Microsoft word - newsletter no. 5_april 2011_approvals.docx

Approvals
Navotek Medical Receives 510(k) Clearance for Radiation Therapy System
Israel-based device developer Navotek Medical, Ltd. has received 510(k) clearance from the FDA for its RealEye monitoring device. The RealEye system is designed to help doctors accurately monitor the delivery of radiation therapy, according the company. Valeritas Receives 510(k) Clearance for Insulin Delivery Device
Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced that the U.S. FDA has cleared the company’s V-Go Disposable Insulin Delivery Device for use with Novo Nordisk’s NovoLog for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. Intel-GE Device Gets FDA Green Light
Intel-GE Innovations LLC has won U.S. Food and Drug Administration approval to market a new in-home health monitoring system, the company announced. The new system addresses the challenges of chronic care. It collects vital signs, offers interactive patient health sessions, video conference capability and multimedia educational content via personal computer with remote capabilities. Silicon Valley / San Jose Business Journal, 3/4/11 Excelsior Medical Receives FDA Clearance for Catheter Syringe Device
Excelsior Medical Corporation announced received FDA 510(k) clearance for SwabFlush, its latest product for the vascular access and infection control markets. Nexera Receives Respirator Mask Clearance
Nexera announced it received FDA 510k and NIOSH clearance to commercially market their SpectraShield Antibacterial N95 Respirator Mask. Covidien Receives FDA Approval for Medical Isotope
Covidien, a leading global provider of healthcare products, received U.S. Food and Drug Administration approval for the use of molybdenum-99 derived from low-enriched uranium in the production of technetium-99m generators. FDA Approves Neurosurgery Bypass Device
The FDA approved The ELANA Surgical Kit, manufactured by Utrecht of the Netherlands that allows neurosurgeons to create a bypass without shutting off the blood flow to the brains of patients at increased risk of having a stroke during bypass surgery. “The ELANA Surgical Kit may help those with a rare condition for whom there previously was no treatment option,” said Jeffrey Shuren, director of the FDA’s CDRH. Stem Cell Growth Device Receives 510(k) Clearance
Life Technologies received FDA 510(k) clearance for its StemPro stem cell culture device. A liquid medium intended for ex vivo use, the StemPro is designed to grow large amounts of human mesenchymal cells (MSCs), which might play a critical role in future regenerative medicine study. FDA Approves Spaulding ECG Device
Spaulding Clinical Research received 510(k) approval for its proprietary ECG device platform, Spaulding IQ. A single-button handheld device designed to be easy-to-use, and efficient in capturing ECG data. Use of the device "will provide clients with more data in less time and at a lower cost, with elimination of nearly all opportunities for error," the company says in a statement. 10) CardioNexus Gets Approval for Ultrasound System
CardioNexus, a joint venture between Panasonic and Houston-based Fairway Medical Technologies, has received FDA approval for an ultrasound system for the early detection of heart disease. 11) Covidien Wins Pipeline FDA Approval for Brain Aneurysms
An FDA panel gave the nod to Covidien plc’s Pipeline embolization device, recommending that it be approved to treat large brain aneurysms. 12) Boston Scientific Wins FDA Nod for Back Pain Device

Boston Scientific Corporation announced U.S. FDA has approval for a new version of its rechargeable device designed to address chronic back pain. The product, called the Clik Anchor for its Precision Plus Spinal Cord Stimulator System is the first rechargeable spinal cord stimulator device for chronic pain management. 13) Medtronic Gets FDA Approval for CRT-P Systems

Medtronic Inc. received U.S. Food and Drug Administration approval for its Consulta and Syncra cardiac resynchronization therapy-pacemaker (CRT-P) systems. The Consulta is the first CRT-P to include Medtronic's OptiVol fluid status monitoring, which identifies patients at risk for worsening heart failure before symptoms develop. Minneapolis / St. Paul Business Journal, 3/25/11 14) FDA Approves Smarter Heart Device from Medtronic
Medtronic received FDA approval for a new generation of heart defibrillators designed to avoid unnecessary shocks. The company's Protecta line of implantable heart devices, using updated programming to monitor the heart and limit therapeutic shocks to life-threatening situations.
Pharma/Biotech
1) Forest, Nycomed Win Narrow FDA Approval on New COPD Drug

Forest Laboratories and Nycomed of Switzerland have managed to overcome some sharp criticism from a panel of experts and win a narrow approval of Daliresp (roflumilast) to prevent the exacerbation of COPD. 2) Edarbi Approved for High Blood Pressure

Takeda Pharmaceutical received U.S. Food and Drug Administration approval for Edarbi (azilsartan medoxomil) to treat adults with high blood pressure. Clinical trials showed Edarbi was more effective in lowering high blood pressure over 24 hours than two previously FDA-approved drugs, Diovan (valsartan) and Benicar (olmesartan), said in a news release. 3) FDA Approves GSK Lupus Drug, First Drug in 50 years

Human Genome Sciences and GlaxoSmithKline have won approval for their lupus drug Benlysta, the first FDA-approved drug for 50 years. “Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, in a news release. 4) Aurobindo Pharma Receives Nod for Famciclovir Tablets

Aurobindo Pharma received final approval from the FDA to market Famciclovir tablets, which are used to treat herpes simplex infections in HIV-infected patients. 5) Bristol-Myers' Melanoma Drug Approved

Bristol-Myers received US FDA approval for Yervoy (ipilimumab), the first drug shown to prolong the lives of people with skin cancer melanoma reported by the New York Times reports.

Source: http://www.biomarketinginsight.com/News_PDFs/Newsletter+No.+5_April+2011_Approvals.pdf