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Draft Guidance for Industry and FDA Staff- Humanitarian Use Device (HUD) Designations

December 13, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation request to the U.S. Food and Drug Administration (FDA or Agency) Office of Orphan Products Development (OOPD). It is...

- Products and Medical Procedures Implants and Prosthetics Current Page is:Gastric Banding - Gastric Banding

December 13, 2011 7:31 am | by U.S. Food & Drug Administration | News | Comments

Gastric banding is a surgical procedure to reduce the size of the stomach for weight loss. In this procedure, a silicone band is placed around the upper portion of the stomach to create a small pouch.

Aptus Endosystems Completes First HeliFX Procedures in U.S.

December 13, 2011 5:27 am | News | Comments

SUNNYVALE, Calif.--(BUSINESS WIRE)--Aptus Endosystems Inc., a medical device company developing advanced technology for endovascular aneurysm repair (EVAR), announced the successful treatment of the first series of patients in the United States with the HeliFXTM Aortic Securement System...

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Phase One Medical Announces Second Patent Issuance For Their Distal Locking Hemodialysis Catheter System

December 13, 2011 5:23 am | News | Comments

HINGHAM, Mass.--(BUSINESS WIRE)--Phase One Medical, L.L.C. a privately held medical device research and development company announced today that the U.S. Patent and Trademark Office has issued a second patent covering their Distal Locking Hemodialysis Catheter Technology.

BSD Medical Signs Exclusive Distribution Agreement with CyberKnife Korea for Distribution of BSD's Hyperthermia Systems in South Korea

December 13, 2011 5:21 am | News | Comments

SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation (Company or BSD), a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company has signed an exclusive agreement with CyberKnife Korea (CKK) for the sale and distribution...

Soteira Inc., Obtains 510(k) Clearance for Shield Kyphoplasty System

December 13, 2011 5:17 am | News | Comments

NATICK, Mass.--(BUSINESS WIRE)--Soteira Inc., today announced the 510(k) clearance of the Shield Kyphoplasty System. Soteira Inc. President and CEO, Larry Jasinski, stated “The Shield Kyphoplasty System includes a unilateral, steerable cavity creator and a self expanding stent-like implant...

ETView Medical, Ltd. Announced Filing of a 510(k) Application with the FDA for the VIVASIGHTâ„¢ DL Line of Innovative Airway Management Devices

December 13, 2011 5:15 am | News | Comments

TEL AVIV, Israel--(BUSINESS WIRE)--ETView today announced that the company has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA). The Company expects feedback from the FDA during the next quarter...

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...

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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.

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.

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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.

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

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...

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