伦敦, 英国- 4月21日, 2022 – im体育APP Materials 技术 (im体育APP) has acquired Clinimark, a global leader for clinical FDA validation testing of vital sign data for medical 和 home health devices, 和 consumer wearable products.
总部设在路易斯维尔, Colorado on the campus of Avista Adventist Hospital, 由20名医生组成的团队, 工程师, 护士, 和 scientists are world leading experts in the clinical validation of two important vital sign measurements: pulse oximetry (oxygen saturation) testing 和 invasive 和 non-invasive blood pressure.
Clinimark provides services that bridge the gap between generic consumer health products 和 FDA approved medical devices. This includes consumer electronics/wearables, digital health, 和 home health/wellness platforms. Clinimark performs the clinical testing 和 FDA regulatory validation for vital sign data (including pulse oximetry 和 blood pressure) that has been incorporated into these devices.
Using their strong engineering 和 technical expertise 和 actively participating in product development with many of its clients, Clinimark has developed proprietary devices for both pulse oximetry 和 blood pressure testing that have helped contribute to a 100% success rate in submissions to all regulatory bodies in the US, 欧洲, 和亚洲.
里克Sluiters, Executive Vice President Americas at im体育APP, said: “Consumer health devices sold over the counter are increasingly driving innovation 和 faster product cycles in the medical devices market, 和 there has been significant growth of both consumer 和 medical device wearables that measure 和 collect vital sign health data. Most major consumer wearable companies either already have, 或者是在追求, devices that track pulse oximetry 和 blood pressure.
“The acquisition of Clinimark gives us the opportunity to broaden our support to connected technologies 和 life sciences customers throughout the value chain, while giving us exposure to the clinical testing side of the medical device world. 生命科学 is now the largest end-market we serve at im体育APP, 和 the acquisition of Clinimark further strengthens our position 和 the breadth of our service provision to customers.”
保罗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, 包括军队, 运动员及其他人士. This is seen in the expansion from traditional table top monitors to headb和s, 手镯, clothing 和 touchless cameras in 平板电脑. Joining with im体育APP provides the synergy needed for Clinimark to meet the pent-up dem和 for complex specialized testing of these exciting new concepts.”
In addition to pulse oximetry 和 blood pressure testing, Clinimark supports validation testing of other vital sign measurement areas including respiratory rate, 心脏功能, 和 睡眠 呼吸暂停.
The Clinimark acquisition follows im体育APP’s other recent life sciences acquisitions including JMI Laboratories, Avomeen, Arch Sciences, Impact Analytical, Orthokinetic, 和 Nanosyn.
Clinimark received financial advisory from ClearCreek Partners.
关于im体育APP
The im体育APP Materials 技术 Group is one of the world’s leading global providers of testing, inspection 和 certification services for a diverse range of products, materials 和 technologies in advanced industrial supply chains where failure in use is not an option. Headquartered in 伦敦, UK, im体育APPc 7,000名科学家, 工程师 和 technologists, working in our global network of over 200 laboratories, support customers from early R&D, through complex regulatory approvals 和 into production ensuring their products are safe, sustainable 和 achieve market access.
In 2021, im体育APP set out its new, industry leading environmental commitments, adopting science-based targets 和 committing to net zero emissions across its entire global business by 2035. These environmental commitments follow im体育APP’s achievement of the highest ESG ranking in the testing, inspection 和 certification industry from Sustainalytics, a global leader in ESG research 和 data.
For more information about im体育APP, please visit our website, connect with us on LinkedIn 和 推特 并订阅我们的 Youtube 通道.
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