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Lantronix Launches EDS-MD: Next Generation Device Aggregator for the Medical Market

December 8, 2011 4:38 am | News | Comments

LONDON--(BUSINESS WIRE)--Lantronix, a leading global provider of smart connectivity solutions that enable virtually any electronic device or machine to communicate and share data with applications and business and technology professionals, today announced the global launch...

Amp Orthopedics Initiates Clinical Trial in Knee Osteoarthritis Pain

December 8, 2011 4:34 am | News | Comments

SEATTLE--(BUSINESS WIRE)--Amp Orthopedics, a privately held medical device company, announced the initiation of a clinical trial in adults with mild-to-moderate knee osteoarthritis (OA) to determine the safety and effectiveness of the company's non-thermal pulsed radio frequency (PRF) technology...

Depuy Spine Launches New System for Neuromuscular Scoliosis

December 8, 2011 4:30 am | News | Comments

RAYNHAM, MA – December 6, 2011 – DePuy Spine, Inc. today announced the launch of the EXPEDIUM® Neuromuscular System, a new modular system of pre-contoured rods and proximal connectors, open and closed iliac screw designs and wires, designed to help surgeons...

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Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events

December 7, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. FDA is working to determine whether reports of bleeding are occurring more commonly than would be expected.

CooperVision Avaira Aquaform Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on Lenses

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

Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Video: LASIK Surgery and its Risks

December 7, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses. The goal of this Web site is to provide objective information to the public about LASIK surgery.

Class I Medical Device Recall: CooperVision AVAIRA AQUAFORM Sphere Soft Contact Lenses

December 7, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: The unintended presence of a silicone oil residue on AVAIRA Sphere soft contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Class I Medical Device Recall: Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)

December 6, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage. Additionally, there may be a 5-10 second delay between the electrocardiogram and blood pressure curves...

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Pressure Sensors with Highest Resolution for Respiration Applications

December 5, 2011 5:47 am | Product Releases | Comments

Sensortechnics’ LBA series offers differential low pressure sensors based on thermal mass flow measurement of air through a micro-flow channel integrated within the silicon sensor chip.

Meeting Materials for December 7-8, 2011 Circulatory System Devices Panel of the Medical Devices Advisory Committee

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

Meeting Materials for December 7-8, 2011 Circulatory System Devices Panel of the Medical Devices Advisory Committee

Tenex Health Named Top Medical Device Company on Forbes America's Most Promising Companies List

December 5, 2011 4:45 am | News | Comments

LAKE FOREST, Calif.--(BUSINESS WIRE)--Tenex Health Inc. today announces its inclusion as the top medical device company on the Forbesâ„¢ list of America's Most Promising Companies, which features 100 privately held up-and-comers with compelling business models, strong management teams...

LDR Receives Approval to Market Two New Stand-Alone Spine Products in China

December 5, 2011 4:43 am | News | Comments

AUSTIN, Texas--(BUSINESS WIRE)--LDR, a privately held medical device company offering innovative spinal implants for both non-fusion and fusion applications, announced that it has received approval to market two innovative spine device systems in China. The ROI-C® Cervical Cage and...

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...

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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.

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...

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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