IDSI PMA judged suitable for filing

AuntMinnie.com staff writers
Jun 17, 2003

CT laser mammography developer Imaging Diagnostic Systems has been notified by the Food and Drug Administration that an initial review of its pre-market approval (PMA) application for its CT breast imaging system has been judged to be suitable for filing. As such, the FDA will now conduct an in-depth evaluation of the safety and effectiveness of the device to determine final approval, according to the Fort Lauderdale, FL-based vendor.

By AuntMinnie.com staff writers
June 18, 2003

Related Reading

Imaging Diagnostic Systems receives 12th U.S. patent, May 29, 2003

Imaging Diagnostic Systems files PMA, April 30, 2003

Imaging Diagnostic Systems adds Berlin site, February 3, 2003

IMDS nets CTLM deal in Dubai, January 23, 2003

IDSI installs CTLM in Berlin, September 12, 2002

Copyright © 2003 AuntMinnie.com

Latest in Breast
Breast Mol
New guidance issued on PET/CT imaging in breast cancer
May 17, 2024
Award-winning research: Screening mammograms showed variable lymph node morphology due to ectopic fat deposition in women with obesity. Image A (above) shows normal axillary lymph nodes measuring < 1.5 cm in 63-year-old woman with a body mass index (BM) = 43.2. Image B shows a possible fat-enlarged axillary node with large fatty hilum measuring 4.2 cm in a 52-year-old woman with a BMI = 45.8. Photo courtesy of American Roentgen Ray Society.
ARRS: Dartmouth poster wins for CVD risk prediction potential using mammograms
May 6, 2024
Breast Cancer3
DBT + CEM boosts cancer detection in women with history of the disease
April 30, 2024
Mammogram Breast
USPSTF finalizes breast cancer screening recommendations
April 30, 2024
Related Stories
Cc99 Ff Dot
Breast
Effective breast CAD still harbors a few workflow caveats
2003 04 25 14 48 38 706
Breast
Breast cancer in younger women calls for flexibility in imaging
2003 04 10 15 09 19 706
Breast
Contrast-enhanced 3-D US boosts mammography results
2003 01 13 15 29 39 706
Breast
Start-up firm Photonify sees promise in optical imaging
More in Breast
New guidance issued on PET/CT imaging in breast cancer
By Will Morton
The world’s top nuclear medicine societies have issued international guidelines on the role of PET/CT in patients with invasive ductal carcinoma.
May 17, 2024
Breast Mol
ARRS: Dartmouth poster wins for CVD risk prediction potential using mammograms
By Liz Carey
A poster on cardiovascular disease (CVD) risk prediction using fat-enlarged axillary nodes on mammograms won a prestigious award at ARRS 2024.
May 6, 2024
Award-winning research: Screening mammograms showed variable lymph node morphology due to ectopic fat deposition in women with obesity. Image A (above) shows normal axillary lymph nodes measuring < 1.5 cm in 63-year-old woman with a body mass index (BM) = 43.2. Image B shows a possible fat-enlarged axillary node with large fatty hilum measuring 4.2 cm in a 52-year-old woman with a BMI = 45.8. Photo courtesy of American Roentgen Ray Society.
DBT + CEM boosts cancer detection in women with history of the disease
By Kate Madden Yee
Adding contrast-enhanced mammography (CEM) to digital breast tomosynthesis (DBT) increases early breast cancer detection in women with a history of the disease.
April 30, 2024
Breast Cancer3
USPSTF finalizes breast cancer screening recommendations
By Liz Carey
The USPSTF's final recommendations support breast cancer screening beginning at age 40, but don’t go as far as many screening advocates had hoped.
April 30, 2024
Mammogram Breast
Large language models underperform in breast imaging
By Amerigo Allegretto
Large language models such as ChatGPT and Google Gemini fall short in breast imaging.
April 30, 2024
Screenshot (1152)
U.S. federally qualified health centers show cancer screening gaps
By Kate Madden Yee
U.S. federally qualified health centers, intended to provide care to underserved populations across the country, show cancer screening gaps.
April 29, 2024
Breast Screening Mammo
RadNet teams up with basketball icon Sheryl Swoopes
By AuntMinnie.com staff writers
RadNet has tapped basketball legend and WNBA superstar Sheryl Swoopes as spokesperson for its nationwide breast cancer screening programs.
April 12, 2024
Mammogramnow
AI can be used to 'rule-out' breast cancer on mammography
By Erik L. Ridley
A deep-learning algorithm can rule out the presence of breast cancer on screening mammograms, improving specificity and yielding significant workflow and downstream savings.
April 10, 2024
Artificial Intelligence Ai Binary Code
AI helps select patients for supplemental breast cancer screening
By Erik L. Ridley
An AI-based method can outperform breast density measurements for flagging patients who would benefit from supplemental breast cancer screening.
April 9, 2024
Breast Cancer 3 D
Cryoablation effective in women with breast cancer
By Will Morton
A minimally invasive procedure called cryoablation that uses ice to freeze and destroy tumors has proven effective for women with large breast cancer tumors.
March 27, 2024
Breast Update
FAPI-PET/CT outperforms FDG-PET/CT in women with invasive breast cancer
By Will Morton
PET/CT imaging using gallium-68 FAPI radiotracer over F-18 FDG appears promising in women with invasive lobular carcinoma.
March 15, 2024
Maximum-intensity projection F-18 FDG-PET (left) and Ga-68 FAPI-PET (right) images of synchronous ILC. (A) A 42-year-old patient with multicentric primary lesions (encircled), regional (solid arrows), and distant inferior jugular lymph node (dashed arrows) seen on F-18 FDG-PET and subsequently confirmed on Ga-68 FAPI-PET, which also revealed additional malignant foci aligned with MRI. Some lesions exhibited high activity retention on Ga-68 FAPI-PET. (B) A 53-year-old patient showing no significant uptake on F-18 FDG-PET but synchronous bilateral lesions (arrows) on Ga-68 FAPI-PET, which also identified pathologic lymph nodes (encircled), resulting in upstaging. Image courtesy of the Journal of Nuclear Medicine.
Use CAD to assess breast tissue volume on MRI
By Kate Madden Yee
Using CAD software to assess enhancing breast tissue as a percentage of the entire breast volume on contrast MR imaging could improve breast cancer diagnosis.
March 14, 2024
Mri Breast Cancer
Page 1 of 569
Next Page