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 […]
Gynesonics
These young medtech companies raised the most money in 2019
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 […]
Gynesonics launches Sonata 2 System
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. […]
Gynesonics touts fibroid study’s long-term outcomes
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 […]
Gynesonics touts 1-year pivotal IDE Sonata trial data
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 […]
Gynesonics closes $75m financing round
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, […]
Hologic CFO McMahon jumps ship to Agilent | Personnel Moves – August 1, 2018
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 […]
Gynesonics touts pivotal IDE Sonata trial results
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 […]
Gynesonics submits 510(k) premarket notification for uterine fibroid treatment
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 […]
Wright Medical COO, ex-Tornier CEO Mowry, steps down | Personnel Moves May 5, 2016
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
RIP medical device pioneer Alfred Mann | Personnel Moves
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 […]
