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Angel Medical Systems, a device company that offers an implantable cardiac monitoring and alerting system, was hit with a Form 483 for corrective and preventive action (CAPA) and documentation lapses observed during a March inspection of its Eatontown, N.J., facility. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) announced strategic priorities for 2022 to 2025 earlier this year that will mean some challenges as well as potential benefits for devicemakers, including increased attention to diversity in clinical trials, according to one prominent regulatory attorney. Read More
Many digital health startups have the online sizzle without the clinical evidence steak, suggests a new study that shows fewer than half of companies surveyed have ever reached the point of clinical trials or regulatory filings. Read More
Finland-based Medix Biochemica is strengthening its presence in the in vitro diagnostic (IVD) market with the purchase of Bioresource Technology for an undisclosed sum. Read More
Carthera, a French medtech company that makes ultrasound-based medical devices to treat brain disorders, has earned the FDA’s Breakthrough Device designation for its SonoCloud-9 system. Read More
The FDA offers recommendations on nonclinical assessments of containment systems used with laparoscopic power morcellators (LPMs) — including testing for permeability, burst strength and leakage — in a new draft guidance. Read More
Establishing operational limits is a key issue to consider. These are the limits that are obtained during the operational qualification (OQ) testing over the expected operating range. So, for instance, this applies to equipment and cleaning practices over the expected range, the history or the variety of products that you’re running. Read More
A new study evaluating Cardiologs’ deep learning tool for identifying patients at risk for atrial fibrillation (AFib) showed that it outperformed regular 12-lead electrocardiogram (ECG) testing. Read More