BioImagene

Recipient: BioImagene
Product: PATHIAM software
Date: 5/25/05

According to your website, PATHIAM is “a hardware-independent, Web-enabled software allowing pathologists to view and analyze immunohistochemically-stained (IHC-stained) slides from any computer via the Internet.” PATHIAM is a device as that term is defined in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S .C. 321(h)) (“the Act”) because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or because it is intended to affect the structure or any function of the body.

The Frequently Asked Questions (FAQ) section of your website notes that “PATHIAM is an intelligent image analysis software system designed to fulfill the needs of objective analysis of oncopathology images. It is [an] information driven Histopathological and Cytopathologic image analysis, quantification, management and retrieval system that assists pathologists in detection, counting, classification and evaluation of cells and tissues in the given image, and caters to the smarter diagnostic practices needed by researches, oncopathologists, and physicians, in their war against cancer – a step ahead in pathological diagnosis and prognosis.”

Issuer: Center for Devices and Radiological Health (CDRH)

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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