Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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Uterine fibroid-treating device developer Mirabilis Medica said today it won CE Mark approval in the European Union and FDA investigational device exemption for its Mirabilis System designed to treat uterine fibroids.
The Bothell, Wash.-based company’s Mirabilis system is designed to use ultrasound to both provide imaging and ablation during procedures to remove uterine fibroids, the company said. Read more
Align Technology said today it inked a sales agreement with Zfx GmbH to expand the sales of its iTero Element intraoral scanners in European, Asian and African countries.
Through the non-exclusive deal, Zfx will act as a sales agent for the company’s iTero Element intraoral scanners amongst its network of customers, including laboratories, milling centers and dental professionals. Read more
Medtronic said today that new guidelines from the American College of Cardiology, the American Heart Association and the Heart Rhythm Society now recommend the use of cardiac monitors for patients with syncope.
The updated guidelines for patients with syncope, or unexplained fainting, was published online in the Journal of the American College of Cardiology, Circulation and HeartRhythm. Read more
A federal court this week certified a class of NuVasive Inc. investors in a suit alleging that the company lost share value after it hid a kickback scheme.
A judge in the US District Court for the Southern District of California this week granted a motion for class certification, appointing Brad Mass and Daniel Popov as class representatives, according to court documents. Read more
Cardinal Health subsidiary Cordis this week released an urgent field safety notice recalling its S.M.A.R.T. Flex vascular stent systems in sizes 5x200mm and 6x200mm over deployment issues.
The company is recalling the devices over reports of deployment difficulty with the devices in the 2 particular sizes. Read more