Viveve Medical's (VIVE) Viveve System Receives FDA 510(k) Clearance
- Wall Street dips as telecoms slump; AmEx surges
- Microsoft (MSFT) Tops Q1 EPS by 8c
- AMD (AMD) Posts Q3 Operating EPS of 3c; Sees Q4 Revenue Down Sequentially
- AT&T (T) Said to Discuss Idea of Takeover in Time Warner (TWX) Meetings
- After-Hours Stock Movers 10/20: (CERC) (ALKS) (PFPT) (MSFT) Higher; (SKX) (RRGB) (AMD) Lower (more...)
News and research before you hear about it on CNBC and others. Claim your 2-week free trial to StreetInsider Premium here.
Viveve Medical, Inc. (Nasdaq: VIVE) announced that the Viveve System has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA). In the United States, the Viveve System is now indicated for use in general surgical procedures for electrocoagulation and hemostasis.
"FDA 510(k) clearance for the Viveve System represents a major milestone in our efforts to bring this safe and effective technology to patients in the United States who can benefit from it," said Patricia Scheller, chief executive officer of Viveve. "We are grateful to all of the clinicians and researchers who have supported the development of the Viveve System over the past several years, and to all of the members of the Viveve team who played a vital role in helping us achieve this goal."
"This clearance represents the first step in our U.S. regulatory strategy," Scheller added. "In September 2016, we announced that the company filed an Investigational Device Exemption (IDE) to the FDA, for authorization to begin the VIveve Treatment of the Vaginal Introitus to EValuate Efficacy (VIVEVE II) study."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- PTC Therapeutics (PTCT) Commences RG7916 Phase 2 in Type 2/3 SMA Patients with Roche, SMAF
- Independent Bank (INDB), Island Bancorp Enter Merger Agreement
- Rosetta Genomics (ROSG) Names New Chief Commercial Officer
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!