FDA's tag archives

Aiming for Near-Normal Blood Sugar Did Not Delay Combined Risk of Diabetic Damage for People With Long-standing Diabetes, NIH-Sponsored Trial Finds

In people with longstanding type 2 diabetes who are at high risk for heart attack and stroke, lowering blood sugar to near-normal levels did not delay the combined risk of diabetic damage to kidneys, eyes, or nerves, but did delay several other signs of diabetic damage, a study has found.  The intensive glucose treatment was compared with standard glucose control. These findings are from the NIH-funded Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.  Although intensive t...

BioMed 2010 week Innovations: The New Generation of PainShield

NanoVibronix will present the second generation of PainShield – for the treatment of pain and chronic wounds using ultrasound waves Following the commercial success of the first generation PainShield device, for the treatment of (surprise, surprise) pain, especially one that stems from Trigeminal Neualgia, the Israeli company NanoVibronix now reveals the second generation of the device. This time, it has some extra capabilities to treat chronic wounds. NanoVibronix, based in Nesher, is develo...

Stem Cells as Seek-and-Destory Missiles against Cancer

As published in New Scientist, stem cells were succesfully modified to act as seek-and-destroy missiles against cancer in mice brains Stem cells are often viewed as the ultimate solution for regenerative medicine, and for a good cause. Given the correct cues, they can regenerate whole parts of the body, and even re-create an entire embryo (although that would require QUITE some understanding of the cues involved in the process). It seems, however, that now a new use has been found for the...

May 5th: Healthcare Reform Webinar

U.S. Health Care Reform Webinar - A Special Presentation for Israeli Pharma, Biotech and Medical Device Companies and Their Investors     Please register for this live webinar.   Meeting Description:    Drug and Biologics Manufacturers: Medicare and Medicaid drug coverage changes Annual fee for branded prescription drug manufacturers Biosimilars   Medical Device Manufacturers: Excise tax Essential Health Benefits Package   Heal...

OrSense Receives FDA Approval for Non-Invasive Oximetry Monitoring System

OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, announced it has received U.S. Food and Drug Administration (FDA) approval for NBM-200MP, a non-invasive oximetry and low signal oximetry sensor.   Non-invasive pulse oximetry has become a standard of care in the operating and recovery rooms, intensive care units and emergency services, yet it has been known to provide erroneous oxygen saturation readings in situations of low perfusion, low...

EnzySurge Receives FDA Approval for SilverStream™ Innovative Wound Management Solution

A novel therapeutic method, which can be used for the treatment of pressure ulcers, diabetic ulcers, post-surgical wounds and first and second degree burns, has received the FDA clearance Rosh Ha’Ayin, Israel, December 15, 2009 – EnzySurge Ltd. (EnzySurge), a provider of innovative solutions for the advanced chronic wound management market, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market  its new SilverStream™ solution for prescri...