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Tuesday, July 10, 2018

美國 FDA510K核准醫療器材利用 "磁場" 刺激大腦治療憂鬱症


Neuronetics reels in $108m from IPO JULY 6, 2018 BY SARAH FAULKNER Neuronetics NeuroStarNeuronetics (NSDQ:STIM) this week closed its initial public offering, according to a document filed with the SEC. The Malvern, Penn.-based company said that it offered 6,325,000 shares of its common stock and that underwriters exercised in full their option to buy additional shares, bringing the total proceeds from the IPO to $107.5 million. Shares began trading on the Nasdaq exchange under the ticker symbol 'STIM' last week. The company's shares closed at $25.50 apiece today, down -1.5%. Neuronetics' NeuroStar device uses strong magnetic fields to stimulate areas of the brain associated with mood. The device is designed to treat patients with major depressive disorder who do not respond to medication. In December of 2008, the NeuroStar device won 510(k) clearance from the FDA as a treatment for adults who previously failed to respond to one medication. But in May 2014, the U.S. regulatory agency expanded the device's indication to include adults who do not respond to one or more medications. Approximately 50,000 patients have been treated with the device, according to Neuronetics.


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