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AdvaMed Fights to Keep User Fees Out of Sequester Cuts for FDA

February 26, 2013 4:20 pm | by Mass Device | News | Comments

The medical device industry doesn't want user fees paid by industry to be included in a series of cuts slated for the FDA's budget this week. The federal watchdog agency will have $210 million, or about 5.1% of its $4.1 billion budget, cut from its 2013 budget March 1 as a result of sequestration, the bargain between the White House and Congress.

UCLA Researchers Further Refine 'Nanovelcro' Device to Grab Single Cancer Cells from Blood

February 26, 2013 4:17 pm | by I-Micronews | News | Comments

Researchers at UCLA report that they have refined a method they previously developed for capturing and analyzing cancer cells that break away from patients' tumors and circulate in the blood. With the improvements to their device, which uses a Velcro-like nanoscale technology, they can now detect and isolate single cancer cells from patient blood samples for analysis.

NuVasive Announces First Patients in Japan Treated With the XLIF(R) Surgical Technique

February 26, 2013 4:15 pm | by The Associated Press | News | Comments

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is proud to announce that the very first eXtreme Lateral Interbody Fusion (XLIF®) procedures were performed yesterday and today at two different...

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Online Tech’s Managed Cloud Protects Online Dermatology Treatment Service, NoviMedicine

February 26, 2013 2:45 pm | by The Associated Press | News | Comments

As the advancements in telemedicine and health apps for mobile devices make receiving health care easier by the day, Los Angeles-based NoviMedicine is getting into the act by building a system for board-certified dermatologists to discuss, evaluate and treat patients’ acne completely online.

Searcy Denney Scarola Barnhart & Shipley Attorney Appointed to Plaintiff's Steering Committee for Stryker Hip Implant Litigation

February 26, 2013 2:15 pm | by Bio-Medicine.Org | News | Comments

WEST PALM BEACH, Fla. , Feb. 26, 2013 /- South Florida law firm Searcy Denney Scarola Barnhart & Shipley PA ( Searcy Denney ) announced today that C. Calvin Warriner , a shareholder at the firm, was appointed to the newly established Plaintiff's Steering Committee for the Stryker Rejuvenate and ABG II hip implant Multi-County Litigation in New Jersey . Warrin...

University of Rhode Island Researchers Use Impulse C to FPGA to Help Amputees Sit, Stand and Climb Stairs with “Smart” Artificial Legs

February 26, 2013 1:59 pm | by Impulse Accelerated Technologies | News | Comments

URI and Impulse Accelerated Technologies (one of the project sponsors) publicized results from student research to improve the live-ability of artificial legs. In this research, students created a neurally controlled artificial leg that enabled users to command it wordlessly for common challenges.

Obesity, Physical Inactivity Linked With Risk for Certain Molecular Subtype of Colorectal Cancer

February 26, 2013 1:00 pm | by AACR | News | Comments

An increasing body mass index was associated with a higher risk for colorectal cancer with a specific molecular characteristic, and inversely, physical activity was linked to a decreased risk for that same cancer, according to data published in Cancer Research, a journal of the American Association for Cancer Research.

Growing Body of Evidence Supports Use of DFINE’s Targeted Radiofrequency Ablation™ (t-RFA) for Treatment of Spinal Tumors

February 26, 2013 12:00 pm | by The Associated Press | News | Comments

SAN JOSE, Calif.--(BUSINESS WIRE)--Feb 26, 2013--DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, today released data presented at the 2013 Annual Symposium of the American Society of Spine Radiology (ASSR) on Feb....

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STENTYS to Present Final Results From 1,000 Heart Attack Patient Study at ACC.13

February 26, 2013 11:35 am | by The Associated Press | News | Comments

STENTYS, a medical technology company commercializing in Europe the world's first and only Self-Apposing ® Stent to treat acute myocardial infarction, announced today that results for the primary endpoint in the APPOSITION III study (MACE at one year on 1,000 STEMI patients) will be presented during ACC.13, the American College of Cardiology’s Scientific Session & Expo.

HD Medical, Inc. Hosts Launch Celebration for Newly Formed US Business Unit at ACC.13

February 26, 2013 11:28 am | by The Associated Press | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Feb 26, 2013--At the American College of Cardiology’s 62nd Annual Scientific Session & Expo, ACC.13, HD Medical, Inc. will hold “Heart & Sound” an ACC.13 Industry Event celebrating the formation of HD Medical in the US. Come rejoice with us and enjoy good...

Bacterin International Holdings, Inc. Announces ISO Certification

February 26, 2013 10:59 am | by The Associated Press | News | Comments

BELGRADE, Mont.--(BUSINESS WIRE)--Feb 26, 2013--Bacterin International Holdings, Inc. (NYSE MKT: BONE), a leader in the development of revolutionary bone graft material and coatings for medical applications, today announced that it has achieved ISO 13485:2003 Certification. This certification is...

HIMSS 13 Product Launch: Ciphertex Announces 24TB Portable Encrypted NAS Server for Medical Offices

February 26, 2013 10:15 am | by The Associated Press | News | Comments

LOS ANGELES--(BUSINESS WIRE)--Feb 26, 2013--Ciphertex, a leading international provider of external HHD and portable encryption network attached storage (NAS) server systems, today announced the CX-6K-MD, a 24TB portable secure NAS server capable of storing more than two million medical images....

Medtronic Gains First FDA Approval to Conduct Early Feasibility Medical Device Study

February 26, 2013 10:06 am | by The Associated Press | News | Comments

Medtronic, Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval to conduct an early feasibility study using the Medtronic Native Outflow Tract Transcatheter Pulmonary Valve (TPV). This approval represents the first-ever FDA approval of an investigational device exemption (IDE) following the new draft FDA guidance for early feasibility studies.

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Quotient Biodiagnostics Raises Further $5.0 Million of Growth Finance Led by Paul Cowan and Galen Partners

February 26, 2013 9:59 am | by The Associated Press | News | Comments

EDINBURGH, Scotland & NEWTOWN, Pa.--(BUSINESS WIRE)--Feb 26, 2013--Quotient Biodiagnostics (“Quotient”), a global transfusion diagnostics group, is pleased to announce that its shareholders have invested a further $5.0 million in the company. Over the past 18 months Quotient has raised over...

FDA Advisory Panel Recommends Approval of the NeuroPace RNS® System for Medically Refractory Epilepsy

February 26, 2013 8:00 am | by The Associated Press | News | Comments

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Feb 26, 2013--NeuroPace, Inc. today announced that on February 22, 2013 the U.S. Food and Drug Administration (FDA) Neurological Devices Panel voted unanimously (11 to 0 with two abstentions) that the clinical benefits of the NeuroPace RNS System outweigh...

Brain Implants Can Reset Misfiring Circuits

February 25, 2013 3:39 pm | by Massachusetts Institute of Technology | News | Comments

A study that combined electrical stimulation of the brain with advanced imaging has shown how correcting misfiring neural circuits can lessen the symptoms of a common psychiatric disorder. A brain-pacemaker helped put out-of-sync brain circuits back on track in patients with extreme forms of obsessive-compulsive disorder.

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...

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.

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."

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...

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.

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.

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...

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.

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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