FDA Approvals - FDA Grants Boston Scientific Clearance To Expand PolarCath(TM) Peripheral Dilatation
FDA Grants Boston Scientific Clearance To Expand PolarCath(TM) Peripheral Dilatation System Offering With New Balloon ... (Medical News Today)
Boston Scientific Corporation (NYSE: BSX) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to expand its PolarCath(TM) Peripheral Dilatation System offering to include a 100-millimeter (mm) balloon. [click link for full article]
Nephros Receives Conditional Approval from the FDA of Investigational Device Exemption Application (Business Wire via Yahoo! Finance)
NEW YORK----Nephros, Inc. today reported that the Company received conditional approval for its Investigational Device Exemption application from the Food and Drug Administration to begin a human clinical trial of the Company's OLpur H2H Hemodiafiltration Module and OLpur MD 220 Hemodiafilter.
Critical Therapeutics Licenses Rights for Vagus Nerve Stimulation Device to Innovative Metabolics (RedNova)
Critical Therapeutics, Inc. (Nasdaq: CRTX) has granted an exclusive worldwide license to Innovative Metabolics, Inc.