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iCAD Announces Recent Adoption of Its Xoft Electronic Brachytherapy System by Leading U. S. Hospitals

November 10, 2011 5:43 am | News | Comments

NASHUA, N.H.--(BUSINESS WIRE)--iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, today announced that its Xoft Axxent® eBx™ electronic brachytherapy system...

PROTECT II Demonstrates That Patients Undergoing Extensive Revascularization Benefit the Most from Impella Support

November 10, 2011 5:22 am | News | Comments

DANVERS, Mass. & SAN FRANCISCO--(BUSINESS WIRE)--Abiomed Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced the final analysis from the PROTECT II trial at the annual 2011 Transcatheter Cardiovascular Therapeutics (TCT) meeting.

Starkey's AMP Wins Consumer Electronics Show Innovations 2012 Award

November 10, 2011 5:17 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Starkey Laboratories, Inc., one of the world's leading hearing technology companies, is excited to announce that it has been named an International CES Innovations 2012 Design and Engineering Awards Honoree for its AMPâ„¢ hearing aid.


1st Findings on Exercise Performance with SynCardia's Total Artificial Heart Published in The Journal of Heart and Lung Transplantation

November 10, 2011 5:02 am | News | Comments

TUCSON, Ariz. – Nov. 10, 2011 – In the November issue of The Journal of Heart and Lung Transplantation (JHLT), Virginia Commonwealth University (VCU) Medical Center in Richmond published the first findings demonstrating that physical exercise and measurable rehabilitation are feasible with the SynCardia...

Circadiance Launches Revolutionary New CPAP Tube

November 10, 2011 5:00 am | News | Comments

PITTSBURGH, Nov. 10, 2011 /PRNewswire/ -- Building on the success of their revolutionary soft cloth nasal SleepWeaver CPAP (Continuous Positive Airway Pressure) mask, Circadiance is proud to introduce a mask tube so lightweight and flexible, that CPAP users will hardly know it's there.

Large-Scale Imaging and Brain Mapping Are Topics of Olympus Symposium at Society for Neuroscience Meeting

November 10, 2011 4:58 am | News | Comments

CENTER VALLEY, Pa., November 9, 2011 - Olympus is hosting its second major symposium on Brain Imaging and Brain Mapping in conjunction with the 2011 annual meeting of the Society for Neuroscience (SfN) in Washington DC on November 13. The Olympus Neuroimaging Symposium will be held at...

Cerebral Stethoscope Offers New Tool for Early Detection of Aneurysms

November 10, 2011 4:41 am | News | Comments

ALPINE, N.J., Nov. 9, 2011 /PRNewswire/ -- ProTron Technologies announces a new approach to early detection of aneurysms in vascular systems through the patented Stethotron® Cerebral Stethoscope. In the USA alone, six million people have a brain aneurysm. In 50% of ruptured aneurysms...

Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (...

November 10, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA?s Investigational Device Exemptions (IDE) regulations, Title 21 Code of Federal Regulations (CFR) Part 812.


Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including C...

November 10, 2011 3:30 am | by U.S. Food & Drug Administration | News | Comments

This document is intended to provide guidance to FDA staff, clinicians, clinical innovators, and industry on the development and review of Investigational Device Exemption (IDE) applications for early feasibility studies of significant risk devices.

High Powered Medicine

November 9, 2011 11:02 am | by Dr. Thomas Dittrich | Articles | Comments

The trend to miniaturize medical devices is active throughout the industry. With it, the challenge of identifying power solutions for these technologies is one that medtech companies are eager to solve. This article highlights one specific design option, that is, high energy lithium metal oxide batteries and showcases the advantages they present.

Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury

November 9, 2011 10:31 am | by U.S. Food & Drug Administration | News | Comments

Potential for patient falls or unanticipated patient movement, which may result in serious injury or death.

Trilipix (fenofibric acid): Drug Safety Communication - Label Change

November 9, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

The ACCORD Lipid trial found no significant difference in the risk of a major adverse cardiac event between group treated with fenofibrate plus simvastatin compared with simvastatin alone.

EarlySense Launches in Europe the Most Advanced Contact-free Patient Monitoring System at Medica 2011

November 9, 2011 5:14 am | News | Comments

Duesseldorf, Germany, and Ramat Gan, Israel, October 31, 2011--- EarlySense announced today that the Company will launch its contact-free patient monitoring system in Europe at MEDICA in Duesseldorf, November 16 - 20, 2011. Live demonstrations of the EarlySense system will be available...


Svelte Medical Systems Announces Treatment of First Patient in the DIRECT Drug-Eluting Stent Study

November 9, 2011 4:44 am | News | Comments

NEW PROVIDENCE, N.J.--(BUSINESS WIRE)--Svelte® Medical Systems today announced treatment of the first patient in the DIRECT (Direct-on-a-wire Implantation of Rapamycin-eluting stent with bio-Eroding Carrier Technology) study at Auckland City Hospital in Auckland, New Zealand.

XDx Announces Highmark's Coverage of AlloMap® for Monitoring Heart Transplant Rejection

November 9, 2011 4:41 am | News | Comments

BRISBANE, Calif.--(BUSINESS WIRE)--XDx, Inc., a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value non-invasive diagnostic tests to monitor immune-mediated conditions, today announced that Highmark...

Positive Long Term Clinical Data of the Cappella Sideguard® Stent System Announced at TCT 2011

November 9, 2011 4:38 am | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Cappella Medical Devices Ltd (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, announced today at the 2011 TCT (Transcatheter Cardiovascular Therapeutics) Conference in San Francisco...

St. Jude Medical Expands Hospital Access to Wireless Fractional Flow Reserve Technology with New Agreement

November 9, 2011 4:32 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced its wireless PressureWireâ„¢ Aeris technology, which aids in the diagnosis and treatment of coronary artery blockages by measuring Fractional Flow Reserve...

Study of Medtronic Endeavor® Drug-Eluting Stent Demonstrates Long-Term Advantages over Taxus® DES

November 9, 2011 4:26 am | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--New research findings released at TCT 2011 show that the Endeavor® zotarolimus-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT) outperformed Boston Scientific Corp.'s Taxus® paclitaxel-eluting stent on standard measures of safety and efficacy through five years of clinical follow-up.

Needles and Other Sharps (Safe Disposal Outside of Health Care Settings)

November 8, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

This webpage gives tips for safely disposing needles and other sharp devices that are used outside of health care settings. Patients and caregivers should keep these tips in mind when at home, at work, and while traveling.

Getinge Group: Getinge finalizes the acquisition of Atrium Medical Inc. and changes the date of its AGM

November 8, 2011 5:04 am | News | Comments

Getinge has been granted the approval of US anti-trust authority FTC (Federal Trade Commission) to go ahead with the acquisition of Atrium Medical Inc. The acquisition was finalized on 4 November, 2011, and will be consolidated in Getinge's accounts as of 1 November this year.

IntraPace Introduces New Lead For abiliti® System Resulting in Reduced Procedure Time

November 8, 2011 5:01 am | News | Comments

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--IntraPace, Inc. announced today that it has received CE Mark for the LGL102, a new gastric stimulation/food sensing lead designed to work with the innovative abiliti® system, an implantable weight loss management system.

Toshiba's Large Monitor Display Enhances Visibility for More Accurate Diagnoses

November 8, 2011 4:58 am | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--In cath lab procedures, clearly visualizing complex vascular structures is crucial to making exams faster and easier. Toshiba will showcase a new 56-inch LCD monitor for the InfinixTM-i line at this year's Transcatheter Cardiovascular Therapeutics (TCT)...

InfraReDx Announces the Launch of the TVC Imaging Systemâ„¢ for True Vessel Characterization of Coronary Artery Disease

November 8, 2011 4:57 am | News | Comments

BURLINGTON, Mass.--(BUSINESS WIRE)--InfraReDx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery and other vascular diseases, today announced the launch of its TVC Imaging Systemâ„¢, an enhanced version of the LipiScanâ„¢ IVUS Coronary Imaging System.

Medtronic CoreValve® System Gains CE Mark for New Direct Aortic Approach to Transcatheter Aortic Valve Implantation

November 8, 2011 4:54 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced it has received CE (Conformité Européenne) Mark for the Medtronic CoreValve® System to be delivered using direct aortic access. The Medtronic CoreValve System is now the only transcatheter aortic valve implantation (TAVI) system...

Femasys Receives FDA 510(k) Clearance for First Low Pressure HSG Device

November 8, 2011 4:27 am | News | Comments

ATLANTA, Nov. 7, 2011 /PRNewswire/ -- Femasys Inc., an emerging medical device developer of women's healthcare solutions, announced today that it has received 510(k) clearance for the FemChecâ„¢ Pressure Management Device, the first device designed for a low pressure HSG...

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