Neuronetics lands CE mark for neurostim depression therapy
Pennsylvania-based Neuronetics won CE Mark approval in the European Union for its NeuroStar non-invasive electromagnetic field treatment designed to stimulate brain cells linked to depression.
NeuroStar was approved for use in adults with treatment-resistant major depressive disorder. The system has had FDA approval since 2008.
NeuroStar is a rarity in the med-tech world: A device-based approach to a psychiatric disorder.
"The only other widely used device-based therapy in psychiatry is shock therapy, and that’s been around since the 1930s," Neuronetics president & CEO Bruce Shook told MassDevice.com last year.
Learn more about the device and its background in MassDevice.com’s podcast interview with Bruce Shook.
Siesta Medical wins CE Mark, begins U.S. trials for sleep apnea system
California-based Siesta Medical won CE Mark approval for its Encore tongue suppression system for treatment of obstructive sleep apnea. The company plans to begin marketing the implant later this year.
Siesta also announced the launch of U.S. clinical trials enrolling 20 patients for follow-up at 3 and 12 months after implantation.
Erchonia touts FDA win for arm-shaping laser treatment
Texas-based Erchonia won FDA clearance for its Zerona non-invasive laser-based treatment for contouring and reduction of the arms based on results from a blinded and controlled clinical trial.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.