New breast cancer drugs could help more than previously thought
Conclusion Advances in genetic technology are happening fast, improving our knowledge about which treatments may be most suitable for which types of cancer. However, testing these theories takes time, which can be frustrating for researchers, when newspaper headlines suggest people should already be receiving new treatments. This study potentially widens the pool of people who may benefit from targeted cancer treatment with PARP inhibitors, from around 5% to around 20%. That's clearly good news, but the potential for benefit needs to be tested in clinical trials. The researchers express a great deal of confidence in the ac...
Source: NHS News Feed - March 15, 2017 Category: Consumer Health News Tags: Cancer Genetics/stem cells Medication Source Type: news

AirXpanders lands $34m private placement
AirXpanders (ASX:AXP) said today that it has commitments from investors in a private placement to raise A$45 million, or $34 million USD. The Palo Alto, Calif.-based company said that its investors committed to subscribe for 16.3 million shares of common stock at ¢70 apiece. The company plans to use the funds to bring its breast tissue expansion device to the U.S., including building inventory for the U.S. market and hiring a sales force. AirXpanders also said it plans to complete its expansion of commercial manufacturing capacity in Costa Rica. “Following receipt of FDA de novo clearance in December 2016, we are n...
Source: Mass Device - January 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Funding Roundup Implants Surgical Women's Health AirXpanders Source Type: news

AirXpander ’ s AeroForm tissue expander transforms decades-old procedure
For 40 years, plastic surgeons have used saline injections to expand tissue and prepare patients for breast implants following mastectomies. These tissue expanders consist of a silicone shell with a magnet and a self-sealing port; a doctor uses a different magnet above the skin to access the port and inject saline to stretch the skin. The process is lengthy – patients come into the doctor’s office every week for as much as 3 months. Dr. Tracey Stokes, a plastic surgeon based in Fort Lauderdale, Fla., has spent 11 years working with mastectomy patients, often using saline expanders to prepare them for breast impl...
Source: Mass Device - January 5, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Implants Oncology Surgical Women's Health AirXpanders Source Type: news

AirXpanders wins de novo FDA clearance for AeroForm breast tissue expander
AirXpanders (ASX:AXP) said yesterday it won FDA de novo clearance for its AeroForm tissue expander system designed for breast reconstruction procedures, and announced it is preparing to launch the device in the U.S. The Palo Alto, Calif.-based company’s AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand and stretch the skin and underlying muscle prior to a permanent breast implant. “While approximately 70% of women who opt for reconstructive surgery undergo tissue expansion to prepare a space for breast implants, little progress has been made with regard to tissue ...
Source: Mass Device - December 22, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Regulatory/Compliance Women's Health AirXpanders Source Type: news

If You’re Called Back After a Mammogram
By Stacy Simon Most of the time, women getting their routine mammogram will receive a letter within 30 days saying the results were normal. But if doctors find something suspicious, they’ll call you back – usually within just 5 days – to take new pictures or get other tests.Getting that call can be scary, but a suspicious finding does not mean you have cancer. What else could it be? A suspicious finding may be just dense breast tissue, a cyst, or even a tumor that isn’t cancer. Other times, the image just isn’t clear and needs to be retaken. Or, if this is your first mammogram, your doctor may...
Source: American Cancer Society :: News and Features - September 29, 2016 Category: Cancer & Oncology Tags: Breast Cancer Prevention/Early Detection Source Type: news

ASTRO: Radiation boost cuts local recurrence in DCIS patients
A supplemental boost of radiation cuts breast cancer recurrence in women with...Read more on AuntMinnie.comRelated Reading: New treatment guidelines issued for DCIS Needle biopsy hormone testing unnecessary for DCIS Delayed rad therapy puts women with DCIS at risk ASBrS: No, we're not overtreating DCIS New study to examine how to treat early breast cancer (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 28, 2016 Category: Radiology Source Type: news

FDA releases June 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD June 2016 TOTAL 510(k)s THIS PERIOD 258 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 23 DEVICE: ORAL BOND STEINER LABORATORIES 510(k) NO: K142130(Traditional) ATTN: GREGORY G STEINER PHONE NO : 866 3171348 1051 Olsen Street, Building 3611 SE DECISION MADE: 06-JUN-16 Henderson NV 89011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QiF Blood and Fluid Warmer Quality in Flow Ltd. 510(k) NO: K150404(Traditional) ATTN: Neta Sherman PHONE NO : 972 54 6600146 3A Bazel ...
Source: Mass Device - August 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 25, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Cigna adds reimbursement coverage for 3D breast scans Cigna said this week that it’s revising its coverage to include 3D mammography for routine breast cancer screening. The Bloomfield, Conn.-based health insurer only reimbur...
Source: Mass Device - August 25, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Dune Medical lands $3.4m EU grant
Dune Medical Devices said today it won a $3.4 million (EU €3 million) European Union Horizon 2020 research grant. The company said it is 1 of 65 companies selected to receive funding from the $91 billion (EU €80 billion) 7-year program aiming to “secure Europe’s global competitiveness.” “This 3 million euro grant will expedite bringing our soft tissue biopsy system to the market. It will provide radiologists and surgeons immediate graphic characterizations of tissue abnormalities along the tip of the biopsy needle, just before samples are taken. This real-time insight can help reduce the time t...
Source: Mass Device - August 23, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diagnostics Oncology Dune Medical Devices Inc. Source Type: news

Needle biopsy hormone testing unnecessary for DCIS
Patients with ductal carcinoma in situ (DCIS) breast cancer don't need hormone...Read more on AuntMinnie.comRelated Reading: Delayed rad therapy puts women with DCIS at risk ASBrS: No, we're not overtreating DCIS Rates of high-grade DCIS increase with age Various DCIS treatments produce similar survival rates Kopans: JAMA Oncology paper misinterprets DCIS data (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - August 10, 2016 Category: Radiology Source Type: news

Needle biopsies for noninvasive breast cancer: Routine analysis wastes millions
For patients with the most common type of noninvasive breast cancer, routine testing for estrogen and progesterone receptors in tissue taken at the first ' needle ' biopsy is both unnecessary and wasteful, according to results of a study. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - August 8, 2016 Category: Science Source Type: news

Needle biopsies for noninvasive breast cancer: Routine analysis wastes millions
(Johns Hopkins Medicine) For patients with the most common type of noninvasive breast cancer, routine testing for estrogen and progesterone receptors in tissue taken at the first 'needle' biopsy is both unnecessary and wasteful, according to results of a study led by Johns Hopkins pathologists. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - August 8, 2016 Category: Cancer & Oncology Source Type: news

Study backs laser prostate ablation with Medtronic’s Artemis
Laser ablation may be a feasible and safe treatment option for men with intermediate risk prostate cancer, according to a new study published in the Journal of Urology. The treatment operates using magnetic resonance imaging to guide a laser fiber into a cancerous tumor in the prostate to destroy the tissue with extreme heat. The study of the technique, funded by Medtronic (NYSE:MDT) and undertaken at UCLA, reported no serious adverse effects or changes in urinary or sexual function at 6-months post procedure. “Our feeling was that if you can see prostate cancer using the fusion MRI and can put a needle in the spot ...
Source: Mass Device - June 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Oncology Medtronic Source Type: news

Sharing in Tough Decisions: Guidelines for Making Medical Choices
By Kelly Michelson, MD MPH At two months old, when most babies are starting to smile, Anna* began getting weaker. Over the next several months, Anna would lose the ability to move her arms and legs, leaving only a few facial muscles functioning to express her thoughts. Anna had spinal muscular atrophy, a disease that affects children and impairs the nerves that tell muscles to move. Abandoned by her muscles, her mind would remain intact, able to develop, understand, and learn. Because Anna's muscles would get progressively weaker in the coming months, her parents needed to make a decision. They could either avoid surge...
Source: Healthy Living - The Huffington Post - June 10, 2016 Category: Consumer Health News Source Type: news

FDA releases May 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 TOTAL 510(k)s THIS PERIOD 213 TOTAL WITH SUMMARIES 205 TOTAL WITH STATEMENTS 8 May 2016 510(k) Clearances SHARE TWEET LINKEDIN PIN IT EMAIL PRINT 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 DEVICE: O-PEP PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K150044(Traditional) ATTN: Michael Judge PHONE NO : 1 804 2537274 2412 PARI Way SE DECISION MADE: 27-MAY-16 Midlothian VA 23112 510(k) SUMMARY AVAILABLE FROM ...
Source: Mass Device - June 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news