Biosig Technologies Inc. is on a hot streak this week. In addition to reporting the close of a private placement of almost $4.3 million, the company said it had scored 510(k) clearance from the FDA for its first product, the Pure EP system. The noninvasive system is designed to help electrophysiologists make decisions during procedures to diagnose and treat patients with abnormal heart rates and rhythms.
More than three years after it faced a huge setback with a study of Endobarrier, which is designed for patients diagnosed with type 2 diabetes and obesity, GI Dynamics Inc., of Boston, has received good news from the FDA. The agency has allowed a pivotal trial evaluating the safety and efficacy of Endobarrier in the U.S., pending institutional review board approval.
Menlo Park, Calif.-based Intersect ENT was dinged after the company lowered its guidance for the year to $106 million to $109 million, down from $111 million to $116 million reported during the first-quarter earnings call. Despite closing down at $26.05 in the wake of the second-quarter review and hitting a low of $25.15 Wednesday, the company (NASDAQ:XENT) stood at $26.88 when the market closed Thursday.
Backed by GV, formerly Google Ventures, Verana Health Inc. has picked up $30 million in series C financing, with participation from a host of leading investors. Joining the round were existing investors Biomatics Capital, Brook Byers, founder of Kleiner, Perkins, Caufield & Byers, GE Ventures and Lagunita Biosciences.
Hologic Inc. had double good news regarding patent fights. First, an administrative law judge of the U.S. International Trade Commission (ITC) issued a favorable initial ruling in a patent complaint filed by Hologic against Fujifilm related to X-ray mammography with tomosynthesis and other related mammography technologies. In addition, a jury has awarded the Marlborough, Mass.-based company almost $5 million in damages for Minerva Surgical Inc.'s infringement of two patents related to endometrial ablation technology.
Roughly two months after detailing positive results related to its Tendyne transcatheter mitral valve replacement (TMVR) system, Abbott Laboratories is highlighting progress in the U.S. Specifically, the Abbott Park, Ill.-based company revealed the start of the pivotal clinical study in the U.S. with the Tendyne system for the treatment of mitral regurgitation (MR).
