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The FDA has recently approved the following devices to be marketed. Additional items can be found on the Recently Approved Devices page.
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JUVÉDERM VOLUX XC is a gel implant or dermal filler that is injected in specific areas of facial tissue to add definition or reduce the appearance of lines and wrinkles. It consists of the chemical hyaluronic acid, 1,4-butanediol diglycidyl ether (BDDE), and 0.3% of the drug lidocaine hydrochloride to reduce pain on injection.
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FoundationOne CDx is a laboratory test designed to find genetic variations in 324 genes, as well as some specific gene rearrangements and other biomarkers, including microsatellite instability (MSI) in the genomic makeup of a tumor.
This test is a companion diagnostic that is used to help match a patient to a specific drug or therapy. It is approved to find genetic mutations in patients that might show they would benefit from FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, bile duct cancer (cholangiocarcinoma), prostate cancer, ovarian cancer, and solid tumors.
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The ADVIA Centaur Anti-HBc2 and Atellica IM HBc Total 2 (HBcT2) assays are laboratory tests used to detect antibodies to a protein on the surface of the hepatitis B virus, the c antigen (HBc). The ADVIA Centaur Anti-HBc2 and Atellica IM HBc Total 2 (HBcT2) assay is used with the laboratory systems ADVIA Centaur XP and ADVIA Centaur XPT.
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The SBL-3 Multifocal Intraocular Lens (IOL) is an artificial lens permanently implanted inside the eye. The lens is intended to provide vision correction after the eye’s natural lens is removed because it has become cloudy (cataract).
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The GORE TAG Thoracic Branch Endoprosthesis is designed to repair the damage to the largest artery that is located in the chest (descending thoracic aorta). The Thoracic Branch Endoprosthesis consists of three implantable fabric tubes supported by a nitinol framework (stent grafts). Each stent graft has a catheter-based delivery system.
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The Alinity m CMV Assay Test is a laboratory test used to measure the amount of cytomegalovirus (CMV) genetic material, or viral DNA, in a patient’s blood. The test is designed for use on the Alinity m system, which runs the assay and analyzes the results.
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The AccelStim Bone Growth Stimulator delivers a high frequency sound wave (ultrasound signal) to encourage bone growth and help heal broken bones (bone fractures). The portable, handheld, battery-powered device includes the following parts:
- A signal generator that controls the type of ultrasound signal needed
- A transducer that produces the ultrasound signal
- An external power supply/cord to power or charge the signal generator
- A transducer holder with an elastic strap to hold the device over the fracture
- Ultrasound gel to help the ultrasound signal flow from the transducer to the fracture
The AccelStim Bone Growth Stimulator device is prescribed by a doctor and used at home by the patient.
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The ENROUTE Transcarotid Stent System is used to re-open narrowed parts of the neck arteries that supply blood to the brain (carotid arteries). The implant consists of a self-expanding stent and a delivery catheter system. The stent is made of nickel-titanium alloy (nitinol) tubing, laser-cut into a mesh shape.
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The TransMedics Organ Care System (OCS) Heart System is designed to preserve donor hearts prior to transplantation. The system includes:
- A portable enclosure that warms the donor heart and provides it with oxygen and nutrients
- Heart preservation solution
The OCS Heart System was previously approved for the preservation of donation-after-brain-death donor hearts that could not be preserved using standard cold storage.
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The Thoraflex Hybrid is a device system designed to repair a weakened and bulging section (aneurysm) and/or a tear in the lining (dissection) of the aorta behind the heart (aortic arch). The system includes a polyester graft section that reinforces a weakened section of the blood vessel, a connected stented section (nitinol wire frame on polyester graft material) that holds the artery open, and a delivery catheter that is used to place the device. The polyester graft and stented sections are coated with a protein substance taken from animal body parts (gelatin) to seal the implant and prevent blood from leaking out.
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The EVO/EVO+ Visian Implantable Collamer and EVO/EVO+ Visian TORIC Implantable Collamer Lenses are artificial lenses permanently implanted inside the eye. The lens is intended to correct nearsightedness (myopia) and to correct blurred vision due to an irregularly shaped cornea (astigmatism).
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Et Control is a software feature that is indicated for use with the Datex-Ohmeda Aisys CS2 anesthesia system. When a patient is under anesthesia, the software helps patients reach and maintain target exhaled oxygen levels (targeted end tidal levels) and the right mixture of anesthetic gas to control pain (end tidal anesthetic) that are set by the health care provider.
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