SoniVie last week won FDA breakthrough device designation for its Therapeutic Intra-Vascular Ultrasound System for patients with pulmonary arterial hypertension. The Therapeutic Intra-Vascular Ultrasound (TIVUS) System is a dedicated therapeutic ultrasound catheter that enhances the treatment of PAH, according to the company. It is inserted into the pulmonary artery during right heart catheterization and is […]
Ultrasound
Ultrasound firm Terason partners with DiA Imaging Analysis
Ultrasound imaging company Terason said today that it has inked a deal with y DiA Imaging Analysis to provide DiA Imaging’s cardiac solutions on Terason’s point-of-care ultrasound devices. The partnership fills a market need for more accurate and objective image analysis for clinicians in hospitals and outpatient settings, that commonly analyze ultrasound images visually, according […]
Department of Justice clears Misonix in China FPCA probe
Misonix (NSDQ:MSON) said last week that the U.S. Department of Justice has dropped its inquiry into the company following a probe of self-reported possible Foreign Corrupt Practices Act violations in China. The Justice Department action, detailed in an August 13, 2019, letter to the company, follows the Securities & Exchange Commission’s June 18, 2019, letter […]
SofWave Medical closes $8.4 million financing round, announces Louis Scafuri as CEO
SofWave Medical secured an $8.4 million financing round, led by co-founder and chairman Shimon Eckhouse and XT Hi-Tech, as the Israeli-based company develops non-invasive fractional ultrasound technology for skin tightening. “This financing round of SofWave Medical will enable us to execute aggressively on our plan to build and position the company as a leader in […]
Misonix lands CE Mark for Nexus ultrasonic platform
Misonix (NSDQ:MSON) said today that it has received the CE Mark for a new ultrasonic surgical platform. The Nexus platform combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single, fully integrated platform that was also designed to accommodate future solutions. The Nexus platform is driven by a new […]
Hologic offers up to $85m for SuperSonic Imagine
Hologic (NSDQ:HOLX) and SuperSonic Imagine (EPA:SSI) yesterday revealed a binding offer that would see Hologic pay some $85 million to acquire the French ultrasound device maker. Marlborough, Mass.-based Hologic’s €1.50-per-share bid amounts to about $42 million for all outstanding SSI shares and warrants, plus not more than $43 million to pay off any debts owed by Aix-en-Provence-based […]
SEC clears Misonix in China FCPA probe
Misonix (NSDQ:MSON) said today that the U.S. Securities & Exchange Commission cleared it after a probe of self-reported possible Foreign Corrupt Practices Act violations in China. The case dates back to the fall of 2016, when then-chairman & CEO Michael McManus Jr. stepped down just before Misonix delayed its annual report due to “deficiencies” in its internal […]
Philips, University of Vermont health system ink long-term pact
Royal Philips (NYSE:PHG) and the University of Vermont (UVM) Health Network today announced they will extend an existing strategic partnership by 10 years. UVM will get Philips imaging systems, ultrasound, patient monitoring, and clinical informatics, and a range of clinical and business solutions and consulting services. The pact aims to help the UVM Health Network […]
Misonix gains FDA clearance for ultrasonic surgical platform
Misonix (NSDQ:MSON) said today that it received FDA 510(k) clearance for a new ultrasonic surgical platform. The Nexus platform combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single, fully integrated platform that was also designed to accommodate future solutions. The Nexus platform is driven by a new […]
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 […]
Insightec wins expanded Medicare coverage for essential tremor treatment
Incisionless neurosurgery company Insightec said it has won Medicare coverage for its Neuravive MR-guided focused ultrasound device in 13 more states, effective April 1, 2019. Health insurance administrator Noridian extended coverage to Medicare recipients in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. Insightec’s Neuravive technology is designed to treat essential tremor […]