Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers May 27, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 27, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 37     Next >>     Go To Page:

5/27/15 - Dr. Frank Chae at Sky Ridge Medical Center First in Colorado Certified to Offer VBLOC Vagal Blocking Therapy for the Treatment of Obesity
Frank Chae, Chief of Bariatric Surgery at Sky Ridge Medical Center, is among one of the first physicians in the country certified in implanting the VBLOC vagal blocking therapy for the treatment of obesity. On January 14, 2015, EnteroMedics Inc. announced that the U.S. Food and Drug Administration approved VBLOC vagal blocking therapy, delive
5/27/15 - EXCITE ISR Landmark Study Proves Durability at 12-Months, Findings Validate Safety and Superiority of Laser Atherectomy With PTA vs. PTA Alone; Data Presented at NCVH 2015
The Spectranetics Corporation today announced that 12- month data from the EXCITE ISR clinical trial were presented by Craig Walker, MD, at New Cardiovascular Horizons in New Orleans. Results of the landmark study show that Spectranetics' laser atherectomy devices used with PTA, are safer and more effective than PTA alone for treating femoropopli
5/27/15 - FDA Approves New Procedure Giving Baby-boomers Camera-like Vision
SAN ANTONIO, May 27, 2015/ PRNewswire-iReach/ A new eye procedure recently approved by the Food and Drug Administration corrects the most common vision problem in adults. The inlay is called "Kamra", because it works to restore the eye's zoom capability, just like a camera. The office of Greg Parkhurst, MD, a San Antonio ophthalmologist, is one o
5/27/15 - RegenScientific announces FDA-clearance of its Renu Gel injectable implant
RegenScientific announced that it has received FDA- clearance for its Renu Gel injectable implant indicated for vocal fold injection augmentation and today the company commenced shipments of this new product to physicians and hospitals in the United States. The company already has FDA- clearance for its Renu Voice injectable implant based o
5/27/15 - U.S. Food and Drug Administration Approves Humalog 200 units/mL KwikPen
Food and Drug Administration has approved Humalog 200 units/mL KwikPen , a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentr
5/27/15 - Viora's Receives CFDA Approval for Reaction?, Multi-RF Technology Bi-Polar Device in China
Viora is proud to announce that Reaction?, a leading bi-polar multi-RF technology device has officially received CFDA approval by the China Food and Drug Administration. This achievement now opens the doors to the expanding market in China, allowing medical aesthetic practitioners and medical spa clinics to offer non-surgical treatments with Reac
5/26/15 - Cancer drugs approved quickly but not to patient's benefit: York University researcher
By a News Reporter-Staff News Editor at Cancer Weekly TORONTO, Highly priced cancer drugs get rushed approvals despite poor trial methodology and little effect on the longevity of patients, cautions York University Professor Dr. "Drug agencies like the Food and Drug Administration and the European Medicine Agency don't actually look at whether p
5/26/15 - Enrollment Begins in Cellceutix Phase 2 Trial of Brilacidin-OM to Prevent Oral Mucositis in Patients Undergoing Chemoradiation
Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antibiotic applications, is pleased to announce that enrollment has commenced in the Company's Phase 2 clinical trial of Brilacidin-OM for the prevention and treatment of oral mucositis in patients undergoing...
5/26/15 - FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration approved once-daily STIOLTO? RESPIMAT Inhalation Spray. While no treatment slows the rate of decline, maintenance treatment with STIOLTO RESPIMAT initiated at the time of diagnosis will improve lung function, "said Danny McBryan, MD, vice president, Clinical Deve
5/26/15 - InvisionHeart Receives FDA 510(k) Clearance of its InvisionECG Technology
InvisionHeart, a Nashville- based leading developer of a disruptive ECG technology with a secure cloud-based, healthcare IT platform, announced today that the Food and Drug Administration has cleared the InvisionECG technology for sale. Earlier diagnosis of cardiac issues via improved access will benefit patients, whether in the hospital setting or
5/26/15 - Lumicell Reports FDA Approval to Launch Feasibility Study [Health & Beauty Close - Up]
Lumicell recently received Investigational Device Exemption approval from the U.S. Food and Drug Administration to launch a feasibility study for intraoperative imaging of breast cancer during surgery. The study will be conducted at Massachusetts General Hospital. Barbara Smith, Director, Breast Cancer Program and Co-Director, Gillette Center for..
5/26/15 - Nitiloop Reports FDA 510(k) Clearance for Its NovaCross Microcatheter [Professional Services Close - Up]
Nitiloop recently reported that it has received FDA clearance for its first product, NovaCross, which is intended to be used in conjunction with a guidewire to access discrete regions of the coronary or peripheral vasculature. According to a release, in addition to the recent granting of FDA clearance, the company reported successful results from a
5/26/15 - Research and Markets Offers Report: Regulation on In-Vitro Diagnostics (IVDs) Registration in China [Professional Services Close - Up]
Research and Markets has announced the addition of the "Regulation on In-Vitro Diagnostics Registration in China" report to its offerings. In a release, Research and Markets noted that report highlights include:. Regulation on In-Vitro Diagnostics Registration in China has been approved by China Food and Drug Administration on June 27, 2014 and wil
5/26/15 - Roche Receives FDA Approval for cobas KRAS Mutation Test
By a News Reporter-Staff News Editor at Cancer Weekly Roche announced that the U.S. Food and Drug Administration has approved the cobas KRAS Mutation Test for diagnostic use. "As more targeted treatment options for cancer patients become available, the importance of identifying the right molecular information to define their disease becomes c
5/26/15 - Roche receives FDA clearance for the cobas Cdiff Test to detect Clostridium difficile
Roche announced today that the US Food and Drug Administration has provided 510 clearance for the cobas Cdiff Test to detect Clostridium difficile in stool specimens. Steve Young, Professor of Pathology, Department of Pathology UNMHSC and Tricore Reference Lab. In a clinical trial program conducted at sites throughout the United States, the co
5/26/15 - Sunshine Heart Announces FDA Approval to Resume Enrollment in COUNTER HF(TM) US Pivotal Study for C-Pulse(R) Heart Assist System
Sunshine Heart, Inc. is pleased to announce that the US Food and Drug Administration has approved the resumption of patient enrollment in its COUNTER HF US pivotal study for the C-Pulse Heart Assist System. We are encouraged by our investigators' enthusiasm as witnessed by the high site representation at our recent investigator meeting, "commente
5/26/15 - Sunshine Heart Announces FDA Approval to Resume Enrollment in COUNTER HF(TM) US Pivotal Study for C-Pulse(R) Heart Assist System [Construction Machinery Middle East (United Arab E]
-Sunshine Heart, Inc. is pleased to announce that the US Food and Drug Administration has approved the resumption of patient enrollment in its COUNTER HF US pivotal study for the C-Pulse Heart Assist System. We are encouraged by our investigators' enthusiasm as witnessed by the high site representation at our recent investigator meeting, "commented
5/26/15 - Thoratec Receives Conditional FDA Approval For The Shield II U.S. Clinical Trial For HeartMate PHP
Thoratec Corporation, a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced that the FDA has granted conditional approval for a U.S. Final FDA approval is expected in the coming months pending resolution of certain routine technical questions. "Swift FDA approval of our newly proposed U
5/26/15 - Ventripoint Receives Marketing Clearance from the FDA to Expand the Use of the VMS Heart Analysis System
Ventripoint Diagnostics Ltd. is pleased to announce that it has received Marketing Clearance from the U.S. Food& Drug Administration for the expanded Indications for Use of its VMS? product which states; "The VMS system is indicated for use where RV volumes and ejection fractions are warranted or desired". "This change in use criteria means phys
5/26/15 - Verax Biomedical Gains FDA Clearance for Expanded Platelet Safety Measure Testing Indications
MARLBOROUGH, Mass., May 26, 2015/ PRNewswire-USNewswire/ Verax Biomedical today announced that the company has gained FDA clearance to expand the use of its Verax Platelet PGD test a rapid test for the detection of bacterial contamination in platelets intended for transfusion. The new FDA clearance makes the Verax Platelet PGD test the only
5/26/15 - VertiFlex, Inc. Announces FDA PMA Approval for the Superion Interspinous Spacer
VertiFlex , Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosis, announced today that the U.S. Food and Drug Administration has issued a PMA Approval Order for the company s Superion Interspinous Spacer System, clearing the way for commercialization in the United States. Largest, most robust IDE device
5/25/15 - First Drug to Treat Radiation Sickness Approved [FARS News Agency]
TEHRAN- New research has led to FDA approval of the use of a drug to treat the effects of radiation exposure following a nuclear incident. The research was done by Thomas J. MacVittie, PhD, professor, and Ann M. Farese, MA, MS, assistant professor, both in the University of Maryland School of Medicine Department of Radiation Oncology's Division of
5/25/15 - Nevro Receives FDA Approval for Senza Spinal Cord Stimulation System Delivering HF10? Therapy
By a News Reporter-Staff News Editor at Pharma Business Week Nevro Corp., a medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, announced that it has received approval from the United States Food and Drug Administration for its Senza spinal cord stimulation system. Nevro also announced t
5/25/15 - Ventripoint Receives Marketing Clearance From the FDA to Expand the Use of the VMS Heart Analysis System
Ventripoint Diagnostics Ltd. is pleased to announce that it has received Marketing Clearance from the U.S. Food& Drug Administration for the expanded Indications for Use of its VMS? product which states; "The VMS system is indicated for use where RV volumes and ejection fractions are warranted or desired." "This change in use criteria means phys
5/24/15 - St. Jude Medical Receives FDA Approval for the World's Smallest Upgradeable MR-Conditional Spinal Cord Stimulation System
By a News Reporter-Staff News Editor at Heart Disease Weekly "The launch of the Protege MRI system provides physicians with a solution that offers the benefits of future therapy upgrades as they are approved without the need for a future surgery," said Robert Levy, M.D., Ph.D., director of the Marcus Neuroscience Institute in Boca Raton, Florida.
Articles(s): 1 - 25 of 37     Next >>     Go To Page:


© 2015 Thomson Reuters. All rights reserved.

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

FEATURED CE LESSON

Pharmacy Spanish
This lesson is supported by:
Hands on Spanish
Drug Therapy Management Series Part III: Geriatric Disorders
This lesson is supported by:
RxSchool

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...


Websites » RxCareerCenter.comRxSchool.comRxProHealth.comNursingJobSource.comNurseZone.comRN.com
Copyright © 2009 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415