Breaking News
September 21, 2018 - FDA takes new steps to address opioid crisis by approving Opioid Analgesic Risk Evaluation and Mitigation Strategy
September 21, 2018 - Positive Barhemsys Phase 3 Treatment Data Published in Anesthesia & Analgesia
September 21, 2018 - Celiac Disease Screening: MedlinePlus Lab Test Information
September 21, 2018 - Autism linked to egg cells’ difficulty creating large proteins
September 21, 2018 - Tweaking nuclear pores could provide new avenue to battle against cancer
September 21, 2018 - Experts warn health care providers to slow down in allowing smart pill in patient care settings
September 21, 2018 - MoreGrasp reports breakthrough development of grasp neuroprosthetics activated by thought control
September 21, 2018 - Study reveals new way to target HER2-negative metastatic breast cancer
September 21, 2018 - CHMP grants positive opinion for VENCLYXTO plus rituximab for treating relapsed/refractory CLL
September 21, 2018 - Study offers solid link between visceral organs and brain’s reward, motivation system
September 21, 2018 - First U.S. patient treated with innovative gene therapy at Bascom Palmer Eye Institute
September 21, 2018 - Choroidal Detachment – The American Society of Retina Specialists
September 21, 2018 - Discovery of a key protein involved in the development of autism
September 21, 2018 - Henry Ford Health System receives $600k grant to study genetic makeup of gliomas
September 21, 2018 - Arthritis common in individuals with varying degrees of depression, finds study
September 21, 2018 - Scientist intends to fight pathogenic bacteria with viruses
September 21, 2018 - New research suggests link between PFAS chemicals and hyperthyroidism in pet cats
September 21, 2018 - Multi-year study data shows impact of new soft contact lens to slow myopia progression in children
September 21, 2018 - Neuroscientists identify circuit for brain’s statistical inference about motion
September 21, 2018 - MILabs’ VECTor6 system wins Commercial Innovation Award at WMIC 2018
September 21, 2018 - Scientists find wild African monkeys infected with bacterium that causes syphilis, yaws in humans
September 21, 2018 - 2006 to 2015 Saw Increase in Severe Maternal Morbidity
September 21, 2018 - Similar changes in the brains of patients with ADHD and emotional instability
September 21, 2018 - Cobalt mining in DR Congo takes a high toll on both creuseurs and environment
September 21, 2018 - Eating fatty fish during pregnancy may boost unborn child’s brain development
September 21, 2018 - Study reveals promising new drug candidate to treat acute renal failure
September 21, 2018 - Neural signal that urges to eat overpowers the one that says to stop
September 21, 2018 - Scientists achieve breakthrough in accelerated diagnosis of multi-resistant hospital pathogens
September 21, 2018 - Researchers simulate how different breast tissues respond to heat from MRIs
September 21, 2018 - Despite red flags at surgery centers, overseers award gold seals
September 21, 2018 - Zapping Airway Nerves May Help COPD Patients Breathe
September 21, 2018 - Researchers find answers as to why some people are at risk of gout
September 21, 2018 - Stars of Stanford Medicine: Genetic counseling and compassion
September 21, 2018 - Researchers use reinforcement learning to train gliders to soar like birds
September 21, 2018 - New federally-funded research project could lead to treatments that extend human lifespan
September 21, 2018 - Health insurance ads have shifted over time due to health plans offered via ACA
September 21, 2018 - Use of transcranial electrical stimulation to bolster creativity has far-reaching implications
September 21, 2018 - Scientists find way to boost efficacy of powerful antimalarial drug with anti-cancer medicines
September 21, 2018 - Weighing the risks and benefits of drug tapering—two patients, two perspectives
September 21, 2018 - The “exposome” revealed: a barrage of bacteria, chemicals, microscopic animals and more
September 21, 2018 - Top three immune boosting recommendations to ward off freshers’ flu
September 21, 2018 - Young children’s oral microbiota could serve as early indicator for obesity
September 21, 2018 - Older individuals with multiple sclerosis report higher quality of life than younger counterparts
September 21, 2018 - LineaRx signs agreement with Takis/Evvivax to develop linear-DNA based anti-cancer vaccines
September 21, 2018 - AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress
September 21, 2018 - Alzheimer’s drug may stop disease if used before symptoms develop
September 21, 2018 - Human skeletal stem cell can generate cartilage, bone
September 21, 2018 - UK and European research collaborations receive vote of confidence by three major cancer charities
September 21, 2018 - Microbiota in the intestines and cell stress cause colon cancer
September 20, 2018 - Arizona EMTs have 39% higher risk for suicide than general public
September 20, 2018 - Driving and older adults: MedlinePlus Medical Encyclopedia
September 20, 2018 - Brain region for stress control is enlarged in people with depression, finds study
September 20, 2018 - Researchers test autobiographical memory for early Alzheimer’s detection
September 20, 2018 - Organizations join forces to help teens with severe mental health challenges | News Center
September 20, 2018 - Neurons in the human brain can encode numerical information
September 20, 2018 - Potential drugs to treat neurodegenerative diseases garner $3 million grant
September 20, 2018 - Processing speed important to higher order cognitive function in multiple sclerosis patients
September 20, 2018 - Helping a patient survive a hurricane
September 20, 2018 - Tafamidis Treats Transthyretin Amyloid Cardiomyopathy
September 20, 2018 - Low academic achievement can lead to drug abuse decades later, research finds
September 20, 2018 - Study identifies stem cell that gives rise to new bone, cartilage in humans | News Center
September 20, 2018 - Celltrion and Emory University sign ‘Incubation’ agreement to develop new drug candidates for atherosclerosis
September 20, 2018 - TGen and PNOC take part in launch of NIH-supported Kids First Data Resource Portal
September 20, 2018 - Could Household Cleaners Make Your Kid Fat?
September 20, 2018 - Addiction nonprofit makes searching for services simple
September 20, 2018 - We are bombarded by thousands of diverse species and chemicals | News Center
September 20, 2018 - Experts to Present Prostate Cancer Advances at Patient Summit
September 20, 2018 - Alector announces initiation of Phase 1 trial of AL001 for treating frontotemporal dementia
September 20, 2018 - Pfizer’s 20vPnC vaccine receives Breakthrough Therapy designation from FDA
September 20, 2018 - Study could allow doctors to screen patients at risk from Aspergillus
September 20, 2018 - Emergex signs MoU with Brazil’s Fiocruz for development of viral vaccines
September 20, 2018 - The ‘real you’ is a myth – we constantly create false memories to achieve the identity we want
September 20, 2018 - Researchers describe cell mechanism that optimizes proteins production in stressful situations
September 20, 2018 - Cell Medica successfully doses first patient with CMD-501 targeting pediatric neuroblastoma
September 20, 2018 - Sesen Bio to present its three-month Phase 3 VISTA Trial data at Global Congress
September 20, 2018 - Senators unveil legislation to protect patients against surprise medical bills
September 20, 2018 - Study provides insights into development of special-purpose cosmetic products
September 20, 2018 - Research shows enlarged genotype-phenotype correlation for three-base pair deletion in NF1
September 20, 2018 - 91% of people around the world believe medical research will result in dementia cure
September 20, 2018 - DePuy Synthes introduces CONCORDE LIFT Expandable Interbody Device at EUROSPINE 2018
Cianna Medical receives FDA 510(k) clearance to extend indication of SCOUT reflector for use in soft tissue localization

Cianna Medical receives FDA 510(k) clearance to extend indication of SCOUT reflector for use in soft tissue localization

image_pdfDownload PDFimage_print

The SCOUT reflector can now be used to mark soft tissue sites including lymph nodes

Cianna Medical, Inc., the world leader in wire-free breast localization, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to extend the indication of its SCOUT reflector for use in localization of soft tissue. The SCOUT System has been in use for wire-free breast tumor localization since 2016 and has been proven in over 42,000 procedures in more than 325 medical centers in the U.S.

“SCOUT resolves one of the most difficult aspects of breast cancer treatment by allowing us to accurately localize soft tissue such as axillary lymph nodes,” states Ari Brooks, surgical breast oncologist and Director of the Integrated Breast Center at Penn Medicine. “The SCOUT reflector is very well suited for use in the lymph nodes.”

SCOUT is uniquely suited for marking tumors, biopsy sites and lymph nodes prior to neoadjuvant therapy. Because the SCOUT reflector does not have a clinically significant MRI artifact, it does not interfere with MRI studies; there is no restriction on the imaging modalities that can be used effectively throughout a patient’s treatment.

Physicians are using SCOUT as a solution for breast tumor localization, bracketing of large or diffuse breast lesions, targeted lymph node dissection, placement at the time of biopsy and to mark tissue prior to neoadjuvant chemotherapy. With seven peer-reviewed publications and over 20 clinical abstracts, the SCOUT system has been proven to be easy to use and provides accurate detection and precise localization.

SCOUT has also been shown to improve radiology work flow and significantly reduce OR delays. SCOUT has received significant recognition from medical societies and industry associations including the 2016 Scientific Impact Award from the American Society of Breast Surgeons, the 2017 Gold Award for Medical Design Excellence and the 2018 Premier Breakthrough Technology Award.

“Radiologists and surgeons have expressed a strong clinical need for wire-free lymph node localization and targeted axillary node dissection. This is one more way Cianna Medical is providing solutions to real healthcare needs,” said Jill Anderson, President and CEO of Cianna Medical. “This expanded FDA clearance gives physicians even greater flexibility for planning individualized breast cancer treatment and offers more patients a better experience.”

Beyond the technology, Cianna Medical believes in community education and offering the same standard of care to all patients regardless of their ability to pay. SCOUTCare™, an award-winning program that provides assistance for uninsured patients and multi-modality training for radiologists, surgeons and allied health professionals.

Source:

Indication for Use of SAVI SCOUT® Wire-Free Radar Breast Localization System Expands to Include Localization of Soft Tissue

Tagged with:

About author

Related Articles