Recently Approved Devices

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

CentriMag Circulatory Support System - P170038 The CentriMag Circulatory Support System is a blood pump system intended to be used temporarily to help the heart pump blood in patients whose circulatory systems (heart and blood vessels) are not able to perform well enough on their own.  The CentriMag Circulatory Support System includes a blood pump, a motor that drives the pump, a console that controls the motor, a monitor, a flow probe, and flexible tubes (cannulae).

FoundationOne®CDx - P170019/S006 FoundationOne®CDx (F1CDx) is a laboratory test designed to detect genetic mutations in 324 genes and two genomic signatures in tumor tissue. F1CDx is a companion diagnostic that was originally approved for the detection of genetic mutations in patients who may be eligible for treatment with one of fifteen FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer. This approval expands the indications for use of the F1CDx test to include breast cancer patients with certain genetic mutations in the PIK3CA gene. Identifying these changes will help breast cancer patients get personalized treatment with PIQRAY® (alpelisib), a drug used to treat patients with breast cancer.

LIAISON QuantiFERON-TB Gold Plus, LIAISON Control QuantiFERON-TB Gold Plus, LIAISON QuantiFERON Software - P180047 The LIAISON QuantiFERON-TB Gold Plus assay is an in vitro diagnostic test intended to determine if a person could be infected with tuberculosis (TB) bacteria. The LIAISON Control QuantiFERON-TB Gold Plus is used as a quality control to ensure the test is working properly. The LIAISON QuantiFERON-TB Software is used to analyze the test results on the LIAISON XL Analyzer.

Tula® System - P190016 The Tula® System is intended to insert ear tubes (tympanostomy tubes) into the eardrum to treat repeated ear infections (recurrent acute otitis media) or fluid in the ear (otitis media with effusion) in young children and adults using local anesthesia in a physician’s office.  The Tula® System consists of the Tula Iontophoresis System and the Tula Tube Delivery System.  The Tula Iontophoresis System, which includes individually-fitted disposable ear plugs and ear sets, delivers a local anesthetic solution, TYMBION™, to the eardrum resulting in numbness of the eardrum.  The Tula Tube Delivery System is then used to place the ear tube in the eardrum.

MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear - P180035 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are intended to slow the progression of nearsightedness in children ages 8-12. Additionally, the contact lenses are intended for vision correction of nearsightedness. The contact lenses are worn on the eye every day and discarded each day after every use. The use of this contact lens requires periodic eye doctor’s visits and a prescription.

Axonics Sacral Neuromodulation (SNM) System for Urinary Control - P180046 The Axonics Sacral Neuromodulation (SNM) System is a sacral nerve stimulation (SNS) system that is intended to treat urinary retention and the symptoms of overactive bladder. It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve.

Myriad myChoice CDx - P190014 The myChoice CDx is a laboratory test that  detects homologous recombination deficiency (HRD) status. A positive HRD status means that there are mutations in BRAC1 and BRCA2 genes or a high Genomic Instability Score (GIS) in patients with ovarian cancer. With a positive HRD status, a patient’s DNA is unable to repair. When patients with ovarian cancer test positive for HRD, the doctor can determine if they are eligible for treatment with Zejula® (niraparib).

LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab - P190011 The LIAISON XL MUREX HCV Ab is a laboratory test used to detect antibodies to the hepatitis C virus (HCV) in a patient’s blood. The presence of antibodies against HCV can help determine if a patient has been exposed to HCV but will not be able to tell if a patient has a recent or chronic HCV infection, or if a patient has recovered from HCV infection.

iDESIGN® Refractive Studio and STAR S4 IR® Excimer Laser Systems - P930016/S057 This approval expands the indications for use of the iDesign Refractive Studio (iDesign) and STAR S4 IR Excimer Laser System (Laser System) to wavefront-guided photorefractive keratectomy (PRK) to reduce or eliminate nearsightedness (myopia) with or without astigmatism

Axonics Sacral Neuromodulation (SNM) System - P190006 The Axonics Sacral Neuromodulation (SNM) System is a sacral nerve stimulation (SNS) system that is intended to treat bowel (fecal) incontinence using mild electrical pulses.

Alcon Laboratories, Inc. AcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60) - P040020/S087 The AcrySof® IQ PanOptix® Toric Intraocular Lens is an artificial lens implant that is used to improve vision after cataract removal in people who also have blurred vision due to an irregularly shaped cornea (corneal astigmatism).