Approvals

FDA Allows Marketing of ADHD Device

The FDA has given a green light for NeuroSigma’s Monarch external Trigeminal Nerve Stimulation (eTNS) system, a non-drug treatment for pediatric patients with ADHD.

The cell-phone sized device generates a low-level electrical pulse and is attached, by wire, to a small patch on the patient’s forehead. It is designed for home use under caregiver supervision.

The system is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication.

It is the first non-drug treatment for ADHD granted marketing authorization by the FDA. The system gained the CE Mark in November 2015

Konica Minolta’s X-Ray Technology Receives FDA Clearance

The FDA granted 510(k) clearance for Konica Minolta’s Dynamic Digital Radiography (DDR) technology, used to produce medical images that show movement.

The DDR technology depicts movement in a single exam and the images can be annotated and can include diagrams.

The X-ray technology shows clinicians the interaction between anatomical structures like tissue and bone with physiological changes over time. It is particularly useful for musculoskeletal and thoracic imaging.

FDA Clears SurModics’ Sublime Sheath

The FDA granted 510(k) clearance to SurModics’ Sublime guide sheath, a radial artery access device for use in coronary procedures.

Designed for kink resistance and strength, the flexible braid-reinforced device has a working length covered in hydrophilic coating, creating a lubricious surface. It includes a dilator and hemostasis valve with a side arm for flushing.

The device will be available in two lengths (120 and 150 centimeters) and two diameters (five and six French gage).

New York Authorizes Veracyte’s Genomic Test for Patients

Veracyte received regulatory authorization from the New York State Department of Health for its genomic test for idiopathic pulmonary fibrosis (IPF).

The Envisia Genomic Classifier is the first commercially available test that doesn’t require surgery to distinguish IPF from other interstitial lung diseases.

The genomic test uses RNA sequencing and machine learning to recognize the pattern of usual interstitial pneumonia, an indicator of IPF.

FDA Clears AliveCor’s Electrocardiogram Device

AliveCor received 510(k) clearances for two new indications for its KardiaMobile electrocardiogram device that now detects the three most common forms of heart arrythmia.

The newly cleared indications are for slow heartbeat (bradycardia) and fast heartbeat (tachycardia). The product was previously cleared for detecting atrial fibrillation (AFib).

The device, which works with most smartphones, can now inform physicians and patients about non-AFib arrhythmias that indicate bradycardia or tachycardia.

The ECG monitor can also share its rhythm results via the Apple Watch, allowing for the preemptive detection and treatment of AFib.