PRECLINICAL TESTING
Implant Pathology
Our founder, Dr. Kamal, is one of very few pathology experts in the implantable medical device field (Implant Pathology). He was one of the main contributors to the first ever long-term implantable glucose sensors, when he designed the first clinical pilot study in which 10 diabetic patients were implanted with a long-term glucose sensor. Dr. Kamal managed the preclinical trial and authored the FDA submission, which resulted in approval of the pilot study.
OmniPathology under Dr. Kamal’s leadership participated in numerous preclinical GLP studies for many implantable products. Our GLP protocols allow us to provide this unique service.
“Since 2003, I have been using the pathology services of OmniPathology for our implantable medical device preclinical studies. As a chief scientists and director of regulatory affairs for many medical device companies (Advanced Bionics, Boston Scientific), we were looking for a pathology expert who has knowledge of the FDA regulations and familiar with implantable devices. We were also looking for a laboratory that is capable of conducting GLP studies. We found our need in Dr. Mohammad Kamal and OmniPathology. It was tremendously advantageous that OmniPathology is local. In the past, it was very challenging to use out of state laboratories. With OmniPathology, we can have face-to-face meeting with Dr. Kamal at our location or at Omni’s facility in Pasadena, where Dr. Kamal can present his findings to our team.
Dr. Kamal’s past experience in the medical device industry was extremely valuable to us. He is very resourceful. In addition to being accurate, relevant and comprehensive, Omni reports always include a table summary of the findings and representative photomicrographs. These features are of great value in our FDA submissions. Furthermore, OmniPathology has an excellent turnaround time.
I recommend Dr. Kamal and OmniPathology without hesitation.”
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