Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Viveve, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, announced today that the Company has received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a stress urinary incontinence (SUI) multicenter, randomized, double-blinded, sham-controlled clinical trial entitled PURSUIT – Prospective U.S. Radiofrequency SUI Trial. The trial is designed to evaluate the safety and efficacy of Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment versus an inert sham tip for the improvement of SUI in women. Read more.
Source: BioSpace, July 7, 2020
Rigicon announces that ContiClassic® Artificial Urinary Sphincter and the ContiReflex® Artificial Urinary Sphincter models have recently received CE Mark Approval and is initially available in all major European markets. ContiClassic® Artificial Urinary Sphincter and ContiReflex® Artificial Urinary Sphincter are implant devices that treat Urinary Incontinence (UI). Conti® Artificial Urinary Sphincter Systems are indicated to treat urinary incontinence due to intrinsic sphincter deficiency in cases such as incontinence following prostate surgery. Conti® Artificial Urinary Sphincter Systems are designed to restore the function of the normal (healthy) urinary sphincter that restricts urine flow out of the bladder. Read more.
Source: PRWeb, May 7, 2020
UAE-based medical devices company ProvenMed Global FZ-LLC announced today that its online store, shop.provenmed.com, is now open for business. The company is also offering a limited time-only discount up to 40% on all products purchased via the online store. ProvenMed specializes in urinary continence innovation and is renowned for their flagship suite of products called ActivGo®. It was the world’s first reusable and washing system-integrated urinary external catheter for male incontinence management. Read more.
Source: ProvenMed, April 12,2020
StimGuard LLC, a privately-held medical device company engaged in the development, manufacture and pre-commercialization of innovative wireless, injectable electroceutical device solutions for urological conditions, today announced that it is changing its corporate name to Micron Medical Corporation. In addition, effective immediately, Stephen Deitsch has been appointed as Chief Executive Officer (CEO) and will join the Company’s board of directors. Co-founder Laura Tyler Perryman will now assume the role of Chief Operating Officer (COO) in order to focus on product development, regulatory and clinical affairs efforts. Read more.
Source: StreetInsider, April 3, 2020
Hygiene and health company Essity is strengthening its offering in incontinence products through the acquisition of the Dutch company Novioscan. The company develops a wearable ultrasound technology that monitors the bladder and enables continence control. The purchase price is approximately SEK 70m (EUR 6.5m) on a debt-free basis. The SENS-U innovation is a wearable ultrasound sensor that measures the level in the bladder. It sends a discrete notification that allows the user to empty their bladder in time. A version of SENS-U for children is already available in the market and an adult version is under development. Read more.
Source: PRNewswire, April 1, 2020
Urovant Sciences (Nasdaq: UROV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application. Read more.
Source: Businesswire, March 5, 2020
Viveve Medical, Inc. (VIVE), a medical technology company focused on women’s intimate health, announced today that it has completed enrollment in its three-arm, three-month feasibility study to compare Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. The Investigational Testing Application (ITA) study, approved by the Canadian Ministry of Health, was initiated in January 2020. Read more.
Source: Yahoo Finance!, March 4, 2020