Feb 23, 2009 (Datamonitor via COMTEX) –
— Medtronic, a medical technology company, has received approval from the FDA for a humanitarian device exemption for its Reclaim deep brain stimulation therapy for chronic, severe obsessive-compulsive disorder.
The company also announced the first enrollment in its multi-center, randomized clinical trial of deep brain stimulation (DBS) for treatment-resistant depression.
Medtronic is proceeding with Read the rest of this entry »

The FDA approval is based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of atrial fibrillation (AFib). In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug therapy for the treatment of drug refractory recurrent symptomatic paroxysmal AFib.
The approval by the FDA also includes the EZ Steer Thermocool navigational catheter, which is a bi-directional Read the rest of this entry »

An agreement via the special protocol assessment (SPA) procedure is an agreement with the FDA that a Phase III clinical trial’s design (endpoints, sample size, control group and statistical analyses) is acceptable to support a regulatory submission seeking new drug approval. After the study begins, the FDA can only change an SPA for very limited reasons.
Based on data from the prior Phase III study of orBec, the upcoming confirmatory Phase III protocol Read the rest of this entry »

Dec 23, 2008 (Datamonitor via COMTEX) –
— Novartis has announced that its Gleevec tablets have received approval from the FDA for the post-surgery treatment of adult patients following complete surgical removal of Kit-positive gastrointestinal stromal tumors.
According to the company, Gleevec is now the only post-surgery treatment indicated to delay the return of this highly aggressive cancer, filling a major need for gastrointestinal stromal Read the rest of this entry »

Prism intends to submit a supplemental new drug application (NDA) for the premixed configurations which will form the focus of the commercial launch of Nexterone as a complete product line.
Prism is currently implementing a full scale manufacturing development program with the medication delivery business of Baxter Healthcare, a developer of premix technologies.
The FDA approval of Nexterone triggers a second $10 million milestone payment from Read the rest of this entry »

1) New U.S. Administration Offers Hope for Women and Girls
The election of Barack Obama as the 44th President of the United States provides an opportunity to uphold human rights, promote health for all, and change the future of millions. Women’s health and rights advocates in every corner of the world expressed excitement and hopefulness.
: For many, the most urgent issues facing the United States are the financial crisis and the wars in Iraq Read the rest of this entry »

LLC was awarded the contract to advise a hospital in Georgia on the construction of a new facility.
The company will provide advisory services and a strategic project launch readiness assessment for a new Phoebe-Sumter Hospital in Americus, Ga., said a news release.
KLMK said the hospital plans to build a 50,000- to 60,000-square-foot medical office building and a 76-bed hospital.
It will include an emergency department, diagnostic imaging, Read the rest of this entry »

Nov 14, 2008 (Datamonitor via COMTEX) –
— Wyeth Pharmaceuticals, a division of Wyeth, has announced that Premarin vaginal cream 0.5gm has been approved by the FDA for a new indication and a new less frequent twice-weekly dosing regimen to treat moderate to severe postmenopausal dyspareunia.
The approval is based on efficacy results from a multicenter clinical study that included a 12-week randomized, double-blind placebo phase followed by a Read the rest of this entry »

Buffalo Hospital has received full accreditation by the nonprofit Joint Commission, the Minnesota hospital’s parent Allina Hospitals & Clinics said Tuesday.
Hospitals need accreditation to receive reimbursement from the federal Medicare and Medicaid health insurance programs, said Nancy Kielhofner, a registered nurse who manages quality care at the hospital.
The Oakbrook Terrace, Ill.-based Joint Commission accredits and certifies more than Read the rest of this entry »

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