London, UK – April 21, 2022 – Element Materials Technology (Element) has acquired Clinimark, a global leader for clinical FDA validation testing of vital sign data for medical and home health devices, and consumer wearable products.
Based in Louisville, Colorado on the campus of Avista Adventist Hospital, the team of 20 doctors, engineers, nurses, and scientists are world leading experts in the clinical validation of two important vital sign measurements: pulse oximetry (oxygen saturation) testing and invasive and non-invasive blood pressure.
Clinimark provides services that bridge the gap between generic consumer health products and FDA approved medical devices. This includes consumer electronics/wearables, digital health, and home health/wellness platforms. Clinimark performs the clinical testing and FDA regulatory validation for vital sign data (including pulse oximetry and blood pressure) that has been incorporated into these devices.
Using their strong engineering and technical expertise and actively participating in product development with many of its clients, Clinimark has developed proprietary devices for both pulse oximetry and blood pressure testing that have helped contribute to a 100% success rate in submissions to all regulatory bodies in the US, Europe, and Asia.
Rick Sluiters, Executive Vice President Americas at Element, said: “Consumer health devices sold over the counter are increasingly driving innovation and faster product cycles in the medical devices market, and there has been significant growth of both consumer and medical device wearables that measure and collect vital sign health data. Most major consumer wearable companies either already have, or are pursuing, devices that track pulse oximetry and blood pressure.
“The acquisition of Clinimark gives us the opportunity to broaden our support to connected technologies and life sciences customers throughout the value chain, while giving us exposure to the clinical testing side of the medical device world. Life sciences is now the largest end-market we serve at Element, and the acquisition of Clinimark further strengthens our position and the breadth of our service provision to customers.”
Paul Batchelder, Chief Clinical Officer at Clinimark, said: “The large upsurge in development of new vital sign technologies will soon reach far beyond the medical care environment to all areas of life, including the military, athletes and beyond. This is seen in the expansion from traditional table top monitors to headbands, bracelets, clothing and touchless cameras in tablets. Joining with Element provides the synergy needed for Clinimark to meet the pent-up demand for complex specialized testing of these exciting new concepts.”
In addition to pulse oximetry and blood pressure testing, Clinimark supports validation testing of other vital sign measurement areas including respiratory rate, heart function, and sleep apnea.
The Clinimark acquisition follows Element’s other recent life sciences acquisitions including JMI Laboratories, Avomeen, Arch Sciences, Impact Analytical, Orthokinetic, and Nanosyn.
Clinimark received financial advisory from ClearCreek Partners.
The Element Materials Technology Group is one of the world’s leading global providers of testing, inspection and certification services for a diverse range of products, materials and technologies in advanced industrial supply chains where failure in use is not an option. Headquartered in London, UK, Element’s c 7,000 scientists, engineers and technologists, working in our global network of over 200 laboratories, support customers from early R&D, through complex regulatory approvals and into production ensuring their products are safe, sustainable and achieve market access.
In 2021, Element set out its new, industry leading environmental commitments, adopting science-based targets and committing to net zero emissions across its entire global business by 2035. These environmental commitments follow Element’s achievement of the highest ESG ranking in the testing, inspection and certification industry from Sustainalytics, a global leader in ESG research and data.
Devan LaBrash, Pagoda Public Relations
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