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Biopsy Procedure Articles & Analysis

22 news found

Integrating Fusion Biopsies into Your Practice II

Integrating Fusion Biopsies into Your Practice II

It combines the accuracy of MRI with the real-time monitoring of ultrasound to detect more clinically significant cancer, while preventing unnecessary biopsies. Unlike standard systematic biopsy, fusion can track lesions over time with imaging or repeat biopsy during active surveillance. ...

ByFocal Healthcare


Raleigh’s UVision360 Gets FDA OK For Biopsy Sheath

Raleigh’s UVision360 Gets FDA OK For Biopsy Sheath

The device expands the startup’s “all-in-one” gynecological system LUMINELLE DTx, an endoscopic platform that enables diagnostic and operative procedures, such as uterine and bladder biopsies, to be performed in the office. ...

ByLUMINELLE


Seno Medical’s Imagio Breast Imaging System Named Science and Medical Category Finalist in 2022 Edison Awards Program

Seno Medical’s Imagio Breast Imaging System Named Science and Medical Category Finalist in 2022 Edison Awards Program

We truly believe that Imagio® can make a difference in both diagnostic confidence and patient experiences.” Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year. ...

BySeno Medical Instruments, Inc.


Sonic Incytes Successfully Completes Series A Raise of US$7.3M to Accelerate VelacurTM Commercialization

Sonic Incytes Successfully Completes Series A Raise of US$7.3M to Accelerate VelacurTM Commercialization

Cleared by the FDA, VelacurTM is a handheld, point of care ultrasound solution that quantifies liver stiffness using technology similar to MRI elastography combined with 3D tissue sampling. Unlike biopsy and MRI, the procedure is non-invasive, comfortable and convenient. ...

BySonic Incytes Medical Corp.


Poster Presentation at RSNA Compares Seno Medical’s OA/US Breast Imaging with AI Decision Support to Ultrasound Alone; Finds Significantly Better Specificity to Support Clinical Decision Making Conf

Poster Presentation at RSNA Compares Seno Medical’s OA/US Breast Imaging with AI Decision Support to Ultrasound Alone; Finds Significantly Better Specificity to Support Clinical Decision Making Conf

“When used alongside the AI decision support tool, OA imaging has the potential to reduce false positives and thus biopsies of benign masses, versus ultrasound alone, without sacrificing sensitivity.” Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 ...

BySeno Medical Instruments, Inc.


Velacur Data Presented at 2021 AASLD The Liver Meeting

Velacur Data Presented at 2021 AASLD The Liver Meeting

It provides consistently accurate results, enabling a clear picture of liver health in real time, so physicians can be confident in the diagnosis, treatment and care of their patients with chronic liver disease. Unlike biopsy and MRI, the procedure is non-invasive, comfortable and convenient. ...

BySonic Incytes Medical Corp.


Seno Medical Launches CONFIDENCE Registry Study for Imagio® Breast Imaging System

Seno Medical Launches CONFIDENCE Registry Study for Imagio® Breast Imaging System

CONFIDENCE registry endpoints to be analyzed include: Specificity, negative-likelihood ratio, sensitivity, and positive-likelihood ratio for the Imagio® System versus other standard-of-care imaging modalities, Use of the Imagio® System in comparison to, and in combination with, other imaging modalities in impacting the decision to biopsy, Quality of Life Assessment ...

BySeno Medical Instruments, Inc.


Lightpoint Medical to Present Positive Clinical Trial Data for SENSEI Miniature Gamma Probe in Prostate Cancer Surgery

Lightpoint Medical to Present Positive Clinical Trial Data for SENSEI Miniature Gamma Probe in Prostate Cancer Surgery

We look forward to using SENSEI in more procedures and evaluating the probe in combination with the new targeted imaging agent, 99mTc-PSMA, for direct detection of disease metastasis in pelvic lymph nodes." ...

ByLightpoint Medical, Ltd


Sonic Incytes Showcases Velacur at ACG 2021

Sonic Incytes Showcases Velacur at ACG 2021

It provides consistently accurate results, enabling a clear picture of liver health in real time, so physicians can be confident in the diagnosis, treatment and care of their patients with chronic liver disease. Unlike biopsy and MRI, the procedure is non-invasive, comfortable and convenient. ...

BySonic Incytes Medical Corp.


U.S. Food and Drug Administration Clears UVision360, Inc. Novel LUMINELLE® 360° Bx (Biopsy) Sheath

U.S. Food and Drug Administration Clears UVision360, Inc. Novel LUMINELLE® 360° Bx (Biopsy) Sheath

The LUMINELLE 360° Bx sheath, combined with the LUMINELLE DTx System, is the first and only integrated directed biopsy device not requiring the use of additional instruments, and indicated for uterine and bladder biopsies. ...

ByLUMINELLE


New Studies Examine the Use of ExactVu Micro-Ultrasound to Improve on Prostate MRI

New Studies Examine the Use of ExactVu Micro-Ultrasound to Improve on Prostate MRI

Clinical evidence for micro-ultrasound is growing exponentially with publications from more than a dozen institutions reporting on more than 3,000 individual biopsy cases. Toronto, Canada -- (March 31, 2021) Exact Imaging™ (www.exactimaging.com), the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy ...

ByExact Imaging


Bio-Techne`s Exosome Diagnostics Laboratory Announces CE-IVD Certification for Exodx Prostate Test

Bio-Techne`s Exosome Diagnostics Laboratory Announces CE-IVD Certification for Exodx Prostate Test

The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result, thereby reducing complications from unnecessary and invasive procedures. ...

ByExosome Diagnostics, Inc.


Bio-Techne Announces ExoTRU Kidney Transplant Rejection Assay Data Publication

Bio-Techne Announces ExoTRU Kidney Transplant Rejection Assay Data Publication

The current standard of care relies on measuring changes in serum creatinine levels, which has poor sensitivity and specificity for detecting kidney transplant rejection, and can rise and fall due to numerous factors, leading to challenges making therapeutic decisions in a timely manner. Utilization of needle biopsy procedure and histology is more accurate; ...

ByExosome Diagnostics, Inc.


FDA Approves Seno Medical’s Ground-Breaking Breast Cancer Diagnostic Technology

FDA Approves Seno Medical’s Ground-Breaking Breast Cancer Diagnostic Technology

The company’s Imagio® Breast Imaging System uses non-invasive opto-acoustic ultrasound (OA/US) technology to provide information on suspicious breast lesions in real time, helping providers characterize and differentiate masses that may – or may not – require more invasive diagnostic evaluation. Breast biopsy procedures caused by ...

BySeno Medical Instruments, Inc.


Publication of a Health Economic Analysis Demonstrates IsoPSA Significantly Reduces Unnecessary Prostate Cancer Biopsies and Costs

Publication of a Health Economic Analysis Demonstrates IsoPSA Significantly Reduces Unnecessary Prostate Cancer Biopsies and Costs

Among patients scheduled for repeat biopsies, the econometric model indicated that the use of IsoPSA reduced the number of biopsies required by 34% overall, generating significant cost savings to the healthcare system (16% savings compared to the standard care arm). ...

ByCleveland Diagnostics, Inc.


CrossBay Medical Receives FDA Clearance for CrossGlide ETS Plus

CrossBay Medical Receives FDA Clearance for CrossGlide ETS Plus

CrossBay Medical receives FDA Clearance for CrossGlide™ ETS Plus for frictionless, office-based endometrial biopsy procedures focused on patient comfort. Similar to the CrossGlide ETS, Endometrial Tissue Sampler (which received FDA clearance this summer), the ETS Plus also enables medical providers to perform a frictionless, office-based endometrial ...

ByCrossBay Medical


Basic ENT Surgery Set

Basic ENT Surgery Set

Buck Ear Curettes are used to debride and excise tissues as part of a biopsies or cleaning procedures in ear pathologies. The long hexagonal handle and shaft end with a resilient ring-shaped blade. ...

BySurtex Instruments Limited


CrossBay Medical Receives FDA Clearance for CrossGlide Endometrial Tissue Sampler

CrossBay Medical Receives FDA Clearance for CrossGlide Endometrial Tissue Sampler

The CrossGlide™ ETS, the third product to utilize the frictionless CrossGlide technology platform, enables medical providers to perform an office-based endometrial biopsy procedure gently, effortlessly and without a tenaculum. The product is designed for simpler access to the uterine cavity than currently available ...

ByCrossBay Medical


Crossbay medical announces ce mark marketing authorization for its endometrial tissue sampler (ETS)

Crossbay medical announces ce mark marketing authorization for its endometrial tissue sampler (ETS)

The use of this technology allows a novel way to obtain an office-based endometrial biopsy, a very common tissue-sampling procedure performed in women’s health offices worldwide. The ETS is the third product using the frictionless CrossGlide™ technology to receive marketing authorization and will be made available for use in endometrial ...

ByCrossBay Medical


Seno Medical: Making a Difference for Breast Cancer in San Antonio

Seno Medical: Making a Difference for Breast Cancer in San Antonio

Employees spent time getting to know patients, their first-hand experience and the many exams they underwent, including painful biopsy procedures, to assess whether the suspicious mass was benign or malignant. ...

BySeno Medical Instruments, Inc.

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