Updated to correct distributor information from an updated version of Nexstim’s press release. Nexstim said today that it won approval from Health Canada for its NBS system and NexSpeech devices. The Helsinki-based company’s NBS system and NexSpeech comprise a diagnostic device intended for the non-invasive localization of the brain areas that control motor and speech functions. […]
FDA clears shorter protocol for Nexstim’s NBT TMS depression treatment
Nexstim said today that it won FDA 510(k) clearance for a new, shorter treatment protocol for its Navigated Brain Therapy transcranial magnetic stimulation system intended to treat major depressive disorder. The Helsinki-based company said that the FDA cleared the system for a Theta Burst Stimulation treatment protocol, which is much shorter than its previously cleared […]
Nexstim pulls trigger on 30-to-1 reverse split
Nexstim said this week it pulled the trigger on a 30-to-1 reverse split of its stock as the company looks to reduce its share capital. Through the move, each shareholder in the Helsinki, Finland-based company will receive a single share for every 30 shares they previously owned. The shift went into effect on Monday, with […]
Nexstim launches NBT major depressive disorder TMS treatment device in US
Nexstim said today it launched its Navigated Brain Therapy transcranial magnetic stimulation system designed to treat major depressive disorder in the US, having won FDA approval for the device last November. The Helsinki-based company announced the launch at the Clinical TMS Society’s annual meeting in New York. “We are extremely pleased to announce the launch of […]
7 medtech stories we missed this week: Nov. 17, 2017
From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. […]
Finland extends due date on Nexstim R&D loans
Nexstim said today that the Finnish Funding Agency for Innovation has agreed to extend the due date for repayment of 2 of its research & development project loans. According to Loans Geeks, the company was supposed to provide cash repayments up to €1.8 million ($2 million) between 2017 and 2019. Now, that range has been pushed […]
Slow enrollment delays Nexstim pivotal trial
Nexstim said today that slow enrollment in pivotal trial of its Navigated Brain Therapy transcranial magnetic stimulation device in treating patients rehabilitating from stroke. The 60-patient E-Fit study, launched in March, is designed to supplement Nexstim’s already complete Niche study. The Finnish company originally expected to conclude the E-Fit supplemental during the 1st quarter next year, but said […]
7 medtech stores we missed this week: March 10, 2017
The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are 7 medtech stories we missed this week but were still worth mentioning. 1. FDA clears Medela’s neonatal enteral feeding device Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal […]
7 medtech stories we missed this week: Feb. 24, 2017
Several companies made distribution deals this week, while others received approval for their products. Here are 7 medtech stories we missed this week but were still worth mentioning. 1. Israel OKs E-Qure’s BST device for chronic wounds E-Qure Corp. announced this week that it received marketing approval for its Bio-electrical Signal Therapy Device (BST Device) from […]
Nexstim wins CE Mark for brain therapy treatment for chronic neuropathic pain
Brain therapy system developer Nexstim said late last month it won expanded CE Mark approval in the European Union for its Navigated Brain Therapy system, now cleared for the relief of chronic neuropathic pain. The NBT system uses navigated transcranial magnetic stimulation to treat exact areas in the brain using a 3D image rendered from […]
HeartWare nabs JenaValve exec Leadley for medical chief | Personnel Moves
