Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus
SPRING HOUSE, PENNSYLVANIA, June 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today its decision to discontinue the Phase 3 LOTUS study of STELARA® (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE.The decision is based on data from a pre-planned interim efficacy analysis. Interim safety findings were consistent with the known safety profile of STELARA, and no new safety signals were identified. Investigators, study participants and health authorities have been informed of the decision. The company intends to thoroughly analyze the totality of...
Source: Johnson and Johnson - June 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Life, the universe and medicine – part 4
I had my appointment with the breast team on the 19th July. After being told off by the surgeon for not having mammograms, I was then subjected to the examination itself which was excruciating on my right breast because of the lump. It had already reacted badly to the surgeon’s examination and was definitely not a happy puppy! The radiographer was lovely and gave me a hug afterwards. The ultrasound was just as bad, pressing down with a bar with cold gel on it does nothing to make you feel better! It all came back clear – it was just a cyst and they offered to drain it there and then because of the pain. I, of c...
Source: The Hysterectomy Association - June 15, 2020 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Thought for the day my story Source Type: news
Life, the universe and medicine – part 1
Like everyone, I assume I’ll live forever. Although I often wonder whether anyone would come to my funeral and who would wear black, it never actually occurrs to me that there is an endpoint. It’s almost as if I would come along too to watch proceedings running smoothly and along the lines I wanted. Death was something I thought about, but in a rather abstract, offhand sort of way. It happened, of course I knew I would die at some point, but that point was somewhere out there … way off from here, where I am now. And then I hit a brick wall. The wall consisted of a tiny little bit of blood coughed up in s...
Source: The Hysterectomy Association - April 28, 2020 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Emotional Health Happiness Thought for the day Women's Health my story Source Type: news
Wire-free breast tumor localization improves quality, efficiency, capacity - Sponsor Supplied
For many patients, the most dreaded aspect of breast surgery is the needle...Read more on AuntMinnie.comRelated Reading: Clinical Case Review: Long-term SCOUT® placement prior to surgery Merit Medical to unveil ScoutShare risk model at RSNA 2019 Merit Medical's Wrapsody gains FDA designation Merit Medical posts mixed Q3 results RADAR Localization: Reducing the Burden of Breast Cancer (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 7, 2020 Category: Radiology Source Type: news
Team plucks needle from genomic haystack, finding essential transcription factor binding sites
(Children's National Hospital) Using CRISPR/Cas9 knockout screens, a multi-institutional research team systematically interrogated the essentiality of more than 10,000 forkhead box protein A1 (FOXA1) and CTCF binding sites in breast and prostate cancer cells, finding that essential FOXA1 binding sites act as enhancers to orchestrate the expression of nearby essential genes. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - November 11, 2019 Category: Cancer & Oncology Source Type: news
Why the Women Most Likely to Die of Breast Cancer Have Gotten the Least Attention
How can you have a moonshot trying to cure cancer and not mention people dying of cancer?I believed the narrative that is pushed on women, that if you check your breasts and if you catch it early, you’re fine.ide class="right-rail__container right-rail__container--ad"> Lianne Kraemer had been living with metastatic breast cancer for more than a year when I met her in December 2017 at the Henry B. González Convention Center in San Antonio. Throughout the week, more than 7,000 doctors, scientists and pharmaceutical-company representatives would descend on the city for the country’s most impor...
Source: TIME: Health - October 1, 2019 Category: Consumer Health News Authors: Kate Pickert Tags: Uncategorized Breast Cancer health Source Type: news
Teaching by Touch
The devices and tools used by medical professionals today certainly appear a lot different than from just a short time ago. In general, medical professionalsâand their patientsâhave become much more accepting of smart, data-driven medical technologies that streamline and improve the accuracy of a treatment process. Wearable therapeutic and drug-delivery devices, robotic surgical systems, and telehealth monitoring devicesÂ represent some of the many recent advancements that have changed the medical device industry for the better. However, even with the introduction ofÂ&nb...
Source: MDDI - May 6, 2019 Category: Medical Devices Authors: Rob Podoloff and Andy Dambeck Tags: Design Source Type: news
Dune Medical launches first-in-man Smart Biopsy trial
Dune Medical Devices said today that it launched a first-in-man trial of its Smart Biopsy device, touting that the first patients in the trial have already been treated. The first-in-man cases were performed by Dr. Noemi Weissenberg of Kfar Saba, Israel’s Meir Medical Center, the Alpharetta, Ga.-based company said. Dune Medical’s Smart Biopsy system is a percutaneous soft tissue biopsy device that uses miniaturized sensors in the core needle to generate electrical parameters on sampled tissue in real-time. Those electrical signals are compared to histopahtologic findings to improve diagnosis and read-out. &ldqu...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Dune Medical Devices Inc. Source Type: news
First in Michigan: Self-controlled tissue expanders for breast reconstruction after mastectomy
(Henry Ford Health System) Henry Ford Cancer Institute is the first in Michigan to offer a needle-free, patient-controlled tissue expansion system for women undergoing breast reconstruction after mastectomy. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - March 19, 2019 Category: Cancer & Oncology Source Type: news
Smart Biopsy Device Could Diagnose Breast Cancer Using Miniature Radiofrequency Sensors
Normally, when a physician notices a suspicious mass or lesion on a mammogram, he or she will request an ultrasound to explore it further. Based on those results, a biopsy may be performed to determine whether the mass is cancerous. âUnfortunately, right now, in some cases, physicians either overdiagnose or underdiagnose based on that biopsy, because with ultrasound they can only see so much,â said Lori Chmura, CEO of Dune Medical Devices. âThe doctor is essentially going in blindly, trying to see what looks like the most suspicious area, and theyâre t...
Source: MDDI - March 12, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Business Source Type: news
New machine learning method could spare some women from unnecessary breast surgery
(Dartmouth-Hitchcock Medical Center) Dartmouth researchers have developed and evaluated a machine learning approach of using patient core needle biopsy data to identify the risk that atypical ductal hyperplasia (ADH) breast lesions may upgrade to cancer. This knowledge can potentially help clinicians and low-risk patients decide whether active surveillance and hormonal therapy is a reasonable management approach. Using the method could spare patients with benign lesions from invasive surgeries while maintaining high sensitivity for predicting malignant lesions. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 12, 2019 Category: International Medicine & Public Health Source Type: news
Cook affirms safety record of Zilver PTX stents
In response to a recent meta-analysis that linked paclitaxel-coated devices...Read more on AuntMinnie.comRelated Reading: IZI buys Cook biopsy, breast localization needle assets Cook recalls catheters with Beacon tip Cook recalls angiography catheters Cook begins inferior vena cava filter studies Cook debuts new embolization coil (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 23, 2019 Category: Radiology Source Type: news
IZI buys Cook biopsy, breast localization needle assets
Interventional radiology technology provider IZI Medical Products has purchased...Read more on AuntMinnie.comRelated Reading: Cook recalls catheters with Beacon tip Cook recalls angiography catheters Cook begins inferior vena cava filter studies Cook debuts new embolization coil Landauer buys IZI Medical Products (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 8, 2019 Category: Radiology Source Type: news
IZI Medical picks up Cook Medical ’ s Quick-Core biopsy and breast localization needle assets
IZI Medical Products extended its M&A spree today with the acquisition of a set of biopsy and breast localization needles from Cook Medical for an undisclosed amount. Last September YY-based IZI picked up Benvenue Medical’s vertebral augmentation portfolio, also for an undisclosed amount; in May 2017, the company paid an unspecified price for Cook’s vertebroplasty devices, including the Duro-Ject Osteo-Site, Osteo-Force and Vertefix brands. The latest deal with Cook includes the Quick-Core biopsy needle, MReye breast localization coil and the Kopans and X-Reidy lesion localization needle...
Source: Mass Device - January 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Wall Street Beat Women's Health Cook Medical IZI Mecial Products LLC Source Type: news
US-CNB Superior for Axillary Staging in Breast Cancer US-CNB Superior for Axillary Staging in Breast Cancer
Dr Lowenfels reviews a study that compares diagnostic accuracy of ultrasound-guided fine-needle aspiration and ultrasound-guided core-needle biopsy for axillary staging in breast cancer.Medscape General Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 9, 2018 Category: Consumer Health News Tags: General Surgery Viewpoint Source Type: news
Robot arm assists with PET/CT-guided needle biopsies
By combining a robotic arm-assisted needle navigation system with PET/CT, researchers...Read more on AuntMinnie.comRelated Reading: FDG-PET/CT fails for peripheral T-cell lymphoma outcomes FDG-PET/CT helps stage men with breast cancer, too PET/CT key to NIH's tuberculosis research plan PET/CT makes case for directing cervical cancer treatment Can deep learning monitor lesions on F-18 NaF PET/CT? (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - November 6, 2018 Category: Radiology Source Type: news
Health Tip: What to Expect From a Breast Biopsy
-- A breast biopsy involves removing a sample of breast tissue or fluid to test for the presence of cancerous cells. The U.S. National Library of Medicine says here's what you can expect from a non-surgical needle biopsy: You will lay on your side... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - October 24, 2018 Category: General Medicine Source Type: news
AirXpanders Is Pumped for Anticipated Growth After Recent Financing
The company responsible forÂ the first major change in breast tissue expansion in almost 40 years is getting strong support from investors. San Jose, CA-based AirXpanders recently closed a rights offering in Australia to raise roughly A$15.7 million, along with a U.S. placement to raise about $3.4 million (A$4.6 million), equivalent to a total of about $15 million before transaction costs. Vivo Ventures invested $3.3 million of the U.S. placement and the company's board chairman invested $500,000. "We are confident of the outlook for the company and the successful closing of our A$20.3 million raising place...
Source: MDDI - September 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Implants Source Type: news
Nonradioactive Breast Cancer Marking Platform Gains Second Nod from FDA
Most breast cancer patients have some type of surgery to take out their tumors. But that is not sufficient to ensure that all cancer cells are found and removed. âCancer cells primarily use the lymphatic system to spread throughout the body and are most like to be found in the first draining lymph node, as the node filters out these cells,â said Mathew Stephens, commercial director, Endomag,Â in an interview with MD+DI. âThese âsentinelâ nodes are the most likely place to find cancer, and so the surgeon will want to be able...
Source: MDDI - September 4, 2018 Category: Medical Devices Authors: Susan Shepard Tags: Business Source Type: news
7 medtech stories we missed this week: June 22, 2018
[Image from unsplash.com]From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India for its Radixact X9 System. The approval allows the company to sell the TomoTherapy platform while allowing hospitals throughout India to import the system. The Radixact and TomoTherapy Systems are radiation th...
Source: Mass Device - June 22, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Diagnostics Endoscopic / Arthroscopic Food & Drug Administration (FDA) Hospital Care Imaging Patient Monitoring Regulatory/Compliance Ultrasound Accuray Inc. Arcuro Medical BTG Masimo MedTech NuSight P Source Type: news
4 Trends Advancing Medtech
For the past 20 years, the Medical Design Excellence Awards have celebrated medical products that improve the quality and accessibility of healthcare. Our finalists this year carry on this tradition, while also keeping in step with today’s high-tech digital and consumer trends. With the help of our esteemed jurors, we have identified four key trends in this year’s group of finalists: risk reduction; faster, more-efficient healthcare delivery; the influence of the Internet of Things; and the consumerization of healthcare. We’ve been tracking a few of these trends in past awards programs, so they’re n...
Source: MDDI - April 27, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M East (New York) Design Source Type: news
Abortions in the U.S. Are Safe and Effective, a New Report Says
The majority of legal abortions performed in the U.S. are safe, free of complications and devoid of long-term health effects, according to a comprehensive new report. A committee assembled by the National Academies of Sciences, Engineering, and Medicine analyzed available data on abortion safety, quality and care. The resulting report, published Friday, says the four major abortion methods used in the U.S. — medication, aspiration, induction and dilation and evacuation (D&E) — are all safe and effective, and that complications are rare. The vast majority of U.S. abortions — 90% — are also perfor...
Source: TIME: Health - March 16, 2018 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthytime onetime Reproductive Health Source Type: news
Artificial intelligence could prevent breast cancer false positives: Here ’s how
[Image from maf04 on Flickr]Artificial intelligence could improve detection and diagnosis of breast cancer and eliminate false positives, according to new research out of the Massachusetts Institute of Technology’s Computer Science and Artificial Intelligence Laboratory (CSAIL). A team of researchers from MIT’s CSAIL, Massachusetts General Hospital and Harvard Medical School developed an AI system with machine learning that can predict if high-risk lesions on needle biopsies found during a mammogram will turn out to be cancerous after surgery. High-risk lesions that appear on mammograms and have abnormal cells ...
Source: Mass Device - October 19, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Oncology Research & Development Women's Health artificial intelligence Breast Cancer Harvard Medical School Massachusetts General Hospital Massachusetts Institute of Technology MedTech Source Type: news
Diagnostic Performance of USFNA of Nonpalpable Breast Lesions Diagnostic Performance of USFNA of Nonpalpable Breast Lesions
How well does ultrasound-guided fine-needle aspiration perform as a diagnostic procedure in nonpalpable breast lesions? How does it compare to other biopsy methods?American Journal of Clinical Pathology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 6, 2017 Category: Consumer Health News Tags: Pathology & Lab Medicine Journal Article Source Type: news
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, ...
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 ...
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 tis...
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 St. POB 10159 SE DECISION MA...
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 rei...
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 ...
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 s...
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 FDA ...
Source: Mass Device - June 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
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. ...
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: firstname.lastname@example.org 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. &l...
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 Ti...
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 Ti...
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 chemo...
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:...
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