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Summary Information for: M-Vu Algorithm Engine

January 27, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for M-Vu Algorithm Engine (P100005).

Bruker Acquires Hecus MICROcaliX Product Line to Expand Product Portfolio for Small Angle X-ray Scattering (SAXS)

January 27, 2012 4:59 am | News | Comments

KARLSRUHE, Germany--(BUSINESS WIRE)--Bruker AXS GmbH announced today that it has acquired the assets of Hecus X-ray Systems GmbH, a company focused on analytical instrumentation for Small Angle X-ray Scattering (SAXS) based on advanced Kratky technology.

Temptime and Numedis Collaborate to Bring Proprietary Storage and Transportation Technologies That Advance Corneal Transplant Outcomes

January 27, 2012 4:54 am | News | Comments

MORRIS PLAINS, N.J.--(BUSINESS WIRE)--Temptime Corporation, the world leader in time-temperature indicators, and Numedis, Inc., the developers and manufacturers of advanced, high-performance corneal preservation systems, have collaborated to combine technologies that will maintain...


US Diagnostic Electrocardiography Device Market to Grow at a Slow Rate of 1.5 Percent Through 2016

January 27, 2012 4:50 am | News | Comments

TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, declining demand in private practices for diagnostic electrocardiography (ECG) devices will contribute to slow growth in the United States market...

UF cardiologists, surgeons team up to offer life-extending procedure

January 27, 2012 4:35 am | News | Comments

GAINESVILLE, Fla. - For patients who have severe narrowing of the aortic valve, a condition known as aortic stenosis, standard treatment is surgical replacement of the damaged valve. But advanced age or medical problems such as lung disease prevent many of those patients from...

CardioComm Solutions, Inc. Passes Canadian Medical Devices Conformity Assessment System ISO 13485:2003 Audit

January 26, 2012 6:05 am | News | Comments

TORONTO--(BUSINESS WIRE)--CardioComm Solutions, Inc., received confirmation from the Canadian Medical Devices Conformity Assessment System (CMDCAS) that it had cleared an ISO audit performed by DQS Medizinprodukte GmbH. CardioComm Solutions is registered...

Reverse Medical Corporation Announces Sale of its Neurovascular Guide Catheter Business

January 26, 2012 5:58 am | News | Comments

IRVINE, Calif.--(BUSINESS WIRE)--Reverse Medical Corporation today announced that it has sold its line of neurovascular guide catheters to Covidien, a leading global provider of healthcare products. The terms of the transaction were not disclosed. “Despite being a young company...

ZELTIQ Initiates Patent Infringement Lawsuit Against Clinipro

January 26, 2012 5:54 am | News | Comments

PLEASANTON, Calif.--(BUSINESS WIRE)--ZELTIQ Aesthetics, Inc., a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, and the charitable trust of Massachusetts General Hospital (MGH)...


SANUWAVE Technology Shown to Promote Fracture Healing by Affecting Growth of New Blood Vessels and Bone

January 26, 2012 5:51 am | News | Comments

ALPHARETTA, Ga.--(BUSINESS WIRE)--SANUWAVE Health, Inc. today announced the publication of preclinical data demonstrating that the Company's Extracorporeal Shock Wave Technology (ESWT) promoted fracture healing by eliciting the production of specific growth...

Fenwal Receives New Regulatory Clearances for Amicus Separator and DXT Relay Software

January 26, 2012 5:47 am | News | Comments

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fenwal Inc., a global medical technology company focused on improving blood separation, collection, safety and availability, announced today it has received clearances from the U.S. Food and Drug Administration to market the Fenwal Amicus® separator...

BIOTRONIK Successfully Completes Testing of BIOTRONIK EHR DataSync— Connecting BIOTRONIK Home Monitoring to Electronic Health Record Systems

January 26, 2012 5:45 am | News | Comments

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--BIOTRONIK, a worldwide leader in manufacturing cardiac medical devices and pioneer of remote patient management solutions, today announced it has successfully completed its final interoperability testing process for BIOTRONIK Home Monitoring®...

The EF Precision Group Receives Patent for Orthopaedic Mallet

January 26, 2012 5:41 am | News | Comments

WILLOW GROVE, Pa.--(BUSINESS WIRE)--The EF Precision Group, a leading contract manufacturer, announced today that it has received patent number USD649,246 from the United States Patent Office for the assembly of an orthopaedic mallet currently being used by hospitals and orthopaedic clinics...

Summary Information for: MelaFind & #xae;

January 25, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for MelaFind® (P090012).


KFx Medical Corporation Awarded New Medical Devices Patent

January 25, 2012 5:53 am | News | Comments

SAN DIEGO--(BUSINESS WIRE)--KFx Medical Corporation today announced that it was granted a new patent from the United States Patent and Trademark Office: U.S. Patent No. 8,100,942 broadly covering knotless double row rotator cuff repair. The new patent bolsters KFx Medical's...

Medtronic Completes Enrollment of Extreme Risk Patient Group in CoreValve U.S. Pivotal Trial

January 25, 2012 5:50 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. today announced it has completed patient enrollment in the extreme risk study in its CoreValve U.S. Pivotal Trial. The company also received approval from the U.S. Food and Drug Administration (FDA) for an extended investigation...

First Patient Enrolled in Medtronic-Supported Head-to-Head Clinical Trial Comparing Cryoballoon Ablation to RF Ablation for Paroxysmal Atrial Fibrillation

January 25, 2012 5:46 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. today announced the first patient was enrolled in the FIRE AND ICE clinical trial, which is a prospective, randomized, multinational head-to-head clinical trial comparing the long-term safety, effectiveness and ease of use of the Medtronic Arctic...

Spectranetics Strengthens Peripheral Vascular Portfolio with a Partnership to Distribute the TAPAS Catheter

January 25, 2012 5:42 am | News | Comments

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--Spectranetics Corporation today announced an agreement with ThermopeutiX, Inc. to commercialize the TAPAS catheter, a therapeutic infusion system. The product has recently received U.S. Food and Drug Administration (FDA) 510(k) clearance...

Choice Spine Launches Major System into Lucrative Pedicle Screw Spine Market

January 25, 2012 5:36 am | News | Comments

KNOXVILLE, Tenn.--(BUSINESS WIRE)--Choice Spine, a Knoxville, TN based spine manufacturer, announces the launch of its new Starfire Pedicle Screw System. Pedicle screw systems are a basic product component of any spine company. Having an effective system allows Choice Spine distributors...

Zogenix and Battelle to Collaborate on Advanced Drug Delivery Technology

January 25, 2012 5:32 am | News | Comments

The companies have signed a Letter of Intent to enter into an exclusive co-marketing and technology development option agreement to utilize Zogenix's DosePro® needle-free drug delivery technology for new commercial out-licensing opportunities. DosePro technology enables...

Suspension Orthopaedics Gets FDA Clearance for Surgical System

January 25, 2012 5:23 am | News | Comments

ARNOLD, MD - Suspension Orthopaedic Solutions announced it has received FDA 510(k) clearance for two new products - its Distal Clavicle Fracture Fixation Systemâ„¢ and a new plate designed to address repair of mid-shaft clavicle fractures. The new Distal Clavicle Fracture Fixation System features...

CN Creative Raises Series a Funding To Develop First Medically Approved Electronic Inhaler Nicotine Replacement Therapy for Smoking Cessation

January 25, 2012 5:17 am | News | Comments

MANCHESTER, UK – CN Creative, Ltd. (CNC), a healthcare company providing innovative and sustainable solutions to reduce smoking and smoking-related illnesses, today announced it has raised a Series A financing round led by Advent Life Sciences. The financing raised £2 million...

Ukraine Fortifies Cancer Management Capabilities with New Elekta Technology

January 25, 2012 5:10 am | News | Comments

KYIV, Ukraine /PRNewswire/ -- The Rinat Akhmetov (Development of Ukraine) Foundation took bold strides in 2011 to advance patient care by acquiring a comprehensive range of cancer management technology to equip the radiotherapy department at Rivne Regional Oncologic Dispensary in Ukraine.

Invibio's PEEK-OPTIMA Polymer Used in Aesculap's FDA 510k Cleared EnduRo Rotational Knee System

January 25, 2012 5:01 am | News | Comments

Thornton Cleveleys, UK -- Invibio® Biomaterial Solutions, the market leader in providing PEEK-based biomaterial solutions to medical device manufacturers around the world, announced today that its PEEK-OPTIMA® Carbon Fibre Reinforced (CFR) polymer is utilized in Aesculap's FDA...

Atlanta Medical Center Selects RF Detection Technology for the Prevention of Retained Surgical Items

January 25, 2012 4:57 am | News | Comments

BELLEVUE, Wash.--(BUSINESS WIRE)--RF Surgical Systems, Inc., the market leader in retained surgical item (RSI) detection, today announced that Atlanta Medical Center, a Level 1 Trauma Center based in Atlanta, Ga., has selected the RF Assureâ„¢ Detection System for use...

PMD Healthcare Launches Spiro PD—The First Personal Spirometer to Monitor Lung Function

January 24, 2012 5:26 am | News | Comments

ALLENTOWN, PENNSYLVANIA -- PMD Healthcare Inc., announced today the launch and availability of its novel new lung health monitoring device – Spiro PD. Recently cleared by the U.S. Food and Drug Administration (FDA), Spiro PD is the first and only personal spirometer...

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