Product Approval Summaries

DEVICES

FDA has cleared an AnthroTronix 510(k) for its computerized cognitive test battery DANA, which is intended to provide clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual’s medical or psychological state. The phone and tablet based app is indicated for use as part of any clinical assessment where concerns for changes in cognitive or psychological status are present, according to the company.

FDA has cleared a Clinical Innovations (Salt Lake City) 510(k) for its Koala Toco, a tocodynamometer that is designed to utilize air-charged technology to accurately measure uterine contractions. The company says the device uses an “advanced signal amplification technology, which is designed to improve performance, particularly in traditionally difficult-to-monitor patients such as those with high Body Mass Index.”

FDA has cleared expanded the indications for iTraumaCare’s iTClampHemorrhage Control System, to include the temporary control of severe bleeding of the neck. Previously, the product’s indications for use in the U.S. included the extremities (arms and legs), axilla (arm pit), inguinal (groin) areas and the scalp.

Medtronic has received FDA approval of its PMA for its CapSureFix Novus MRI SureScan 5076 Lead for use with magnetic resonance imaging (MRI). The lead is approved for MRI scans positioned on any region of the body when paired with a Medtronic dual-chamber MR-conditional pacemaker. The leads come in lengths from 35cm to 85cm.

FDA has cleared a Quidel Corp. 510(k) to market its Lyra Adenovirus Assay, a real-time polymerase chain reaction (PCR) test for the qualitative detection of human adenovirus viral DNA isolated from nasal swab and nasopharyngeal swab specimens.

FDA has approved a de novo petition to allow the marketing of Vesiflo, Inc.’s inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility or IDC).

FDA has approved a VisionCare Ophthalmic Technologies PMA for its Implantable Miniature Telescope for use in patients living with bilateral end-stage age-related macular degeneration (AMD) who are age 65 or older. The implant is designed to improve visual acuity and quality of life for suitable patients with AMD whose sight is permanently obstructed by a blind spot in their central vision, making it difficult or impossible to see faces, read, and perform everyday activities such as watching TV, preparing meals, and self-care, according to the company.

HUMAN DRUGS

FDA approved Boehringer Ingelheim Pharmaceuticals’ Ofev (nintedanib) for treating idiopathic pulmonary fibrosis (IPF). It is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue.

Eisai won FDA approval for its Akynzeo drug to treat common side effects in patients undergoing chemotherapy. The pill combines two drugs, palonosetron and netupitant.

Intermune has received FDA approval of an NDA for Esbriet (pirfenidone) for treating idiopathic pulmonary fibrosis. It was approved five weeks ahead of its 11/23 user fee date. The agency says Esbriet acts on multiple pathways that may be involved in the scarring of lung tissue.

FDA has approved a Navidea Biopharmaceuticals supplemental NDA for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors, and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications.