FDA Grants Clearance to Perspectum’s CoverScan – A New Platform-Based Tool to Assess Multiple Organs in One MRI Scan
- May 22, 2022
Perspectum’s CoverScan Obtains FDA Clearance; Builds on Recent UKCA Marking, Oxford, United Kingdom, May 25, 2022 — On May 19, 2022, the United States Food and Drug Administration (FDA) granted 510(k) clearance to Perspectum’s CoverScan, a noninvasive multiparametric advanced cloud-based software suite that provides comprehensive assessments of six organs, including the heart, liver, lungs, kidneys, pancreas, and spleen. The FDA’s action further solidifies Perspectum as a global leader in the development of medical quantitative assessment technologies.
“CoverScan’s clearance by the FDA is an exciting step forward in Perspectum’s journey towards achieving better outcomes for millions of patients. Our goal is to enable healthcare providers to use precision medicine to meet the needs of the individual,” said CEO of Perspectum, Rajarshi Banerjee, Ph.D., M.D.
Perspectum’s multi-organ software as a service (SaaS) solution is built for existing MRI scanners and uses artificial intelligence (AI) algorithms. The same medical technology recently received UKCA certification and is part of the protocol for a 2-year, 2,000 patient long COVID study in the U.K. called Stimulate-ICP.
“The clearance of Perspectum’s CoverScan imaging technology by FDA and its UKCA certification represents great strides in building the company. By applying AI to imaging (MRI), Perspectum is building a platform of technologies that will provide a new level of decision-support for physicians,” said Michael Rosenblatt, M.D., a member of the Perspectum Board of Directors.
CoverScan joins the Perspectum family of FDA-cleared platform-based products, including LiverMultiScan, Hepatica, and MRCP+ — all developed to empower physicians with fast and accurate information to assess patient health. The multiparametric multi-organ technology has been available as a tool to aid diagnosis within the U.K.’s National Health Service (NHS) since January 2021, under the Medicines & Healthcare products Regulatory Agency’s (MHRA) temporary authorization, in response to the COVID-19 pandemic.
“As we wait for a final determination from the United States Centers for Medicare and Medicaid Services on coverage within Medicare and Medicaid, Perspectum is currently focusing on imaging centers, hospital systems, and physicians across the country for adoption. We believe the voice of the patient matters and that each case is unique,” continued Dr. Banerjee. “Use in the National Health Service can serve as a benchmark, and we expect clinicians in the U.S. may soon see value in adding CoverScan to their imaging services.”
Perspectum, a global medical technology company with offices in the U.K., the U.S., Portugal and Singapore, delivers leading digital technologies that help clinicians provide better care for patients with chronic metabolic diseases, multi-organ pathology, and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers, and technologists, Perspectum offers a way to manage complex health problems at scale.
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