Milestone Scientific Announces 510(k) FDA Clearance for CompuFlo(R) Epidural Instrument

LIVINGSTON, NJ--(June 12, 2017) - Milestone Scientific Inc. (NYSE: MLSS) today announced that the CompuFlo® Epidural Computer Controlled Anesthesia System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The CompuFlo® Epidural System provides anesthesiologists and other Health Care Providers for the first time, the ability to quantitatively determine and document the pressure at the needle tip in real-time. The CompuFlo® Epidural's proprietary DPS Dynamic Pressure Sensing Technology™ (DPS) allows the CompuFlo® Epidural to provide objective visual and audible in-tissue pressure feedback that allows anesthesiologists to identify the epidural space.
Published: 12 June 2017
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EnteroMedics Announces the Acquisition of the Gastric Vest System

- At 12 Months, Gastric Vest System™ Patients Demonstrated Excess Weight Loss (EWL) of 85% and Waist Circumference Reduction of 38 Centimeters -
- Company to Host Conference Call Today at 10:00 AM Eastern Time -
 
ST. PAUL, Minn., May 23, 2017 -- EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices treating obesity, metabolic diseases and other gastrointestinal disorders, announced today that it has acquired the Gastric Vest System™ (the "Gastric Vest" or "Vest"), through its acquisition of BarioSurg, Inc.
 
The Gastric Vest is an investigational, minimally-invasive, laparoscopically implanted medical device being studied for weight loss in morbidly obese patients. The device, which wraps around the stomach and emulates the effect of conventional weight loss surgery, enables gastric volume reduction without permanently changing patient anatomy. In a pilot study conducted outside the U.S., at 12 months, Vest patients demonstrated a mean percent excess weight loss (%EWL) of 85%, an average drop in HbA1c (Hemoglobin A1c) of 2.1 points, and an average waist circumference reduction of 38 centimeters, or approximately 15 inches.
Published: 23 May 2017
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Second Sight ’s Argus II Retinal Prosthesis Implanted in First Patient in Asia

--Underscores Second Sight’s Commitment to Expansion in Asia--
 
SYLMAR, Calif. --  Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to provide some useful vision to blind patients, today announced that the Argus® II Retinal Prosthesis System ("Argus II") has been implanted in the first patient in Asia through an exclusive distribution partnership with Orient Europharma Co., Ltd. (OEP) and with charitable support from the Hong-Lu Foundation in Taiwan. The Argus II was provided under special import permits authorized by the Taiwan Food and Drug Administration (TFDA).
Published: 13 April 2017
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Mazor Robotics Receives FDA Clearance for Spinal Deformity Correction Planning Software for the Mazor X Surgical Assurance Platform

CAESAREA, Israel -- Mazor Robotics Ltd. (TASE: MZOR)(NASDAQGM: MZOR), a pioneer and leader in the field of surgical guidance systems, has received FDA clearance for its Mazor X Align™ software. Mazor X Align is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform. The new software will be demonstrated during exhibit hours at the 2017 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Los Angeles, CA, April 22-26.
 
Mazor X Align leverages Mazor Robotics’ extensive experience in pre-operative planning, image processing, computerized anatomy recognition, and registration of different imaging modalities. It is the latest module to be added to the Mazor X proprietary Pre-operative Analytics software suite, and enables surgeons to create a patient-specific, three-dimensional spinal alignment plan. The 3D plan simulates an entire spine, allowing pre-operative estimation of the impact of a planned surgical correction on the patient’s posture post-operatively, considering segmental range-of-motion and final alignment parameters.
Published: 12 April 2017
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Sunshine Heart Provides Business Update Regarding Execution of Strategic Growth Plan

EDEN PRAIRIE, Minn., March 23, 2017 -- Sunshine Heart, Inc. (NASDAQ:SSH) announced today its progress in successfully executing its Aquadex growth strategy. After acquiring the Aquadex business from Baxter International in August of 2016, the company began executing a revenue growth strategy focused on increasing utilization in the top 55 hospital accounts, which made up 80% of the business. By the end of 2016, there were 95 hospital accounts that have re-engaged and are purchasing the disposable blood sets on a regular basis. As of March 2017, there are now 115 active hospital accounts.
 
“Our momentum is increasing as we reach more hospital accounts that have been quiet over the past few years,” said John Erb, Chairman of the Board and CEO of Sunshine Heart.
Published: 23 March 2017
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