New Products: Single-use ureteroscope, new FDA Approvals for RCC treatment, and an App that helps IC, chronic prostatitis patients

Check out the latest new products. From Single-use ureteroscope addresses shortcomings of reusable scopes, to an App that helps IC, chronic prostatitis patients choose the right foods and much more.




Single-use ureteroscope addresses shortcomings of reusable scopes

Marlborough, MA-Boston Scientific Corp. announced the launch of the LithoVue Single-Use Digital Flexible Ureteroscope for minimally invasive endoscopic procedures to diagnose and treat stones and other conditions of the kidney, ureter, and bladder. The LithoVue system, cleared for marketing by the FDA under the 510(k) regulatory process, is designed to address the inconsistent performance, operational challenges, and costs associated with reusable scopes. It delivers high-quality digital visualization and seamless navigation for consistent clinical performance, according to Boston Scientific. Features include a digital CMOS imager in the 7.7F tip with a working distance of 2- to 50-mm for high-quality images; 270˚ scope deflection in both directions to provide accurate navigation toward the targeted treatment area; workstation monitor with integrated image processing software mounted on a compact, rolling mobile cart that can be used alone during a ureteroscopic procedure or connected to existing monitors and integrated video systems in the operating room suite.

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FDA approves RCC treatment that targets immune system

Princeton, NJ-Bristol-Myers Squibb received FDA approval for nivolumab (Opdivo) injection, for intravenous use, for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that works by targeting the immune system through the PD-1 immune checkpoint pathway. It is the first PD-1 inhibitor to deliver significant overall survival in patients with advanced RCC who have received prior anti-angiogenic therapy, according to Bristol-Myers Squibb. The approval was based on data from a study of patients with advanced RCC who were randomized to receive either nivolumab or everolimus (Afinitor). Those treated with nivolumab lived an average of 25 months after treatment initiation versus 19.6 months in those treated with everolimus. The most common side effects associated with the use of nivolumab include weakness and lack of energy, cough, nausea, rash, dyspnea, and arthralgia.

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Urology-specific EHR is all-in-one system, supports subspecialties

Thousand Oaks, CA-Compulink Business Systems, Inc. introduced Urology Advantage, a specialty-specific version of its fully integrated all-in-one system. It features visual documentation engine technology, which allows physicians to quickly document the diagnosis, drive orders, testing, and patient education by dragging and dropping a single icon. Urology Advantage supports all subspecialty areas including pediatric urology, urologic oncology, renal transplantation, male reproductive medicine/infertility, and nephrology. It also includes assessment tools, which automatically calculate symptom scores based on the AUA’s Symptom Score Index. It automates ICD-10 and is certified for meaningful use.

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App helps IC, chronic prostatitis patients choose the right foods

Healdsburg, CA-The Interstitial Cystitis Network Food List App is designed to help patients with interstitial cystitis and chronic prostatitis choose foods that will soothe rather than irritate their bladder or prostate. Ideal for use when shopping or eating out, it contains a searchable database of more than 250 foods rated for their ability to trigger discomfort. Foods are listed by: bladder friendly, try it, or caution.

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Blood-based test used to detect, monitor late-stage prostate Ca

San Diego-Biocept, Inc. launched a CLIA-validated androgen receptor expression assay that uses a patient's blood to detect and monitor late-stage prostate cancer. The Biocept assay uses circulating tumor cells from a blood draw to detect androgen receptor expression, which is prevalent in patients with advanced prostate cancer.

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Alcohol-free formula of docetaxel earns FDA approval

San Jose, CA-Teikoku Pharma USA has received FDA approval for a non-alcohol form of docetaxel injection, for the treatment of prostate cancer and other cancers. The new formula requires no prior dilution with a diluent and is ready to add to the infusion solution. It is available in three presentations: 20 mg/mL in single-dose vials, and 80 mg/4 mL or 160 mg/8 mL in multiple-dose vials. Teikoku said the novel formulation will provide an option for patients with alcohol sensitivity or a preference for an alcohol-free treatment.

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Drug provides treatment option for kidney transplant patients in U.S.

Hørsholm, Denmark-Veloxis Pharmaceuticals A/S announced the launch of tacrolimus extended-release tablets (Envarsus XR) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from immediate-release tacrolimus products to once-daily extended-release tacrolimus. The agent has an orphan drug status in the U.S. and has been issued a unique reimbursement J-code by the Centers for Medicare & Medicaid Services for 2016 and beyond, Veloxis said.

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