Nevro Receives Approvable Letter from U.S. Food and Drug Administration for Senza® Spinal Cord Stimulation System

Nevro to Host Investor Conference Call Friday, January 23 at 8:30 a.m. ET

MENLO PARK, Calif., Jan. 22, 2015 -- Nevro Corp. (NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) informing the company of the approvability of its Premarket Approval Application (PMA) for the Senza spinal cord stimulation (SCS) system.  According to the approvable letter, approval of the PMA is subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza to ensure compliance with the FDA's Quality System Regulation, as well as finalization of the product's labeling with the FDA.

EnteroMedics Announces FDA Approval of VBLOC® Vagal Blocking Therapy for the Treatment of Obesity

First New Medical Device Approved for Obesity in Over a Decade
Novel Neuroscience-Based Technology Enables Safe, Durable Weight Loss
Company to Host Conference Call Today at 12:00 PM ET

ST. PAUL, Minn., Jan. 14, 2015 -- EnteroMedics Inc. (ETRM) today announced that the U.S. Food and Drug Administration (FDA) has approved VBLOC® vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years. 

TransEnterix Completes Successful Pre-Clinical Robotic Surgical Procedures; Management Affirms FDA Timeline

SurgiBotTM system FDA 510(k) filing on track for mid-2015 submission

RESEARCH TRIANGLE PARK, N.C.-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the successful completion of four general surgery and urology procedures using its SurgiBot system patient-side robotic surgery system. Management also stated that the preparation of its FDA 510(k) filing is proceeding as planned, and affirmed prior guidance of its intention to submit the filing in mid-2015.

EDAP's Focal One HIFU Device Approved by Health Canada

LYON, France, Jan. 9, 2015 - EDAP TMS SA (EDAP), the global leader in therapeutic ultrasound, today announced that its Focal One HIFU device has been approved by Health Canada. With this approval, the Company is able to market the Focal One device for the treatment of prostate cancer in Canada.

Marc Oczachowski, EDAP's Chief Executive Officer, commented, "Health Canada approval of Focal One, our revolutionary tool for the focal treatment of prostate cancer, represents an important milestone for EDAP. Moreover, this is the first regulatory approval for our Focal One device in the Americas, and a key step forward in our overall regulatory strategy as we work to expand Focal One's global footprint and bring our innovative cancer therapies to a growing number of patients worldwide."

Philips to acquire Volcano to expand global leadership position in image-guided therapy market

- Philips to acquire Volcano for USD 18.00 per share; total transaction value of USD 1.2 billion (approx. EUR 1 billion), inclusive of Volcano's cash and debt
- Agreement to acquire Volcano, a global leader in catheter-based imaging and measurement solutions for cardiovascular applications, advances Philips' focused strategy in image guided therapy
- Volcano provides proven clinical development and commercialization capabilities for Philips' next generation of imaging and measurement technologies
- Philips expects the transaction to accelerate sales growth as combined business is optimally positioned to address unmet needs in EUR 4 billion image-guided therapy market
- Transaction expected to be accretive to Philips EPS by 2017 driven by revenue and cost synergies