Medical Devices News and Research

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Genetic testing should be conducted by qualified health professionals

In a letter to theFood and Drug Administration (FDA), the American Medical Association (AMA) today called for genetic testing to be conducted under the guidance of a physician, genetic counselor, or other genetics specialist. The letter was sent to the Molecular and Clinical Genetics Panel of the FDA's Medical Devices Advisory Committee regarding direct to consumer genetic tests prior to the panel’s hearings on the topic, scheduled for March 8 and 9.

23 Feb 2011

Versatile ultra-low power biomedical signal processor

At today’s International Solid-State Circuit Conference (ISSCC2011), imec, Holst Centre and NXP present a versatile ultra-low power biomedical signal processor, CoolBioTM, meeting the requirements of future wearable biomedical sensor systems. The biomedical signal processor consumes only 13pJ/cycle when running a complex ECG (electrocardiogram) algorithm at 1MHz and 0.4V operating voltage. This C-programmable chip is voltage and performance scalable supporting a frequency range of 1MHz up to 100MHz with an operating voltage from 0.4 to 1.2V.

23 Feb 2011

Scientists receive HHS grant to investigate DSC127 in treatment of skin injuries linked with radiation exposure

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced that researchers who invented DSC127 have been awarded a $4.5 million, 16-month grant by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority to investigate preclinically the use of DSC127 in the treatment of skin injuries associated with acute radiation exposure.

23 Feb 2011

Biomoda completes sample collection in pilot study of CyPath diagnostic assay for lung cancer

Cancer diagnostics company Biomoda, Inc. today announced that it has completed patient enrollment and sample collection for the pilot study to determine the clinical sensitivity and specificity of its CyPath® diagnostic assay for the early detection of lung cancer.

23 Feb 2011

Researchers identify practical strategies to implement environmental practices in operating rooms

Johns Hopkins researchers say they have identified practical strategies to implement environmentally friendly practices in operating rooms and other hospital facilities that could result in vastly reduced health care costs and pose no risk to patient safety.

22 Feb 2011

Sorin Group achieves 100,000 Mitroflow Aortic Pericardial Heart Valve implantation milestone

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced a major milestone today: more than 100,000 Mitroflow Aortic Pericardial Heart Valves have now been implanted worldwide.

21 Feb 2011

$Tip sheets provide details on hip and knee fracture treatment$

Tip sheets provide details on hip and knee fracture treatment

Patients who wait more than 36 hours for surgery to correct a hip fracture have a 39 percent rate of medical complication and those who wait 48 hours have a 46 percent complication rate. Patients who receive surgical treatment within 24 hours have a lower complication rate of 25 percent and a shorter hospital stay. Each day the surgery was delayed added an additional two days to hospital stay.

21 Feb 2011

New blood pressure measurement device may enable doctors to treat patients more effectively

In a major scientific breakthrough, a new blood pressure measurement device is set to revolutionise the way patients' blood pressure is measured.

20 Feb 2011

Smith & Nephew's OXINIUM material receives C1 price reimbursement in Japan for hip replacements

OXINIUM Oxidized Zirconium, the patented advanced bearing material from Smith & Nephew Orthopaedics Division, has been awarded a C1 premium reimbursement classification in Japan for use in hip replacement surgery.

19 Feb 2011

New, simple device to detect lung pathogens causing pneumonia

Researchers from the Georgia Institute of Technology have created a new sampling device that could prevent thousands of people worldwide from dying of pneumonia each year.

19 Feb 2011

Kentucky, Virginia LapBand centers install Crospon's EndoFLIP system

Crospon, an Irish medical device developer based in Galway, has announced that its EndoFLIP system is now being used in two leading LapBand centers in Kentucky and Virginia.

19 Feb 2011

Merck Canada announces $6.8 million investment in AmorChem for biopharmaceutical research

Merck Canada announced today a $6.8 million investment in AmorChem, a Quebec life sciences venture capital fund. This is the latest investment made by Merck following a commitment made in 2010 to invest an incremental $100 million over five years in biopharmaceutical research and development in Quebec.

19 Feb 2011

FDA defends record for approving medical devices

The Food and Drug Administration defended its approval process for medical devices during a congressional hearing Thursday and said industry comparisons with Europe are off the mark.

18 Feb 2011

Ascom receives ISO certification for its medical devices

Ascom (US) Inc., is proud to announce that it has achieved ISO 9001 and ISO 13485 certification. ISO 13485 emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.

17 Feb 2011

ASN opposes proposed $1.6 billion reduction to NIH budget

Proposed cuts to the National Institutes of Health (NIH) budget for 2011 will limit the nation's ability to advance patient care and public health.

17 Feb 2011

SPC launches new aluminum oxide coating for medical devices

MICRALOX, a revolutionary new aluminum oxide coating for finishing aluminum medical devices, is being launched into the global marketplace by the Sanford Process Corporation (SPC), a wholly owned subsidiary of Duralectra-CHN.

17 Feb 2011

Sonablate HIFU device is now available in Brazil to treat prostate cancer

USHIFU LLC, a world leader in minimally invasive high intensity focused ultrasound technologies and manufacturer of the Sonablate 500 medical device, announces that HIFU with the Sonablate is available to prostate cancer patients for the first time in Brazil at Hospital Nossa Senhora das Gracas in Curitiba, capital city of the state of Parana in southern Brazil.

17 Feb 2011

U.S. Patent Office issues notification of allowance to AirPal's inflatable patient positioning system

AirPal, a medical device manufacturer headquartered in North Wales, Pennsylvania, has received notification of allowance from the U.S. Patent Office for its modular system of inflatable devices used to position patients for situations such as difficult airway management, laryngoscopies, diagnostic exams, surgeries, and related procedures.

16 Feb 2011

Study: Expedited medical device reviews account for majority of recalls

The analysis, which was published in the Archives of Internal Medicine, connected the Food and Drug Administration's most urgent medical device recalls with high-risk devices that were subject to "speedy" review.

16 Feb 2011

First Edition: February 15, 2011

Today's headlines include reports about the health portion of the President's budget blueprint along with the politics that accompany it.

15 Feb 2011

Medical Devices News and Research

Genetic testing should be conducted by qualified health professionals

Versatile ultra-low power biomedical signal processor

Scientists receive HHS grant to investigate DSC127 in treatment of skin injuries linked with radiation exposure

Biomoda completes sample collection in pilot study of CyPath diagnostic assay for lung cancer

Researchers identify practical strategies to implement environmental practices in operating rooms

Sorin Group achieves 100,000 Mitroflow Aortic Pericardial Heart Valve implantation milestone

Tip sheets provide details on hip and knee fracture treatment

New blood pressure measurement device may enable doctors to treat patients more effectively

Smith & Nephew's OXINIUM material receives C1 price reimbursement in Japan for hip replacements

New, simple device to detect lung pathogens causing pneumonia

Kentucky, Virginia LapBand centers install Crospon's EndoFLIP system

Merck Canada announces $6.8 million investment in AmorChem for biopharmaceutical research

FDA defends record for approving medical devices

Ascom receives ISO certification for its medical devices

ASN opposes proposed $1.6 billion reduction to NIH budget

SPC launches new aluminum oxide coating for medical devices

Sonablate HIFU device is now available in Brazil to treat prostate cancer

U.S. Patent Office issues notification of allowance to AirPal's inflatable patient positioning system

Study: Expedited medical device reviews account for majority of recalls

First Edition: February 15, 2011

Industry Focus eBook - Medical Devices (3rd Edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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