Regulatory Approvals

NeuroOne secures FDA clearance for OneRF ablation system

The US Food and Drug Administration (FDA) has cleared NeuroOne’s radiofrequency ablation system, with a rollout of the device expected by the company in...

BD receives clearance for new blood collection device

Becton, Dickinson and Company (BD) has obtained 510(k) clearances from the US Food and Drug Administration (FDA) for its new fingertip blood collection device,...

Biospectal obtains CE mark for blood pressure monitoring app

Biospectal has obtained European CE MDR Class IIa medical device certification for its OptiBP optical fingertip blood pressure monitoring app. OptiBP is claimed to be...

Exactech wins clearance for new ankle surgery navigation system

(Image Credit: Business Wire) Exactech announced today that its BlueOrtho subsidiary has received FDA 510(k) clearance for ExactechGPS Ankle.The Gainesville, Florida–based company described the...

ABK Biomedical obtains breakthrough designation for microspheres device

ABK Biomedical has received breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its Eye90 microspheres Y90 radioembolisation device. This designation...

Monarch surgical robot earns regulatory approval in China

Johnson & Johnson MedTech’s Monarch platform and Monarch bronchoscope obtained regulatory approval in China. Approval makes Monarch the first minimally-invasive, robotic-assisted technology approved for peripheral lung...

ScandiDos quality system receives MDR certification

ScandiDos, a provider of patient-specific quality assurance solutions, has attained certification under the European Union Medical Device Regulation (MDR) for its quality system and...

AWAK obtains breakthrough device designation for KDPP tool

AWAK Technologies has obtained breakthrough device designation from the US Food and Drug Administration for its AI-enabled kidney disease progression prediction (KDPP) tool. The KDPP model helps...

Supira receives FDA breakthrough device designation for ventricular assist device

Supira Medical, a company of medical technology incubator Shifamed, has received the US Food and Drug Administration (FDA) breakthrough device designation for its Supira...
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