Archive for November, 2009

Despite caution, device companies upbeat about 2010 prospects

Emergo GroupAccording to a survey conducted by Emergo Group Medical device and in vitro diagnostics manufacturers are increasingly optimistic about their prospects in 2010. The survey of 1,141 industry managers found that more than two of three believe the overall business environment will be better for the industry next year. A majority also said they expect to hire additional workers during 2010.

CleveMed Receives ISO 13485, CE Mark, Canadian Certificate Approval

CleveMedCleveMed has received ISO 13485 certification issued by BSI Management Systems America Inc. CleveMed has also received the CE Mark and CMDCAS allowing its products to be distributed to the large European and the Canadian markets which will strengthen its worldwide market presence. CleveMed designs and manufactures a number of telemetry-based patient monitors for sleep disorders such as sleep apnea and movement disorders including Parkinson’s disease.

FlowCardia Introduces FlowMate(TM) Injector

FlowCardiaFlowCardia, Inc has launched the FlowMate Injector, which dramatically simplifies central lumen crossing of CTOs using the CROSSER CTO Recanalization Catheter. FlowMate provides unparalleled convenience by granting full control of the procedure to a physician via a single foot pedal, which initiates FlowMate’s precise saline delivery as well as the Generator which activates the CROSSER Catheter. Fixed injector settings are integrated into the FlowMate adding even greater convenience and ease of use.

Dey Launches Needle-Protected EpiPen(R) (Epinephrine) Auto-Injector with Enhanced Features

Dey PharmaDey Pharma, L.P., has launched a newly designed, patient-friendly EpiPen® Auto-Injector 0.3/0.15 mg. This next-generation EpiPen Auto-Injector maintains the simplicity, speed, safety and reliability of EpiPen Auto-Injector with several new, user-friendly features, including being the only auto-injector with needle-protection before and after use. Side effects may include an increase in heart rate, a stronger or irregular heartbeat, sweating, nausea and vomiting. If you have Parkinson’s disease, your symptoms may temporarily get worse.

Palomar to launch Anti-Aging Laser Device without JJDC

Palomar Medical TechnologiesPalomar Medical Technologies Inc. will go ahead with the commercialization of its FDA-cleared home-use laser device for treatment of periorbital wrinkles, despite the termination of its commercialization agreement with Johnson & Johnson. Palomar plans to launch the products during the second half of next year. With the agreement cancellation, JJCC avoids having to commit to the significant level of funding required to successfully launch a new product into the mass market.