Regulatory Approvals

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

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 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...

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 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...

Chepstow, 13 November 2023 – IQ Endoscopes is delighted to announce that it has achieved UKCA regulatory approval on its first product, the Q Vision...

The system has been approved after receiving a favourable recommendation from the FDA Advisory Committee Panel. Recor Medical, along with its parent company Otsuka Medical...