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FDA Clears First-Ever AI Mammography Triage Software that Supports both 3D and 2D Mammography

By MedImaging International staff writers
Posted on 21 Apr 2021

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The US Food and Drug Administration has cleared the first-ever artificial intelligence (AI) mammography triage software that supports both 3D and 2D mammography.

DeepHealth (Cambridge, MA, USA), a subsidiary of RadNet, Inc. (Los Angeles, CA, USA), has received FDA clearance for Saige-Q, its mammography triage software. Saige-Q is a screening worklist prioritization tool that enables radiologists to more effectively manage their mammography cases with the use of AI. DeepHealth’s powerful new AI technology automatically identifies suspicious screening exams that may need prioritized attention, allowing radiologists to optimize their workflow for efficiency and effectiveness.

“Saige-Q is built using our core artificial intelligence algorithms, described in a recent article in Nature Medicine,” said Bill Lotter, Ph.D., CTO, and co-founder of DeepHealth. “As the first FDA-cleared mammography triage product that supports 3D mammography in addition to 2D mammography, Saige-Q demonstrates high performance that is maintained across different breast densities and lesion types.”

“As our first FDA-cleared product, Saige-Q is a major milestone for our team. It represents the first step of many towards delivering the best care possible for patients through rigorous science that clinicians and patients can trust,” said Gregory Sorensen, M.D., CEO, and co-founder of DeepHealth. “We have developed an advanced algorithm to support radiologists with the significant challenge of finding breast cancer as early as possible. Saige-Q empowers radiologists to optimize how and when they read cases marked by Saige-Q as suspicious or those not marked as suspicious, enhancing their ability to deliver the best care.”

“Receiving FDA clearance for our first mammography AI software algorithm is an important step in RadNet’s commitment to delivering the best quality of care for our patients,” added Dr. Howard Berger, President and Chief Executive Officer of RadNet. “With the almost two million mammography exams we perform annually in our markets, we will now begin to deploy this tool, enabling our mammographers to become more accurate and productive. The efficiency gains and accuracy should be further enhanced by a more advanced diagnostic algorithm we plan to submit to the FDA for its review by year end.”

“With the purchase of DeepHealth last year and the ongoing investments we are making in AI, we are dedicated to leading the transformation of our industry into utilizing machine learning to enhance patient outcomes, improve the productivity of radiologists and offer unique screening programs to health insurers which we believe will have a profound impact on population health and wellness,” Dr. Berger noted.

Related Links:
DeepHealth
RadNet, Inc.

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69 (962.97264099121): SELECT id,name,sponsor_text FROM jos_deeppockets dp left outer join jos_channel_sponsor cs on dp.id=cs.fid WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id=217 ORDER BY `ordering`

70 (382.90023803711): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294787962 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

71 (213.1462097168): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294787962 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

72 (62.942504882812): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`

73 (68.902969360352): SELECT show_live FROM jos_com_show_setting LIMIT 1

74 (29.087066650391): SELECT show_live FROM jos_com_show_setting LIMIT 1

75 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1

76 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

77 (23.841857910156): SELECT show_live FROM jos_com_show_setting LIMIT 1

78 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1

79 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1

80 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

81 (24.795532226562): SELECT show_live FROM jos_com_show_setting LIMIT 1

82 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

83 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1

84 (24.795532226562): SELECT show_live FROM jos_com_show_setting LIMIT 1

85 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1

86 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1

87 (61.988830566406): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294787962 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

88 (30.040740966797): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294787962 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

89 (31.948089599609): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`

90 (45.061111450195): SELECT show_live FROM jos_com_show_setting LIMIT 1

91 (99.18212890625): SELECT show_live FROM jos_com_show_setting LIMIT 1

92 (350.9521484375): SELECT show_live FROM jos_com_show_setting LIMIT 1

93 (41.961669921875): SELECT show_live FROM jos_com_show_setting LIMIT 1

94 (386.95335388184): SELECT show_live FROM jos_com_show_setting LIMIT 1

95 (33.140182495117): SELECT show_live FROM jos_com_show_setting LIMIT 1

96 (33.855438232422): SELECT show_live FROM jos_com_show_setting LIMIT 1

97 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1

98 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1

99 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1

100 (27.179718017578): SELECT show_live FROM jos_com_show_setting LIMIT 1

101 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1

102 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1

103 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1

104 (917.91152954102): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

105 (!!!!! 4705.9059143066): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

106 (82.969665527344): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294787962 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

107 (52.928924560547): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294787962 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

108 (!!!!! 3166.9139862061): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

109 (138.99803161621): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

110 (51.021575927734): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294787962 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

111 (399.11270141602): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294787962 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

112 (548.12431335449): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1

113 (344.03800964355): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1

114 (74.148178100586): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

115 (57.93571472168): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

116 (108.00361633301): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

117 (84.161758422852): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

118 (47.922134399414): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

119 (36.954879760742): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

120 (236.03439331055): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`

121 (!!!!! 36298.036575317): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7

122 (88.930130004883): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

123 (43.153762817383): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

124 (427.0076751709): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294787962 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294787962 AND type='deeppockets_item' AND published='1' LIMIT 1

125 (!!!!! 549824.95307922): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3

126 (!!!!! 679973.12545776): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3

127 (108.95729064941): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800513 LIMIT 1

128 (45.061111450195): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800513 LIMIT 1

129 (74.863433837891): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800359 LIMIT 1

130 (39.100646972656): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800359 LIMIT 1

131 (41.961669921875): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800361 LIMIT 1

132 (32.901763916016): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800361 LIMIT 1

133 (592.94700622559): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

134 (516.89147949219): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

135 (272.03559875488): SELECT name FROM jos_deeppockets WHERE id=217

136 (46.014785766602): SELECT name FROM jos_deeppockets WHERE id=217

137 (636.81602478027): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))217((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3

138 (576.97296142578): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))217((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3

139 (91.075897216797): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

140 (65.088272094727): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

141 (!!!!! 9990.930557251): TRUNCATE TABLE jos_trademed_module

142 (139.95170593262): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294787962 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

143 (74.863433837891): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294787962 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

144 (556.94580078125): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

145 (77.962875366211): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

146 (115.15617370605): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

147 (67.949295043945): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

148 (!!!!! 1600.980758667): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6

149 (85.830688476562): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

150 (64.13459777832): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

151 (59.843063354492): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294787962 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294787962 AND type='deeppockets_item' AND published='1' LIMIT 1

152 (46.968460083008): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=217 or channel_id is null)

153 (41.961669921875): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=217 or channel_id is null)

154 (42.915344238281): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1

155 (173.80714416504): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

156 (68.902969360352): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294787962 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294787962 AND published='1' LIMIT 1

157 (53.882598876953): select jos_twitters.link from jos_twitters where cat=10

158 (39.100646972656): select jos_facebook.link from jos_facebook where cat=10

159 (38.14697265625): select jos_google_plus.link from jos_google_plus where cat=10

160 (39.100646972656): select jos_linkedin.link from jos_linkedin where cat=10

161 (389.09912109375): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)

162 (!!!!! 1526.1173248291): insert into jos_banners_delta values (14615,'2025-04-30 21:15:10','3.145.80.205','view'),(14202,'2025-04-30 21:15:10','3.145.80.205','view'),(14203,'2025-04-30 21:15:10','3.145.80.205','view')

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