Approvals

Abiomed Nabs Premarket Approval for Latest Heart Pump

The FDA granted Abiomed premarket approval for the Impella 5.5 with SmartAssist, its newest heart pump for treating cardiogenic shock.

The minimally invasive device can be used by heart surgeons for up to two weeks in the treatment of cardiogenic shock that occurs less than 48 hours after open heart surgery or acute myocardial infarction.

The temporary pump can deliver flows greater than six liters per minute at its peak and is easier to insert than the previous model. The device eliminates the need for sternotomies or removal of tissue.

ProciseDxs Near-Patient Diagnostic Platform Gains CE Mark

In vitro diagnostics firm ProciseDx has earned the CE Mark for its point of care rapid diagnostic test platform.

The test quantifies diagnostic and treatment monitoring markers for inflammatory and autoimmune diseases, including celiac, and metabolic syndromes such as diabetes and pre-diabetes. It is slated to be launched in Europe next year, the company said.

Personal Genome’s Tissue Complete Assay Gets CE Marked

Personal Genome Diagnostics has gained the CE Mark for another PGDx elio panel, this time for its tissue complete assay.

The panel tests for somatic alterations across 507 genes. It can detect single nucleotide variants, small insertion/deletions, amplifications and rearrangements.

The tissue complete assay also tests for microsatellite instability (MSI) and tumor mutation burden (TMB). MSI has received FDA approval for identifying cancer patients whose tumors may respond to immune checkpoint inhibitor therapy and the use of TMB for that purpose is at the clinical trial stage.

Exact Sciences’ Colorectal Cancer Test Gets Expanded Indication

The FDA approved Exact Sciences’ noninvasive colorectal cancer screening test, Cologuard, for eligible patients aged 45 years and older.

Cologuard is a stool DNA-based colorectal cancer screening test for average-risk individuals. The test uses a biomarker panel, which analyzes a stool sample for 10 DNA markers.

FDA Approves Roche’s Donated Blood Screener

The FDA granted approval to Roche’s individual blood donation screening test for use on its cobas 6800/8800 systems.

Roche’s cobas Babesia test is a whole blood test used to screen donations. The company said it follows agency guidance that advises screening and testing for Babesia to reduce the parasite’s transmission from infusions.

The diagnostic test detects parasites that live in red blood cells. This is significant because the parasite can’t be detected in traditional plasma or serum samples, Roche said.