Product Approval Summaries
DEVICES
FDA has approved an Aspire Bariatrics PMA for the AspireAssist, a new obesity treatment device that uses a surgically-placed tube to drain stomach contents after every meal. “The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight,” an agency release says. It is intended for use in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed other non-surgical weight-loss efforts.
Masimo has received FDA 510(k) clearance for its O3 regional oximetry. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure being performed, the company says. The device uses near-infrared spectroscopy to continuously monitor absolute and trended regional tissue oxygen saturation in the cerebral region.
FDA has cleared a Meridian Bioscience 510(k) for a new molecular diagnostic test for Mycoplasma pneumonia. The Illumigene Mycoplasma Direct assay features a simplified three-step procedure that provides definitive results in less than one hour, the company says. The Illumigene Mycoplasma Direct “accurately detects infection on the first day of symptoms and provides the ability to avoid treating patients empirically to reduce the administration of broad spectrum antibiotics and the likelihood of antimicrobial resistance,” Meridian says. It uses throat swabs and samples are in process in less than two minutes of hands-on time. The Illumigene molecular assays also test for C. difficile, Group A Streptococcus, Group B Streptococcus, HSV 1 and 2, and Pertussis.
REBIScan has gained 510(k) from FDA for the Pediatric Vision Scanner, a handheld device designed to help physicians screen for amblyopia (lazy eye) and strabismus (misaligned eyes) in young children, as early as preschool age when the condition is easiest to treat. The device uses a new technology — retinal birefringence scanning, which was co-invented by company founder David Hunter — to detect amblyopia and strabismus. Medical assistants in the pediatric office may operate the device to perform annual vision scans, the company says.
FDA has cleared a SpineGuard 510(k) for the PediGuard Threaded DSG device for use in pedicle screw insertion. “A single-use DSG pin embedded with the bipolar sensor is inserted into the cannula of the threaded shaft and connected to the electronic processor inside the single-use DSG handle.” the company says. “The distal tip of the threaded shaft includes an awl-like tip to facilitate redirection of the device until the tip is past the pedicle isthmus.” The company says PediGuard is the first stand-alone, handheld instruent capable of accurately detecting changes in tissue type, alerting surgeons of potential pedicular or vertebral breaches during pedicle screw site preparation. Real-time feedback, provided via audio and visual signals, gives surgeons additional information about the trajectory during pedicle preparation.
Tyber Medical has received FDA 510(k) clearance for its headed and snap-off screw systems, indicated for use throughout the extremities in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair and fracture fixation appropriate for the size of the device. The cannulated headed screws (available in 1.5mm-9.0mm) and snap-off screw (available 1.5mm-3.0mm) are intended to complement the company’s headless trauma screw. Included within the 510(k) clearance are screw configurations incorporating the company’s proprietary BioTy modified surface treatment, Tyber says.
HUMAN DRUGS
Perrigo Company plc has received final FDA approval for the generic version of Mallinckrodt Pharmaceuticals’ Ofirmev (acetaminophen) injection 1000 mg/100 mL, indicated for managing mild to moderate pain, moderate to severe pain with adjunctive opioid analgesics, and reducing fever.
Shire’s emphysema therapy Glassia has received FDA approval for an expanded label, marking the first time that patients can self-infuse at home. Glassia is an alpha-1 proteinase inhibitor licensed for treating adults with emphysema due to severe alpha-1 antitrypsin deficiency, a protein that helps protect lung tissue from damaging enzymes released by white blood cells.