Approvals

ElectroCore’s Nerve Stimulator Receives Expanded Clearance

The FDA granted 510(k) clearance for an expanded label for ElectroCore’s GammaCore non-invasive vagus nerve stimulator therapy for the preventive treatment of cluster headache in adults.

Also known as “suicide headaches,” cluster headaches last a relatively short time but cause extreme pain, affecting approximately 350,000 patients in the US.

The device is the only product cleared by the FDA for prevention of cluster headache and is only available through prescription.

Quidel Gains CE Mark for High-Sensitivity Troponin I Test

Quidel earned the CE Mark for its TriageTrue near-patient diagnostic troponin assay, used for diagnosing heart attacks.

The single-use fluorescence immunoassay detects a subunit of the troponin complex that heart muscle cells release after a myocardial infarction.

The test uses whole blood or plasma specimens that have been anticoagulated with EDTA on Quidel’s Triage Meter Pro device.

Aziyo’s Bioscaffold Cleared By FDA for Expanded Use

The FDA has granted 510(k) clearance for Aziyo’s CanGaroo envelope, a naturally occurring bioscaffold used to hold cardiac implantable electronic devices (CIEDs).

The bioscaffold conforms to the implantable device to provide a stabilized environment for CIEDs like pacemakers and defibrillators after implantation.

The device can help to improve patient comfort, reduce device migration and make device removal easier for exchanges or revisions.

Asuragen’s DM1 Assay Gets CE Mark

Asuragen’s myotonic dystrophy type I (DM1) assay, the AmpliedeX DM1 Dx Kit, has earned the CE Mark.

The device helps in the diagnosis of DM1, also known as Steinert’s disease, an inherited form of muscular dystrophy.

The kit includes reagents to accurately measure every expansion of the disease using as little as 20 nanograms of DNA.

FDA Approves Test for Herpes Virus in Newborns

The FDA approved Meridian Bioscience’s diagnostic test for detecting cytomegalovirus (CMV), a type of herpes virus that occurs in newborns.

Most babies with CMV will show no signs or symptoms of infection, but some can develop hearing problems or other long-term health issues from the virus.

The test diagnoses CMV in newborns less than three weeks old by detecting virus DNA from a saliva swab.

Diabetes Management System Earns CE Mark

Diabeloop’s DBLG1, a hybrid closed-loop diabetes management system that serves as an artificial pancreas, earned a CE Mark.

The artificial pancreas-like device provides glucose measurements every five minutes.