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FDA Shows Big-Company Bias in Inspections, Reviews: Devicemaker

September 23, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

SOUTH SAN FRANCISCO, Calif. – The FDA may be giving large companies preferential treatment when conducting inspections and reviewing device submissions, an executive with a smaller company alleged during a CDRH town hall meeting.

510(k) Guidance Fallout, Review Clock Revamp Discussed in User Fee Talks

September 23, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

A possible tripling of the CDRH review workload and a revamped regulatory review clock were main topics of separate Medical Device User Fee and Modernization Act (MDUFMA) reauthorization meetings involving the FDA and device industry.

Acetylon starts multiple myeloma treatment trial

September 23, 2011 8:33 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Acetylon Pharmaceuticals Inc. of Boston has begun a Phase 1-2a clinical trial of its multiple myeloma treatment, ACY-1215, just on the heels of the start of a patient study by the Multiple Myeloma Research Foundation.

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NxStage: NIH Study Published in New England Journal of Medicine Adds to Growing Body of Evidence in Support of More Frequent Hemodialysis

September 23, 2011 8:32 am | by Bio-Medicine.Org | News | Comments

LAWRENCE, Mass., Sept. 23, 2011 /- NxStage Medical, Inc. (Nasdaq: NXTM ), a leading manufacturer of innovative dialysis products, today commented on the just-released findings of an NIH sponsored study which shows that event rates, including mortality, were significantly higher for...

Personalized multiple myeloma study of 1,000 patients starts

September 22, 2011 8:34 am | by Mass High Tech: The Journal of New England Technology | News | Comments

The Multiple Myeloma Research Foundation said it has enrolled the first person in a 1,000-patient study aimed at discovering variations of the incurable blood cancer.

Cardica Achieves Milestone Under Century Distribution Agreement

September 22, 2011 8:34 am | by Bio-Medicine.Org | News | Comments

REDWOOD CITY, Calif., Sept. 22, 2011 /- Cardica, Inc. (Nasdaq: CRDC ) today announced that it has achieved the first MicroCutter™ milestone under its distribution agreement and loan commitment with Century Medical, allowing Cardica to draw the first $2 million of an up to $4...

Sanovas CEO Larry Gerrans Featured Speaker at AdvaMed 2011

September 22, 2011 8:34 am | by Bio-Medicine.Org | News | Comments

SAUSALITO, Calif., Sept. 22, 2011 /- Sanovas Inc. , a leading developer of minimally invasive technologies for the diagnosis and treatment of pulmonary disease and lung cancer, today announced that CEO and co-founder Larry Gerrans will speak at AdvaMed 2011, the industry's premier...

High-risk, Underserved Women Benefited from MRI Screening for Breast Cancer

September 21, 2011 8:37 am | by AACR | News | Comments

Tweet •    Results based on lower-cost MRI screenings for high-risk, uninsured or under-insured women.•    MRI screenings found more cancer cases in high-risk women than mammography.•    Underserved women can benefit from...

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Arena Pharmaceuticals to Present at the Sixth Annual JMP Securities Healthcare Conference

September 21, 2011 8:34 am | by Bio-Medicine.Org | News | Comments

SAN DIEGO, Sept. 21, 2011 /- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA ) announced today that the company is scheduled to present at the Sixth Annual JMP Securities Healthcare Conference on Tuesday, September 27, 2011, at 9:30 a.m. Eastern Time (6:30 a.m. Pacific Time) at The St....

At Home Healthcare Expands Telehealth Program With Cardiocom® Telehealth Technology

September 21, 2011 8:34 am | by Bio-Medicine.Org | News | Comments

TYLER, Texas, Sept. 21, 2011 /- At Home Healthcare, a leading provider of home care announced it has entered into a business relationship with Cardiocom to provide advanced home telehealth technology to patients with chronic illness. Cardiocom®, Experts in Telehealth(SM), is a world...

Minutes From Stakeholder Meeting on MDUFA III Reauthorization, August 18, 2011

September 21, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

To provide a status update of the ongoing MDUFA III negotiations.

Minutes From Negotiation Meeting on MDUFA III Reauthorization, August 9, 2011

September 21, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

To discuss potential workload and performance impacts of the Institute of Medicine?s report on 510(k)s and the draft guidance on 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.

Common Genetic Variants Associated with Development of High-risk Neuroblastoma, Poorer Treatment Outcomes

September 20, 2011 9:41 am | by AACR | News | Comments

Tweet •    African ancestry linked to increased rates of high-risk disease.•    Variants may be found in patients of any ethnic makeup. WASHINGTON, D.C. — Patients with a high degree of African ancestry had a greater incidence of high-risk...

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Misonix Reports Fourth Quarter and Year-End Fiscal 2011 Financial Results

September 20, 2011 9:40 am | by Bio-Medicine.Org | News | Comments

FARMINGDALE, N.Y., Sept. 20, 2011 /- Misonix, Inc. (NASDAQ: MSON ), a medical device company that designs, manufactures and markets innovative therapeutic ultrasonic products worldwide for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and...

SWIFT MRI Teases Out Jawbone Cancer

September 20, 2011 9:38 am | by Diagnostic Imaging | News | Comments

A magnetic resonance imaging technique called SWIFT (sweep imaging with Fourier transform) can help detect oral cancer in the jawbone, according to a report in the September issue of Archives of Otolaryngology–Head and Neck Surgery, a JAMA/Archives journal.

Johnson & Johnson Makes Strong Progress in First Year of Initiative to Improve Health of Millions of Women and Children in the Developing World

September 20, 2011 8:37 am | by Bio-Medicine.Org | News | Comments

NEW BRUNSWICK, N.J., Sept. 20, 2011 /- Johnson & Johnson (NYSE: JNJ ) today announced important progress made in the inaugural year of the Company's comprehensive effort designed to improve the health of as many as 120 million women and children each year in developing countries by...

Quantum Materials Corp and Nanoaxis Announce Technology Alliance

September 20, 2011 8:34 am | by Bio-Medicine.Org | News | Comments

TEMPE, Ariz., Sept. 20, 2011 /- Quantum Materials Corporation ( www.qdotss.com ) (Pink Sheets: QTMM ) Quantum Materials Corp. and Nanoaxis, LLC announce the formation of a technology alliance combining Quantum Materials tetrapod quantum dot mass production technology with...

AACR Awards 23 Minority Scholar in Cancer Research Awards

September 20, 2011 7:40 am | by AACR | News | Comments

Tweet WASHINGTON, D.C. — The American Association for Cancer Research is awarding 23 Minority Scholar in Cancer Research Awards at the Fourth AACR Conference on The Science of Cancer Health Disparities, held Sept. 18-21, 2011, in Washington, D.C. The award, now in its 26th year, is...

AACR Honors Seven Scientists with Minority-serving Institution Faculty Scholars in Cancer Research Awards

September 20, 2011 7:39 am | by AACR | News | Comments

Tweet WASHINGTON, D.C. — The American Association for Cancer Research will recognize leaders in the minority cancer community with the Minority-serving Institution Faculty Scholars in Cancer Research Awards. The seven recipients will be honored at the Fourth AACR Conference on The...

AACR to Host Conference on The Science of Cancer Health Disparities

September 20, 2011 7:39 am | by AACR | News | Comments

Tweet WASHINGTON, D.C. - The American Association for Cancer Research will host its Fourth AACR Conference on The Science of Cancer Health Disparities from Sept. 18-21, 2011, in the Grand Hyatt Washington, located in Washington, D.C. This conference will bring together scientists,...

What Bundled Payments Could Mean for Radiology

September 20, 2011 7:39 am | by Diagnostic Imaging | News | Comments

The way you receive reimbursement for your services could soon transform. There are two problems, however: no one is sure to what degree it will change, and radiologists haven't really had a voice in the conversation.

CMS Testing Four Bundled Payment Models

September 20, 2011 7:39 am | by Diagnostic Imaging | News | Comments

CMS recently extended to Oct. 6 the application deadline for hospitals interested in testing the first of four bundled payment models. It will be a while until you find out while which system the agency ultimately chooses, but this is certain - you will be affected.

Public Workshop ? Magnetic Resonance Imaging Safety, October 25-26, 2011

September 20, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

FDA is announcing a public workshop entitled: Magnetic Resonance Resonance Imaging (MRI) Safety Public Workshop. The purpose of the public workshop is to discuss factors affecting the safe use of magnetic resonance imaging MRI and approaches to mitigate

Preetha Reddy, Managing Director, Apollo Hospitals Invited to United Nations Summit on NCDs

September 20, 2011 6:38 am | by Bio-Medicine.Org | News | Comments

NEW YORK, September 20, 2011 /- Preetha Reddy, Managing Director, Apollo Hospitals, was invited to attend the United Nations Summit at New York held by the UN General Assembly for the prevention and control of Non-Communicable Diseases. Non-communicable diseases, such as heart attacks...

Rock Creek Pharmaceuticals Discloses Further Anatabine Patent Filing

September 20, 2011 6:35 am | by Bio-Medicine.Org | News | Comments

GLEN ALLEN, Va., Sept. 20, 2011 /- Rock Creek Pharmaceuticals, a subsidiary of Star Scientific, Inc. (NASDAQ: CIGX ), announced that on September 19, 2011 a utility patent application was filed with the Patent and Trademark Office ("PTO"). This utility patent application is based on...

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