Boston Scientific touts 65% efficacy for Farapulse PFA in persistent AF trial
Boston Scientific has shared efficacy data for its Farapulse pulsed-field ablation (PFA), recording 65% efficacy for the system at one …
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ProSomnus secures FDA clearance for RPMO2 device
ProSomnus Sleep Technologies has received the US Food and Drug Administration (FDA) Class II 510(k) clearance for its RPMO₂ OSA …
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Heartflow sues Cleerly over patent infringement allegations
Heartflow has filed a lawsuit against Cleerly, alleging that three of the Texas-based company’s artificial intelligence (AI)-based tools for coronary …
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J&J reports 12-month data for Varipulse PFA platform
Johnson & Johnson (J&J) has reported interim 12-month results from the VARIPURE study, assessing the effectiveness and safety of its …
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Stryker agrees to acquire IVL developer Amplitude Vascular Systems
Stryker has agreed to acquire Amplitude Vascular Systems (AVS) in a move to broaden the medtech giant’s vascular care portfolio …
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Beckman Coulter obtains CE mark for bacterial-viral differentiator test
Beckman Coulter Diagnostics has obtained a European CE mark for the use of its laboratory test designed to distinguish between …
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Roche’s Elecsys NfL test earns CE mark for multiple sclerosis detection
Roche has received CE mark approval of its Elecsys neurofilament light chain (NfL) test, which is designed to detect neuroinflammation …
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Zebra Technologies and Aiva Health team up on nurse solutions
Zebra Technologies and Aiva Health have collaborated to support hands-free nurse workflows with Aiva's AI-powered solution. This partnership integrates Aiva’s AI-based …
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Dreem Health joins Amazon’s Health Benefits Connector
Sunrise Group’s Dreem Health, a virtual sleep clinic for the treatment and evaluation of conditions such as sleep apnoea, has …
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Boehringer hands over $50m and market rights for Click’s digital therapeutic
Boehringer Ingelheim and Click Therapeutics have shifted the dynamic of their long-term collaboration, which will see Click take the commercialisation …
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Waters lands FDA clearance for at-home cervical cancer screening kit
The US Food and Drug Administration (FDA) has cleared Waters Corporation’s Onclarity human papillomavirus (HPV) self-collection kit in a development …
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FDA clears Sibel Health’s ANNE Maternal wireless system
Sibel Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for ANNE Maternal, a wireless maternal-foetal …
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GE HealthCare and Medtronic integrate bkActiv iUS and Stealth AXiS system
GE HealthCare has integrated its bkActiv intraoperative ultrasound (iUS) system with Medtronic's Stealth AXiS surgical navigation system to provide imaging …
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Medline hit with FDA warning letter over angiographic syringe manufacturing failures
The US Food and Drug Administration (FDA) has issued a warning to Medline over deficiencies relating to the company’s angiographic …
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MiRus treats first patients in STAR trial of Siegel 8-French heart valve
MiRus has enrolled and treated the first patients in the Siegel transcatheter aortic valve replacement (STAR) trial evaluating the Siegel …
