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Improved Molecular Breast Imaging Screening System Receives CE Marking

By MedImaging International staff writers
Posted on 26 Oct 2015

A breast imaging medical device manufacturer has announced that their Molecular Breast Imaging (MBI) system, intended for women with dense breast tissue, has received the European CE Marking.

The MBI screening system is already in use in leading hospitals in the US following approval by the US Food and Drug Administration (FDA) in 2011. The system is intended for the screening and early detection of breast cancer in women with dense breast tissue for whom conventional mammography and screening with other modalities is insufficient.

CE Marking approval of the LumaGEM MBA screening system was announced by the manufacturer, Gamma Medica (Salem, NH, USA), a women’s health company, and enables the company to sell and distribute the system in the European Economic Area (EEA).

Nearly one in 10 women in Europe develops breast cancer before the age of 80, making it the common cancer affecting women. Conventional mammography has less sensitivity when imaging dense breast tissue – both dense tissue and cancerous areas appear white on the mammogram. At the same time women with dense breast have an increased risk of developing breast cancer. A recent has shown that the addition of MBI screening test to an annual mammogram resulted in a nearly 400% percent increase in detection rates of invasive breast cancer. The use of MBI screening also resulted in 50% less biopsies, and cost savings of 15% per cancer detected, compared to only screening with conventional mammography.

MBI is a functional imaging modality and can show activity and detect tumors in dense tissue, whereas other modalities such as ultrasound, Magnetic Resonance Imaging (MRI), and tomosynthesis, are anatomical imaging systems. MBI is also useful for high-risk patients, and those who cannot undergo an MRI exam.

Philip M. Croxford, President and CEO of Gamma Medica, said, “Securing the CE Mark for the LumaGEM MBI system represents a major step forward in our commercialization plans to market this technology to benefit women with dense breast tissue in Europe. By offering the best MBI solution to physicians, we are helping them manage their patients’ risk efficiently by providing a highly accurate and cost-efficient secondary breast cancer screening for women with complex mammograms and dense breast tissue.”

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69 (43.869018554688): 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=211 ORDER BY `ordering`

70 (627.99453735352): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294761021 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

71 (!!!!! 4009.0084075928): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294761021 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

72 (219.10667419434): 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 (556.23054504395): SELECT show_live FROM jos_com_show_setting LIMIT 1

74 (195.02639770508): SELECT show_live FROM jos_com_show_setting LIMIT 1

75 (39.100646972656): SELECT show_live FROM jos_com_show_setting LIMIT 1

76 (303.03001403809): SELECT show_live FROM jos_com_show_setting LIMIT 1

77 (60.081481933594): SELECT show_live FROM jos_com_show_setting LIMIT 1

78 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1

79 (412.94097900391): SELECT show_live FROM jos_com_show_setting LIMIT 1

80 (41.007995605469): SELECT show_live FROM jos_com_show_setting LIMIT 1

81 (102.04315185547): SELECT show_live FROM jos_com_show_setting LIMIT 1

82 (38.14697265625): SELECT show_live FROM jos_com_show_setting LIMIT 1

83 (35.04753112793): SELECT show_live FROM jos_com_show_setting LIMIT 1

84 (35.04753112793): SELECT show_live FROM jos_com_show_setting LIMIT 1

85 (35.04753112793): SELECT show_live FROM jos_com_show_setting LIMIT 1

86 (36.001205444336): SELECT show_live FROM jos_com_show_setting LIMIT 1

87 (!!!!! 1214.9810791016): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294761021 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

88 (48.160552978516): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294761021 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

89 (145.91217041016): 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 (627.04086303711): SELECT show_live FROM jos_com_show_setting LIMIT 1

91 (46.014785766602): SELECT show_live FROM jos_com_show_setting LIMIT 1

92 (!!!!! 2295.0172424316): SELECT show_live FROM jos_com_show_setting LIMIT 1

93 (413.89465332031): SELECT show_live FROM jos_com_show_setting LIMIT 1

94 (53.167343139648): SELECT show_live FROM jos_com_show_setting LIMIT 1

95 (38.862228393555): SELECT show_live FROM jos_com_show_setting LIMIT 1

96 (221.96769714355): SELECT show_live FROM jos_com_show_setting LIMIT 1

97 (41.007995605469): SELECT show_live FROM jos_com_show_setting LIMIT 1

98 (248.90899658203): SELECT show_live FROM jos_com_show_setting LIMIT 1

99 (41.961669921875): SELECT show_live FROM jos_com_show_setting LIMIT 1

100 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1

101 (38.14697265625): SELECT show_live FROM jos_com_show_setting LIMIT 1

102 (200.98686218262): SELECT show_live FROM jos_com_show_setting LIMIT 1

103 (39.815902709961): SELECT show_live FROM jos_com_show_setting LIMIT 1

104 (783.20503234863): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

105 (211.00044250488): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

106 (242.94853210449): 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=294761021 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

107 (644.92225646973): 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=294761021 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

108 (!!!!! 2728.9390563965): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

109 (216.00723266602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

110 (302.07633972168): 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=294761021 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

111 (733.85238647461): 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=294761021 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

112 (!!!!! 1010.8947753906): 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 (581.02607727051): 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 (397.92060852051): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

115 (257.01522827148): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

116 (427.0076751709): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

117 (61.988830566406): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

118 (382.90023803711): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

119 (220.06034851074): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

120 (231.98127746582): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

121 (190.97328186035): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

122 (444.17381286621): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`

123 (!!!!! 66824.913024902): 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

124 (657.08160400391): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294761021 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294761021 AND type='deeppockets_item' AND published='1' LIMIT 1

125 (327.82554626465): ( 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 (51.021575927734): ( 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 (236.03439331055): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1

128 (46.968460083008): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1

129 (322.81875610352): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1

130 (169.99244689941): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1

131 (43.153762817383): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1

132 (38.862228393555): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1

133 (199.0795135498): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1

134 (44.107437133789): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1

135 (!!!!! 1418.8289642334): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

136 (864.02893066406): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

137 (231.02760314941): SELECT name FROM jos_deeppockets WHERE id=211

138 (44.107437133789): SELECT name FROM jos_deeppockets WHERE id=211

139 (777.9598236084): 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 '((;)|(^))211((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3

140 (630.85556030273): 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 '((;)|(^))211((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3

141 (789.88075256348): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

142 (!!!!! 1760.9596252441): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

143 (!!!!! 20527.124404907): TRUNCATE TABLE jos_trademed_module

144 (!!!!! 4472.9709625244): 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=294761021 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

145 (!!!!! 3311.8724822998): 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=294761021 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

146 (!!!!! 1462.9364013672): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

147 (265.12145996094): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

148 (!!!!! 6106.1382293701): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

149 (553.13110351562): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

150 (!!!!! 2374.8874664307): 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

151 (!!!!! 2934.2174530029): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

152 (608.92105102539): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

153 (51.975250244141): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294761021 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294761021 AND type='deeppockets_item' AND published='1' LIMIT 1

154 (112.05673217773): 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=211 or channel_id is null)

155 (166.89300537109): 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=211 or channel_id is null)

156 (180.00602722168): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1

157 (581.97975158691): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

158 (519.99092102051): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761021 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761021 AND published='1' LIMIT 1

159 (425.81558227539): select jos_twitters.link from jos_twitters where cat=10

160 (41.007995605469): select jos_facebook.link from jos_facebook where cat=10

161 (36.954879760742): select jos_google_plus.link from jos_google_plus where cat=10

162 (188.11225891113): select jos_linkedin.link from jos_linkedin where cat=10

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