Brainscope ahead 100
WebMar 8, 2011 · BrainScope® Prepares to Introduce Ahead™ EU-100 to Aid in Assessment of Head Injury in the United Kingdom /PRNewswire/ -- BrainScope Company, Inc. announced today that it is preparing for...
Brainscope ahead 100
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WebBrainScope Company Inc. Michael Singer CEO 4350 East West Hwy, Ste 1050 Bethesda, Maryland 20814 Re: K183241 Trade/Device Name: BrainScope TBI (Model: Ahead 400) Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, … WebBrainScope Launches Next-Gen Medical Device: First and only FDA-cleared system for true point-of-care assessment of both concussion and brain bleeds now includes Concussion Index BrainScope today announced the availability of its third groundbreaking FDA-cleared algorithm on the BrainScope device.
WebFeb 15, 2024 · BrainScope is a medical neurotechnology company that is developing a new generation of handheld, easy-to-use, non-invasive devices designed to aid medical professionals in rapidly and objectively assessing various neurological conditions, starting with traumatic brain injury including concussion. Web2006. Type: Company - Private. Industry: Health Care Products Manufacturing. Revenue: $1 to $5 million (USD) Competitors: Unknown. Changing Lives through Technology …
Webbrainscope ahead 100: brainscope company, inc: den140025: 11/17/2014: heartflow ffrct: heartflow: den130045: 11/26/2014: perkinelmer enlite neonatal trec test sy: wallac oy: den140010: 12/15/2014: amigo remote catheter system: catheter robotics inc: den140009: 12/18/2014: moerae surgical marking pen WebAug 19, 2015 · In late 2012, BrainScope announced that it had been awarded a $2.67 million contract by the United States Army for development of the Ahead 200, a smaller, more rugged and modernized version of its Ahead 100 …
WebDec 16, 2011 · BrainScope Company Inc. has been awarded a contract by the United States Department of Defense for the "Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope Ahead Technology." This contract is valued at $7.5 million throughout18 months and is effective immediately. BrainScope's …
WebSep 9, 2011 · There are four co-primary endpoints in this study: two sets of sensitivity and specificity to divide the data into three classes. Using a BrainScope classification algorithm, the Ahead M100 will identify subjects showing sensitivities among 3 classes: Green-normal, nonhead injured controls,Yellow-head injured subjects who do not exhibit brain electrical … the number 94Webepic research & diagnostics inc - epic clearview sys; brainscope company ic - brainscope ahead 100; auxogyn inc - eeva sys, etc q-submission mtgs relating to de novo applications, etc the number 9 millionWebDevice Classification Under Section 513(f)(2)(De Novo) FDA Home; Medical Devices; Databases - 131 to 140 of 358 results Decision Date To: 04/14/2024 michigan ologyWebMar 16, 2012 · Using a BrainScope classification algorithm, the Ahead® M-100 will identify subjects showing sensitivities among 3 classes: Green - brain electrical activity that is … the number 911WebBrainScope® is an FDA-cleared, handheld decision-support tool that uses A.I. and machine learning technology to identify objective biomarkers of structural and functional brain injury in patients with suspected mild … michigan olive oilWebbrain injury adjunctive interpretive electroencephalograph assessment aid. 22. De Novo Number. DEN140025. Device Name. BrainScope Ahead 100. Requester. BRAINSCOPE COMPANY, INC. 4350 east-west hwy. michigan omaWebFeb 7, 2024 · The device was first approved for commercialisation under the name Ahead 300 by the US Food and Drug Administration (FDA) in September 2016. It was launched in January 2024 and received 510(k) certification from the FDA for clinical use in May 2024, when it was re-branded as BrainScope One. ... BrainScope One EEG-based device … the number 943 is between what two tens