Regulatory Approvals

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...

IQ Endoscopes receives UKCA regulatory approval for its first generation gastroscope

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

Recor Medical receives FDA approval for hypertension treatment system

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...

AliveDx secures IVDR certification for sites in UK and Switzerland

Two manufacturing facilities across Europe have received IVDR certification following the transition away from IVDD. Switzerland-based vitro diagnostic company AliveDx has announced it received an...

Smileyscope secures FDA clearance for VR device in acute pain relief

The device, which replaces needle pricks with fish nibbles, is part of a global VR market estimated to be worth $51bn by 2030. The US...

Neurovalens wins FDA clearance for insomnia device

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Neurovalens’s Modius Sleep, a device used to treat chronic insomnia. The Belfast-based company...
1...585960...113Page 59 of 113

Latest articles