Regulatory Approvals

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...

Creo Medical to launch UltraSlim device 18 months ahead of schedule

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...

Chordate Medical Secures EU Trademark Registration for Ozilia®

Chordate Medical has obtained the registration of the trademark Ozilia® in the EU from EUIPO (EU Intellectual Property Office) in trademark classes 9 and...

Positive six-month follow-up results for Recor’s renal denervation system

Recor Medical has followed up its US Food and Drug Administration (FDA) approval of its Paradise ultrasound renal denervation system earlier this year with...
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