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Cook Medical is Awarded New Contract with Novation for Cook Central Venous Catheters

December 5, 2011 4:24 am | News | Comments

Bloomington, Ind., December 5, 2011 – Beginning January 1, 2012, Cook Medical's central venous catheters (CVCs) will be available to the members served by Novation, the supply contracting company for more than 30,000 members of VHA Inc., UHC, and Provista. This expands nationwide access...

Radient Pharmaceuticals' Two Abstracts Submitted to 2012 Gastrointestinal Cancers Symposium (ASCO) Regarding Onko-Sure® Utility in Colorectal Cancer Are Accepted for Presenta...

December 5, 2011 2:33 am | by Bio-Medicine.Org | News | Comments

TUSTIN, Calif., Dec. 5, 2011 /- Radient Pharmaceuticals Corporation  (OTCQX:RXPC) (OTCPK:RXPC), developer and marketer of the Onko-Sure® In Vitro Diagnostic (IVD) cancer test, announced today that the two abstracts it submitted to the 2012 Gastrointestinal Cancers...

Ethicon Drops Sedasys PMA Appeal As FDA Agrees to & #8220;Expeditious & #8221; Review

December 2, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA has agreed to review its denial of sedation system Sedasys, prompting Johnson & Johnson subsidiary Ethicon Endo-Surgery to drop an appeal.

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FDA Hopes Artificial Pancreas Guidance is Flexible, Encouraging

December 2, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA intends a new draft guidance on development of artificial pancreas device systems to be a map rather than a roadblock, an FDA official said in a Dec. 1 briefing.

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available)

December 2, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. Links to all available summary review memos can be found here.

CJPS Medical Systems Introduces Remote Patient Monitoring With Tablet PCs

December 2, 2011 4:56 am | News | Comments

AUBURN HILLS, Mich.--(BUSINESS WIRE)--CJPS Medical Systems announces today that VitalPoint® HOME, its remote patient monitor, can be used with Microsoft Windows®-based Tablet PCs. This announcement comes on the heels of CJPS being the first company waiving all connectivity fees...

GE healthymagination Fund Invests in C8 MediSensors, a Developer of Non-invasive Continuous Glucose Monitors

December 2, 2011 4:40 am | News | Comments

NORWALK, Conn. & MILWAUKEE--(BUSINESS WIRE)--GE Capital and GE Healthcare, the financial services and healthcare divisions of General Electric Company, announced today an investment in C8 MediSensors, Inc., a privately held developer of non-invasive continuous glucose monitors for diabetic patients.

Covidien's Embolic Protection Device Receives FDA Clearance

December 2, 2011 4:35 am | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Covidien, a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has cleared SpiderFX® for the treatment of severely calcified lesions used in conjunction with plaque excision...

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Acacia Subsidiary Acquires 13 Patents for Drug Delivery Technology

December 2, 2011 4:32 am | News | Comments

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Acacia Research Corporation announced today that a subsidiary has acquired patents for inhaler drug delivery technology from a major medical company.

Purdue, Notre Dame and GE Healthcare Partner to Make 'Ultra Low' Radiation-Dose, High-Clarity CT Imaging a Reality

December 2, 2011 4:29 am | News | Comments

WEST LAFAYETTE, Ind., NOTRE DAME, Ind. & WAUKESHA, Wis.--(BUSINESS WIRE)--Demonstrating their shared legacy of innovative research and commitment to patient-centered medical technology, Purdue University, University of Notre Dame and GE Healthcare announce a proprietary new CT scanning...

JDRF Encouraged By Draft FDA Artificial Pancreas Guidance

December 2, 2011 4:24 am | News | Comments

Washington, D.C. – The JDRF today said it is encouraged that the Food and Drug Administration (FDA) has issued a draft guidance which appears to lay a foundation for accelerating the development and availability of artificial pancreas technology (AP) that will improve the lives of millions...

Nanofiber Solutions Develops World's First Synthetic Tracheal Implant Made from Nanofibers to be Successfully Transplanted into Cancer Patient

December 2, 2011 4:16 am | News | Comments

COLUMBUS, Ohio – Nanofiber Solutions, LLC, announced today the first successful transplant of its electrospun nanofiber tissue engineered tracheal implant into a 30-year old Baltimore resident, Christopher Lyles, who was diagnosed with inoperable tracheal cancer.

Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas D...

December 1, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance is intended to provide recommendations to Sponsors or Applicants planning to develop and submit an Investigational Device Exemption (IDE) or premarket approval (PMA) application for an Artificial Pancreas Device System (APDS) for...

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Updated Information on Artificial Pancreas Systems

December 1, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

The FDA is helping advance the development of an artificial pancreas system -- an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with type 1 diabetes.

St. Jude Medical Announces FDA Approval of Industry's First Quadripolar Pacing System

December 1, 2011 6:07 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc., a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) approval of its Unify Quadra® cardiac resynchronization therapy defibrillator (CRT-D) and Quartet® Left Ventricular Quadripolar Pacing Lead.

Toshiba Introduces New Applications Taking CT from Anatomical to Functional

December 1, 2011 6:00 am | News | Comments

CHICAGO--(BUSINESS WIRE)--Toshiba America Medical Systems, Inc. announces new functional-based clinical applications – Dual Energy and Myocardial Perfusion (both works-in-progress), as well as Body Perfusion – for its AquilionTM CT systems. These applications are shown at...

GE Healthcare Helps Radiologists Connect and Collaborate

December 1, 2011 5:57 am | News | Comments

CHICAGO--(BUSINESS WIRE)--Today at RSNA 2011, GE Healthcare announced a leap forward in radiology department workflow with an interoperable suite of advanced visualization and image management applications. Using these tools, radiologists are empowered with access...

Emboline receives U.S. allowance for key piece of its seminal patent portfolio of aortic embolic protection technologies for percutaneous heart valve procedures such as TAVR

December 1, 2011 5:54 am | News | Comments

FREMONT, Calif.--(BUSINESS WIRE)--Emboline, Inc., an emerging medical device company, has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) related to its aortic embolic protection devices for percutaneous heart valve repair and replacement.

GE Healthcare Reveals New Features Across Its Ultrasound Product Lines

December 1, 2011 5:52 am | News | Comments

CHICAGO--(BUSINESS WIRE)--GE Healthcare is showcasing its latest advances in ultrasound today at RSNA 2011. As healthcare providers increasingly incorporate ultrasound into their practice, GE Healthcare is accelerating its development of solutions and tools that help advance...

PMA Final Decisions for October 2011

November 30, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for October 2011.

New GORE EXCLUDER AAA Endoprosthesis Sizing Options Available

November 30, 2011 5:39 am | News | Comments

FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) has received FDA approval for the 23 mm and 27 mm diameter sizes of the contralateral leg component of the GORE® EXCLUDER® AAA Endoprosthesis for treatment of abdominal aortic aneurysm (AAA).

Carestream Shows Latest Innovative Medical Imaging Technologies At World's Largest Radiology Conference

November 30, 2011 5:35 am | News | Comments

Carestream Health provides innovative digital radiography systems that satisfy these goals while simultaneously helping to reduce expenses for healthcare providers worldwide. It also markets powerful systems that efficiently manage radiology workflow-from the scheduling of patient x-ray...

Control Your Impulses, Manage Your Stress, and Prevent Potential Injuries with Innovations and Research from San Jose Med-Tech Company PreviMed, Inc.

November 30, 2011 5:31 am | News | Comments

SAN JOSE, Calif.--(BUSINESS WIRE)--An inventive San Jose medical technology development group has thrown aside the idea of profits first, targeting niche health needs with the potential for mass market appeal. Among their 23 unique inventions and research concepts are a device...

GE Healthcare ‘Humanizes' Radiology Exams with MR Patient Experience Suite

November 30, 2011 5:27 am | News | Comments

CHICAGO--(BUSINESS WIRE)--Today at RSNA 2011, GE Healthcare introduced the innovative Magnetic Resonance (MR) Patient Experience Suite, part of its healthymagination strategy to improve the quality of patient care. The suite aims to ‘humanize' radiology...

Covidien Endo Stitch Automated Suturing Device Reduces Hospitalization Costs and Operating Room Time

November 30, 2011 5:22 am | News | Comments

NORTH HAVEN, Conn.--(BUSINESS WIRE)--Covidien, a leading global provider of healthcare products, today announced study data demonstrating that use of its Endo Stitchâ„¢ automated suturing device lowers mean hospital costs and operating room (OR) time during total laparoscopic hysterectomies...

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