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RegenArouse: Recall - Undeclared Drug Ingredient

February 13, 2012 3:30 am | by U.S. Food & Drug Administration | News | Comments

Product marketed as dietary supplement contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (March 23, 2012)

February 12, 2012 11:31 pm | by U.S. Food & Drug Administration | News | Comments

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Philips Vital Signs Camera app

February 12, 2012 8:43 am | by Philips | Videos | Comments

The Vital Signs Camera app from Philips (http://www.vitalsignscamera.com) performs a contactless measurement of your heart rate and breathing rate, simply by using the camera of your iPad 2. This breakthrough technology allows you to measure your vital signs in an easy and unobtrusive way...

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Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or Effective

February 10, 2012 5:31 pm | by U.S. Food & Drug Administration | News | Comments

Products could potentially expose users and patients to unnecessary and potentially harmful X-rays.

Wholistic Herbs, Inc. "Koff and Kold" and "Kold Sore" Spray: Recall - Non-Sterile Products

February 10, 2012 5:31 pm | by U.S. Food & Drug Administration | News | Comments

Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. Also, nasal solutions that are not sterile could lead to a respiratory infection.

S & #38;N Pays $22.2 Million to Settle Foreign Bribery Charges

February 10, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Smith & Nephew has agreed to pay the U.S. government $22.2 million to settle allegations it bribed Greek doctors to encourage the use of its orthopedic products.

Battle Heats Up for Repeal of Device Tax; Language May Be MDUFA Rider

February 10, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

The device industry and congressional allies are considering using the Medical Device User Fee Act (MDUFA) reauthorization package or other legislation as a vehicle to repeal the medical device tax before it can take effect in January 2013.

Health Discovery Corporation and Doctors Optimal Formula Launching Retinalyze Analytics for Detection of Macular Degeneration

February 10, 2012 10:57 am | News | Comments

SAVANNAH, Ga.--(BUSINESS WIRE)--Health Discovery Corporation, a molecular diagnostics leader in the use of patent protected advanced mathematical techniques and pattern recognition technology (SVM) for personalized medicine, and Doctors Optimal Formula LLC...

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Medical Components, Inc. Awarded Agreement for Three Venous Access Catheter Categories with Novation LLC

February 10, 2012 10:53 am | News | Comments

HARLEYSVILLE, Pa.--(BUSINESS WIRE)--Medical Components, Inc. (aka Medcomp, Inc.) has been awarded a 36-month agreement with Novation, the leading health care supply contracting company for the members of VHA Inc., UHC, and Provista LLC, effective April 1, 2012.

Orthofix International Launches Centronail Ankle Compression Nailing and Lapidus Plating Systems in the U.S.

February 10, 2012 5:34 am | News | Comments

LEWISVILLE, Texas--(BUSINESS WIRE)--Orthofix International N.V., (the Company) announced today the full U.S. launch of two differentiated internal fixation repair solutions for the foot and ankle market with the Centronail Ankle Compression Nailing and Contours Lapidus Plating Systems.

CLSI Publishes New Guideline Describing the Principles of Estimating Measurement Uncertainty

February 10, 2012 4:57 am | News | Comments

Wayne, Pennsylvania, USA-The Clinical and Laboratory Standards Institute (CLSI) recently published Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline (C51-A). This document describes a practical approach to assist clinical laboratories and in vitro diagnostic...

Transcripts of January 11, 2012 Gastroenterology-Urology Devices Panel Meeting

February 10, 2012 4:31 am | by U.S. Food & Drug Administration | News | Comments

The Gastroenterology-Urology Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gastroenterology, urology and nephrology devices...

New Uses of Adhesives in Durable Medical Diagnostic Equipment

February 9, 2012 8:46 am | by Jeremy Cooler | Articles | Comments

Design engineers for medical diagnostic equipment are acutely aware of the dramatic growth and change in the healthcare industry. Medical OEMs and contract manufacturers are looking for suppliers who can help them meet new industry and federal regulations, achieve the highest quality products, support new care approaches (including patient-controlled monitoring and treatment), and drive down manufacturing costs.

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Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions

February 9, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments

Interactions between Victrelis and ritonavir-boosted atazanavir, lopinavir, and darunavir can potentially reduce the effectiveness of these medicines when co-administered.

MEDICREA's PASS MIS: FDA Approval and First Surgery in the US

February 9, 2012 5:18 am | News | Comments

LYON, France--(BUSINESS WIRE)--The MEDICREA group, a medical company specialized in the development of innovative surgical technologies for the treatment of spinal pathologies, today announced the approval by the FDA of the PASS MIS system and the first PASS MIS surgery...

AIMIS Joins Endoscopy Leader in Program to Facilitate Conversion of Open Surgeries to Laparoscopic Procedures

February 9, 2012 5:15 am | News | Comments

LAS VEGAS--(BUSINESS WIRE)--The American Institute of Minimally Invasive Surgery (AIMIS) announced that it is working with KARL STORZ Endoscopy-America, Inc., a leader in endoscopy and operating room integration solutions, on a program to apply advanced remote presence technology...

Tornier to Highlight Products and Education Programs at American Academy of Orthopedic Surgeons (AAOS) Meeting

February 9, 2012 5:13 am | News | Comments

AMSTERDAM--(BUSINESS WIRE)--Tornier N.V., a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, today announced it will highlight a range of products and patient education programs at the American Academy of Orthopaedic Surgeons...

UroShield Applied to Urinary Catheters Increases Susceptibility of Bacteria Biofilm to Antibiotic Treatment

February 9, 2012 5:11 am | News | Comments

NESHER, Israel--(BUSINESS WIRE)--NanoVibronix, a medical device company which develops innovative therapeutic ultrasound applications, reported that a study titled “Surface Acoustic Waves Increase the Susceptibility of Pseudomonas Aeruginosa Biofilms to Antibiotic Treatment” has been published...

Medtronic Stent Resulted in 90% Freedom from Reinterventions in Narrowed Leg Arteries at 12 Months in International Study

February 9, 2012 5:09 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Consistent with its commitment to developing better treatments for peripheral arterial disease (PAD), Medtronic Inc. today announced the one-year results of an international study of the Complete SE (self-expanding) vascular stent for the treatment of atherosclerosis...

Orthofix International Announces International Launch of Galaxy Fixation

February 9, 2012 5:07 am | News | Comments

LEWISVILLE, Texas--(BUSINESS WIRE)--Orthofix International N.V., (the Company) announced today the international launch of Galaxy Fixation at the American Academy of Orthopedic Surgeons (AAOS) Annual Meeting this week in San Francisco, CA. This new external fixation system...

BioMimetic Therapeutics, Inc. to Introduce Augmatrix Biocomposite Bone Graft Product Line at AAOS

February 9, 2012 5:05 am | News | Comments

FRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. today announced it will introduce Augmatrixâ„¢ Biocomposite Bone Graft, a new bone graft substitute product line, to surgeons and distributors at its exhibit booth during the American Academy of Orthopedic Surgeons...

BD Veritor System for Flu A+B Featuring Alverix Technology Receives Regulatory Approval in Japan

February 9, 2012 5:02 am | News | Comments

SAN JOSE, Calif.--(BUSINESS WIRE)--Alverix announced today that BD (Becton, Dickinson and Company) has received approval from the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the BD Veritorâ„¢ System Flu A+B Test. The BD Veritor System was developed...

Flipping a Light Switch in the Cell: Quantum Dots Used for Targeted Neural Activation

February 9, 2012 4:59 am | News | Comments

WASHINGTON--(BUSINESS WIRE)--By harnessing quantum dots-tiny light-emitting semiconductor particles a few billionths of a meter across-researchers at the University of Washington (UW) have developed a new and vastly more targeted way to stimulate neurons in the brain.

Cellnovo Launches World's F?rst Mob?le-Connected D?abetes Management System

February 9, 2012 4:40 am | News | Comments

LONDON UK. Cellnovo today announced both the commercial launch of the world's only mobile-connected diabetes management system, and the start of the largest usability trial ever to investigate insulin pump technology for patients with type 1 diabetes. The trial will also be the first in...

Survey: Medical Device Industry Reports Healthy Sales, Ongoing BRIC Interest

February 9, 2012 4:36 am | News | Comments

AUSTIN, Tex.-Despite a tepid economy, medical device manufacturers' international sales growth rates continued to outpace their domestic business in 2011, demonstrating the increasingly global nature of the industry. According to a new survey of more than 2,600 medical device industry...

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