Atossa Genetics Signs National Distribution Agreement With Thermo Fisher Scientific for FullCYTE Breast Aspirator

SEATTLE, WA--(Feb 9, 2015) - Atossa Genetics Inc. (NASDAQ: ATOS), the Breast Care Company, has signed an agreement with Thermo Fisher Scientific for distribution of Atossa's FullCYTE Breast Aspirator device in the United States through the Fisher HealthCare channel. Atossa's FullCYTE Breast Aspirator is used by physicians and nurses to collect nipple aspirate fluid from a patient's breasts for cytological analysis.

Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics, said, "Access to the hospital market, including breast clinics and women's health centers, is a critical part of our launch strategy for the FullCYTE Breast Aspirator in the United States. Fisher HealthCare is a recognized leader in providing medical device solutions through their world class sales and marketing team. We couldn't be more pleased to work with their organization."

Published: 09 February 2015
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FDA Approves Dexcom G4 Platinum Continuous Glucose Monitoring System with Share

Now people with diabetes as young as 2 years of age can automatically and securely share real-time CGM data from their Dexcom receiver to a caregiver’s mobile app

SAN DIEGO--  DexCom, Inc., (DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Dexcom G4® PLATINUM Continuous Glucose Monitoring System with Share. The Dexcom Share receiver uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient’s receiver and an app on the patient’s smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients, or “followers,” without the need for a dedicated docking cradle. These followers can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere, initially via their Apple® iPhone® or iPod® touch and in the future on Android devices, giving them peace of mind and reassurance when they are apart. The “Share” and “Follower” apps will be available on the Apple App Store at no charge.

Published: 26 January 2015
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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.

Published: 23 January 2015
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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. 

Published: 14 January 2015
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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."

Published: 09 January 2015
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