Abiomed Nabs Premarket Approval for Latest Heart Pump September 25, 2019 The temporary pump supports the patient’s left ventricle. Read More
FDA Calls Out Florida Contract Manufacturer for Complaint Handling September 24, 2019 The complaint procedure had no requirements for investigating complaints without a lot number. Read More
California Devicemaker Slammed for Labeling Activities, Validation September 24, 2019 The firm didn’t put in place written procedures for labeling of its FemCap devices. Read More
FDA Approves Roche’s Donated Blood Screener September 24, 2019 The test detects parasites in red blood cells. Read More
Exact Sciences’ Colorectal Cancer Test Gets Expanded Indication September 24, 2019 The test uses a biomarker panel, which analyzes a stool sample for 10 DNA markers. Read More
Texas Devicemaker Scolded for Software Validation, Design Reviews September 23, 2019 The firm failed to maintain records of design reviews. Read More
Contract Manufacturer Cited for Procedural Issues September 23, 2019 The facility’s records showed that a class II component tension screw was distributed despite the failure to follow procedures. Read More
Lineage Cell Obtains CE Mark for Facial Lipoatrophy Treatment September 23, 2019 The product mimics the naturally occurring extracellular matrix in the body. Read More
Clever Culture’s Plate Reader Earns CE Mark September 23, 2019 The reader removes the need for microbiologists to process many negative plates themselves. Read More
FDA Cites German Devicemaker for MDRs, Software Validation September 20, 2019 The facility used the unvalidated software for device history records, traceability and other quality management activities. Read More
Panacea Medical Earns CE Mark for Two Devices September 20, 2019 Lilac’s wide-angle tomography offers high-resolution images at low radiation doses. Read More
Lax Quality Observed at Device Facility in China September 20, 2019 The company failed to investigate a customer complaint about a malfunctioning device. Read More