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FDA Considers More Registries, Virtual Research for Devices

December 9, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

For some devices, laboratory testing and computer modeling may work better than clinical trials, William Maisel, deputy center director of CDRH, said.

GE, Microsoft to Launch Joint Venture Aimed at Global Healthcare System Transformation

December 9, 2011 5:54 am | News | Comments

BARRINGTON, Ill. & REDMOND, Wash.--(BUSINESS WIRE)--General Electric Company, through its healthcare IT business, and Microsoft Corp. today announced plans to create a joint venture aimed at helping healthcare organizations and professionals use real-time, system-wide intelligence...

Invacare Corporation Announces Discussions with The FDA

December 9, 2011 5:48 am | News | Comments

ELYRIA, Ohio--(BUSINESS WIRE)--Invacare Corporation today announced that the U.S. Food and Drug Administration (FDA) has requested that the Company negotiate and agree to a consent decree of injunction relating to previously disclosed inspectional observations...

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Spinal Modulation System Receives CE Mark for the Management of Chronic Intractable Pain

December 9, 2011 5:45 am | News | Comments

LAS VEGAS--(BUSINESS WIRE)--Spinal Modulation, a privately held global medical device company, announced today that the Spinal Modulation Neurostimulator System has received the CE Mark for the management of chronic intractable pain. The Spinal Modulation System utilizes low-level electrical signals...

FDA Advisory Panel Recommends Expanded Indication for Medtronic Cardiac Resynchronization Therapy with Defibrillator (CRT-D) Devices

December 9, 2011 5:35 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration's (FDA) Circulatory Systems Devices Advisory Panel determined that the overall clinical benefits of Medtronic cardiac resynchronization therapy...

LifeScience Alley and FDA's Devices Center Sign Memorandum of Understanding to Advance Regulatory Science

December 9, 2011 5:33 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--LifeScience Alley announced today that it has signed a memorandum of understanding (MOU) with the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The MOU formalizes interactions that have been occurring

Sony DADC and Maven Biotechnologies to Develop Smart Consumables for Novel Label-Free Detection

December 9, 2011 5:27 am | News | Comments

SALZBURG, Austria & MONROVIA, Calif.--(BUSINESS WIRE)--Sony DADC BioSciences and Maven Biotechnologies today announced a collaboration to develop and manufacture smart consumables for Maven's LFIREâ„¢ detection platform. LFIREâ„¢ stands for Label-Free Internal Reflection Ellipsometry.

COMPAS Trial Results Demonstrate the Safety and Efficacy of Daily Remote Monitoring with BIOTRONIK Home Monitoring in Pacemaker Patients

December 8, 2011 4:42 am | News | Comments

BERLIN--(BUSINESS WIRE)--BIOTRONIK today announced the publication of the COMPAS clinical trial results in the European Heart Journal1. COMPAS is the first large-scale, prospective, multi-center, randomized clinical trial to demonstrate the safety and efficacy of remote monitoring...

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Radient Pharmaceuticals Submits an Abstract to the American Society of Colon and Rectal Surgeons

December 8, 2011 4:40 am | by Bio-Medicine.Org | News | Comments

TUSTIN, Calif., Dec. 8, 2011 /- Radient Pharmaceuticals Corporation  (OTCQX:RXPC) (OTCPK:RXPC), developer and marketer of the Onko-Sure® In Vitro Diagnostic (IVD) cancer test, announced today that it has submitted one abstract for the American Society of Colon and Rectal...

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...

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.

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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...

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...

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.

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