NEW YORK, Sept. 17, 2015 /PRNewswire-iReach/ -- Picofemto LLC today announced it has received FDA 510(k) clearance on its Cliniscan platform and Cliniscan EEG, its first diagnostic and imaging software modality. Cliniscan is a cloud-based platform designed to aid clinicians at the point of interpretation for rapid analysis of complex data, including neurology, radiology, and ophthalmology. The Cliniscan EEG modality, the first of several planned modalities, incorporates industry standards of measurement and supports the clinician by providing comprehensive visualization and analysis of the EEG including activity localization, coherence mapping, and signal analysis. Cliniscan EEG incorporates automated seizure detection and classification.
Picofemto designed and evaluated the Cliniscan platform through a clinical study, enabling the FDA to assess the core platform, visualizer, and the Cliniscan seizure detection algorithms. The FDA cleared these components in May 2015, with supporting evidence that found Cliniscan EEG to be equal and/or superior across each category evaluated compared with current leading EEG analysis devices. Four new modalities are being developed, validated, and prepared for submission to the FDA in the coming quarters, including MR-DTI, fundus imaging, PET/CT of the lung, and MR of the prostate.
“We’re very excited about the FDA clearance of the Cliniscan platform and Cliniscan EEG modality,” said Dr. Andre Khoury, Founder and Chief Medical Officer. “I can see that this will make a significant difference in time, convenience, accuracy, and efficiency for physicians, technicians, and healthcare facilities everywhere.”
Cliniscan leverages the power and security of the cloud in order to support providers through proprietary algorithms and enhanced visualization services. Cliniscan is accessible via a web browser anywhere, anytime regardless of geographic location.
“Given our experience with clinical practice, we developed the Cliniscan platform to be as nimble and flexible as possible, to deliver multiple diagnostic and imaging modalities across organs and acquisition types,” said Fady Rizk, Founder and President of Picofemto. “FDA clearance of the Cliniscan platform should allow us to rapidly prepare the protocols to gain clearance on our subsequent products.”
As part of its rapid deployment strategy, Picofemto has initiated partnership agreements with leading academic medical centers in the New York Metropolitan area, reaching a total population of more than one million patients annually. Furthermore, Picofemto has engaged in technology agreements with top universities to incorporate advanced algorithms for delivery through Cliniscan.
Picofemto was founded in late 2012, raised approximately $3MM in a Round A offering, and has initiated a Round B series of financing. Since inception, Picofemto has focused on acquiring the best talent and relationships to ensure quality and precision in creating innovative products. Srikant Krishna, Founder and CEO of Picofemto states “Diagnostic imaging is a hotbed of activity right now. We are fortunate to have our team, which is comprised of a distinct combination of skill sets necessary to ensuring that the products in our platform make diagnostic visualization clearer, easier, and faster to help providers. Everyone here has that singular mission in mind and it really drives us forward, as we grow and rapidly develop these much-needed solutions.”
About Picofemto
Picofemto was founded with the goal of enabling clinicians to avail high-throughput data analytics and innovative visualization for complex biomedical data. The company is comprised of a team of software engineers, biomedical experts, and quality assurance professionals that develop cloud-based solutions and browser-based visualizers to support providers in decision-making and computer-aided detection.
For more information on Picofemto or the Cliniscan suite of products, please contact 844-847-2696, e-mail contact@picofemto.com, or visit http://www.picofemto.com.
Media Contact:Srikant Krishna, Picofemto LLC, 844-847-2696, contact@picofemto.com
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Photo - http://photos.prnewswire.com/prnh/20150916/267049
SOURCE Picofemto LLC
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