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EchoSure

FDA approves Sonavex's EchoSure system

par John R. Fischer , Staff Reporter
The FDA has granted its seal of approval to Sonavex to begin shipping its EchoSure system to providers across the U.S.

A combination of 3D ultrasound imaging and advanced deep learning algorithms, the device automates visual and quantitative analysis to monitor and provide up-to-date information on blood flow following surgical procedures.

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“Doppler ultrasound is an accurate imaging modality that is inexpensive, portable, and safe due its not emitting ionizing radiation,” David Narrow, chief executive officer of Sonavex, told HCB News. These qualities make it the preferred modality for routine imaging at the bedside.”

Its use is made simple with the addition of Sonavex’s EchoMark bioresorbable markers for marking soft tissue sites in surgical patients. Cleared by the FDA last year, the highly echogenic, resorbable polymeric implants eliminate the need for expertise in ultrasound to measure blood flow.

Also connected with the system is the EchoSure App, which enables surgeons to monitor patients remotely with mobile phones.

Narrow says the adoption of the system will enable nurses and hospital staff to detect vascular issues early on, enabling quicker interventions and improved patient outcomes. He expects it to benefit a variety of providers, particularly “reconstructive surgeons for plastic surgery and otolaryngology, vascular surgeons, and transplant surgeons.”

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(11)

Wayne Moore

Sonavex and the FDA

March 15, 2019 08:08

Your readers deserve correct information - the FDA does not grant "seals of approval". This device was simply cleared for sale through the normal 510(k) process.

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