Zoll Wins Health Canada Clearance for Two AEDS
Massachusetts-based Zoll has received marketing clearance from Health Canada for its AED 3 and AED 3 BLS automated external defibrillators.
The AED 3 BLS model is designed specifically for first responders. The model includes a CPR dashboard, which shows critical information such as the rate and depth of each compression. It is also Wi-Fi enabled so first responders can export clinical data.
The units are not available for sale in the United States.
Mirabilis Medical Wins CE Mark for Uterine Fibroids
Mirabilis Medical has been granted a CE Mark to market a robotically assisted, non-invasive ultrasound system to treat uterine fibroids.
The clearance was granted based on the completion of an initial clinical trial, which treated 73 women in Mexico with an average active treatment time of less than 10 minutes.
The company has also been cleared by the FDA to conduct a pivotal study in the U.S., which will start in the second half of this year. A total of 180 patients will participate in the trial at 12 sites, including nine in the U.S., two in Canada, and one in Germany.
FDA Approves iCAD’s PowerLook Tomo Detection Device
New Hampshire–based iCAD has received FDA premarket approval for its PowerLook Tomo detection platform.
The 3D image improves detection of hidden or obscured areas on a 2D mammography. The platform also identifies suspicious areas that radiologists may not see initially.
The device received a CE Mark and Health Canada approval in 2016.
Syneron Candela Wins CE Mark for CO2RE Intima
Syneron Candela has secured a CE mark for CO2RE Intima, a non-surgical in-office laser treatment that relieves the effects of childbirth and aging on the vagina.
In a clinical study, 82 percent of women showed a statistically significant improvement after treatment.
FDA Grants Investigational Device Exemption for Human Trial of Prosthetic Hand
The FDA awarded an investigational device exemption to Florida International University for a human trial of its neural-enabled prosthetic hand system.
The device is not approved by the FDA for U.S. commercial distribution.
FDA Clears Providence Medical Technology’s Cervical Cage-L System and Facet Screws
Providence Medical Technology has won two FDA marketing clearances for its Cavux cervical cage-l system and Ally facet screws to compliment the company’s DTRAX Spinal System for use in cervical fusion.
The Cavux cervical cage-l system is made from titanium and is available in a variety of sizes.