Regulatory Approvals

Epiminder’s implantable EEG system for epilepsy receives FDA authorisation

Australia-based company Epiminder has received Food and Drug Administration (FDA) authorisation through the De Novo classification for its implantable continuous electroencephalogram (EEG) monitoring system...

Sanoculis wins CE mark for minimally invasive glaucoma treatment device

Sanoculis received CE mark for its MINT (minimally invasive nasal trabeculostomy) product. MINT, a stent-free platform, helps treat adult patients undergoing glaucoma angle surgery....

LUMA Vision nets FDA clearance for 4D imaging catheter

The US Food and Drug Administration (FDA) has cleared LUMA Vision’s Verafeye catheter-based imaging system. Verafeye is a four-dimensional (4D), ultrasound-based cardiac visualisation and navigation...

EBR Systems wins FDA nod for leadless cardiac pacing device for heart failure

EBR Systems announced that it received FDA approval for its wireless cardiac pacing device for heart failure. The FDA approved its WiSE cardiac resynchronization...

CeriBell earns FDA nod for pediatric seizure detection software

CeriBell received FDA 510(k) clearance for its next-generation Ceribell Clarity algorithm. Clarity detects electrographic seizures in patients ages one and older. The company says...

DESKi wins FDA clearance for HeartFocus AI heart exam software

DESKi announced FDA clearance of HeartFocus, its AI-enabled heart exam software. Bordeaux, France–based DESKi says it only takes a few hours of training for any...

Bruno Vision Care receives FDA approval for Deseyne Contact Lens with FusionTechnology

Bruno Vision Care, a leader in eye care innovation, received FDA approval to sell its Deseyne® (vifilcon C) daily disposable contact lens with FusionTechnology...

FDA grants 510(k) clearance to Turbett Surgical’s Instrument Pods

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Turbett Surgical’s improved line of Instrument Pods, notably the TS1500, TS1200, and...

FDA clears first stapler for single-port robotics from Intuitive

Intuitive received FDA clearance for its fully wristed SP SureForm 45 stapler. The stapler works with the surgical robotics leader’s da Vinci SP surgical system in...
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