Regulatory Approvals

Singaporean startup Respiree gets US FDA 510(k) for respiration monitor

Singaporean startup Respiree gets US FDA 510(k) for respiration monitor Respiree, a med tech spinoff of Singapore's Agency for Science, Technology and Research, has obtained...

FDA clears Essenz heart-lung machine from LivaNova

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...

Coreline Soft bags FDA 510(k) for AI lung cancer detection software

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...

Irish firm’s tinnitus treatment approved for US market

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 Milestones 

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...

FDA clears surgical robot from Noah Medical

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...

Theranica receives FDA 510(k) for migraine prevention device

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...

FDA clears Elekta’s radiation therapy automation

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 Enhances Pulmonary Embolism Care Solution with FDA 510(k) Clearance for Rapid RV/LV

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...
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