Regulatory Approvals

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...

Pixyl secures FDA approval for AI-based brain MRI software Pixyl.Neuro

French medical technology company Pixyl has received the US Food and Drug Administration (FDA) 510(k) approval for its next-generation AI software, Pixyl.Neuro, for brain...

Masimo medical watch gets clearance for prescription and OTC use

Masimo has obtained US Food and Drug Administration (FDA) 510(k) clearance for prescription (Rx) and over-the-counter (OTC) use of its Masimo W1 medical watch. Masimo W1 is...

Ethicon receives CE mark for haemostatic sealing patch

Johhnson & Johnson MedTech company Ethicon has obtained CE mark approval for its adjunctive haemostatic sealing patch, ETHIZIA. It was approved as an adjunctive haemostat for disruptive...

Zynex seeks FDA approval for M-Wave NMES device

Zynex has submitted a 510(k) application seeking approval from the US Food and Drug Administration (FDA) for its M-Wave Neuromuscular Electrical Stimulation (NMES) device. The M-Wave is...
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