08 October 2024
Medical technology company, Occuity, has secured CE marking for its handheld non-contact optical pachymeter, the PM1 Pachymeter.
The portable device measures central corneal thickness quickly, with a target accuracy of ±10 microns, and does not require the use of anaesthetic eye drops or physical contact with the eye.
The CE marking confirms that the PM1 complies with the safety, health, and environmental standards required for the European Economic Area.
This paves the way for distribution across Europe and globally, the company has said.
Dr Dan Daly, co-founder and CEO of Occuity, commented: “It has been a long and, at times, challenging road to get approval, but we are thrilled that our team’s hard work has paid off. The CE marking is a significant achievement for Occuity, and we are excited to now begin supplying the PM1 to professionals across Europe and beyond via our well-developed network of distributors.”
Describing the PM1 as a “gamechanger,” Daly said: “We are confident that it will greatly enhance the experience of both clinicians and patients alike.”
Occuity has suggested the device could be a tool for intraocular pressure refinement in glaucoma screening, and could also be used in refractive surgery clinics, keratoconus screening, and myopia management.
The PM1 has been tested in clinical trials led by Professor John Lawrenson and his team at City St George’s University of London, in collaboration with optometrists from Moorfields Eye Hospital. The trials validated the device as a safe alternative to traditional ultrasound pachymetry, Occuity said.
Birmingham Optical is the distributor for Occuity’s PM1 in the UK and to celebrate the CE marking, is offering a £500 discount on the first 50 PM1s shipped.
Amanda Higginbotham, chief commercial officer at Birmingham Optical, said: “We anticipate that the PM1 will be widely used in various clinical settings, from general ophthalmic practice to refractive surgery and cataract clinics. Its non-contact nature and portability make it a versatile tool that can revolutionise how pachymetry is conducted.”
Occuity has said its next product to launch will be the AX1 Axiometer, a handheld optical biometer designed for myopia management.
Looking further ahead, the company is working on a “pipeline of products” aimed at non-invasive screening and monitoring for conditions such as diabetes and Alzheimer’s disease.
Pictured: Occuity co-founders, Dr Robin Taylor, chief technology officer, and Dr Dan Daly, CEO.
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