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Recently Approved Devices
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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The ReActiv8 Implantable Neurostimulation System includes an implantable pulse generator (IPG), two stimulation leads, a magnet, and a wireless remote. The IPG delivers electrical stimulation pulses to certain nerves responsible for activating the lumbar multifudus muscle, the key muscles responsible for stabilizing the lower back.
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The WATCHMAN Left Atrial Appendage Closure Device with Delivery System (WATCHMAN device) and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (WATCHMAN FLX device) are permanently implanted devices intended to prevent blood clots in the left atrial appendage (LAA) from entering the bloodstream. Both devices are made of a Nitinol (nickel-titanium) frame with an attached fabric cap. The WATCHMAN device and the WATCHMAN FLX device have the same intended use but different shaped frames.
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The VENTANA HER2 Dual ISH DNA Probe Cocktail is a lab test that estimates the number of copies of the HER2 gene in breast cancer tissue samples to help doctors identify breast cancer patients who should be treated with the drug HERCEPTIN (transtuzumab). It is a type of laboratory test called a companion diagnostic.
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The Neuroform Atlas Stent System is intended to hold in place coil devices used to plug up aneurysms in the brain that have a neck size greater than or equal to 4 mm or a dome-to-neck ratio less than 2 (wide-necked brain aneurysms). The Neuroform Atlas Stent System consists of a self-expandable metal (nitinol) tube-shape device (stent) and a wire to place it inside a brain artery.
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Guardant360 CDx is a laboratory test that detects genetic mutations found in circulating cell-free DNA (cfDNA) to help doctors identify patients with non-small cell lung cancer who should be treated with TAGRISSO (osimertinib). It is a type of lab test called a companion diagnostic.
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Kendall Multifunction Defibrillation Electrodes, MEDI-TRACE Cadence Defibrillation Electrodes, Physio-Control/Stryker QUIK-COMBO Pacing/Defibrillation/ECG Electrodes (“Multifunction Defibrillation Electrodes”), are a set of sensors that are attached to a compatible defibrillator and then placed on a person experiencing cardiac arrest to detect and help correct irregular heartbeats.
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The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent Systems are intended to treat a narrowed blood vessel (coronary artery) caused by coronary artery disease. The system consists of a catheter delivery system and a platinum-chromium metal stent. The stent is coated with the drug everolimus and a thin coating of poly(lactic-co-glycolic acid) (PLGA), a material that dissolves into the body.
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The FoundationOne Liquid CDx is a laboratory test that detects specific gene mutations found in circulating cell-free DNA (cfDNA) isolated from whole blood plasma specimens, also called liquid biopsy specimens to help doctors identify patients with metastatic castration resistant prostate cancer who may benefit from treatment with the cancer drug RUBRACA. (rucaparib). It can also help identify patients with non-small cell lung cancerExternal Link Disclaimer who may benefit from treatment with IRESSA (gefitinib), TAGRISSO (osimertinib), or TARCEVA (erlotinib). This lab test is a companion diagnostic for these indications.
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The LIAISON XL MUREX anti-HBe is a laboratory test used to detect human antibodies against the hepatitis B virus e antigen (Anti-HBe) in a patient’s blood. Anti-HBe may be detectable in patients with a recent (acute) hepatitis B virus (HBV) infection and in some patients with long-term (chronic) HBV infection.
The test is used with the LIAISON XL analyzer which runs the assay and analyzes the results.
The LIAISON XL MUREX Control anti-HBe is used as a quality check to ensure that the test is working properly.
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The Alinity m HBV is a laboratory test used to detect hepatitis B virus (HBV) DNA in a patient’s blood sample. The presence of HBV DNA means that the virus is replicating in the body and that the patient has an active hepatitis B viral infection.
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The LIAISON XL MUREX HBc IgM is a laboratory test used to detect human immunoglobulin (IgM) antibodies against the hepatitis B virus (HBV) core antigen in a patient’s blood. The presence of IgM antibodies against HBV core antigen can help determine if a person has been exposed to HBV but will not be able to tell if a person is acutely infected, chronically infected, or has recovered from HBV infection.
The test is used with the LIAISON XL analyzer which runs the assay and analyzes the results.
The LIAISON XL MUREX Control HBc IgM is used as a quality control to check that the test is working properly.
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The LIAISON XL MUREX HBeAg is a laboratory test used to detect human hepatitis B e antigen (HBeAg) associated with hepatitis B virus (HBV) infection. Detection of HBeAg in a patient’s bloodstream indicates active replication of HBV. This may occur in patients with recent (acute) or chronic (long-term) HBV infection.
The test is used with the LIAISON XL analyzer which runs the assay and analyzes the results.
The LIAISONXL MUREX Control HBeAg is used as a quality control to ensure that the test is working properly.
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