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 …
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CorTec gains FDA breakthrough designation for stroke rehabilitation BCI
CorTec’s brain-computer interface (BCI) has obtained breakthrough device designation from the US Food and Drug Administration (FDA) for use in …
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MHRA secures $4.8m to expand AI medical device programme
The Medicines and Healthcare products Regulatory Agency (MHRA) has secured a £3.6m ($4.8m) funding increase over three years to expand …
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FDA approves Endospan’s aortic stent
Israel’s Endospan has received US Food and Drug Administration (FDA) approval for the NEXUS aortic graft stent system, priming the …
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Route 92 Medical raises $50m to support growth strategy
Route 92 Medical has secured $50m in financing to support the next phase of its growth strategy. New investor Sectoral Asset …
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E2 raises $80m to advance VTE system’s commercialisation
Endovascular Engineering (E2) has raised $80m to advance commercialisation efforts for Hēlo, a platform for venous thromboembolism (VTE) treatment. The California-based …
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J&J advances PFA portfolio with Varipulse Pro launch in Europe
Johnson & Johnson (J&J) has launched Varipulse Pro in Europe after securing CE Mark approval, strengthening its pulsed field ablation …
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TRiCares gains FDA IDE to initiate tricuspid regurgitation treatment pivotal trial
TRiCares has been granted an investigational device exemption (IDE) by the US Food and Drug Administration (FDA) to initiate a …
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Egg Medical unveils new radiation protection system for clinical use
Egg Medical has introduced EggNest Complete Flex, a new radiation protection system designed for use in clinical settings without requiring …
