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ResMed Takes Aim at APEX Medical over Respiratory Device Patents

March 29, 2013 2:36 pm | by Mass Device | News | Comments

San Diego medical devices maker ResMed announced this week that it's going to "take action" to protect its respiratory patents, most recently by filing an infringement lawsuit against APEX Medical. ResMed filed parallel actions with the the International Trade Commission and in U.S federal courts, alleging that a handful of APEX's products violate patents for respiratory devices and masks.

Recall: Spacelabs Healthcare Pulls Anesthesia Workstations over Excess CO2 Risk

March 27, 2013 4:33 pm | by Mass Device | News | Comments

Washington-based Spacelabs Healthcare recalled a slate of its Spacelabs BleaseSirius and BleaseFocus anesthesia workstations as well as certain absorbers contained in service kits over concerns that they may contain a defect which could result in excess carbon dioxide in the gas delivered to a patient. The FDA slapped the recall with Class I status...

Class I Medical Device Recall: Spacelabs Medical, Inc., Spacelabs Anesthesia Workstations and Service Kits

March 26, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

These products are used in the hospital environment and in locations not requiring mobility of the products. They provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to deliver anesthetic vapor.

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COWIN Helps Sensaris Certify the ZAO Biomedical Sensor

March 25, 2013 10:13 am | by COWIN | News | Comments

Sensaris has announced that it has developed a novel, multi-sensor device for monitoring vital signs. Called the ZAO, it is currently going through the certification process and will be available mid 2013. Roughly the same size as a thick paperback book, it is designed to provide professional level diagnostic data so that it can be used by medical professionals and yet its low target volume price point of around €550 means that it can also be used by the home health market.

Leading U.S. Pulmonologists to Investigate Impact of Mauna Kea Technologies' Cellvizio on Lung Cancer Diagnosis

March 21, 2013 12:45 pm | by The Associated Press | News | Comments

Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, announced today that it has launched a registry study to determine the impact of Cellvizio optical biopsies on the diagnosis of lung cancer, the leading cause of cancer death in the world.

"Miracle" Medical Device Saves Teen from Lifetime on Ventilator

March 20, 2013 11:45 am | by PR Newswire | News | Comments

FORT LAUDERDALE, Fla., March 20, 2013 /PRNewswire/ -- In January, 18 year old Reggie Lamour's neck was broken while he played in a rugby game in Naples, Florida. In one moment, the active, athletic young adult with a bright future faced a life-time of ventilator dependency. But there...

Wearable Artificial Lung to Be Developed at Pitt Through $3.4 Million Grant

March 19, 2013 11:50 am | by University of Pittsburgh | News | Comments

Each year, nearly 350,000 Americans die of some form of lung disease, with another 150,000 patients needing short- and long-term care. Unfortunately, current breathing-support technologies are cumbersome, often requiring patients to be bedridden and sedated.

Premier Healthcare Alliance Doles Out Four New Contracts

February 27, 2013 3:09 pm | by Mass Device | News | Comments

Group purchasing organization Premier Healthcare Alliance awarded 4 new contracts for regional anesthesia, surgical instruments, operating room lights and brooms and instrument containers to a bevy of medical device companies. All of the new deals became available to acute care and continuum care Premier members Feb. 1.

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ALung Technologies Receives CE Mark Approval for Hemolung Respiratory Assist System

February 25, 2013 3:00 pm | by The Associated Press | News | Comments

PITTSBURGH--(BUSINESS WIRE)--Feb 25, 2013--ALung Technologies, Inc., a leading developer of innovative respiratory assist devices, announced today that it has received CE Mark approval for its Hemolung Respiratory Assist System (RAS). Receipt of the CE Mark allows the Hemolung RAS to be sold in...

Teleflex Launches The Invisible Risk Campaign to Educate PACU Clinicians About Waste Anesthetic Gas Exposure

February 20, 2013 7:00 am | by The Associated Press | News | Comments

LIMERICK, Pa.--(BUSINESS WIRE)--Feb 20, 2013--Teleflex Incorporated (NYSE:TFX), a corporate partner of the American Society of PeriAnesthesia Nurses (ASPAN) and the American Society of Anesthesiologists (ASA), has launched The Invisible Risk campaign. The campaign is designed to educate clinicians...

Sorin Group Announces the Acquisition of Alcard

February 19, 2013 3:30 am | by The Associated Press | News | Comments

MILAN--(BUSINESS WIRE)--Feb 19, 2013--Sorin Group (MIL:SRN) (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the acquisition of Alcard Industria Mecanica Ltda (“Alcard”), a Brazilian leading manufacturer of medical...

Class I Medical Device Recall: GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems

February 14, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The oxygen and air wall inlet fittings and/or labels on the back panel of the resuscitation systems may have been reversed during assembly. As a result, this could potentially reverse the air/oxygen concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen and vice versa. The settings of the blender knob would no longer be accurate.

Sorin Group Announces Preliminary Results for 2012

February 7, 2013 12:06 pm | by The Associated Press | News | Comments

MILAN--(BUSINESS WIRE)--Feb 7, 2013--At a meeting held today and chaired by Rosario Bifulco, the Sorin S.p.A. (MIL:SRN) Board of Directors analyzed the results for the fourth quarter 2012 and the preliminary unaudited consolidated results for the year of 2012. The final draft of the financial...

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European patient registry in venous thromboembolism (VTE) enrols first patient

February 6, 2013 11:29 am | by PR Newswire | News | Comments

MUNICH, February 6, 2013 /PRNewswire/ -- The registry plans to gather data from more than 4,000 patients with VTE across seven European countries, providing insights into the clinical management of a disease that is a leading cause of morbidity and mortality[1] Daiichi Sankyo...

ERT, Johns Hopkins University and the University of Washington Expand Study on Effects of Home-Health Monitoring on Exacerbations of Cystic Fibrosis

February 4, 2013 9:52 am | News | Comments

ERT, a global technology-driven provider of health outcomes research services to biopharmaceutical organizations, medical device companies and contract research organizations (CROs), along with pulmonary researchers at the Johns Hopkins University School of Medicine  and University of Washington, today announced an expansion to the Early Intervention in Cystic Fibrosis Exacerbation (eICE) Study.

Covidien Supports Centers for Medicare & Medicaid Services Quality Measure #3040

January 21, 2013 9:24 am | by Covidien | News | Comments

Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announces its support for the Centers of Medicare & Medicaid Services (CMS) proposed quality measure #3040, currently considered for a Medicare program rule. Quality measures help CMS assess performance of hospitals participating...

Dip Molded Products Play Critical Role in Medical Equipment Design

December 19, 2012 3:10 pm | by Ed Sullivan | Articles | Comments

Dip molding may not be a term that readily comes to mind when surgeons begin complicated procedures. Yet, without this sophisticated, highly controllable process, many medical devices used daily in hospitals could not meet stringent certification requirements.

UMCG Enrolls First Patients in PneumRx RENEW Pivotal Trial for Treatment of Severe Emphysema

December 17, 2012 2:47 pm | by PRNewswire | News | Comments

PneumRx, Inc., a leader in interventional pulmonology, announced today that University Medical Center Groningen has enrolled and treated the first patients in the FDA-approved RENEW pivotal trial to evaluate the RePneu Lung Volume Reduction Coil (LVRC). The RePneu LVRC, a minimally invasive medical implant designed to treat the symptoms of severe emphysema...

Novel Stethoscope Using Solvay's Radel® PPSU is First to Assess Injured in High-Noise Environments

November 8, 2012 12:02 pm | News | Comments

Active Signal Technologies Inc., Linthicum Heights, Md., a leading contract research firm specializing in electromechanical devices, has developed the first stethoscope that can detect heart/lung activity in high ambient noise (above 90 dBA) including combat casualty and civilian emergency medical environments.

Ceretec Inc., Medical Device and Pharmaceutical Product Innovators, Introduces NO-Diff, a Nitric Oxide Lung Diffusion Gas Mixture

October 17, 2012 11:21 am | by PRNewswire | News | Comments

Ceretec, Inc. today announced that it has introduced an FDA-listed nitric oxide gas product (NO-Diff™ Nitric Oxide 800 ppm Lung Diffusion Mixture) for use in membrane diffusing capacity (DLNO) testing in pulmonary function laboratories in the U.S.

VBOX, Inc.'s Trooper Oxygen Concentrator Receives FDA Approval

October 2, 2012 11:02 am | by PRNewswire | News | Comments

VBOX, Inc., a medical device company, today announces that the U.S. Food and Drug Administration has approved its Trooper™ portable oxygen concentrator for prescription oxygen therapy. The Trooper will be available in second quarter of 2013 for patients who are prescribed oxygen and want to maintain a more active lifestyle.

Covidien recalls tracheostomy tubes

August 15, 2012 12:00 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Medical device firm Covidien plc (NYSE: COV) has recalled several lots of cuffed Shiley brand tracheostomy tubes, which are inserted into patients’ windpipes to help them breathe when they can not do so on their own. The recall followed customer complaints about leakage or disconnection between inner and outer cannulae during mechanical ventilation of patients.

Breathe's Non-Invasive Open Ventilation System Approved for Department of Veterans Affairs Federal Supply Schedule

August 13, 2012 1:35 pm | News | Comments

Breathe Technologies, Inc. received official approval from the Department of Veterans Affairs for its Non-Invasive Open Ventilation (NIOV™) System to be added to the Federal Supply Schedule (FSS). The NIOV System has important benefits for patients with later stage chronic obstructive pulmonary disease...

New Biotech Company Launches After Discovery

July 30, 2012 11:03 am | by Casandra Andrews, Press-Register | News | Comments

The business, Exscien -- which in Latin means 'for science' -- was recently awarded a grant by the National Institutes of Health to support the development of a new drug aimed at preventing and reversing acute lung injury.

Covidien Announces Global Launch of Nellcor SpO2 Module for Philips IntelliVue Patient Monitors

June 25, 2012 6:11 am | News | Comments

Covidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced the launch of its Nellcor™ SpO2 single parameter module for use with the Philips IntelliVue patient monitoring platform.

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