FDA updates adverse event report for NY mammo facility

The U.S. Food and Drug Administration (FDA) has updated an adverse event report...Read more on AuntMinnie.comRelated Reading: FDA posts final guidance for new 510(k) pathway FDA files action against Nev. imaging center for mammography FDA posts alert for NC mammography facility FDA issues update on cancer linked to breast implants FDA issues adverse MQSA report for ND hospital
Source: AuntMinnie.com Headlines - Category: Radiology Source Type: news

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ConclusionsData suggest that supplemental screening use in North Carolina did not change after enactment of a breast density notification law, though the increase in new use of any screening DBT was greater for women with dense breasts. The short-term lack of change in supplemental screening should be considered as additional notification laws are developed.
Source: Journal of the American College of Radiology - Category: Radiology Source Type: research
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency. In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job. On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Software Source Type: news
This article summarises the information that should be provided to women and referring physicians about breast ultrasound (US). After explaining the physical principles, technical procedure and safety of US, information is given about its ability to make a correct diagnosis, depending on the setting in which it is applied. The followingdefinite indications for breast US in female subjects are proposed: palpable lump; axillary adenopathy; first diagnostic approach for clinical abnormalities under 40 and in pregnant or lactating women; suspicious abnormalities at mammography or magnetic resonance imaging (MRI); suspicious ni...
Source: Insights into Imaging - Category: Radiology Source Type: research
Conclusions:Our results showed a high compliance rate with fasting and warming instructions, however, findings suggest that a 3-hour fast and warming of the upper torso, does not result in significant improvements in image count density in the clinical environment. These findings are in contrast to count density improvements observed in a controlled research study as a function of fasting or warming, where serial examinations were assessed within the same patient. A limitation of the current analysis conducted in clinical practice is that fasting status is patient-reported and time spent warming is patient-directed, which ...
Source: Journal of Nuclear Medicine - Category: Nuclear Medicine Authors: Tags: TS17: Student Tech Papers I Source Type: research
Although breast implants lowered the cancer detection rate on screening mammography,...Read more on AuntMinnie.comRelated Reading: At high risk for breast cancer? Start screening early What's the best way to follow up breast cancer survivors? FDA issues update on cancer linked to breast implants SABCS: RT complicates breast implant reconstruction MRI adds to cancer detection in women with breast implants
Source: AuntMinnie.com Headlines - Category: Radiology Source Type: news
Authors: Ekpo EU, Alakhras M, Brennan P Abstract Mammography has been the frontline screening tool for breast cancer for decades. However, high error rates in the form of false negatives (FNs) and false positives (FPs) have persisted despite technological improvements. Radiologists still miss between 10% and 30% of cancers while 80% of woman recalled for additional views have normal outcomes, with 40% of biopsied lesions being benign. Research show that the majority of cancers missed is actually visible and looked at, but either go unnoticed or are deemed to be benign. Causal agents for these errors include human r...
Source: Asian Pacific Journal of Cancer Prevention - Category: Cancer & Oncology Tags: Asian Pac J Cancer Prev Source Type: research
Background: Breast augmentation with subglandular versus subpectoral implants may differentially impact the early detection of breast cancer and treatment recommendations. The authors assessed the impact of prior augmentation on the diagnosis and management of breast cancer in women undergoing mastectomy. Methods: Breast cancer diagnosis and management were retrospectively analyzed in all women with prior augmentation undergoing therapeutic mastectomy at the authors’ institution from 1993 to 2014. Comparison was made to all women with no prior augmentation undergoing mastectomy in 2010. Subanalyses were performed ac...
Source: Plastic and Reconstructive Surgery - Category: Cosmetic Surgery Tags: Breast: Original Articles Source Type: research
970Educational objectives: 1. Learn the mechanism of Tc-99m sestamibi localization in tissue. 2. Learn the major indications of Tc-99m sestamibi imaging. 3. Be aware and recognize patterns of various incidental findings on Tc-99m sestamibi scintigraphy. Technetium-99m sestamibi myocardial perfusion imaging (most often employing the 1-day rest/stress protocol) is a commonly used non-invasive test for evaluation and risk stratification of patients with known or suspected coronary artery disease. Another well-established indication for Tc-99m sestamibi is parathyroid imaging for pre-operative localization of parathyroid adeno...
Source: Journal of Nuclear Medicine - Category: Nuclear Medicine Authors: Tags: Educational Exhibits Posters Source Type: research
ByChristine A. Hamori, MDRecent media coverage of an FDA update regarding BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma) is causing a lot of concern among breast implant patients. First of all, patients should know that BIA-ALCL is not new, and that this is a very rare disease. Also, it is only associated with textured implants. During every breast augmentation consult I do with every potential patient, we go over this information. In fact, rarely do my patients and I choose a textured implant.My colleague Dr. William Adams has published this informative update with a video from the Plastic Surgery Cha...
Source: What's New In Plastic Surgery? - Category: Cosmetic Surgery Tags: bia-alcl breast cancer breast implant associated anaplastic large cell lymphoma breast implants fda Source Type: blogs
Conclusions AFG is a promising method in achieving autologous cosmetic breast augmentation with satisfactory volume retention and satisfaction rates in eight and six studies, respectively. Complications and radiological findings are comparable to those after implant augmentation. Future studies should focus on cancer occurrence and detection to further substantiate AFG safety. In addition, grafting methods and the use of auxiliary procedures to identify factors leading to better outcomes in terms of volume retention should be investigated. Finally, objective questionnaires are needed to represent patient satisfaction. Lev...
Source: Aesthetic Surgery Journal - Category: Cosmetic Surgery Authors: Tags: Original Article Source Type: research
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