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FDA Approves Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

February 20, 2013 6:17 pm | by The Associated Press | News | Comments

IRVINE, Calif.--(BUSINESS WIRE)--Feb 20, 2013--Allergan, Inc. (NYSE: AGN) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast...

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FDA Approves New Silicone-Gel Breast Implant

February 20, 2013 6:05 pm | by The Associated Press | News | Comments

The Food and Drug Administration said Wednesday that it approved a new type of breast implant from Allergan for women 22 years and older. The FDA said the Natrelle 410 implant contains silicone gel that is firmer than Allergan's older Natrelle models. Allergan's studies did not compare the safety...

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Proto Labs Helps Bring Mobility to Amputees in the Developing World

February 20, 2013 4:12 pm | by Proto Labs | Proto Labs, Inc. | News | Comments

The ReMotion Knee, a low cost prosthetic knee joint, is the latest winner of the Cool Idea! Award from Proto Labs, the world’s fastest manufacturer of CNC machined and injection molded parts. Proto Labs launched the Cool Idea! Award in 2011 to give product designers the opportunity to bring their innovations to life by presenting up to $250,000 worth of prototyping...

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Positiveid Corporation Announces License of iglucose Technology for up to $2 Million

February 20, 2013 3:37 pm | by I-Micronews | News | Comments

PositiveID Corporation, a developer of biological detection and diagnostics solutions, announced it has entered into an agreement to license its iglucose™ technology to Smart Glucose Meter Corp. ("SGMC") for up to $2 million based on potential future revenues of glucose test strips sold by SGMC.

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Stryker Recommends More Vigilant Monitoring of Patients with Recalled Hip Implants

February 20, 2013 3:09 pm | by Mass Device | News | Comments

Stryker's Australian arm provided national health regulators with updated recommendations for monitoring patients who received the company's now-recalled ABG II Modular hip systems. Australia's Therapeutic Goods Admin. issued the new guidelines for patient follow-up, advising regular blood testing and soft tissue cross-sectional imaging for all ABG II patients, even in the absence of pain or swelling.

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Premier healthcare alliance awards new radiation treatment system contract to member hospital

February 20, 2013 2:55 pm | by Mass Device | News | Comments

Group purchasing organization Premier inked a contract with Philips Healthcare for radiation treatment planning. The new team-based radiation treatment program was available to the Philips Healthcare network on Jan. 1, but Premier made the announcement this month.

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FDA 510(k) Review Times Improving, Annual Analysis Shows

February 20, 2013 2:37 pm | by Emergo Group | News | Comments

Review times for medical device 510(k) premarket notifications by the US Food and Drug Administration improved somewhat in 2011 after several years of lengthening review times, according to a new analysis of publically available FDA data by Emergo Group.

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Saving Patients From the Needle Boosts Drug Delivery Company Revenues: Report

February 20, 2013 2:21 pm | by The Associated Press | News | Comments

Led by needle-free delivery systems the advanced implantable/injectible drug delivery market reached revenues of $13.3 billion in 2012, according to their recently published report Injectable, Implantable and Needle-Free Drug Delivery Systems. In 2017, the implantable/injectable drug...

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Women's health company lands $21M Series D for uterine fibroid ablation

February 20, 2013 1:38 pm | by Mass Device | News | Comments

Women's health devices maker Gynesonics landed $21 million in new financing in supports of its ultrasound-guided uterine fibroid ablation system, the company announced today. The California company plans to use the funds to further clinical and commercial progress for its VizAblate system.

FotoFinder Releases handyscope®: Mobile Dermatoscope for iPhone 5

February 20, 2013 1:14 pm | by The Associated Press | News | Comments

BAD BIRNBACH, Germany--(BUSINESS WIRE)--Feb 20, 2013--FotoFinder, manufacturer of medical imaging solutions, announces the launch of its mobile dermatoscope, handyscope®for iPhone 5. handyscope®will debut in the United States at the Annual Meeting of the American Academy of Dermatology in Miami,...

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Weight loss: EnteroMedics names new operating chief ahead of FDA bid

February 20, 2013 12:31 pm | by Mass Device | News | Comments

Minnesota weight-loss devices maker EnteroMedics announced today that CFO and senior vice president Greg Lea had also been appointed chief operating officer. Lea will help the company get through its 2013 objective to make progress on its pre-market approval application for the Maestro vagal blocking system.

Silicone Tubing Offers a Flexible Fluid Transfer Solution

February 20, 2013 11:52 am | by MDT Staff | Newage Industries, Inc. | Product Releases | Comments

NewAge Industries’ Silcon tubing solves application requirements that many other plastic or rubber materials cannot, namely combining temperature usage with flexibility. Silcon works with temperatures spanning 600 degrees – from -100°F to 500°F (-73°C to 260°C).

Hydrophilic Pebax Med Polymer Grade

February 20, 2013 11:48 am | by MDT Staff | Product Releases | Comments

Hydrophilic Pebax MV1074 SA 01 MED polymer is suitable for use in minimally invasive devices that are exposed to bodily fluids for less than 30 days, such as surgical tubing.

Flexpoint Announces Development Partnership with Haemoband Surgical, Ltd.

February 20, 2013 11:36 am | by The Associated Press | News | Comments

Flexpoint Sensor Systems, Inc. (OTCQB: FLXT) today announced that it is in advanced development on a disposable colonoscope application with Haemoband Surgical, Ltd. an Ireland-based company specializing in unique medical technologies. Phase I testing  has recently been satisfactorily...

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SEMDA Announces SpotLight Award Winners at 2013 Conference

February 20, 2013 11:36 am | by The Associated Press | News | Comments

Cynthia L. Clark, President of ibiliti, and EndoChoice Inc. have received the 2013 SEMDA SpotLight Awards. Clark and Mark Gilreath, Founder and President of EndoChoice, accepted the awards. The awards were presented during the Gala Dinner at the highly successful 7th annual conference of the...

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