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...
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...
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...
Creo Medical’s Speedboat UltraSlim to hit the market in early 2024 following guidance from EU regulator.
UK-based company Creo Medical is planning the launch of...
