White Paper: Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
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One in five Americans will develop skin cancer in their lifetime, and this ratio will continue to grow as generations continue to age. As a result, it’s become increasingly difficult for patients to schedule an appointment with a dermatologist, which contributes to disease progression and increased stress for the patients.
3Derm is a Boston-based technology startup focused on optimizing the dermatology care process. 3Derm aspired to increase dermatology patient access to care by creating a hand-held stereoscopic imaging system for remote skin monitoring. Initial efforts to marry their software with iPhone cameras resulted in a high number of false negatives. After realizing that commercial cameras were incapable of producing the images necessary for an accurate diagnosis, 3Derm turned to Veranex (formerly Ximedica) to develop an integrated software and imaging device.
3Derm elicited Veranex’s expertise in:
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In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss...
During this session, Brandon Bogdalek will interview three (3) panelists in the diagnostics industry. The panelists will discuss best practices for...