Total review times for 510(k) submissions have increased by more than 55 percent since 2005 because of poor quality submissions by medical device manufacturers, according to a July 2011 FDA report. Tim Kulbago, President & CEO of ImageIQ, tells us how to increase funding and improve regulatory approvals with extremely powerful imaging data.
Interview Highlights with Tim Kulbago
- How ImageIQ turns subjective opinion into hard data and visual results.
- Examples of how imaging and analytics have made the difference in medical device approvals by the FDA.
- Can image analytics really help to reduce the length and cost of pre-market approvals and enhance post-market surveillance?
- Improving physician-adoption through enhanced image analytics.
- Tim’s advice for other medical device doers.
Tim Kulbago is the President and CEO of Image IQ, a Cleveland Clinic Innovations company that specializes in utilizing software engineering, high-resolution 2D/3D/4D imaging, and custom-tailored image analysis and visualization to support a vast array of biomedical preclinical and clinical specialties. Tim has over 14 years of experience in the medical imaging industry. Most recently he was responsible for two businesses within Merge Healthcare (NASDAQ: MRGE). Tim was formerly the Chief Technology Officer of RIS Logic, a Solon Ohio based start-up company which created an industry-leading information system for radiology practices. Before joining the medical industry, Tim spent several years as a Research Assistant at the Applied Research Laboratory at The Pennsylvania State University, developing virtual reality training and visualization systems. Tim holds a Bachelor of Science degree from John Carroll University in Cleveland Ohio with studies in Computer Science, Physics and Math, and was honored with their “Distinguished Physics Alumnus Award” in 2004. He has a Master’s Degree in Acoustics from The Pennsylvania State University.
Total review times for 510(k) submissions have increased by more than 55 percent since 2005 because of poor quality submissions by medical device manufacturers, according to a July 2011 FDA report. Tim Kulbago, President & CEO of ImageIQ, tells us how to increase funding and improve regulatory approvals with extremely powerful imaging data.
Interview Highlights with Tim Kulbago
- How ImageIQ turns subjective opinion into hard data and visual results.
- Examples of how imaging and analytics have made the difference in medical device approvals by the FDA.
- Can image analytics really help to reduce the length and cost of pre-market approvals and enhance post-market surveillance?
- Improving physician-adoption through enhanced image analytics.
- Tim’s advice for other medical device doers.
Tim Kulbago is the President and CEO of Image IQ, a Cleveland Clinic Innovations company that specializes in utilizing software engineering, high-resolution 2D/3D/4D imaging, and custom-tailored image analysis and visualization to support a vast array of biomedical preclinical and clinical specialties. Tim has over 14 years of experience in the medical imaging industry. Most recently he was responsible for two businesses within Merge Healthcare (NASDAQ: MRGE). Tim was formerly the Chief Technology Officer of RIS Logic, a Solon Ohio based start-up company which created an industry-leading information system for radiology practices. Before joining the medical industry, Tim spent several years as a Research Assistant at the Applied Research Laboratory at The Pennsylvania State University, developing virtual reality training and visualization systems. Tim holds a Bachelor of Science degree from John Carroll University in Cleveland Ohio with studies in Computer Science, Physics and Math, and was honored with their “Distinguished Physics Alumnus Award” in 2004. He has a Master’s Degree in Acoustics from The Pennsylvania State University.
