ Sonata platform integrates what the company touts as the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device. The system provides an incision-free, uterus-preserving transcervical treatment for symptomatic […]

Filed Under: 510(k), Business/Financial News, Food & Drug Administration (FDA), Gynecological, Regulatory/Compliance, Women's Health Tagged With: FDA, Gynesonics

These young medtech companies raised the most money in 2019

February 20, 2020 By Danielle Kirsh

Medical device industry insiders may very well remember 2019 as the year that IPOs came back — but another sign that the U.S. economy has left the Great Recession far behind. Among the top investment deals in the space, half involved public offerings, according to the MoneyTree report from PricewaterhouseCoopers (PwC) and CB Insights. Total investments […]

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Filed Under: Cardiovascular, Catheters, Clinical Trials, Diagnostics, Drug-Device Combinations, Featured, Funding Roundup, Gynecological, Imaging, Optical/Ophthalmic, Pharmaceutical, Research & Development, Women's Health Tagged With: Ablative Solutions, Acutus Medical, Avedro, Click Diagnostics, Gynesonics, Imperative Care, InMode Aesthetic Solutions, Shockwave Medical, Silk Road Medical Inc.

Gynesonics launches Sonata 2 System

November 14, 2019 By Sean Whooley

Gynesonics has announced the full U.S. and European launch of its Sonata 2 transcervical fibroid ablation system for incisionless, uterus-preserving procedures. The Sonata 2 system is the world’s first and only transcervical fibroid ablation system to combine intrauterine ultrasound guidance with targeted radiofrequency energy in the incisionless procedure, according to a Nov. 11 news release. […]

Filed Under: Business/Financial News, Gynecological Tagged With: Gynesonics

Gynesonics touts fibroid study’s long-term outcomes

March 6, 2019 By Nancy Crotti

A long-term retrospective study of patients treated with Gynesonics’ Sonata uterine fibroid treatment system revealed low rates of surgical reintervention, improved symptom severity and quality of life, the company said today. Patients at the study site in Monterrey, Mexico were treated with the Sonata system, designed to provide incisionless transcervical radiofrequency energy ablation of uterine […]

Filed Under: Clinical Trials, Gynecological, Imaging, News Well, Ultrasound, Women's Health Tagged With: FDA, Gynesonics

Gynesonics touts 1-year pivotal IDE Sonata trial data

January 11, 2019 By Fink Densford

Gynesonics yesterday released 12 month results from the FDA investigational device exemption pivotal trial of its Sonata system intended for diagnostic intrauterine imaging and the transcervical treatment of symptomatic uterine fibroids. Results from the trial were published in the journal Obstetrics and Gynecology, the Redwood City, Calif.-based company said. The company’s flagship Sonata System is a […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Women's Health Tagged With: Gynesonics

Gynesonics closes $75m financing round

January 3, 2019 By Fink Densford

Gynesonics said today that it closed a $75 million equity financing round to support its Sonata system intended for diagnostic intrauterine imaging and the transcervical treatment of symptomatic uterine fibroids. The round was led by Bain Capital Life Sciences and joined by all the Redwood City, Calif.-based company’s existing investors, including Abingworth, Advanced Technology Ventures, […]

Filed Under: Business/Financial News, Featured, Wall Street Beat, Women's Health Tagged With: Gynesonics

Hologic CFO McMahon jumps ship to Agilent | Personnel Moves – August 1, 2018

August 1, 2018 By Fink Densford

Hologic (NSDQ:HOLX) said yesterday that its CFO Bob McMahon is leaving to take up a CFO role at Agilent Technologies. The Marlborough, Mass.-based company said that its current chief accounting officer Karleen Oberton has been lifted to CFO, effective today. “Bob has made tremendous contributions to Hologic over the last four years, and we wish him […]

Filed Under: Business/Financial News Tagged With: Agilent Technologies Inc., becton dickinson, Bluewind Medical, C.R. Bard, Gynesonics, Hologic, ICON plc, lineusmedical, Medtronic, Oticon Medical, Philips, Repro Med Systems

Gynesonics touts pivotal IDE Sonata trial results

January 9, 2018 By Fink Densford

Gynesonics today released results from the pivotal FDA investigational device exemption cleared trial for its Sonata system designed for the incision-free treatment of uterine fibroids, touting a 99% freedom from surgical reintervention for heavy menstrual bleeding. The Redwood City, Calif.-based company’s Sonata trial is a prospective, longitudinal, multi-center trial exploring the safety and effectiveness of […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Women's Health Tagged With: Gynesonics

Gynesonics submits 510(k) premarket notification for uterine fibroid treatment

December 21, 2017 By Danielle Kirsh

Gynesonics announced that it has submitted its 510(k) Premarket Notification to the FDA for its Sonata System. The Sonata System is a uterus preserving, incision-free uterine fibroid treatment that was designed to treat fibroids transcervically with radiofrequency energy. “Submission of the 510(k) application is an important milestone for our company,” Chris Owens, president and CEO […]

Filed Under: 510(k), Regulatory/Compliance, Women's Health Tagged With: Gynesonics

Wright Medical COO, ex-Tornier CEO Mowry, steps down | Personnel Moves May 5, 2016

May 5, 2016 By Fink Densford

Wright Medical COO, ex-Tornier CEO Mowry, steps down Wright Medical (NSDQ:WMGI) said yesterday its exec veep and chief operating officer, and former Tornier (NSDQ:TRNX) CEO, David Mowry will be stepping down from the company on May 6 to pursue other opportunities. The company did not indicate who would take Mowry’s position. Read more

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Filed Under: Business/Financial News Tagged With: Alfred Mann Foundation, Asante Solutions, BaroNova, Baxter, Biolase, Capsule Tech Inc., Gynesonics, Medtronic, NeoChord Inc., Neurotech Pharmaceuticals, NinePoint Medical Inc., Notal Vision, Olympus, Patient Safety Technologies Inc., Repro Med Systems, SafeOp Surgical, Tornier Inc., wrightmedical

RIP medical device pioneer Alfred Mann | Personnel Moves

February 26, 2016 By Brad Perriello

Alfred Mann, a medical device entrepreneur who helped develop several groundbreaking technologies, died yesterday at age 90, shortly after stepping down from a pair of companies he founded. Mann founded 17 companies over his 70-year career, in industries ranging from aerospace to medtech, according to the L.A. Times. After Johns Hopkins University researchers in 1969 […]

Filed Under: Business/Financial News Tagged With: Abiomed, Advanced Bionics LLC, ConMed Corp., Corindus Vascular Robotics, Gynesonics, Hansen Medical Inc., LifeImage, mannki, Medtronic, MedX Health, Penumbra Inc., Personnel Moves, second-sight-medical, Valeritas

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