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Microneedle Sensors May Allow Real-Time Monitoring Of Body Chemistry

December 13, 2011 4:44 am | News | Comments

Researchers from North Carolina State University, Sandia National Laboratories, and the University of California, San Diego have developed new technology that uses microneedles to allow doctors to detect real-time chemical changes in the body...

Nonin Medical GO2 Finger Pulse Oximeter to be Featured on The Balancing Act TV Show on Lifetime Television

December 12, 2011 3:40 pm | by Bio-Medicine.Org | News | Comments

MINNEAPOLIS, Dec. 12, 2011 /- Nonin Medical, Inc., the inventor of finger pulse oximetry and a leader in noninvasive medical monitoring, today announced that the GO2™ Personal Finger Pulse Oximeter will be featured on "The Balancing Act" TV Show on Lifetime Television,...

Depuy Orthopaedics Receives FDA PMA Approval for New AOX Antioxidant Polyethylene

December 12, 2011 8:42 am | News | Comments

WARSAW, IN – December 12, 2011 – DePuy Orthopaedics, Inc. (DePuy) has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for use of the new AOX ™ Antioxidant Polyethylene material with its SIGMA® Rotating Platform Knee System and LCS® COMPLETE® Mobile Bearing Knee System.

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Data Shows Medtronic AdaptiveStim with RestoreSensor Provides Pain Relief and Convenience

December 12, 2011 4:51 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Clinical trial data presented at the 15th Annual Meeting of the North American Neuromodulation Society demonstrate the AdaptiveStimâ„¢ with RestoreSensorâ„¢ neurostimulation system from Medtronic provides clinical benefits for many patients...

Bluegrass Vascular Technologies Begins First Clinical Study of the Surfacer Inside-Out Access Catheter System

December 12, 2011 4:23 am | News | Comments

LEXINGTON, Ky.--(BUSINESS WIRE)--Bluegrass Vascular Technologies, a medical technology company focused on life-saving devices and methods for vascular access procedures, has announced patient enrollment in the first clinical study of its Surfacerâ„¢ Inside-Out Access Catheter System...

Exactech Continues to Expand Spine Portfolio with Comprehensive Solution to Posterior Cervical Fusion

December 12, 2011 4:20 am | News | Comments

GAINESVILLE, Fla.--(BUSINESS WIRE)--Exactech, Inc., a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced the full market launch of its Gibralt® spinal system at the Cervical Spine Research Society Annual Meeting this week.

Law Expert Says High Court Likely to Favor Prometheus Test Patent

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

The U.S. Supreme Court appears unconvinced after oral arguments on Prometheus Laboratories’ thiopurine metabolites test patent, but one legal expert predicts the high court will uphold an appeals court decision in favor of Prometheus.

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.

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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...

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

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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...

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.

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.

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