martes, 26 de diciembre de 2017

Recently Approved Devices

The FDA has recently approved the following devices to be marketed:

Vercise Deep Brain Stimulation (DBS) System
The Vercise DBS System is a neurostimulator used to reduce motor symptoms associated with Parkinson's disease. The system includes a 16-channel, rechargeable, implanted stimulator that is connected to two DBS extensions and two DBS leads. The implanted stimulator generates an electrical pulse that is carried through the lead extensions to the lead and delivered to the subthalamic nucleus in the brain.

The HEMOBLAST™ Bellows is a handheld device used to achieve hemostasis (control bleeding) during surgical procedures. The HEMOBLAST Bellows includes a dry, sterile powder made of highly purified porcine collagen (with glucose), chondroitin sulfate, and thrombin. Users do not need to thaw, mix, or heat the powder, and the powder is absorbed by the body within four weeks.

FoundationOne CDx
FoundationOne CDx (F1CDx) is a laboratory test designed to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor. F1CDx is a companion diagnostic used to identify patients with certain genetic mutations who may benefit from FDA-approved treatments for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer.

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