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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...

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Study: 1 in 10 Recalled St. Jude Medical Riata Lead Coatings Fail Within Six Years

February 25, 2013 2:43 pm | by Mass Device | News | Comments

Danish researchers reported this week that their latest studies of St. Jude Medical's recalled Riata defibrillator leads found that 1 in 10 had poked through their coating in an average of just over 5 years. The study included 298 Danish patients, representing "virtually every living patient in Denmark who received Riata defibrillator leads," according to Heartwire.

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FDA Issues Draft Guidance on Distinguishing Medical Device Recalls from Product Enhancements

February 25, 2013 2:38 pm | by Mass Device | News | Comments

The FDA issued draft guidance for medical device companies on distinguishing between a recall and a product enhancement that doesn't need 1, saying it recognizes that "continuous improvement activities" "often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient."

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Jury Awards $3.35 Million to Victim of Prolift Vaginal Mesh Injuries

February 25, 2013 2:38 pm | by Bio-Medicine.Org | News | Comments

A New Jersey state court jury today awarded $3.35 million to 47-year-old Linda Gross , a woman whose life took a significant turn for the worse in 2006 after she received a Prolift vaginal mesh implant manufactured by Johnson & Johnson's Ethicon unit. Concluding the trial of the first of the 2,100 personal injury cases...

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FDA slaps Lumenis recall with Class I status

February 25, 2013 2:27 pm | by Mass Device | News | Comments

The FDA slapped the recall of the Lumenis VersaCut tissue morcellator with Class I status, denoting a device that can cause serious injury or death. Morcellators are used to cut and remove large masses of tissue during laparoscopic procedures. Yokneam, Israel-based Lumenis is pulling the devices due to a labeling problem.

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Medtronic Adds to Intersect ENT's $30M Series D Round

February 25, 2013 12:52 pm | by Mass Device | News | Comments

Medtronic is once again backing sinus implant developer Intersect ENT, this time in a $30 million Series D round led by new investor Norwest Venture Partners. All of Intersect's existing "significant" backers participated in the latest round, including Kleiner Perkins Caufield & Byers, U.S. Venture Partners, PTV Sciences and Medtronic, according to a press release.

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Which Medical Device Companies Are the Best to Work for?

February 25, 2013 12:38 pm | by Mass Device | News | Comments

Johnson & Johnson (NYSE:JNJ) tops the charts as the best medical device company to work for according to Glassdoor.com, a database of anonymously posted information about salaries, interviews and jobs from current and former medical device industry employees.

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Ascendx Spine™ Receives Recognition from SEMDA for Its Ascendx VCF Repair System Designed to Help Spine Surgeons Treat Vertebral Compression Fractures (VCFs)

February 25, 2013 12:20 pm | by The Associated Press | News | Comments

WINTER PARK, Fla.--(BUSINESS WIRE)--Feb 25, 2013--Ascendx Spine™, Inc. has received the ‘Spotlight’ award from SEMDA (Southeast Medical Device Association) as the best presentation at the Seventh Annual SEMDA Conference last week. As a result, Ascendx was asked to be a...

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Who Will Win The Battle For Tougher Medical Device Regulations, the European Commission or Device Manufacturers?

February 25, 2013 12:04 pm | by GlobalData | News | Comments

Faulty breast implants at risk of bursting, and defective metal-on-metal hip prostheses, both raising grave concerns about patient health and long-term toxicity, have plagued the reputation of the medical device industry over the past year, states a GlobalData healthcare analyst.

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Regulators Probe J&J's Marketing of Recalled Hip Implants

February 25, 2013 12:04 pm | by Mass Device | News | Comments

Federal investigators recently launched an additional inquiry into Johnson & Johnson and its DePuy Orthopaedics subsidiary, taking a closer look at marketing practices surrounding a line of recalled metal-on-metal hips. J&J confirmed in regulatory filings last week that the U.S. State Attorney's Office for the District of Massachusetts and the Civil Division of the U.S. Justice Dept...

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Saint Luke's Mid America Heart Institute Clinical Trial To Investigate Effectiveness Of Cardiac Surgery Device

February 25, 2013 11:45 am | by PR Newswire | News | Comments

Clinical trial to determine if chest closure device leads to better bone healing following cardiac surgery KANSAS CITY, Mo., Feb. 25, 2013 /PRNewswire-USNewswire/ -- Patients undergoing open heart procedures such as coronary artery bypass or valve surgery may be...

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Electrochem Announces Presence at Medical Devices Summit East

February 25, 2013 11:33 am | by The Associated Press | News | Comments

CLARENCE, N.Y.--(BUSINESS WIRE)--Feb 25, 2013--Electrochem Solutions, Inc. (Electrochem), a subsidiary of Greatbatch, Inc. (NYSE: GB) today announced its participation at the Medical Devices Summit East, hosted by Opal Events, beginning February 28, 2013 in Boston, Massachusetts. As Electrochem...

CSI Presents Three-Year Orbit I Coronary Data at CRT 2013

February 25, 2013 11:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn. & WASHINGTON--(BUSINESS WIRE)--Feb 25, 2013--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today presented three-year data from its ORBIT I feasibility study of calcified coronary lesions during a poster session at the 2013 Cardiovascular Research Technologies (CRT)...

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Compact Rotary Stage with Torque Motor Drive

February 25, 2013 10:49 am | by MDT Staff | Steinmeyer, Inc. | Product Releases | Comments

Steinmeyer, Inc. today announced a new addition to its line of precision rotary stages. The DT240 stage is driven by a torque motor for high speed motion. With an overall height of 100 mm and width of 240 mm this stage is ideal for applications requiring space saving solutions.

Versatile Power Entry Module Offered with Custom Wires

February 25, 2013 10:40 am | by MDT Staff | Schurter, Inc. | Product Releases | Comments

Schurter’s KFA power entry module with IEC C14 inlet, EMC filter, fuseholder, and optional voltage selector, can now be supplied with custom wiring for optimized cost, integration, and speed of assembly.

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