Health

Upsher-Smith Announces Launch Of The First And Only Generic Transdermal Testosterone Gel Available In Three Convenient Configurations Testosterone Gel (1%), the Generic Equivalent to Vogelxo™ (testosterone) Gel, Expected to Increase Access for Patients Who Need It PR Newswire MAPLE GROVE, Minn., July 2, 2014 MAPLE GROVE, Minn. , July 2, 2014 /PRNewswire/ — Upsher-Smith Laboratories, Inc ., today announced the launch of Testosterone Gel (1%), the generic of the newly Food and Drug Administration (FDA) approved Vogelxo ™ (testosterone) gel 1%, for topical use, CIII, and the first and only available generic testosterone replacement therapy (TRT) available in three convenient configurations. […]

U.S. FDA Accepts NDA Filing for Boehringer Ingelheim’s Investigational Nintedanib and Grants Priority Review Designation for the Treatment of Idiopathic Pulmonary Fibrosis PR Newswire RIDGEFIELD, Conn., July 2, 2014 RIDGEFIELD, Conn. , July 2, 2014 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc […]

BioLight Announces Issuance of U.S. Patent for the Long-Term Controlled-Release Drug-Delivery Insert Platform PR Newswire TEL AVIV, Israel, July 2, 2014 TEL AVIV, Israel , July 2, 2014 /PRNewswire/ — BioLight Israeli Life Sciences Investments Ltd. […]

Pharma Two B Expands List of Clinical Sites Enrolling for Phase IIb Study of P2B001 for PD to 25 PR Newswire REHOVOT, Israel, July 2, 2014 REHOVOT, Israel , July 2, 2014 /PRNewswire/ — Pharma Two B announced today that the company’s ongoing Phase IIb study of P2B001 for the treatment of early stage Parkinson’s disease is now enrolling qualifying patients at 25 clinical sites throughout the US and Israel . Study details, site locations and contact people can be found here . The study, titled A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson’s Disease, will enroll a total of 150 patients […]

Inova Labs Receives FDA Clearance for Activox DUO2™ – The First Integrated Stationary and Portable Oxygen Concentrator System PR Newswire AUSTIN, Texas, July 1, 2014 AUSTIN, Texas , July 1, 2014 /PRNewswire/ — Inova Labs Inc . (” Inova Labs “), a leading manufacturer of innovative oxygen therapy solutions has received FDA-clearance for Activox DUO2™, the first fully-integrated stationary and portable oxygen concentrator system. Activox DUO2™ combines the benefits of a home-use stationary concentrator with the portability of a best-in-class LifeChoice Activox POC into one integrated system. […]

ReShape Medical Submits PMA Application to FDA for Non-Surgical Weight Loss Device ReShape™ Integrated Dual Balloon System to Fill Significant Gap in Obesity Treatment Spectrum PR Newswire SAN CLEMENTE, Calif., July 1, 2014 SAN CLEMENTE, Calif. , July 1, 2014 /PRNewswire/ — ReShape Medical today announced that the Company has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the ReShape Integrated Dual Balloon System, the first and only dual balloon for non-surgical weight loss designed for people with a 30-40 body mass index (BMI) […]

Amgen Receives FDA Breakthrough Therapy Designation For Investigational BiTE Antibody Blinatumomab In Acute Lymphoblastic Leukemia Breakthrough Designation Reinforces Significant Unmet Need in the Treatment of This Highly Aggressive Cancer PR Newswire THOUSAND OAKS, Calif., July 1, 2014 THOUSAND OAKS, Calif. , July 1, 2014 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. […]

Expanding Orthopedics Inc. has Obtained CE Mark for its Unique FLXfit™, 3D Expandable Interbody Cage Expanding Orthopedics Inc., announced today that the FLXfit™, its novel expandable and articulated TLIF cage with lordotic correction, has received CE Mark. […]

Nephros Announces FDA 510(k) Submission of DSU-H and SSU-H Ultrafilters to be used to filter EPA quality drinking water to remove microbiological contaminants and waterborne pathogens PR Newswire RIVER EDGE, N.J., June 30, 2014 RIVER EDGE, N.J. , June 30, 2014 /PRNewswire/ — Nephros, Inc. […]

Surgical Theater’s Surgical Navigation Advanced Platform Receives FDA Clearance Technology provides surgeons with advanced imaging and augmented reality capabilities in the operating room PR Newswire CLEVELAND, June 30, 2014 CLEVELAND , June 30, 2014 /PRNewswire/ — Surgical Theater, LLC today received Food and Drug Administration (FDA) clearance on the recently launched Surgical Navigation Advanced Platform (SNAP). The SNAP integrates with operating room technology to provide advanced 3D capabilities and augmented reality, allowing surgeons to enhance their surgery performance and “see what can’t be seen.” The SNAP is the second of the company’s line of products combining flight simulation technology with advanced CT/MRI imaging for use in brain surgery to receive FDA clearance. It enables surgeons to perform a real-life “fly through” of a “patient-specific” surgery and receive unique virtual-reality guidance to determine the safest and most efficient pathway to remove cerebral tumors and treat vascular anomalies. […]

SteriWeb Medical Receives FDA OTC Clearance for Resistance Free Antimicrobial Gel PR Newswire VANCOUVER, Wash., June 30, 2014 VANCOUVER, Wash. , June 30, 2014 /PRNewswire/ — SteriWeb Medical has announced FDA over the counter clearance for Omnicide Antimicrobial Gel , a long-lasting, non-antibiotic, petrolatum based topical gel with proven effectiveness against even the most resistant, virulent bacteria, such as MRSA, VRE, and CRE. Laboratory data has also demonstrated complete effectiveness against pathogenic fungi, molds, and yeasts, rendering Omnicide an appropriate choice for a wide variety of clinical conditions and an ideal addition to any topical infection treatment protocol. […]

First Patient Enrolled in FDA Phase 1/2a Clinical Trial With BioLight’s Controlled-Release Latanoprost Insert for the Treatment of Glaucoma PR Newswire TEL AVIV, Israel, June 30, 2014 TEL AVIV, Israel , June 30, 2014 /PRNewswire/ — BioLight Israeli Life Scienc es Investments Ltd. (TASE: BOLT) ( OTCQX: BLGTY), a firm that invests in, manages and commercializes biomedical innovations grouped into clusters around defined medical conditions, announces that the first patient has been enrolled in the U.S. […]

Edwards Receives FDA Clearance For Advanced Noninvasive Monitoring System ClearSight system enables clinicians to reduce risk of post-surgical complications PR Newswire IRVINE, Calif., June 30, 2014 IRVINE, Calif. , June 30, 2014 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received U.S. […]

Thermedx Receives FDA 510(k) for Arthroscopy and Hysteroscopy Fluid Warming FluidSmart™ System Now FDA Cleared for Surgical Irrigation and Warming in Orthopedics, Gynecology & Urology PR Newswire CLEVELAND, June 30, 2014 CLEVELAND , June 30, 2014 /PRNewswire-USNewswire/ — Thermedx, LLC, an innovative designer and manufacturer of “smart” surgical irrigation products, received FDA 510(k) clearance for optional fluid warming in arthroscopic and hysteroscopic procedures. Building upon its prior FDA 510(k) clearance(s) for irrigation, distension, and deficit monitoring in gynecology, urology, and orthopedics, and optional fluid warming for urology, the fluid warming capabilities added to Thermedx’s multi-functional Thermedx FluidSmart™ System provide hospitals and surgery centers with a single solution for surgical irrigation and optional warming within multiple disciplines. Click HERE to watch the product video and learn more about the Thermedx FluidSmart Surgical Irrigation System […]

Ohm Laboratories to Launch Valsartan Tablets Receives first-to-file FDA approval, with 180-day marketing exclusivity for generic version in the treatment of hypertension and heart failure PR Newswire NEW BRUNSWICK, N.J., June 27, 2014 NEW BRUNSWICK, N.J. , June 27, 2014 /PRNewswire/ — Ohm Laboratories, Inc. (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that Ohm has received approval from the U.S […]

ReWalk™ Personal Exoskeleton System Approved by FDA for Home Use Revolutionary technology that allows individuals with Spinal Cord Injury, such as paraplegia, to stand & walk receives clearance for personal use in the U.S. PR Newswire MARLBOROUGH, Mass., June 27, 2014 MARLBOROUGH, Mass. […]

Encision Receives FDA 510(k) Approval on its AEM EndoShield™ Burn Protection System PR Newswire BOULDER, Colo., June 27, 2014 BOULDER, Colo. , June 27, 2014 /PRNewswire/ — Encision Inc. (ECIA:PK), a medical device company owning patented surgical technology that prevents dangerous stray electrosurgical burns in minimally invasive surgery, today announced that it has received FDA 510(k) premarket notification approval for its AEM Endoshield™ Burn Protection System (“EndoShield”). […]

Boehringer Ingelheim’s Investigational Antidote for Pradaxa (dabigatran etexilate mesylate) Receives FDA Breakthrough Therapy Designation Idarucizumab being evaluated to specifically reverse the anticoagulant effect of PRADAXA PR Newswire RIDGEFIELD, Conn., June 26, 2014 RIDGEFIELD, Conn. , June 26, 2014 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. […]

Paragon BioTeck, Inc. Receives FDA Clearance for Comfortear Lacrisolve Absorbable Punctum Plug PR Newswire PORTLAND, Ore., June 25, 2014 PORTLAND, Ore. , June 25, 2014 /PRNewswire/ — Paragon BioTeck, Inc., a privately held biopharmaceutical and medical device company specializing in the development of ophthalmic pharmaceuticals, devices and therapies, announced today it has received 510(k) clearance from the U.S. […]

Ampio Pharmaceuticals, in Response to Positive Feedback, Closes Enrollment in the OptimEyes Study (Optina™) and Will Present the Data to the FDA for Guidance PR Newswire GREENWOOD VILLAGE, Colo., June 25, 2014 GREENWOOD VILLAGE, Colo. , June 25, 2014 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that it has informed the Transplant and Ophthalmology Division of the FDA of its intent to reduce the patient sample size in the OptimEyes Study for the treatment of Diabetic Macular Edema (oral treatment with Optina™). […]