New Products: MRI System improves lesion conspicuity, biopsy device receives FDA clearance and an App that tracks stent implants

Noninvasive prostate MRI system improves lesion conspicuity

Malvern, PA-Siemens Healthcare received FDA clearance for its noninvasive SEEit prostate magnetic resonance imaging (MRI) solution. SEEit uses high-channel surface coils, providing a noninvasive image technique that improves lesion conspicuity in diffusion-weighted imaging with Siemens’ RESOLVE technology, the company says. It offers improved patient set-up and accelerated scans to help optimize process efficiency. Powered by syngo MR E11 software architecture, SEEit gives users high-performance MAGNETOM Aera 1.5 Tesla and MAGNETOM Skyra 3T MRI systems that can perform a routine prostate exam in just 10 minutes without using an endorectal coil. Use of Direct RF and high-density coil technology Tim 4G and RESOLVE technology delivers the essential signal-to-noise ratio and resolution that enable users to perform prostate MRI using only the company’s new Body 30/60 surface coil, according to Siemens.

For more information, visit www.usa.siemens.com/prostatemri.

Targeted prostate biopsy device receives FDA clearance

Toronto-Focal Healthcare Inc. received 510(k) FDA clearance for its targeted prostate biopsy device, Fusion Bx. It is designed to take targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound fusion technology. According to the company, fusion biopsy has been shown to detect high-grade cancer in 30% more men compared to traditional systematic biopsy. By accurately determining the location and extent of the cancer, this procedure also allows clinicians to confidently monitor cancer progression over time and prescribe the appropriate course of treatment to patients with varying grades of cancer. The 510(k) clearance includes the use of Fusion Bx for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2-D and 3-D image visualization, including review, manipulation, and analysis tools.

For more information, visit http://focalhealthcare.com/

Test predicts prostate Ca progression in newly diagnosed men

San Diego-GenomeDx Biosciences has launched Decipher Biopsy, a genomic test that evaluates RNA expression-based biomarkers to predict the risk of high-grade disease, metastasis, and cancer-specific death at the time of biopsy in men with prostate cancer. According to the company, Decipher Biopsy is the only genomic test available to assess tumor aggressiveness across very low-, low-, intermediate-, and high-risk patients, enabling physicians to accurately determine if the patient may safely consider delaying initial local treatment or if he may benefit from earlier intensification of treatment with one or more therapies.

For more information, visit www.GenomeDx.com.

App tracks stent implants in patients with kidney stones

Marlborough, MA-Boston Scientific has introduced an app designed to track stent implants in patients with kidney stones. Clinicians and staff can log into a smartphone, tablet, or computer and record when a stent is placed, enter the date for follow-up/removal, set up automated reminders, and receive recurring email notifications regarding stent status. This can potentially help reduce the risk of complications, as digital tracking has been shown to reduce forgotten stents from 13% to 1%, according to Boston Scientfic. The Ureteral Stent Tracker, developed in partnership with Visible Health, is HIPAA-compliant to safely store patient information.

For more information, visit http://www.bostonscientific.com/en-US/medical-specialties/urology/ureteral-stent-tracker.html.

Reference book on GU tumors covers new ICD-10 codes, genetics

Geneva, Switzerland-The International Agency for Research on Cancer and International Academy of Pathology collaborated on “WHO Classification of Tumours of the Urinary System and Male Genital Organs,” the eighth volume in the 4th edition of the World Health Organization series on histologic and genetic typing of human tumors. The book includes diagnostic criteria, pathologic features, and associated genetic alterations, which are described in a strictly disease-oriented manner. Sections on all recognized neoplasms and their variants include new ICD-10 codes, epidemiology, clinical features, macroscopy, pathology, genetics, and prognosis and predictive factors. It contains numerous color photographs, MRIs, ultrasound images, computed tomography scans, charts, and references.

For more information, visit www.who.int/en/.

Portable 3-D ultrasound improves accuracy, reduces catheter UTIs

Bothell, WA-Verathon Inc. has launched its new portable 3-D ultrasound instrument, BladderScan Prime. It features a touchscreen interface, live B-mode scanning, and on-board self-diagnostics. Prime is designed to help reduce catheter-associated urinary tract infections by reducing the use of catheters. Prime’s VMODE technology acquires multiple scan planes inside the body, producing a 3-D quantification of the bladder. Based on this quantification, the instrument automatically calculates and displays urinary bladder volume. Also, it provides simple and advanced aiming modes, immediate feedback for off-center scans and pubic bone interference, and on-board help/tutorial assistance available at any point in the exam, Verathon says.

For more information, visit www.verathon.com.