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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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xT CDx is a laboratory test designed to detect the presence of multiple changes in the genetic material (mutations in 648 different genes) in a person previously diagnosed with solid malignant tumors. The test detects certain mutations in KRAS and NRAS genes to help doctors identify if a person with colorectal cancer may benefit from personalized treatment with: ERBITUX (cetuximab) when there is an absence of mutations in codons 12 or 13 of KRAS, and VECTIBIX (panitumumab) when there is an absence of mutations in exons 2, 3, or 4 of KRAS and an absence of mutations in exons 2, 3, or 4 of NRAS. This test is a companion diagnostic for these personalized treatments.
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The ADVIA Centaur Anti-HBc Total 2 tests for antibodies to a viral protein within the hepatitis B virus, also known as the core antigen (HBc).
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The FoundationOne Liquid CDx assay is a laboratory test designed to detect several mutations in circulating cell-free DNA (cfDNA). This test helps doctors identify people with cancer who may benefit from specific FDA-approved treatments. This approval expands the indications for use of the FoundationOne Liquid CDx test to include people with non-small cell lung cancer who have an EGFR exon 20 insertion in their tumor DNA. Identifying whether a patient has this insertion may help people with non-small cell lung cancer get personalized treatment with EXKIVITY (mobocertinib).
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The REFLECT Scoliosis Correction System is a non-fusion spinal device intended to treat idiopathic scoliosis, an abnormal curve of the spine that happens without a known cause, in children and adolescents whose bones have not fully matured.
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The VEGA Steroid-Eluting Endocardial Pacing Lead is an insulated wire with a screw-in tip that is connected to a permanently implanted pulse generator, or pacemaker device, to carry signals from the heart muscle to the pulse generator and electrical impulses back to the heart to keep the heart beating in a normal rhythm (pace). The lead includes a steroid drug, dexamethasone sodium phosphate, that helps reduce inflammation in the heart muscle after the lead is placed.
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The TactiFlex Ablation Catheter is a long, flexible wire with a metal electrode at its tip. The tip can be heated and is intended to be used as a treatment for atrial fibrillation, an abnormal heart rhythm causing fast and irregular heartbeats, and type I atrial flutter, another abnormal heart rhythm that also causes fast heartbeats (tachycardia).
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PerClot Absorbable Hemostatic Powder (PerClot) is a powder made of absorbable granules of a substance called a polysaccharide. It is used to stop bleeding and promote blood clotting during surgery. The PerClot System includes the following components: PerClot (granules/powder), PerClot Delivery System, and PerClot Accessory Tips (optional)
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LiquiFix Hernia Mesh Fixation devices include a liquid adhesive and an applicator to apply it. These devices are used during surgery to repair groin (inguinal) and upper thigh (femoral) hernias.
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The Perclose ProStyle Suture-Mediated Closure and Repair System (ProStyle) and Perclose ProGlide Suture-Mediated Closure System (ProGlide) use a stitch (suture) to close openings made in blood vessels (access sites) during catheterization procedures. The suture stays in place after the procedure to prevent bleeding until the opening heals. ProStyle is a newer variation of the ProGlide device but is very similar. Both devices work in the same way. This approval expands the indications for use to include closing multiple access sites in a single large blood vessel of the groin (femoral vein).
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The DETOUR System is intended to treat narrowed or blocked arteries that carry blood to the knee and lower leg (superficial femoral and popliteal arteries). It consists of three components: a small, spiral tube (stent) made of metal (nitinol) enclosed in a polymer (ePTFE), a delivery catheter, and a crossing tool that helps guide the delivery catheter and covered stent to the correct position
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The FoundationOne Liquid CDx assay is a laboratory test that detects a number of mutations in circulating cell-free DNA (cfDNA). This test helps doctors identify people who may benefit from specific FDA-approved treatments. This approval expands the indications for use of the FoundationOne Liquid CDx test to include people with metastatic colorectal cancer who have a change to the DNA of their tumors (BRAF V600E alteration). Identifying whether a patient has a BRAF V600E alteration in their tumor may help determine if they may benefit from personalized treatment with BRAFTOVI (encorafenib) in combination with cetuximab.
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The Inspire Upper Airway Stimulation (UAS) system is an implantable nerve stimulator used to treat obstructive sleep apnea. The Inspire UAS system includes the implantable pulse generator (IPG), stimulation lead, and sensing lead, as well as external components: the physician programmer and the patient remote. This approval expands the indications for use to include people with obstructive sleep apnea who have an upper limit baseline apnea-hypopnea index (AHI) of 100 (increase from ≤65 to ≤100). The approval also increases the upper limit for recommended body mass index (BMI) to 40 (increase from ≤32 to ≤40).
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