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Email to On-line Distributors About Unlawful Marketing of Decorative Contact Lenses

March 4, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this Email is to provide you with important information about regulatory requirements and safety concerns associated with the sale, marketing, and distribution of decorative or cosmetic contact lenses in the United States.

Types of Communication During the Review of Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff

March 4, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

During the review of a premarket submission, FDA?s practice has been to communicate with applicants1 through either a formal communication (such as a Major Deficiency Letter or an additional information request issued through a letter, or through phone...

ResurFX Fractional Non-Ablative Laser Module to Be Unveiled by Lumenis at the American Academy of Dermatology's Annual Meeting

March 2, 2013 2:30 pm | by The Associated Press | News | Comments

At the 71st Annual Meeting of the American Academy of Dermatology (AAD), the ResurFX* module will be launched for international sales by Lumenis Ltd., the world's largest developer and manufacturer of advanced medical lasers for aesthetic, surgical, and ophthalmic applications.


Are Surgical Robots Worth It?

March 1, 2013 4:47 pm | by Massachusetts Institute of Technology | News | Comments

The FDA looks into the safety of the da Vinci system in light of increased adverse incidents.Surgical robots allow surgeons to perform a variety of less invasive operations because their miniaturized instruments can work through small incisions in the body and are more dexterous than traditional laparoscopic tools (see “The Slow Rise of the Robot Surgeon”). 

Hospira Announces Executive Changes

March 1, 2013 2:32 pm | by Bio-Medicine.Org | News | Comments

LAKE FOREST, Ill. , March 1, 2013 /-  Hospira, Inc. (NYSE: HSP) , the world's leading provider of injectable drugs and infusion technologies, today announced that Royce R. Bedward has been appointed corporate vice president, general counsel and secretary, effective immediately. In his new role, Mr. Bedward will oversee the company's legal department, including litigation...

FDA Warns Doc on CoreValve Heart Implant Trial Record-Keeping Issues

March 1, 2013 1:51 pm | by Mass Device | News | Comments

Hard on the heels of a regulatory win in Europe for one of its heart implants, Medtronic got some bad news from the FDA regarding another. Yesterday Fridley, Minn.-based Medtronic won CE Mark approval in the European Union for its next-generation Engager transcatheter aortic valve implant.

Closing Arguments in DePuy ASR Lawsuit

March 1, 2013 11:51 am | by Mass Device | News | Comments

Johnson & Johnson's DePuy Orthopaedics unit played "Russian roulette" with its ASR metal-on-metal hip implant, a jury heard yesterday in the closing arguments of a high-profile personal injury lawsuit; J&J denies the allegations, saying the plaintiff's ills were due to other medical problems.

FDA Probes Intuitive Surgical on Complication Rates

March 1, 2013 11:11 am | by Mass Device | News | Comments

The FDA is looking into complication rates for surgeries using Intuitive Surgical's da Vinci surgical robot, sending a survey to doctors who use the device. New of the probe, first reported by Bloomberg, sent ISRG shares down 11.1% to $509.89 apiece on Wall Street yesterday.


Zimmer: Justice Dept.-SEC Probe Is Over

March 1, 2013 9:27 am | by Mass Device | News | Comments

A federal probe into possible violations of the Foreign Corrupt Practices Act by Zimmer is over, with both the SEC and the U.S. Justice Dept. telling the medical device company that they're closing the investigation. The probe dates back to September 2007, when the securities regulator told Warsaw, Ind.- based Zimmer of the investigation.

Swallow Solutions, LLC, Secures $1.046 Million Series A Financing

March 1, 2013 9:26 am | by The Associated Press | News | Comments

MADISON, Wis.--(BUSINESS WIRE)--Mar 1, 2013--Swallow Solutions, LLC (Swallow Solutions), a life sciences company with a novel dysphagia treatment platform, announced today it has raised $1.046 million in Series A financing, led by Venture Management, LLC, with participation from NEW Capital Fund,...

Doctors Can Detect Skin Cancer Earlier With New Modernizing Medicine and 3Gen, Inc. Partnership

March 1, 2013 9:03 am | by The Associated Press | News | Comments

Modernizing Medicine, the creator of the Electronic Medical Assistant™ (EMA), a cloud-based specialty-specific electronic medical records (EMR) system, announced today that it has partnered with 3Gen, Inc., a product design and development company which...

Ahead of the Bell: Intuitive Stock Starts Rebound

March 1, 2013 9:01 am | by The Associated Press | News | Comments

Shares of Intuitive Surgical Inc. rebounded in premarket trading Friday, a day after the stock tumbled following a report that regulators were looking into its robotic surgical system. The Sunnyvale, Calif., company makes da Vinci surgical systems that use robotic arms, cameras and a remote...

Santech, Inc. joins Qualcomm Life’s 2net Ecosystem

March 1, 2013 9:00 am | by The Associated Press | News | Comments

SAN DIEGO--(BUSINESS WIRE)--Mar 1, 2013--Santech, Inc. has integrated its mobile messaging platform, SanText®, to the 2net ™ Platform and Hub, designed with attention to HIPAA privacy and security requirements, and leveraging the cloud-based platform for biometric sensor data operated by Qualcomm...


OPKO Point-of-Care Technology Demonstrated on Mobile Device with Cloud Connectivity to Diagnose and Track Disease in Africa

March 1, 2013 8:16 am | by The Associated Press | News | Comments

MIAMI--(BUSINESS WIRE)--Mar 1, 2013--OPKO Health, Inc. (NYSE: OPK) announced that a study published online in Clinical Chemistry, and to be included in the April 2013 print issue, describes the application of OPKO’s point-of-care system to mobile diagnostics, a major advance towards providing...

Stryker Announces $250 Million Accelerated Share Repurchase Program

March 1, 2013 8:06 am | by The Associated Press | News | Comments

Kalamazoo, Michigan - March 1, 2013 - Stryker Corporation (NYSE:SYK) announced today it has entered into an Accelerated Share Repurchase agreement (ASR) with JPMorgan Chase Bank, NA to repurchase an aggregate of $250 million of the Company's common stock.  The ASR is part of the Company's existing...

MEDIAN Technologies Awarded € 1.4 Million Contract

March 1, 2013 1:45 am | by The Associated Press | News | Comments

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Mar 1, 2013--Regulatory News: MEDIAN Technologies (Paris:ALMDT), a leading medical imaging software solutions developer and a service provider for image interpretation and management in oncology clinical trials, announced today it has been selected as...

Consumer Information on: VASCADE Vascular Closure System (VCS) - P120016

March 1, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The VASCADE Vascular Closure System (VCS) is designed to close a puncture site in the major artery of the thigh (femoral artery). The system is comprised of a delivery device and a collagen patch. Over time, the collagen patch breaks down and is...

Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff

March 1, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

FDA has developed this guidance document to assist industry in preparing premarket notifications (510(k)s) for pulse oximeters. These devices are intended for non-invasive measurement of the arterial blood oxygen saturation and pulse rate.

Five Psychiatric Disorders Share Genetic Risk Factors

February 28, 2013 4:01 pm | by Massachusetts Institute of Technology | News | Comments

Five different psychiatric illnesses share a handful of genetic risk factors, report researchers in The Lancet. Four DNA mutations were discovered in the genomes of people who had at least one of five distinct disorders: attention deficit-hyperactivity disorder, autism, bipolar disorder, major depressive disorder and schizophrenia.

ArthroCare® Receives FDA Clearance for SpeedLock® HIP Knotless Fixation Implant

February 28, 2013 4:00 pm | by The Associated Press | News | Comments

ArthroCare Corp., a leader in developing state-of-the-art, minimally invasive surgical products, has announced that it has received clearance from the FDA for its SpeedLock HIP Knotless Fixation implant. SpeedLock HIP is a PEEK (polyether-etherketone) implant that is indicated for soft tissue fixation to bone in the hip.

Study: Boston Scientific's Watchman Heart Implant Bests Warfarin

February 28, 2013 3:32 pm | by Mass Device | News | Comments

The Watchman heart implant made by Boston Scientific improved quality-of-life measures more than warfarin in atrial fibrillation patients after 1 year, according to a study in the Journal of the American College of Cardiology. The more than 700-patient Protect AF trial produced QOL scores that were ahead of warfarin for the study's primary efficacy endpoint.

Philips Receives FDA Clearance to Market MicroDose SI Mammography System

February 28, 2013 2:39 pm | by Bio-Medicine.Org | News | Comments

ANDOVER, Mass. , Feb. 28, 2013 /- Royal Philips Electronics (NYSE: PHG, AEX: PHIA) today announces 510(k) clearance from the Food and Drug Administration (FDA) for its MicroDose SI system, the first full-field digital mammography (FFDM) system on the market with the capability to enable future Single-Shot Spectral Imaging applications*.

ChartMaxx@ and Appian Announce Partnership to Bring Next Generation Business Process Management to the Healthcare Industry at HIMSS13

February 28, 2013 1:08 pm | by The Associated Press | News | Comments

In line with its reputation for being on the forefront of tools that provide insights for better healthcare, Quest Diagnostics (NYSE:DGX), the world's leading provider of diagnostic information services, today announced a partnership between ChartMaxx@, its leading Document Management and...

TAVI: Medtronic Lands European Win for Next-Gen Engager Heart Valve

February 28, 2013 11:44 am | by Mass Device | News | Comments

Medical device giant Medtronic won European regulatory approval for its Engager transcatheter aortic valve implantation system, the company announced today. The CE Mark indication includes approval for transapical delivery of the valve in treatment of patients with aortic stenosis who are too sick to undergo traditional surgery.

Top Snocross Racers Wear Breg Braces to Stay on the Track

February 28, 2013 11:43 am | by Bio-Medicine.Org | News | Comments

CARLSBAD, Calif. , Feb. 28, 2013 /- Breg, Inc. , a premier provider of sports medicine products and services, is proud to support snocross racers Ross Martin and Paul Bauerly . Martin is this year's X Games Silver Medalist and 2 nd ranked racer, and Bauerly is among the top 20 in the sport. Both athletes value wearing knee braces to help prevent injury.

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