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Nexstim

NexStim wins Health Canada approval for NBS, NexSpeech

March 29, 2019 By Fink Densford

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. […]

Filed Under: Neurological, Regulatory/Compliance Tagged With: Nexstim

FDA clears shorter protocol for Nexstim’s NBT TMS depression treatment

March 25, 2019 By Fink Densford

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 […]

Filed Under: Food & Drug Administration (FDA), Neurological, Regulatory/Compliance Tagged With: Nexstim

Nexstim pulls trigger on 30-to-1 reverse split

November 28, 2018 By Fink Densford

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 […]

Filed Under: Business/Financial News, Wall Street Beat Tagged With: Nexstim

Nexstim launches NBT major depressive disorder TMS treatment device in US

May 9, 2018 By Fink Densford

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 […]

Filed Under: Business/Financial News, Neurological, Neuromodulation/Neurostimulation Tagged With: Nexstim

7 medtech stories we missed this week: Nov. 17, 2017

November 17, 2017 By Danielle Kirsh

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. […]

Filed Under: 510(k), Diagnostics, Digital Health, Food & Drug Administration (FDA), Neurological, Neuromodulation/Neurostimulation, Regenerative Medicine, Regulatory/Compliance, Research & Development Tagged With: Helomics, InnerScope, iReliev, LensAR Inc., MedTech, Mevion Medical Systems, Mortise Medical, Nexstim, Skyline Medical

Finland extends due date on Nexstim R&D loans

June 2, 2017 By Sarah Faulkner

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 […]

Filed Under: Funding Roundup, Neurological, Wall Street Beat Tagged With: Nexstim

Slow enrollment delays Nexstim pivotal trial

May 19, 2017 By Brad Perriello

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 […]

Filed Under: Clinical Trials, Neuromodulation/Neurostimulation Tagged With: Nexstim, Stroke

7 medtech stores we missed this week: March 10, 2017

March 10, 2017 By Danielle Kirsh

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 […]

Filed Under: Biotech, Cardiac Implants, Cardiovascular, Clinical Trials, Regulatory/Compliance, Spine Tagged With: Abiomed, Exact Imaging, IntelliJoint Surgical, InVivo Therapeutics, Medela, Nexstim, Pavmed

7 medtech stories we missed this week: Feb. 24, 2017

February 24, 2017 By Danielle Kirsh

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 […]

Filed Under: Digital Health, Electronic Medical Records (EMR), Imaging, Mergers & Acquisitions, Regulatory/Compliance Tagged With: aligntechnology, Clarius Mobile Health, Corin Group, E-Qure, Henry Schein Medical, Nexstim, Skyline Medical

Nexstim wins CE Mark for brain therapy treatment for chronic neuropathic pain

July 8, 2016 By Fink Densford

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 […]

Filed Under: Neurological, Neuromodulation/Neurostimulation, Pain Management, Regulatory/Compliance Tagged With: Nexstim

HeartWare nabs JenaValve exec Leadley for medical chief | Personnel Moves

August 12, 2014 By Brad Perriello Leave a Comment

HeartWare nabs JenaValve exec Leadley for medical chief | Personnel Moves

Filed Under: News Well Tagged With: AngioDynamics, eLux Medical, HeartWare International Inc., JenaValve, Nexstim, Nuvasive, NxStage Medical Inc., Orgenesis, Perseon, Personnel Moves, Revolutions Medical Corp., Terumo, X2 Biosystems

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