Transenterix Inc. has received a nod from the FDA to market the Senhance surgical robotic system. This is the second FDA clearance of a surgical robotic system for abdominal entry since Intuitive Surgical Inc. received FDA clearance for the Da Vinci in 2000. The FDA nod came earlier than the company's year-end expectation. News of the approval caused Morrisville, N.C.-based Transenterix's (NYSEAMERICAN:TRXC) shares to rise as much as 90 percent – closing at $2.81 on Monday.
Nuvasive Inc. has received expanded 510(k) clearance for its Precice platform, which could allow the company to have a deeper reach into the limb lengthening and trauma markets. The expanded indication is one of several key drivers in the San Francisco-based company's growth that have occurred in the past few months.
In a bold move to expand its presence outside of the U.S., Cryolife Inc. revealed its plan to acquire Hechingen, Germany-based Jotec GmbH for an upfront payment of $225 million. The Kennesaw, Ga.-based company said it would close on the deal later this year. Jotec develops stent grafts and generated revenues of $50 million for the 12 months ending June 30.
Edap Tms SA reported FDA clearance of its Ablatherm-Fusion device, a high intensity focused ultrasound (HIFU) technology that enables a method for the targeting of diagnosed areas within the prostate. The FDA's nod for the device comes on the heels of the Centers for Medicare and Medicaid Services (CMS) approval of a new code that could quite possibly lead to an increase in HIFU device adoption.
Boston Scientific Corp. is set to strengthen its atrial fibrillation (AF) treatment offerings by acquiring Apama Medical Inc. in a deal that could be worth up to $300 million. The transaction consists of $175 million in cash up-front and a maximum of $125 million in contingent payments over the period of 2018 to 2020 based on achievements of clinical and regulatory milestones. The deal is set to close in 4Q17.