New Drug Approved by the U.S. Food and Drug First-Line Treatment of Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer

 

Shark.tidbits

WILMINGTON, Del.­­(EON: Enhanced Online News)­­AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved IRESSA® (gefitinib) as a first­line treatment in patients with metastatic non­ small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA­approved test. read more

FDA Clearance for joimax EndoLIF On-Cage: 3D-Printed Fusion Implant

The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endoscopic Lumbar Interbody Fusion, or EndoLIF® On-Cage implant. read more

ReWalk Robotics Launches ReWalk 6.0: the Company’s Sixth Generation Personal System for Home & Community Use

YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., July 14, 2015 /PRNewswire/ — ReWalk Robotics Ltd. (Nasdaq: RWLK), the leading global exoskeleton manufacturer, unveiled today the latest edition of its Personal powered exoskeleton system—the ReWalk Personal 6.0—marking the company’s sixth generation community use product. The ReWalk Personal 6.0 offers those in the spinal cord injured community the most functional exoskeleton system with the fastest walking speed and the most precise fit, among many other key benefits. The ReWalk Personal 6.0 is the latest version of the FDA cleared exoskeleton, which can be used at home and in the community.

Mayo Clinic and Gentag, Inc. Announce Agreement To Develop Wireless Sensors for Treatment of Obesity and Diabetes

ROCHESTER, Minn. — Mayo Clinic and Gentag, Inc. have reached an agreement to develop the next generation of wearable biosensors designed to fight obesity and diabetes.

“We are hoping that this technology will be game-changer. These patch biosensors may help us reduce global obesity and diabetes,” says James Levine, M.D., Ph.D., a Mayo Clinic endocrinologist and obesity researcher. “They are accurate, inexpensive, and can be integrated into the care people receive.”

A first-of-its-kind, the wearable patch sensors are the size of a small bandage, and are designed to be painless, wireless and disposable. In the bandage is a sensor that communicates via a closed-loop diabetes management system which is compatible with cell phones. The system will allow researchers to monitor movement and develop treatments for obesity and related conditions.read more

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