Regulatory Approvals

LivaNova (Nasdaq:LIVN) announced that it received FDA 510(k) clearance for its Essenz heart-lung machine (HLM). With clearance, the London-based company initiated its U.S. commercial launch...

The approval marks its entry into the $160-billion US medical device market. South Korean medtech firm Coreline Soft has obtained the United States Food and Drug Administration's...

Neuromod Device’s treatment is first of its kind signed off by US regulators A tinnitus treatment developed by Irish company Neuromod Devices has been granted...

Nyxoah Announces Achievement of Key Clinical and Regulatory MilestonesAll 115 patients implanted in DREAM U.S. pivotal studyFirst DREAM PMA module submittedFirst patient implanted in...

Noah Medical announced that it received FDA clearance for its Galaxy System for robotic-navigated bronchoscopy. San Carlos, California-based Noah Medical designed Galaxy and its accessories to...

The company had previously received FDA clearance to use its prescription wearable to treat migraines at onset. Prescription digital therapeutic developer Theranica announced it has received FDA...

Elekta (Stockholm:EKTA-B) says an FDA 510(k) clearance represents a new era in precision radiation therapy to treat cancer in the U.S. The Sweden-based cancer and...

RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, announced it has received FDA 510(k) clearance for Rapid...

Medasense Biometrics Ltd. announced that  the U.S. Food and Drug Administration (FDA) has granted marketing authorization to the PMD-200 patient monitor with NOL® technology developed...