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Aspire™ HD – full field digital mammography system from FUJIFILM is ‘all okay’ for the patients: FDA!

 

The industry leading company in diagnostic imaging products, FUJIFILM Medical Systems U.S.A., Inc. has got green signal from the U.S. Food and Drug Administration for its full field digital mammography system (Aspire™ HD).

The equipment with unmatched detector technology (dual layer of amorphous selenium; direct optical switching) is feasible for unusual imaging quality; now, imaging facilities can confidently go forward with this innovative product for enhanced breast mammography procedures.

The direct optical switching technology brings down the requirement of thin film transistors, which are presently used in full field digital mammography detector systems; direct image transfer ensues in better results – images are produced with less noise, and the technology trims down dose, during the process.

Exceptional image quality of the system ascertains for reliable and precise diagnosis, for potential irregularities, resulting in improved productivity and efficiency of clinicians.

The latest technological innovation from the company will surely make a difference in the way imaging facilities/care providers diagnose and treat their patients, to help patients fight cancer, for improved quality of life.

The company (Fujifilm) has more than 8000 FFDMs being installed all over the globe, and has both DR (digital radiography) and CR (computed radiography) based systems available in the healthcare market.

Stay connected with MedicExchange for more new innovations and stories from the medical imaging equipment market, and related!

You can get to acquire both new, as well as refurbished digital mammography machines and more, through many equipment vendors and suppliers, available with us, to restructure your care unit, for better health outcomes.

Mammography has been proved a vital diagnostic/screening tool for early detection of breast cancer; annual mammogram is recommended for women – 40+ years, and with family history!

 

Mammography is a diagnostic approach that uses X-ray to identify and locate breast tumors, and other irregularities of the breast; here breast tissues are examined for abnormalities that any women have in their breasts. Lumps, nipple discharge, pain are some of the symptoms that show out to irregularities in the female breast.

Two different types of mammographic approaches are in practice, viz. full-field digital mammography and screen-film mammography.

For women with no symptoms, mammography is a practicable approach for early detection of breast cancer, as they they get to treat it well in advance; better computer images are being made possible through full-field digital mammography that uses low-radiation dose for precise diagnosis of medical conditions of the breast.

The process is comfortable, and patients are less exposed to the radiation; mammography is significant in cancer detection, to ascertain condition of the breast, even before a lump is felt by a woman.

Medical/health associations over the globe have already suggested for annual mammograms, for women of 40 years and beyond, and others with family history that are at high-risk of getting affected of one.

Women with curable phase of cancer, when the tumor is small enough to be felt/recognized by, can benefit through a mammogram, but, since the technology involves ionizing radiation, pregnant women are always suggested by experts to check with their physicians, prior they go for one.

Regular mammogram, abiding with recommendations and screening guidelines of care providers is to be always considered, to be on the safer side.

For women that are perplexed about diagnostic performance of thermography, we reiterate, it is not a substitute for mammography, and not recommended even by U.S. Food & Drug Administration, and various medical associations.

Healthcare units that are devoid of technology for mammography screening can always opt for mammography imaging services, available easily from various companies.

Besides, for new and refurbished mammography devices (2D, 3D and related), they can always trust some of top-notch mammography equipment manufacturers that are available in the sector.

Stay affixed with MedicExchange for more details about suppliers and vendors that deal in mammography equipment, to benefit on.

Whether full-field digital or screen-film mammography – the technology is contributing a lot to women, for early-stage breast cancer detection and therapy!

 

Mammography is a diagnostic procedure that makes use of X-ray technology for to diagnose and locate breast tumors and other irregular masses of the breast; the medical imaging technology through mammograms of internal breast structures ensure for any abnormality, in it.

Women with early treatable phase of breast cancer, where the tumor is small to be be felt or recognized through other means, can get benefited through a mammogram. Various medical professional associations even recommend for mammography over other diagnostic approaches for diagnosis of breast cancer, and related disorders.

Mammography is feasible for early identification of breast cancer, and women should go for regular mammogram, abiding with screening guidelines and recommendations of care providers. (vide: Oncology)

Women that are confused over diagnostic performance of thermography over mammography, should not remain puzzled over it; thermography is not a replacement for mammography, and not even suggested by the U.S. Food and Drug Administration, and various medical associations.

Two different types of mammographic approaches are in practice, viz. full-field digital mammography and screen-film mammography.

In the former, with a full-field approach, the x-radiations are passed by the breast, onto an image receptor; the scanner transforms information to the digital format, where it is conveyed to the monitor and/or the printing device, for the copies.

On the other, in case of screen-film mammography, x-radiations are passed through the breast, over to the cassette – comprised of screen/film, which requires to be developed by.

Since the device utilizes x-ray technology for breast imaging, small-dose radiation exposure to the patient is common; the hazards related with radiation exposure get outbalanced by the gains of mammography for early-stage breast cancer detection.

There has specific guidelines for mammography equipment, radiation dose, image quality etc., under the Mammography Quality Standards Act, so as to control quality of care.

For more on mammography-specific, and other Healthcare blogs, stay connected with MedicExchange!

Thermography is not a feasible option to Mammography for breast cancer – asserts FDA

 

Thermography is used for to investigate heat distribution in regions/structures of body, for tumor detection; infrared camera is used for thermograms.

Healthcare providers and women are specifically alarmed by the FDA, not to opt for thermography as a substitute for mammography screening, to diagnose breast cancer.

The FDA has no available data of thermographic devices, to show that the screening tool is effectual for any medical condition, inclusive of early detection of breast cancers and/or other breast disorders. (Courtesy: U.S. Food and Drug Administration)

Professional societies and health agencies, inclusive of the American College of Radiology, the American Cancer Society, the National Cancer Institute, the Centers for Disease Control and Prevention, and the Society for Breast Imaging – abide with FDA for clinical relevance of mammography for breast cancer detection, over thermography.

Mobile units, websites and various health facilities are encouraging the use of thermography as a complete assessment tool for breast cancer, laying claim that it is a replacement for mammography; it has even been claimed that – thermography is feasible for pre-cancerous irregularities, and can identify breast cancer, long before mammography. The FDA negates that – breast compression during mammography will make the cancer cells spread to neighboring regions in the body.

The FDA is greatly worried about health of women, and feels that these misguiding claims about thermography will make women go for it, than mammography; the food and drug administration has put forward suggestions for women, to have regular mammogram per screening guidelines, and advice by healthcare providers.

Additional diagnostic procedures are being sanctioned by the FDA, per suggestions of care providers, for: breast ultrasound, MRI/biopsy, clinical breast examination, mammographic views etc.

The FDA has directed the companies to stop making false claims about thermography machines, and is continually observing the marketing/promotional activities of thermography equipment manufacturers and medical practitioners.

Mammographic screening ensues in considerable reduction in breast cancer mortality rate;

Assessment of full-impact of the process requires re-examination times surmounting 20 years, because, number of cancer deaths averted grows with increasing time of redirect examination.

 

The medical research study was conducted by László Tabár, MD; Bedrich Vitak, MD; Tony Hsiu-Hsi Chen, PhD; Amy Ming-Fang Yen, PhD; Anders Cohen, MD; Tibor Tot, MD; Sherry Yueh-Hsia Chiu, PhD; Sam Li-Sheng Chen, PhD; Jean Ching-Yuan Fann, PhD; Johan Rosell, PhD; Helena Fohlin, MSc; Robert A. Smith, PhD and Stephen W. Duffy, MSc from the Departments of Mammography, Surgery, and Pathology, Falun Central Hospital, Falun, Sweden; Department of Mammography, University of Linköping, Linköping, Sweden; Graduate Institute of Epidemiology and Preventive Medicine, National Taiwan University, Taipei, Taiwan; School of Oral Hygiene, Taipei Medical University, Taipei, Taiwan; Department and Graduate Institute of Health Care Management, Chang Gung University, Taoyuan, Taiwan; Department of Nutrition and Health Sciences, Kainan University, Taoyuan, Taiwan; Regional Cancer Center, Southeast Sweden, University Hospital, Linköping, Sweden; American Cancer Society, Atlanta, Ga; and Cancer Research UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, Charterhouse Square, London, England. (Courtesy: RSNA Journal)

The research was done under guidance of Swedish National Board of Health and Welfare; the objective was to reckon long-run (29 years) effect of mammographic screening on breast cancer death rate, in terms of absolute and relative effects.

About 133, 065 women (40-74 years) were set up for mammographic screening; control group received regular care; through with local trial endpoint, and external committee – death reasons and case status were decided by; negative binomial regression was utilized for mortality rate.

Both the data suggested (of local trial endpoint and external committee) of considerable diminution in cancer mortality, in women called for screening.

At 29 years of follow-through (re-examination), the number of women required to be screened for 7 years to impede cancer death was 414, as per local and 519 per accorded data; most inhibited cancer deaths would have come about, due to lack of screening, after first 10 years of re-examination.

Conclusion: mammographic screening ensues in considerable reduction in breast cancer mortality rate; assessment of full-impact of the process requires re-examination times surmounting 20 years, because, number of cancer deaths averted grows with increasing time of redirect examination.

Cancer detection and recall rates increase for at least two-years after the digital transition; PPV after biopsy considerably thinned-out post-digital transition, chiefly in patients with microcalcifications.

 

The medical research study was conducted by Catherine G. Glynn, MBBCh, MRCPI, FRCR; Dione M. Farria, MD; Barbara S. Monsees, MD; Jennifer T. Salcman, MD; Kimberly N. Wiele, MD and Charles F. Hildebolt, DDS, PhD from the Breast Imaging Section, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Mo. (Courtesy: RSNA Journal)

The research objective was to ascertain the effect of changeover to digital screening mammography on clinical outcome measures, inclusive of positive predictive value, recall rate and cancer detection rate.

Practice audit data from year 2004-2009, of three breast-imaging radiotherapists were acquired by; the data were classified in varied groups, per time period, from year 2004-2009: baseline (2004–2005), digital year 1 (2007), digital year 2 (2008), and digital year 3 (2009), respectively.

Through with Fisher exact test and chi-square distribution, divergence in ratio involving and amid years were being assessed; clinical outcomes established on lesion type were even equated, from 2004-2008; computer-aided detection was utilized.

About 33, 879 digital mammograms and 32, 600 screen-film mammograms were translated by all three radiologists.

Recall rates increased from 6.0% at baseline (2004-2005) to 7.1% in digital year 1 (2007), and showed the trend in following years, to 8.5%.

About cancer detection rate – from baseline (3.3), it rose to 5.3 in digital year 1; it continued the higher trend in following years over the baseline figure.

Positive predictive value after screening (mammography), showed following trends: baseline (5.6%) and digital year 1 (7.5%); in digital year 3, it returned back to the baseline level.

In comparison, positive predictive value after biopsy showed negative trend, with baseline at 44.5%, and digital year 3 at 30.3%.

About 3493 lesions and 3444 patients were recalled during year 2004-2008. The proportion of recalls for calcification shot from 13.8% (baseline) to 23.9% (digital year 1) and 17.9%, in digital year 2.

Both positive predictive values after screening (mammography) and biopsies showed negative trend for calcifications, after the digital transition.

Conclusion: Cancer detection and recall rates increase for at the least two-years after the digital transition (mammography); PPV after biopsy considerably reduced post-digital transition, principally in patients with microcalcifications.

Mammography is feasible incidentally for breast irregularities associated to extramammary disease, than its regulars in breast cancer.

 

Submitted over as an education exhibit at 2009 RSNA annual meeting, contributions in this segment are being made by Mailan M. Cao, MD; Anne C. Hoyt, MD and Lawrence W. Bassett, MD from the Iris Cantor Center for Breast Imaging, Department of Radiology, David Geffen School of Medicine at UCLA, Los Angeles, CA.

The article is available in the online journal of Radiological Society of North America.

Even though mammography is principally utilized for to recognize breast cancer, it is feasible incidentally for breast irregularities associated to extramammary disease.

Cardiovascular disorders, viz. central venous obstruction and congestive heart failure may show as breast edema and venous engorgement (congestion), at mammography.

Morbid arterial calcifications observed at mammography can show out to basal risk factor for hastened atherosclerosis, viz. chronic renal failure.

Connective tissue disorders (rheumatoid arthritis, systemic scleroderma, systemic lupus erythematosus, dermatomyositis-polymyositis) characteristically demonstrate with bilateral axillary lymphadenopathy; stromal calcifications are even visible in ultimate three disease procedures.

Disorders like filariasis and neurofibromatosis type 1 may show up with pathognomonic findings at mammography; but in contrast – amyloidosis, wegener granulomatosis and sarcoidosis show as non-specific breast masses, not easily characterized from breast cancer, and generally call for tissue biopsy for ratification.

Facts about imaging attributes of varied systemic disorders that affect breast will help radiologist in to discriminate systemic disorders from questionable breast lesions, thus ascertain relevant follow-up examination.

Besides, identification of systemic disorders like Cowden syndrome, which is related with an enhanced risk of breast cancer will facilitate the radiologists to suggest proper supervision.

somo•v ABUS system, from U-Systems has been sanctioned by Medical Devices Bureau of Health Canada for ancillary diagnostic approach with mammography.

 

U-Systems – the market leader in automated breast ultrasound technology has been authorized with medical device license by the Medical Devices Bureau of Health Canada, recently, ratified on basis of clinical evidence.

somo•v ABUS system has now become sole ultrasound equipment for breast cancer screening across European Union countries.

The company can now market and sell its registered brand – somo•v® Automated Breast Ultrasound (ABUS) system as an appendage to mammography for breast cancer cases (symptomatic/asymptomatic), in Canada.

Medical Devices Bureau of Health Canada is responsible for evaluating medical device safety, efficacy and quality; somo•v ABUS system has been one, solely approved by the agency.

FDA has even sanctioned the somo•v ABUS system in the US for ancillary diagnostic approach with mammography.

Elated with the approval, Ron Ho (President and CEO, U-Systems) now is up to make the technology available for breast cancer patients, in Canada, for better diagnosis and treatment.

He said, somo•v Automated Breast Ultrasound System has not been devised to substitute mammography, but the combined efforts of ultrasound & mammography will be utilized for enhanced cancer detection, than mammography alone.

The technology is ideally fit for high-volume set-ups; somo•viewer™ (3D workstation) facilitates for swift review and storage of patient exams, to optimize workflow.

U-Systems has even patronized national SOMO•INSIGHT Clinical Study, to assess feasibility of the combination – digital mammography with somo•v Automated Breast Ultrasound System over routine mammogram for breast cancer detection, in women.

More than 15,000 female subjects partook in the clinical study, and it recognized considerable amount of patients that showed negative on mammogram, but recognized well through ABUS system.

Plateau curve enhancement and non-mass lesions are prevalent MRI findings of pure ductal carcinoma in situ.

The lesions with mass visibility on MRI findings have more suspicious kinetic features, than non-mass lesions.

 

The medical research study was conducted by Jeong-Ah Kim, Eun Ju Son, Ji Hyun Youk, Eun-Kyung Kim, Min Jung Kim, Jin Young Kwak and Joon Jeong from Department of Radiology and Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.

The study is available in online journal of American Roentgen Ray Society, and the research objective were to examine the kinetic and morphologic features of pure ductal carcinoma in situ, and MR images, and to equate the kinetic characteristics in relation to mammographic/sonographic findings, MRI lesion type and histopathologic factors.

About 67 patients presented with histologically demonstrated pure ductal carcinoma in situ were picked up for the study. Breast Imaging-Reporting and Data System (BIRADS) was utilized to analyze MRI findings, without pathological data. Quantitative variables of enhancement pattern were calculated for lesions, along with assessment of histological factors of hormone receptor and c-erbB-2 expression status, nuclear grade etc.

Independent assessments were made for sonographic and mammographic findings, without facts about MRI, and kinetic features were equated, in relation to MRI lesion type, mammographic/sonographic finding and histopathologic factors.

About the results, the prevalent morphological appearance was a non mass lesion with diverse enhancement, where the pure ductal carcinoma in situ lesions displayed inconsistent enhancement patterns composed of plateau, persistent and washout curves. Other than correlation of MRI lesion type with mean enhancement slope, time to peak enhancement and same of sonographic findings with time to peak enhancement, there was were no statistically significant relationship amid histopathologic factors/mammographic finding and kinetic features.

Conclusion: Plateau curve enhancement and non-mass lesions were prevalent MRI findings of pure ductal carcinoma in situ. In contrast to non-mass lesions, the lesions with mass appearance at MRI findings had more leery kinetic features.

The use of digitized priors enhances full-field digital mammography (FFDM) interpretation time: Study

 

The medical research study was conducted by Akshay S. Garg, Jocelyn A. Rapelyea, Lauren R. Rechtman, Jessica Torrente, Rebecca B. Bittner, Caitrín M. Coffey and Rachel F. Brem from Department of Radiology, Breast Imaging and Interventional Center, The George Washington University Medical Center, Washington, DC.

The study is available in online journal of American Roentgen Ray Society, and the research objective was to quantitatively equate interpretation time of screening full field digital mammography images through prior film-based studies (mammogram) for analogy, in contrast to prior digitized analog mammogram.

Four radiologists translated images through about 100 full field digital mammography studies, all the images had comparison analog mammograms accumulated one year before and so, which were digitized through 43 micrometer film digitizer.

At first, the full field digital mammography images were translated through digitized prior mammogram on two – PACS and 5-megapixel medical monitors. After one month, the 100 full field digital mammography studies were translated through original analog mammograms, on an alternator at 90° to medical monitors utilized to interpret screening FFDMs – the translation time and results were documented, equated and assessed for statistical deviation.

The mean reading time for full field digital mammography studies with prior digitized analog mammography was considerably shorter, in comparison to that of interpretation with prior analog. The recorded time deviation amid digitized analog in contrast to analog varied from 11.31-74.18 seconds. The reading times of all the readers varied from 17.32-185.94 seconds with an average of 58.56 seconds through analog film prior mammograms.

The readings varied from 11.32-109.11 seconds with an average of 39.76 seconds, when used digitized analog prior mammograms. The mean deviation in reading time was 18.80 seconds, and demonstrated 32% increase in interpretation speed on utilizing prior digitized analog contrast to analog prior.

Conclusion: Full-field digital mammographic interpretation with prior digitized analog mammography showed mean improvement (32.1%) than interpretation with prior analog. It will facilitate for more full field digital mammography to be translated over, in same fraction of time, if digitized prior analog mammograms are utilized.