Also read about an expanded indication for a magnetic surgical system, new consumer sexually transmitted disease lab tests, and more.
C-arm technology reduces radiation in fluoroscopic imaging procedures
The FDA has granted 510(k) clearance for ControlRad Trace and manufacturer ControlRad has initiated its commercial launch. The ControlRad Trace can be integrated into existing mobile C-arms to reduce radiation in any fluoroscopic imaging procedure, according to the company. With its proprietary semi-transparent filter, tablet, and image processing technology, the ControlRad Trace solution can be retrofitted on existing C-arms, lowering the barrier to adopting the technology in order to reduce unnecessary radiation up to 89% without compromising image quality and overall workflow. The medical staff draws a region of interest on a ControlRad tablet, which in real time optimizes image quality in the region of interest while reducing unnecessary radiation in the periphery.
For more information, visit www.controlrad.com.
Magnetic surgical system granted indication for use in prostatectomy
The FDA has granted Levita Magnetics an expanded indication to market the first-of-its-kind Levita Magnetic Surgical System for use in prostatectomy procedures. Initially indicated for use in laparoscopic cholecystectomy and bariatric surgical procedures, the shaftless Magnetic Surgical System reduces the number of incisions necessary for minimally invasive procedures, according to the company. The Levita System consists of an external magnet placed on the skin that controls a shaftless detachable grasper that enables surgeons to move the grasper without the constraints of a fixed-position pivot point. The Levita System was designed to address the challenges of laparoscopic procedures by reducing the number of incisions and trocars used and facilitating access and visibility to the surgical site, ultimately enabling safe procedures with better cosmetic outcomes.
For more information, visit www.levita.com.
Male continence therapy system given reimbursement code
ProACT Adjustable Continence Therapy for Men has received a reimbursement code from the Centers for Medicare & Medicaid Services and is now commercially available in the United States. The code, C9746, is associated with a national average payment of $16,243 in the hospital outpatient setting and $10,706 in ambulatory surgery centers. The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a filling port. The implantation procedure lasts approximately 30 minutes and can be performed in ambulatory surgical centers or in the hospital outpatient setting. The balloons are surgically placed in the area where the prostate was removed or resected and the ports are placed underneath the skin. The fluid-filled balloons provide pressure and support at the bladder neck, which protects against accidental leaking of urine. When there is a need to urinate, passing urine requires only a normal amount of bladder effort. The balloon volume can be adjusted at any time to achieve optimal continence. Data from a pivotal trial of ProACT were published in Neurourology and Urodynamics (2018; 37:2854-9).
For more information, visit www.uromedica-inc.com.
Reusable, washable incontinence barrier available for post-RP men
Pacey MedTech Ltd. recently announced the creation of the Pacey Cuff Guard, a reusable and washable incontinence barrier, specifically for men who have undergone prostate cancer treatment and regularly experience urinary incontinence. The Pacey Cuff Guard is made from durable neoprene, which doesn’t irritate the skin, is odorless, and has a slim ergonomic design to ensure a comfortable and discreet fit within form-fitting underwear. The Pacey Cuff Guard’s moisture-absorbent padding catches any excess urinary drops, and is a supplementary device designed to add value to the Pacey Cuff Turbo urethral control device, according to the company.
For more information, visit www.paceycuff.com.
New consumer sexually transmitted disease lab tests launched
Quest Diagnostics has launched three new sexually transmitted disease (STD) laboratory test packages that individuals can purchase online for some of the most prevalent STDs in the United States. The new STD test packages are the first to be offered directly by Quest Diagnostics or any other major national laboratory to allow individuals to purchase tests at their discretion. These new packages have been designed to meet the needs of individuals who want accurate basic or comprehensive STD testing. The STD test services are available in 45 states through QuestDirect, an enhanced online consumer-initiated testing service provided by Quest Diagnostics. Test results are available on MyQuest, the company’s secure patient portal accessible on a smartphone, tablet, or desktop, typically within a week, and may be shared with the individual’s own physician.
For more information, visit www.questdiagnostics.com.
FDA clearance allows addition of STI tests to cobas 6800/8800 Systems
The FDA recently granted 510(k) clearance for the cobas TV/MG test for use on the cobas 6800/8800 Systems for the detection of Trichomonas vaginalis and/or Mycoplasma genitalium DNA in both symptomatic and asymptomatic patients, Roche reported. Laboratories can now simultaneously process from a single patient sample a combination of Chlamydia trachomatis,Neisseria gonorrhoeae,Trichomonas vaginalis, and Mycoplasma genitalium, which provides clinicians the information they need to screen and diagnose sexually transmitted infections and improve patient care.
For more information, visit www.diagnostics.roche.com.
Generic version of overactive bladder medication introduced
Teva Pharmaceutical Industries Ltd. recently announced the launch of a generic version of VESIcare (solifenacin succinate) tablets, 5 mg and 10 mg, in the U.S. Solifenacin is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
For more information, visit www.tevapharm.com.