J&J launches Shockwave C2 Aero catheter for calcified CAD treatment
Johnson & Johnson (J&J) has globally launched its Shockwave C2 Aero coronary IVL catheter, developed to improve deliverability, lesion crossing, …
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Roche’s Elecsys pTau217 blood test secures CE mark for Alzheimer’s
Roche has secured CE mark for the Elecsys pTau217 blood test, developed alongside Eli Lilly, for detecting Alzheimer's disease pathology. The …
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Makary resigns, with Diamantas named as acting FDA commissioner
Following news that started brewing last week, Dr Marty Makary has officially resigned from his post as commissioner of the …
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Bayesian Health secures first FDA clearance for AI-driven continuous sepsis monitor
The US Food and Drug Administration (FDA) has cleared Bayesian Health’s continuous artificial intelligence (AI)-driven sepsis monitor, making the device …
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Biozen secures FDA 510(k) clearance for BP1000 device
Biozen has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its BP1000 device, a calibration-free, cuffless …
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HeartBeam commences pilot study of new 12-lead ECG patch
HeartBeam has initiated a pilot study to evaluate its on-demand 12-lead electrocardiogram (ECG) patch in patients with suspected coronary artery …
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WhiteSwell’s heart failure device promising but patient death rattles results
WhiteSwell has debuted promising early data from a feasibility study on its eLym system in acute decompensated heart failure (ADHF), …
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Latest foreign investment in UK highlights underserved potential of primary care technology
European digital health supplier Doctolib has acquired NHS GP technology supplier Medicus as part of a wider UK expansion strategy …
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SQ Innovation’s home care oedema treatment shows benefit in new data readout
SQ Innovation’s Lasix Onyu, a drug-device combination therapy for fluid retention (oedema) treatment in chronic heart failure patients, has demonstrated value …
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DoJ prioritising enterprise-wide fraud in medtech industry
The US Department of Justice (DoJ) is tightening its focus on identifying fraud – with a particular focus on enterprise-wide …
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Alpha Tau concludes patient enrolment in ReSTART pivotal trial
Alpha Tau Medical has completed patient enrolment in its ReSTART pivotal trial, assessing the efficacy and safety of its Alpha …
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The road to precision medicine in the cardiovascular field
With the rise of technology in the cardiovascular field, there has been a move towards devices that are smaller and …
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CoMira concludes lease agreement for plant in Sudair Industrial City, Saudi Arabia
Co-Diagnostics' joint venture (JV) CoMira Diagnostics has completed a lease agreement for its planned manufacturing facility in the Kingdom of Saudi …
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FDA clears Bright Uro’s abdominal sensor for evaluating bladder dysfunction
Bright Uro’s Glean abdominal sensor has obtained US Food and Drug Administration (FDA) clearance, expanding the company’s broader Glean urodynamics system …
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FDA greenlights Rivanna’s AI musculoskeletal imaging system
Rivanna’s Accuro XV has secured US Food and Drug Administration (FDA) clearance, setting the stage for the artificial intelligence (AI)-based …
