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FDA Warns Against Thermography Breast Cancer Detection

By MedImaging International staff writers
Posted on 11 Mar 2019

Thermography should not be used as an alternative to mammography for breast cancer screening or diagnosis, warns the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

The FDA safety communication was issued to alert women, health care providers, and those wishing to undergo breast cancer screening that thermography is not an effective alternative to mammography, and should not be used in place of mammography for breast cancer screening or diagnosis. The safety communication followed a warning letter issued on February 22, 2019, to Total Thermal Imaging (La Mesa, CA, USA) for marketing and promoting thermography devices for uses that have not received marketing clearance or approval.

The FDA clarified that thermography devices, also known as digital infrared (IR) imaging devices, have been cleared for marketing only for use with another screening or diagnostic test like mammography, and not for use as a standalone diagnostic tool, and that there is no valid scientific data to demonstrate that thermography devices are an effective screening tool for any medical condition, including the early detection of breast cancer or other diseases and health conditions. Thermography is not a substitute for regular mammograms, and should not be used in place of mammography for breast cancer screening or diagnosis.

The FDA also issued several recommendations for health care providers, including that they educate patients about the limitations of thermography, such as that the high false negative and false positive rates of thermography can provide misleading information that could result in a delayed diagnosis or unnecessary medical follow up. Providers should also discourage the use of thermography to diagnose or screen for breast cancer and talk to patients or caregivers about safe and effective ways to screen for breast cancer, including the benefits and risks of available testing options, clinical breast exams, and other breast imaging options such as ultrasound or MRI, or breast tissue biopsy.

“The FDA is aware that health spas, homeopathic clinics, mobile health units, and other health care facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis,” stated the FDA. “These types of facilities provide false information that can mislead patients into believing that thermography can find breast cancer years before it would be detected through other methods or thermography improves detection of cancer in dense breasts.”

Thermography refers to digital infrared thermal imaging (DITI), a test that detects temperature changes on the surface of the skin using an IR thermal camera to record the areas of different temperature in the breasts. The camera displays these patterns as a heat map. As the presence of a tumor is associated with the excessive formation of blood vessels and inflammation in the breast tissue, the theory is that these changes should show up on the IR image as areas with a higher skin temperature.

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70 (312.08992004395): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294777205 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

71 (235.08071899414): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294777205 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

72 (38.14697265625): 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 (576.97296142578): SELECT show_live FROM jos_com_show_setting LIMIT 1

74 (39.100646972656): SELECT show_live FROM jos_com_show_setting LIMIT 1

75 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1

76 (201.94053649902): SELECT show_live FROM jos_com_show_setting LIMIT 1

77 (30.994415283203): SELECT show_live FROM jos_com_show_setting LIMIT 1

78 (28.848648071289): SELECT show_live FROM jos_com_show_setting LIMIT 1

79 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1

80 (169.03877258301): SELECT show_live FROM jos_com_show_setting LIMIT 1

81 (32.186508178711): SELECT show_live FROM jos_com_show_setting LIMIT 1

82 (396.9669342041): SELECT show_live FROM jos_com_show_setting LIMIT 1

83 (39.100646972656): SELECT show_live FROM jos_com_show_setting LIMIT 1

84 (28.848648071289): SELECT show_live FROM jos_com_show_setting LIMIT 1

85 (312.08992004395): SELECT show_live FROM jos_com_show_setting LIMIT 1

86 (33.140182495117): SELECT show_live FROM jos_com_show_setting LIMIT 1

87 (!!!!! 1168.0126190186): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294777205 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

88 (49.114227294922): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294777205 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

89 (35.04753112793): 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 (56.028366088867): SELECT show_live FROM jos_com_show_setting LIMIT 1

91 (28.848648071289): SELECT show_live FROM jos_com_show_setting LIMIT 1

92 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

93 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

94 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1

95 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1

96 (32.901763916016): SELECT show_live FROM jos_com_show_setting LIMIT 1

97 (33.140182495117): SELECT show_live FROM jos_com_show_setting LIMIT 1

98 (36.001205444336): SELECT show_live FROM jos_com_show_setting LIMIT 1

99 (30.040740966797): SELECT show_live FROM jos_com_show_setting LIMIT 1

100 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

101 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

102 (30.994415283203): SELECT show_live FROM jos_com_show_setting LIMIT 1

103 (36.954879760742): SELECT show_live FROM jos_com_show_setting LIMIT 1

104 (442.0280456543): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

105 (60.081481933594): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

106 (55.074691772461): 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=294777205 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

107 (44.107437133789): 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=294777205 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

108 (161.88621520996): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

109 (119.20928955078): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

110 (67.234039306641): 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=294777205 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

111 (416.04042053223): 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=294777205 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

112 (537.87231445312): 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 (349.99847412109): 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 (968.93310546875): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

115 (58.889389038086): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

116 (56.028366088867): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

117 (43.153762817383): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

118 (49.829483032227): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

119 (122.0703125): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

120 (266.07513427734): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`

121 (!!!!! 46982.049942017): 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 (79.870223999023): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

123 (46.014785766602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

124 (442.9817199707): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294777205 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294777205 AND type='deeppockets_item' AND published='1' LIMIT 1

125 (!!!!! 800919.05593872): ( 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 (81.062316894531): ( 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 (61.03515625): 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 (40.054321289062): 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 (39.815902709961): 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 (29.087066650391): 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 (27.894973754883): 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 (27.894973754883): 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 (408.88786315918): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

134 (319.00405883789): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

135 (41.007995605469): SELECT name FROM jos_deeppockets WHERE id=215

136 (26.941299438477): SELECT name FROM jos_deeppockets WHERE id=215

137 (431.06079101562): 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 '((;)|(^))215((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3

138 (333.07075500488): 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 '((;)|(^))215((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3

139 (58.889389038086): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

140 (39.100646972656): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

141 (!!!!! 4607.9158782959): TRUNCATE TABLE jos_trademed_module

142 (142.81272888184): 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=294777205 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

143 (945.09124755859): 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=294777205 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

144 (!!!!! 1875.1621246338): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

145 (69.141387939453): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

146 (56.982040405273): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

147 (41.007995605469): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

148 (!!!!! 1054.048538208): 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 (66.995620727539): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

150 (42.200088500977): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

151 (230.07392883301): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294777205 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294777205 AND type='deeppockets_item' AND published='1' LIMIT 1

152 (67.949295043945): 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=215 or channel_id is null)

153 (47.922134399414): 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=215 or channel_id is null)

154 (51.021575927734): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1

155 (138.99803161621): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

156 (62.942504882812): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294777205 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294777205 AND published='1' LIMIT 1

157 (65.803527832031): select jos_twitters.link from jos_twitters where cat=10

158 (46.968460083008): select jos_facebook.link from jos_facebook where cat=10

159 (26.941299438477): select jos_google_plus.link from jos_google_plus where cat=10

160 (45.061111450195): select jos_linkedin.link from jos_linkedin where cat=10

161 (254.86946105957): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)

162 (!!!!! 3648.042678833): insert into jos_banners_delta values (14615,'2025-06-19 19:47:33','216.73.216.120','view'),(14202,'2025-06-19 19:47:33','216.73.216.120','view'),(14203,'2025-06-19 19:47:33','216.73.216.120','view')

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