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FDA Approves RadNet Cancer Technologies

RadNet Inc. announced that two of its subsidiaries received approval from the Food and Drug Administration for their mammography and prostate artificial intelligence tools.
RadNet is a publicly traded diagnostic imaging company based in Los Angeles. Revenue for the company increased 8.4% year-over-year to $341.8 million in the first quarter of 2022, according to the company’s most recent quarterly report.

DeepHealth is a subsidiary of RadNet that had its cancer detection tool, Saige-Dx, approved by the FDA. Saige-Dx identifies suspicious lesions in mammograms and assigns a suspicion level to each finding and to the entire case. The AI tool specifically helps detect and diagnose breast cancer and reduces unnecessary recalls.

“In our study to support FDA clearance, all 18 radiologists who participated exhibited improved performance when using Saige-Dx, resulting in the largest increase in performance across all mammography AI products on the market to date,” Dr. Bill Lotter, DeepHealth’s chief technology officer, said in a statement. “The improved performance was reflected in both an increase in the percentage of the cancers detected and a lower false positive rate when using Saige-Dx.”

Dr. Gregory Sorensen, chief executive and co-founder of DeepHealth, added that Saige-Dx has shown the ability to find cancer one to two years quicker than trained breast imaging radiologists.
“The feedback from physicians who have worked with our software tools is overwhelmingly positive, making them more accurate and efficient at interpreting mammography images,” Sorensen said in a statement.

Quantib, another RadNet subsidiary, received FDA approval for Quantib Prostate, an AI-powered software that aids in MRI prostate reporting workflow. The software’s tools will help improve reporting quality and speed.
“We are delighted to present this update of Quantib Prostate, including a selection of new features that our customers requested over the past few months,” Arthur Post Uiterweer, chief executive of Quantib, said in a statement. “We seek to continuously improve our software to support radiologists and urologists in the best way possible, and we deliver updated solutions to our customers as quickly as possible.”

“We are very proud that two of our subsidiaries, DeepHealth and Quantib, have received FDA clearance for their flagship products,” Dr. Howard Berger, chief executive of RadNet, said in a statement. “Artificial intelligence will have a transforming impact on radiology and cancer care, and we are committed to delivering those advances to patients and health care providers.”
Prior to the FDA approvals, Berger stated in RadNet’s first-quarter earnings report that the company projected losses for the next 24 months from investments in new technologies.

Paola Mendez
Paola Mendez
Paola Mendez graduated from Los Angeles Valley College, then transferred to University of California, and now serves as a Receptionist and Office Assistant to the Los Angeles Business Journal. Paola wears many hats in different departments and is trilingual in English, Spanish and French.
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