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Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that the company will pursue a Phase 3 clinical program for its autologous cell therapy for the treatment of critical limb ischemia (CLI) through the U.S. Food and Drug Administration's special protocol assessment (SPA) process. Aastrom is currently completing a Phase 2b clinical trial of its cell therapy in patients with CLI and recently met with FDA officials to discuss plans for the Phase 3 program.

7 Jul 2010

FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Angion Biomedica Corp., a biopharmaceutical company dedicated to the discovery and development of novel therapeutics that enhance quality of life, eradicate disease and save lives by modulating the body's protective, reparative and regenerative systems, announced today that its lead therapeutic BB3 was accepted into the Fast Track program of the U.S. Food and Drug Administration (FDA) and has also been designated an Orphan Drug product by FDA.

7 Jul 2010

Hope for ovarian cancer patients not responding to conventional chemotherapy

Investigators at the Translational Genomics Research Institute (TGen) have discovered a way that may help ovarian cancer patients who no longer respond to conventional chemotherapy.

6 Jul 2010

AHRQ publishes new comparative effectiveness report on treatments for rotator cuff tears

Injuries to the rotator cuff are treatable, but it is unclear which treatment option - surgery or nonsurgical treatments such as exercise or medication - is best, according to a new comparative effectiveness report published by HHS' Agency for Healthcare Research and Quality.

6 Jul 2010

Music therapy improves movement in stroke patients

Music therapy provided by trained music therapists may help to improve movement in stroke patients, according to a new Cochrane Systematic Review. A few small trials also suggest a wider role for music in recovery from brain injury.

6 Jul 2010

First Australian intestinal transplant

Mr. Brendan Cole, 32 became the first recipient of a successful intestinal transplant in Australia. Last Friday he had his intestines and organs removed from his abdomen that followed a 12 hour operation at Austin Health.

4 Jul 2010

American College of Surgeons CoC launches national pilot study for ProvenCare Lung Cancer Collaborative

A national pilot study that will promote evidence-based evaluation and treatment standards for patients with resectable non small cell lung cancer (NSCLC) was launched yesterday by the Commission on Cancer (CoC) of the American College of Surgeons.

3 Jul 2010

64-year-old female Latin American receives Elekta VMAT radiotherapy enhanced with Monaco planning software

A 64-year-old female patient with mediastinal metastasis recently became the first in Latin America to receive Elekta VMAT radiotherapy treatment enhanced with Monaco® planning software. Using the arc-based Elekta VMAT delivery method, Monaco displays how the radiation dose should be applied — its distribution and strength on the target. The result is a therapy that not only is rapid, but also fine-tuned to treat cancer and avoid healthy tissues.

From Elekta 3 Jul 2010

EU requirement for HIV, hepatitis screening of ART couples at each donation unnecessary, distressing

European legislation that requires all couples undergoing assisted reproduction treatment (ART) to be screened for HIV and hepatitis at the time of every sperm or egg donation is unnecessary, expensive, and potentially distressing for patients, the 26th annual meeting of the European Society of Human Reproduction and Embryology heard Monday.

2 Jul 2010

Imaging algorithm distributed in top-down fashion reduces unnecessary cervical spine radiographs

An imaging algorithm produced by a radiology department and distributed through the medical director's office, in a top-down fashion, enabled a large, academic medical center to significantly reduce the number of unnecessary cervical spine radiographs (X-rays) in the emergency department, according to a study published in the July issue of the Journal of the American College of Radiology.

2 Jul 2010

Suggestions to reduce impact of anesthesia care on global warming

Inhaled anesthetics widely used for surgery—particularly the anesthetic desflurane—make a measurable contribution to global warming, according to a study in the July issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

2 Jul 2010

ISHLT issues first international consensus formulation of standardized nomenclature for CAV

Cardiac allograft vasculopathy (CAV), the major limitation to long term survival after heart transplantation, occurs when blood vessels in a transplanted heart progressively narrow and lead to dysfunction of the heart muscle or sudden death. Ascertaining benefit from appropriate treatment for this condition has been hampered in part because of the lack of a standard nomenclature.

2 Jul 2010

Karolinska researchers recommend new routine for protection against infection during PEG

Researchers at Karolinska Institutet recommends a new routine for protection against infection when percutaneous endoscopic gastrostomy (PEG), a tube for feeding directly through the abdominal wall, is surgically inserted in the stomach. The new routine is both simpler and cheaper than the one used today. The method, presented in the British Medical Journal, has been clinically tested on over 200 patients at the Karolinska University Hospital in Solna, Stockholm County, Sweden.

2 Jul 2010

Spectranetics commences voluntary recall and replacement of specific lots of thrombus extraction catheter

Spectranetics Corporation today initiated a voluntary recall of specific lots of its thrombus extraction catheter (product number 60090-01) manufactured by Spectranetics since October 2009. The Food and Drug Administration has been informed of this action and communication to various Competent Authorities outside of the United States has begun. While Spectranetics has received and confirmed customer complaints on this issue, no adverse events have been reported to the Company.

2 Jul 2010

Frenotomy procedure can help babies to breastfeed effectively

Doctors advise new mothers to breastfeed for at least the first six months of a baby's life, but a simple yet often untreated problem can sabotage their efforts, University of Florida researchers say.

2 Jul 2010

Allogeneic stem cell transplant holds promise for treatment-resistant chronic lymphocytic leukemia

Allogeneic (donor-derived) stem cell transplant (alloSCT) may be a promising option for patients with treatment-resistant chronic lymphocytic leukemia (CLL), regardless of the patient's underlying genetic abnormalities, according to the results of a study published online today in Blood, the journal of the American Society of Hematology.

2 Jul 2010

Amedica, SUNY Upstate Medical University partner in comparative study of biomaterials

Amedica Corporation, a spinal and orthopaedic implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, announced that it has entered into an agreement with SUNY Upstate Medical University to conduct an additional research study that evaluates the company's SiN ceramic technology compared to PEEK interbody fusion devices. The two-year study will measure the fusion performance of the two biomaterials.

2 Jul 2010

Neuros Medical receives $1.5M Applied Research and Technology Development Award from DMRDP

Neuros Medical, Inc., a medical device company announced today they have received notification of award for $1.5 million from the U.S. Department of Defense. The Applied Research and Technology Development Award was provided by the Defense Medical Research and Development Program (DMRDP).

2 Jul 2010

Clinical study proves effectiveness of acupuncture for heart patients

Acupuncture can improve exercise tolerance in patients suffering from chronic heart failure. This was determined in a clinical pilot study by the team headed by Dr. Johannes Backs, physician and study director at the Department of Internal Medicine III (Cardiology, Angiology, and Pneumology - Medical Director: Professor Dr. Hugo Katus) of Heidelberg University Hospital.

2 Jul 2010

Study finds increased neonatal mortality among planned home births

About 1 in 200 women in the US delivers her baby at home, with approximately 75% of these low-risk, single-baby births planned in advance as home deliveries. In a study published online today by the American Journal of Obstetrics & Gynecology (AJOG), researchers from Maine Medical Center, Portland, Maine, analyzed the results of multiple studies from around the world.

1 Jul 2010

Medical Procedure News

Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Hope for ovarian cancer patients not responding to conventional chemotherapy

AHRQ publishes new comparative effectiveness report on treatments for rotator cuff tears

Music therapy improves movement in stroke patients

First Australian intestinal transplant

American College of Surgeons CoC launches national pilot study for ProvenCare Lung Cancer Collaborative

64-year-old female Latin American receives Elekta VMAT radiotherapy enhanced with Monaco planning software

EU requirement for HIV, hepatitis screening of ART couples at each donation unnecessary, distressing

Imaging algorithm distributed in top-down fashion reduces unnecessary cervical spine radiographs

Suggestions to reduce impact of anesthesia care on global warming

ISHLT issues first international consensus formulation of standardized nomenclature for CAV

Karolinska researchers recommend new routine for protection against infection during PEG

Spectranetics commences voluntary recall and replacement of specific lots of thrombus extraction catheter

Frenotomy procedure can help babies to breastfeed effectively

Allogeneic stem cell transplant holds promise for treatment-resistant chronic lymphocytic leukemia

Amedica, SUNY Upstate Medical University partner in comparative study of biomaterials

Neuros Medical receives $1.5M Applied Research and Technology Development Award from DMRDP

Clinical study proves effectiveness of acupuncture for heart patients

Study finds increased neonatal mortality among planned home births

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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