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Breakthrough Endoscopic Biopsy Device Enables Definitive Diagnosis of GI Cancers

By MedImaging International staff writers
Posted on 13 Sep 2023
Image: The Precision GI endoscopic ultrasound biopsy device has received US FDA 510(k) clearance (Photo courtesy of Limaca Medical)
Image: The Precision GI endoscopic ultrasound biopsy device has received US FDA 510(k) clearance (Photo courtesy of Limaca Medical)

Endoscopic biopsies serve a crucial role in the precise and timely treatment of cancer by allowing for histologic and genetic testing of tissues. The traditional tools used for these procedures are manual Endoscopic Ultrasound (EUS) needles, which come with several drawbacks. They often throw up several challenges like inconsistent biopsy results, dependency on high-level skills, low standardization, multiple needle passes, suboptimal tissue samples for analysis, and higher rates of insufficient tissue during molecular testing. Now, an automated, motorized endoscopic biopsy device has the potential to improve biopsy results for the evaluation of gastrointestinal (GI) malignancies.

Limaca Medical (Yokneam, Israel) has developed the Precision GI EUS biopsy device, marking a major leap forward in obtaining biopsies for a confirmed diagnosis of pancreatic and other severe GI cancers. Unlike existing tools, this automated device is engineered to more efficiently and effectively diagnose GI cancers by securing substantially better quality and greater amounts of biopsy tissue that is crucial for diagnosis. Traditional endoscopic biopsy devices often fall short in consistently collecting quality and adequate tissue samples, leading to issues like fragmented tissue, insufficient volume, and blood contamination.

Physicians are increasingly favoring the Precision GI EUS biopsy device over older endoscopic biopsy tools because of its capability to obtain higher quality and larger tissue samples necessary for in-depth histological and molecular examinations. Furthermore, the device standardizes outcomes, making it effective across a wide range of physician skill sets. The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to Limaca's Precision GI EUS biopsy device, following the company's earlier FDA Breakthrough Device Designation for the same product.

"Our first series of patients have demonstrated that Precision GI enables obtaining contiguous intact core tissue samples adequate for definitive diagnoses of pancreatic lesions,” said Assaf Klein, Limaca CEO. “The clean, non-contaminated tissue samples provide a high percentage of tumor content, with less blood and extraneous fluids. FDA clearance allows us to bring Precision GI to market to fulfill our mission to always achieve precise, efficient, and definitive biopsy samples."

"We are pleased with FDA's clearance of Precision GI, following our FDA Breakthrough Device Designation,” added Carl Rickenbaugh, Limaca Vice Chair. “We are dedicated to our mission to provide a far better endoscopic biopsy experience for the endoscopist and patient, with the goal of achieving faster, more efficient biopsy yield with highly consistent results. We look forward to soon bringing Precision GI to patients in the US."

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93 (56.028366088867): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294798618 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
94 (61.988830566406): 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`
95 (89.168548583984): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (120.87821960449): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (62.942504882812): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (46.968460083008): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (55.789947509766): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (46.968460083008): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (54.121017456055): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (46.968460083008): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (54.836273193359): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (44.822692871094): SELECT show_live FROM jos_com_show_setting LIMIT 1
105 (48.87580871582): SELECT show_live FROM jos_com_show_setting LIMIT 1
106 (43.153762817383): SELECT show_live FROM jos_com_show_setting LIMIT 1
107 (52.928924560547): SELECT show_live FROM jos_com_show_setting LIMIT 1
108 (45.061111450195): SELECT show_live FROM jos_com_show_setting LIMIT 1
109 (121.8318939209): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
110 (72.956085205078): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
111 (106.0962677002): 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=294798618 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (86.069107055664): 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=294798618 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
113 (128.03077697754): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
114 (92.983245849609): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
115 (563.8599395752): 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=294798618 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
116 (497.10273742676): 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=294798618 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
117 (97.036361694336): 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=294798611 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
118 (503.0632019043): 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=294798611 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
119 (846.86279296875): 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
120 (583.88710021973): 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
121 (139.95170593262): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
122 (94.890594482422): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
123 (94.890594482422): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
124 (67.949295043945): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
125 (82.969665527344): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
126 (73.909759521484): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
127 (128.03077697754): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
128 (61.988830566406): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
129 (344.99168395996): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
130 (!!!!! 33768.177032471): 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
131 (630.14030456543): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294798618 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294798618 AND type='deeppockets_item' AND published='1' LIMIT 1
132 (!!!!! 11734.008789062): ( 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
133 (142.81272888184): ( 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
134 (90.122222900391): 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
135 (57.93571472168): 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
136 (80.108642578125): 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
137 (72.956085205078): 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
138 (341.89224243164): 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
139 (63.896179199219): 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
140 (69.141387939453): 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
141 (55.074691772461): 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
142 (551.93901062012): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
143 (445.12748718262): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
144 (218.86825561523): SELECT name FROM jos_deeppockets WHERE id=214
145 (61.03515625): SELECT name FROM jos_deeppockets WHERE id=214
146 (823.974609375): 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 '((;)|(^))214((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
147 (798.94065856934): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))214((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
148 (108.00361633301): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
149 (82.015991210938): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
150 (!!!!! 13733.148574829): TRUNCATE TABLE jos_trademed_module
151 (145.19691467285): 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=294798618 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
152 (81.062316894531): 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=294798618 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
153 (671.1483001709): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
154 (81.062316894531): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
155 (83.92333984375): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
156 (61.988830566406): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
157 (!!!!! 1711.1301422119): 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
158 (82.015991210938): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
159 (77.009201049805): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
160 (56.982040405273): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294798618 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294798618 AND type='deeppockets_item' AND published='1' LIMIT 1
161 (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=0 or channel_id is null)
162 (41.007995605469): 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=0 or channel_id is null)
163 (63.896179199219): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
164 (200.03318786621): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
165 (494.00329589844): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294798618 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294798618 AND published='1' LIMIT 1
166 (61.988830566406): select jos_twitters.link from jos_twitters where cat=10
167 (41.007995605469): select jos_facebook.link from jos_facebook where cat=10
168 (40.054321289062): select jos_google_plus.link from jos_google_plus where cat=10
169 (40.054321289062): select jos_linkedin.link from jos_linkedin where cat=10
170 (380.9928894043): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14202,14203)
171 (!!!!! 1310.8253479004): insert into jos_banners_delta values (14202,'2025-08-04 04:16:40','216.73.216.210','view'),(14203,'2025-08-04 04:16:40','216.73.216.210','view')