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Bard Acquires Lutonix, Inc.

December 22, 2011 5:45 am | News | Comments

MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. today announced that it has acquired Lutonix, Inc. for a purchase price of approximately $225 million paid at closing, with an additional $100 million to be paid upon PMA approval of Lutonix's drug-coated percutaneous transluminal angioplasty (PTA) balloon.

Quanterix Develops Microfluidic Consumable That Will Enable Next Generation Molecular Diagnostic Systems based on Single Molecule Array Technology

December 22, 2011 5:39 am | News | Comments

CAMBRIDGE, Mass., Dec. 22, 2011 /PRNewswire/ -- Quanterix Corporation, a company enabling a new generation of molecular diagnostic tests based on its revolutionary Single Molecule Array (SiMoA™) technology, has reported a method for detecting individual proteins within microfabricated polymer...

ShoulderFlex Massager: Warning - Risk of Strangulation

December 21, 2011 10:31 am | by U.S. Food & Drug Administration | News | Comments

Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation.


Tryton Announces DRG Reimbursement Code for Side Branch Stent in Germany

December 21, 2011 6:39 am | News | Comments

DURHAM, N.C.--(BUSINESS WIRE)--Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, announced that the German Institute for Medical Documentation and Information (DIMDI, Cologne) has revised the procedure code for the treatment of coronary bifurcations lesions...

App Store Names AirStrip CARDIOLOGY the Best iPhone Medical Application

December 21, 2011 6:36 am | News | Comments

SAN ANTONIO--(BUSINESS WIRE)--AirStrip CARDIOLOGYTM, the innovative cardiac patient monitoring solution from AirStrip Technologies Inc., has been named the best US medical application for the iPhone® as part of App Store Rewind 2011, which collects the year's top apps...

CADD-Solis VIP Ambulatory Infusion System Launches in Additional European Markets

December 21, 2011 6:34 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Smiths Medical, a leading global medical device manufacturer, announced today it launched the CADD®-Solis VIP ambulatory infusion system with CADD™-Solis medication safety software in France, Germany, Switzerland and the Netherlands.

3DISC Imaging Acquires CoreWare, Leading Provider of Radiology Software

December 21, 2011 6:22 am | News | Comments

DULLES, Va.--(BUSINESS WIRE)--3DISC Imaging, a manufacturer of high-quality, affordable medical imaging products, has acquired CoreWare, a longtime provider of digital radiography software, in a move that solidifies 3DISC's position as an emerging leader in medical imaging.

Mazor Robotics Enters US Spine Ambulatory Surgery Center Market

December 21, 2011 6:20 am | News | Comments

CAESAREA, Israel--(BUSINESS WIRE)--Mazor Robotics Ltd., the leader in innovative surgical robots and complementary products for spine surgery, announced a purchase agreement with NSH Michigan, Inc. The Renaissanceâ„¢ system will be installed at NSH Michigan, Inc.'s affiliate...


Covidien Announces CE Mark for Nellcor Respiration Rate Software

December 21, 2011 6:17 am | News | Comments

BOULDER, Colo.--(BUSINESS WIRE)--Covidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced it will label the Covidien Nellcorâ„¢ Respiration Rate Version 1.0 Software and...

St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation

December 21, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments

Premature insulation abrasion may cause the conductors to become externalized, which can cause serious adverse health consequences, including death.

Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose

December 20, 2011 10:31 am | by U.S. Food & Drug Administration | News | Comments

Patients with MS should not stop taking Gilenya without talking to their healthcare professional.

Acacia Subsidiary Acquires 8 Patents for Infusion Pump Technology from a Major Medical Device Company

December 20, 2011 4:58 am | News | Comments

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Acacia Research Corporation announced that a subsidiary has acquired patents relating to infusion pump technology from a major medical device company.

Studies Show that EarlySense's Contact-Free Patient Monitoring System Effectively Helps Hospital Patients Avoid Pressure Ulcers

December 20, 2011 4:56 am | News | Comments

WALTHAM, Mass.--(BUSINESS WIRE)--EarlySense, a market leader in proactive patient care solutions, announced today post regulatory approval clinical and interventional study results further confirming the EarlySense contact-free patient monitoring system's high value as a risk assessment tool...


Advances in Early Breast Cancer Detection Using SonoCiné's Automated Whole Breast Ultrasound (AWBU)

December 20, 2011 4:54 am | News | Comments

RENO, Nev.--(BUSINESS WIRE)--SonoCiné, Inc., the leading innovator of Automated Whole Breast Ultrasound (AWBU) screening systems for early detection of breast cancer announced today the publication of two important scientific papers reporting on the effectiveness of SonoCiné AWBU...

AtriCure's Synergy Ablation System Receives FDA Approval for the Treatment of Atrial Fibrillation

December 20, 2011 4:51 am | News | Comments

WEST CHESTER, Ohio--(BUSINESS WIRE)--AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, today announced that the U.S. Food and Drug Administration (FDA) has approved...

Berlin Heart's EXCOR Pediatric Ventricular Assist Device (VAD) Receives FDA Approval

December 20, 2011 4:46 am | News | Comments

THE WOODLANDS, Texas & BERLIN--(BUSINESS WIRE)--The Berlin Heart Group announced today that the FDA has granted “Humanitarian Device Exemption” (HDE) approval of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). The Berlin Heart EXCOR® Pediatric VAD...

Guidance for Industry and Food and Drug Administration Staff - Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices

December 20, 2011 3:30 am | by U.S. Food & Drug Administration | News | Comments

This document is intended to describe FDA?s intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under 21 CFR Part 807, Subpart E. FDA intends to propose the...

World's first production-ready Bluetooth low energy blood pressure monitor will work with any Bluetooth version 4.0 Smart Ready smartphone or computer

December 19, 2011 10:20 am | News | Comments

Oslo, Norway – RF specialist Nordic Semiconductor ASA announces that IDT International Limited – one of the world's leading OEM/ODMs (Original Equipment/Design Manufacturers) of consumer blood pressure monitors for global medical brands – has announced that it has successfully developed...

Lawmakers Concerned About Medical Device Safety

December 19, 2011 10:15 am | News | Comments

WASHINGTON, D.C. – Representatives Edward J. Markey (D-Mass.), Diana DeGette (D-Colo.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) today sent a letter to the Commissioner of the Food and Drug Administration (FDA) raising concerns about flaws...

Summary Information for: AtriCure Synergy Ablation System

December 19, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for AtriCure Synergy Ablation System (P100046).

Consumer Information on: AtriCure Synergy Ablation System - P100046

December 19, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

The AtriCure Synergy Ablation System is used to destroy (ablate) heart tissue that is beating abnormally. It includes the Synergy Ablation Clamp, a handheld surgical device that destroys the heart tissue that is grasped between the clamp?s jaws during...

Clinical Trial Bias Questions Halt CardioMEMS at Circulatory Panel

December 16, 2011 12:32 pm | by U.S. Food & Drug Administration | News | Comments

A negative devices advisory panel opinion, based on inconsistencies in clinical trials, may jeopardize a hoped-for buy-in by St. Jude Medical for the CardioMEMS monitoring device for heart failure.

Sunshine Act Compliance Delayed to 2013 Under CMS Proposed Rule

December 16, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments

Devicemakers no longer need to meet a Jan. 1 Sunshine Act deadline for reporting payments to doctors and hospitals.

Draft Guidance for Industry and Food and Drug Administration Staff - Evaluation of Sex Differences in Medical Device Clinical Studies

December 16, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this guidance is to outline the Center for Devices and Radiological Health?s (CDRH) expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The intent is to improve the quality and...

AngioScore Announces Successful Initiation of Enrollment in Drug-Coated AngioSculpt Scoring Balloon Catheter First-in-Human Study

December 15, 2011 5:49 am | News | Comments

FREMONT, Calif.--(BUSINESS WIRE)--AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, today announced the successful initiation of enrollment in the Drug-Coated AngioSculpt Scoring Balloon Catheter First-in-Human (FIH) Study.

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