biopsy News
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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 biopsy procedure gently, effortlessly and ...
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Integrating Fusion Biopsies into Your Practice I
Compared to standard systematic biopsies, MRI-targeted fusion biopsies improve the detection of clinically significant prostate cancer. Studies have shown MRI can be a cost-effective and accurate first-line diagnostic tool for the early detection of prostate cancer. If the MRI is negative, patients may avoid biopsy, whereas positive results provide an action plan for biopsy and potential ...
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$2M Grant for WMP licensee Tesoro Imaging
November 1, 2016: WMP spin-off (and licensee) Tesoro Imaging Srl and its collaborators won a $2M European grant to examine the role of WMP-designed ultra-high resolution MRI systems in selectively replacing excisional ...
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Integrating Fusion Biopsies into Your Practice II
Targeted MRI-US fusion biopsy is an emerging technology with the potential to change the standard of care for diagnosis and treatment. 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 ...
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Crossbay medical announces ce mark marketing authorization for its endometrial tissue sampler (ETS)
CrossBay Medical, Inc., today announced that it has received clearance to commercialize its product, the Endometrial Tissue Sampler using CrossGlide™ technology, in Europe by obtaining its CE Mark. 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 ...
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CrossBay Medical Receives FDA Clearance for CrossGlide Endometrial Tissue Sampler
CrossBay Medical has received FDA clearance for its 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 ...
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Scion Medical Technologies Receives CE Mark Clearance for Cassi Breast Biopsy System
Newton, MA– Scion Medical Technologies, LLC. has received CE Mark (Conformité Européenne) designation for the Cassi breast biopsy system. The CE Mark paves the way for the Cassi breast biopsy system to be offered to the European market. About Scion Medical Technologies Scion Medical Technologies (Scion) is a global medical device company with US headquarters in ...
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Cost Effectiveness of MRI for Early Detection of Prostate Cancer
Prostate cancer is the second most common and lethal cancer among men in the United States. In 2021, an estimated 250,000 men were diagnosed, with the majority over 65 years old. During the height of the pandemic, diagnosis and screening numbers plummeted, resulting in thousands of missed diagnoses. Lost in the surgical backlog, already delayed diagnoses may be further delayed, potentially ...
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Bio-Techne Announces Publication of ExoDx Prostate Test Study in Patients With Prior Negative Prostate Biopsy
Dr. James McKiernan, Professor of Urology at Columbia University, demonstrated that using the ExoDx Prostate test, or EPI, resulted in good performance ruling out high-grade (Gleason 7 or higher) prostate cancer (HGPCa) in prior negative biopsy patients with the previously validated 15.6 cut-point. Bio-Techne Corporation (NASDAQ:TECH) today announced an important publication in BMC Urology, ...
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SAGA Diagnostics appoints Peter Collins as Chief Executive Officer
SAGA Diagnostics AB, (“SAGA”), a leading cancer liquid biopsy and genomic testing company, is pleased to announce the appointment of Peter Collins as Chief Executive Officer. Mr. Collins is a highly experienced entrepreneur with over 30 years of experience in the pharma and diagnostics sector. He joins SAGA after successful executive roles at major players in the liquid biopsy field ...
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Precision Diagnostic of Cancer Therapies with Dr. Chorom Pak LynxBio
Dr. Chorom Pak, President and CEO, LynxBio was a finalist in the John G. Watson Quick Pitch Competition presented by the Tech Coast Angels and the San Diego Venture Group. She talks about using an advanced approach to diagnosing cancer by using a standard-of-care biopsy to create a living model of a patient's cancer, including the patient's own microenvironment, to rapidly identify effective ...
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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 guidance for the prostate, and its ...
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Raleigh’s UVision360 Gets FDA OK For Biopsy Sheath
A new biopsy sheath developed by Raleigh med tech startup UVision360 is ready to hit the market after landing federal approval this week. UVision360 announced it had received the greenlight from the U.S. Food and Drug Administration for its patented LUMINELLE 360° Bx Sheath. The device expands the startup’s “all-in-one” gynecological system LUMINELLE DTx, an endoscopic ...
By LUMINELLE
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U.S. Food and Drug Administration Clears UVision360, Inc. Novel LUMINELLE® 360° Bx (Biopsy) Sheath
UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the patented LUMINELLE 360° Bx (Biopsy) Sheath which expands the capability of the LUMINELLE® DTx System. The LUMINELLE 360° Bx sheath, combined with the LUMINELLE DTx System, is the first and only integrated directed biopsy device not requiring ...
By LUMINELLE
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Scion Acquires Soft Tissue Marker with FDA Marketing Clearance from Kent Medical Devices, Inc.
June 26, 2012 – Newton, Massachusetts. Scion Medical Technologies, LLC (Scion), a company that manufactures and sells products in the general surgery area, announced today that it has acquired a soft tissue marker product line with FDA marketing clearance from Kent Medical Devices, Inc. of Minneapolis, Minnesota. “The Kent Medical Devices soft tissue marker product line bolsters our ...
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Bio-Techne Announces Paper Publication in Annals of Oncology
This review paper provides unique insight into liquid biopsies and the field of exosomes in the context of other liquid biopsies such as cfDNA and CTC analysis. The exosome field has gone through a rapid growth phase in parallel with the increasing attention over the potential of liquid biopsies. Bio-Techne Corporation (NASDAQ:TECH) today announced that Exosome Diagnostics, a Bio-Techne ...
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Scion Acquires Soft Tissue Biopsy Product Line
June 15, 2012 – Newton, Massachusetts. Scion Medical Technologies, LLC (Scion), a company that manufactures and sells products in the general surgery area, announced today that it has acquired a suite of assets for soft tissue biopsy, including issued intellectual property for a novel approach in the field. Scion is completing the final stages of development of the product and plans to ...
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Lynx Bio Makes Headway on New Diagnostic for Blood Cancer Drugs
In 2009, as a graduate student at the University of Wisconsin-Madison, Chorom Pak was part of a group of researchers working to understand how sensitive patients’ cells were to certain therapies for blood cancers, such as multiple myeloma. The group, which also included UW-Madison professors Shigeki Miyamoto and David Beebe, and postdoctoral fellow Edmond Young, would receive ...
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Rarecells, Inc. announces Appointment of Dr. Neil Gunn as New Director to the Board
Rarecells, Inc. today announced the appointment of Dr. Neil Gunn, a recognized leader and expert in the diagnostic space, as an independent Board Director. “We are delighted to welcome Neil as Board Director. With his broad understanding of diagnostics and the Liquid Biopsy space he is well-positioned to provide valuable perspectives and insight across a broad spectrum of topics, from ...
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The Lancet Oncology: 66% of diagnostic biopsies for common skin cancer can be avoided using Michelson Diagnostics’ VivoSight OCT laser scanner
A major study published in leading cancer journal, The Lancet Oncology1 have ground-breaking findings on Michelson Diagnostics, the UK based medical device company that use multi-beam Optical Coherence Tomography (‘OCT’) technology, which can transform patient’s treatment and care of basal cell carcinomas (BCC). It was concluded that OCT-guided diagnosis, when compared to a ...
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