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LivaNova Receives FDA Premarket Approval for to treat Moderate to Severe Obstructive Sleep Apnea

2 weeks 6 days ago

Hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language. The next-generation, MRI-compatible device is expected to launch in the first half of 2027, pending FDA supplement review.

The post LivaNova Receives FDA Premarket Approval for to treat Moderate to Severe Obstructive Sleep Apnea appeared first on MedTech Intelligence.

Rich West

Perfuze Receives FDA 510(k) Clearance for Millipede88 Aspiration Catheter

2 weeks 6 days ago

Perfuze states the Millipede88 is the first 088 aspiration catheter with patented corrugated technology cleared for standalone direct aspiration — no large-bore intermediary required — backed by independently adjudicated MARRS study data showing a 77% first-pass effect1 in M1 occlusions and 96% delivery success.

The post Perfuze Receives FDA 510(k) Clearance for Millipede88 Aspiration Catheter appeared first on MedTech Intelligence.

Rich West