ACR and SBI Continue to Recommend Regular Mammography Starting at Age 40
Washington, DC (Oct. 20, 2015) — As our shared goal is to save the most lives possible from breast cancer, the American College of Radiology (ACR) and Society of Breast Imaging (SBI) continue to recommend that women get yearly mammograms starting at age 40. New American Cancer Society (ACS) breast cancer screening guidelines, and previous data used by the United States Preventive Services Task Force (USPSTF) to create their recommendations, state that starting annual mammography at age 40 saves the most lives. “The ACS has strongly reaffirmed that mammography screening saves lives. The new ACS guidelines show ...
Source: American College of Radiology - April 13, 2016 Category: Radiology Source Type: news

FDA releases February 2016 510(k) clearances
February 2016 510(k) Clearances 510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016. TOTAL 510(k)s THIS PERIOD 224 TOTAL WITH SUMMARIES 213 TOTAL WITH STATEMENTS 11 February 2016 510(k) Clearances 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2016 DEVICE: ANI Monitor MDOLORIS MEDICAL SYSTEMS SAS 510(k) NO: K142969(Traditional) ATTN: MATHILDE COLLET PHONE NO : 011 333 62092081 6, RUE DU PR LAGUESSE SE DECISION MADE: 23-FEB-16 LILLE FR 59037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBSWIN and VistaEasy Imaging Software Durr Dental...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Advanced cancer screening technology may improve individualized cancer treatments
Despite a growing interest in developing non-invasive methods to identify rare cancer cells or cancer cell DNA in blood, current techniques remain complicated and often prohibitively expensive. UCLA researchers have pioneered a more effective approach to these “liquid biopsies” that has the potential to offer a streamlined and low-cost solution for people with cancer. The technology works by creating millimeter-scale whirlpools to draw in and concentrate circulating tumor cells, known as CTCs, based on their size. CTCs are often larger than normal blood cells, and their presence can be used to monitor disease. Analysis...
Source: UCLA Newsroom: Health Sciences - February 26, 2016 Category: Universities & Medical Training Source Type: news

Meditation Eases Pain, Anxiety and Fatigue During Breast Cancer Biopsy
Contact: Sarah Avery Phone: 919-660-1306 Email: sarah.avery@duke.edu https://www.dukehealth.org EMBARGOED FOR RELEASE until 9 a.m. (ET) on Thursday, Feb. 4, 2015 Hear audio of meditation. DURHAM, N.C. -- Meditation eases anxiety, fatigue and pain for women undergoing breast cancer biopsies, according to researchers at the Duke Cancer Institute. They also found that music is effective, but to a lesser extent. The researchers note that adopting these simple, inexpensive interventions could be especially helpful in light of recent reports citing anxiety and pain as potential harms from breast cancer screenings and testing. ...
Source: DukeHealth.org: Duke Health Features - February 8, 2016 Category: Pediatrics Tags: Duke Medicine Source Type: news

January JACR: Public Education Eases Anxiety About Screening Mammography
Reston, VA — The January Journal of the American College of Radiology (JACR) offers articles highlighting radiologists’ involvement in educating patients about mammography and making imaging safer for children. Select January articles published online ahead of print are listed below. Direct Interactive Public Education by Breast Radiologists About Screening Mammography: Impact on Anxiety and Empowerment: Attendees of radiologist-provided direct public lectures reported decreased anxiety and improved knowledge regarding screening mammography. The resultant reduced anxiety and educational empowerment help enabl...
Source: American College of Radiology - January 4, 2016 Category: Radiology Source Type: news

Medtech approvals: FDA releases October 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015: Summary of PMA Originals & Supplements Approved Originals: 9 Supplements: 133 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 597 Total Active: 433 Total On Hold: 164 Summary of All PMA Submissions Originals: 7 Supplements: 74 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 133 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 161.5 FDA Time: ...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Reliability of Needle Core Biopsies of Large Breast TumorsReliability of Needle Core Biopsies of Large Breast Tumors
This study compared the concordance of histologic analysis of needle core biopsy specimens and whole surgical specimens in large breast tumors. Are NCB specimens adequate for preoperative assessment? American Journal of Clinical Pathology (Source: Medscape Pathology Headlines)
Source: Medscape Pathology Headlines - November 19, 2015 Category: Pathology Tags: Pathology & Lab Medicine Journal Article Source Type: news

Medtech approvals: FDA releases September 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in September 2015: Summary of PMA Originals & Supplements Approved Originals: 4 Supplements: 53 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 31 Total On Hold: 24 Summary of PMA Supplements Under Review Total Under Review: 611 Total Active: 461 Total On Hold: 150 Summary of All PMA Submissions Originals: 3 Supplements: 84 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 53 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 127.6 FDA Time: ...
Source: Mass Device - November 16, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Celebrating My Cancerversary
It's my cancerversary. 8 years ago I was diagnosed with breast cancer. My sister sent me a message this morning reminding me of this fact. This took my by surprise. I don't automatically recognize the date as being significant anymore. I took a moment when I saw the message from her to reflect. I thought about how different my life is now than it was before my diagnosis. Before my diagnosis I was sure that I had to do everything myself. I knew that people were unreliable; if I trusted anyone I was sure I would be let down. Cancer forced me to re-examine this principle. First of all, hospitals don't let patients go to ch...
Source: Healthy Living - The Huffington Post - October 23, 2015 Category: Consumer Health News Source Type: news

Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

Beyond the Mammogram: 11 Awareness Facts I Discovered After My Advanced Breast Cancer Diagnosis
It was a stunning beach setting for an evening of empowerment and education as Dr. Richard Reitherman and I tag teamed to discuss breast health, dense breasts and breast cancer screening. The evening began with a reception, overlooking the Pacific, in Huntington Beach, California. Health care providers, breast cancer survivors and Orange Coast residents listened intently as Dr. Reitherman discussed adjunct screening technologies for dense breasts and I recalled my common story of missed cancer by mammogram. My unanticipated advanced cancer diagnosis in 2004 compelled me to take the bumpy road less travelled, which fueled a...
Source: Healthy Living - The Huffington Post - September 25, 2015 Category: Consumer Health News Source Type: news

Genetic testing all women for breast cancer might not be worth the cost
Women who are carriers of mutated BRCA genes are known to have a significantly higher risk for developing breast and ovarian cancers than those who don’t. But a new study by UCLA faculty questions the value of screening for the genetic mutations in the general population — including those who do not have cancer or have no family history of the disease — because of the high cost. The UCLA researchers found that compared with universal screening, other diagnostic tools remain more efficient and might be more cost-effective.  The paper was authored by Dr. Patricia Ganz, director of the division of cancer prevention and...
Source: UCLA Newsroom: Health Sciences - September 4, 2015 Category: Universities & Medical Training Source Type: news

Voices Of Strength: Your Stories Of Survival
Earlier this summer, I asked to hear stories of survival from Huffington Post readers. I wanted to know about the tragedy you faced, how you survived, how you turned your life around, and how you're doing today. Readers, you didn't disappoint. Over the last few weeks we've heard from more than 500 of you. We've heard stories of illness, loss, natural disaster, bankruptcy, discrimination -- and everything in between. Having recently been confronted with a potentially life-altering diagnosis of breast cancer, I was buoyed by people reaching out to me with their own stories of survival. Many are blessed with never having to...
Source: Healthy Living - The Huffington Post - August 17, 2015 Category: Consumer Health News Source Type: news

Medtech approvals: FDA releases May 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in May 2015: Summary of PMA Originals & Supplements Approved Originals: 5 Supplements: 51 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 26 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 547 Total Active: 379 Total On Hold: 168 Summary of All PMA Submissions Originals: 1 Supplements: 62 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 51 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 109.5 FDA Time: 86.4 D...
Source: Mass Device - August 6, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

SuperSonic Imagine aims to reduce biopsies with ultrasound
French imaging company SuperSonic Imagine thinks its new imaging systems can change the biopsy game for the better, according to an interview with founder and chief strategic and innovation officer Jacques Souquet. SuperSonic Imagine’s flagship device is the Aixplorer ultrasound imaging device which uses the company’s proprietary ShearWave elastography and UltraFast Doppler blood flow imaging. Unlike other similar devices, SuperSonic’s uses software processing coupled with powerful processing boards produced by graphics company Nvidia, according to SuperSonic. “Being able to simplify things changed...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Imaging Ultrasound SuperSonic Imagine S.A. Source Type: news