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Ultra-Sensitive Electrical Biosensor Unlocks Potential for Instant Diagnostic Devices

April 17, 2012 5:50 am | News | Comments

(Santa Barbara, Calif.) A new quantum mechanical-based biosensor designed by a team at University of California, Santa Barbara offers tremendous potential for detecting biomolecules at ultra-low concentrations, from instant point-of-care disease diagnostics, to detection...

New research suggests PIP implant failures significantly higher than previously thought

April 17, 2012 5:48 am | News | Comments

London - New research published in the Journal of Plastic, Reconstructive and Aesthetic Surgery suggests that the failure rate of silicone breast implants manufactured by Poly Implant Prosthèse (PIP) could be as high as 33.8%.

OmniGuide Launches Next Generation System for CO2 Laser Surgery

April 17, 2012 5:23 am | News | Comments

CAMBRIDGE, Mass. – OmniGuide Inc., a Cambridge, Massachusetts medical device company specializing in advanced energy surgical instruments, announces the launch of their new FELS-25A Intelliguide, the next generation laser system for minimally invasive CO2 laser surgery.

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Isansys Lifecare Achieves CE Mark for LifeTouch Patient Surveillance System – World's First Cloud-Ready Medical Device

April 17, 2012 5:15 am | News | Comments

Abingdon, United Kingdom – Isansys Lifecare Limited, the provider of complete real-time physiological patient data services and systems, today announces that it has achieved CE certification for its LifeTouch Patient Surveillance System, comprising the LifeTouch HRV011...

Medical Visualization Technologies

April 17, 2012 12:00 am | by Dr. Euan Morrison | Blogs | Comments

Over the past few decades, we have seen significant advances in medical visualization technologies with the emergence and widespread use of sophisticated techniques such as magnetic resonant imaging (MRI) and X-ray computed tomography (CT scanning).

Less Invasive Liver Surgery Technique Easier on Patient, Equally as Safe as Traditional Surgery Method, Study Says

April 16, 2012 9:30 am | News | Comments

(Washington, DC) - A new study published in the Journal of the American College of Surgeons shows that less invasive laparoscopic-assisted liver surgery performed at MedStar Georgetown University Hospital is easier on the patient and is just as safe and effective as traditional liver surgery...

Harry and David Issues Allergy Alert on Undeclared Peanuts in Harry & David Premium Kansas City Style Barbeque Almonds

April 13, 2012 8:31 pm | by U.S. Food & Drug Administration | News | Comments

Harry and David, is voluntarily recalling approximately 205 2 oz. bags labeled Harry & David Premium Kansas City Style Barbeque almonds, because the bags may contain peanuts. Peanuts are not declared as ingredients, but the label includes the statement "May contain trace amounts of...

Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product

April 13, 2012 8:30 pm | by U.S. Food & Drug Administration | News | Comments

• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a...

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Breast Cancer Ultrasound Device Gets Favorable Panel Recommendation

April 13, 2012 2:32 pm | by U.S. Food & Drug Administration | News | Comments

An FDA advisory panel unanimously recommended approval of a new tool for detecting breast cancer, but advised against Class I status for a preamendment device used for the same purpose.

U.S. Should Bring Developing Nations on Board to Tackle Import Problems: Report

April 13, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA and other agencies must provide expertise, training and tools to developing nations to improve their medical technology monitoring practices and prevent dangerous medical products from entering the U.S., according to an Institute of Medicine (IOM) report. The recommendation is one...

Hospira Infusion Pumps Ranked Top Devices in New KLAS Smart Pumps 2012 Report

April 13, 2012 12:21 pm | News | Comments

LAKE FOREST, Ill. -- Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, today announced its Symbiq™ and LifeCare™ PCA infusion pumps have been ranked as the top devices in their categories in the KLAS report, Smart Pumps 2012...

Medtronic Initiates Landmark U.S. Drug-Eluting Balloon Study

April 13, 2012 7:19 am | News | Comments

MINNEAPOLIS –– Expanding its commitment to developing innovative treatments for cardiovascular disease and the evidence to support their adoption, Medtronic, Inc. announced today the start of the Medtronic IN.PACT SFA II study, the company’s first...

Engineering the Dynamics of Pulsating Blood Flow

April 13, 2012 6:12 am | by Satya Karri, Ph.D. | Articles | Comments

With cardiovascular diseases as the leading cause of death worldwide, device manufacturers are under immense pressure to produce products to address these health concerns. However, prior to launching such devices, the technologies need to be properly tested to ensure success. This article looks at setting up a system to simulate cardiac flow for testing these medical devices.

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InVivo Therapeutics Expects to Commence Human Study after Meeting on IDE Filing for Biopolymer Scaffolding to Treat Spinal Cord Injuries

April 13, 2012 5:36 am | News | Comments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp., a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), announced today that it held a meeting with the U.S. Food and Drug Administration (“FDA”) in which...

Meridian Bioscience Awarded New Agreement with Premier Healthcare Alliance for Molecular Diagnostic Tests and Instruments for C. difficile and Group B Streptococcus

April 13, 2012 5:34 am | News | Comments

CINCINNATI--(BUSINESS WIRE)--Meridian Bioscience, Inc. today announced it has signed a new group purchasing agreement with the Premier healthcare alliance to offer illumigene® C. difficile and illumigene Group B Streptococcus to its members at specially negotiated pricing.

Geomagic Acquires Sensable 3D Design and Haptics Businesses

April 13, 2012 5:32 am | News | Comments

MORRISVILLE, N.C.--(BUSINESS WIRE)--Geomagic®, the leading provider of 3D software for capturing, creating and inspecting digital models of physical objects, today completed an acquisition of Sensable Technology Inc.’s 3D design and haptics businesses. Sensable...

PMA Final Decisions for February 2012

April 13, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for February 2012.

New Radiotherapy System Provides More Effective, Safer Cancer Treatment at DMC Huron Valley-Sinai Hospital

April 13, 2012 5:29 am | News | Comments

COMMERCE, Mich.--(BUSINESS WIRE)--A new image-guided radiotherapy system will be dedicated on Thurs., April 19, 2012 at DMC Huron Valley-Sinai Hospital. The TrueBeam™ system treats cancer more effectively through highly precise targeting of lung...

3M and Sage Products Announce Unique Infection Prevention Offering

April 13, 2012 5:27 am | News | Comments

ST. PAUL, Minn. & CARY, Ill.--(BUSINESS WIRE)--3M’s Infection Prevention Division and Sage Products are working together to offer surgical staff and patients a new preoperative prepping kit to help address surgical site infection (SSI) risk within three main reservoirs of bacteria...

Abiomed gets EU approval for Impella heart pump

April 12, 2012 1:31 pm | by BUSINESS WIRE | News | Comments

DANVERS, Mass., (BUSINESS WIRE) --Abiomed, Inc, a leading provider of break-through heart support technologies, today announced it has received CE Marking approval in the European Union to market the Impella cVAD device, a new percutaneous Impella...

Happy 50th Birthday Breast Augmentation! The Top 10 Myths According to Dr. John Anastasatos, Beverly Hills Plastic Surgeon

April 12, 2012 3:45 am | by The Associated Press | News | Comments

Fifty years have passed since the first breast augmentation was performed in 1962 and yet the public still has wrongful information and many misconceptions about this most popular cosmetic operation. In my Beverly Hills Plastic...

Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

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

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

CDRH Learn (New Module - Factors to Consider When Making Benefit-Risk Determinations in Medical Device PMA and De Novo Classifications)

April 10, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

This guidance document was developed to identify and clarify the factors FDA considers when making benefit-risk assessments in PMA applications, and de novo classification petitions for medical devices.

CDRH Misses MedSun Goals, Cites Success in MDR Reviews, Other Areas

April 6, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Recent agency data show CDRH making slow but steady progress toward several strategic goals — but missing the mark on the Medical Product Safety Network (MedSun) initiative.

Senators Set June Deadline for Sunshine Implementation

April 6, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The senators who co-authored the Physician Payments Sunshine Act are trying once more to exercise their legislative oversight — this time setting a June deadline for overdue implementation of the rules.

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