UroMems eyes regulatory filings for SUI treatment after $60m fundraise
UroMems has raised $60m, priming the French company to complete a pivotal trial of its stress urinary incontinence (SUI) treatment, …
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AngioDynamics reports PRESERVE trial results for NanoKnife system
AngioDynamics has reported two-year findings from the PRESERVE pivotal trial, showing durable outcomes for the NanoKnife irreversible electroporation (IRE) system …
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Revvity secures FDA clearance for total testosterone immunoassay
Revvity has received clearance from the US Food and Drug Administration (FDA) for its total testosterone automated chemiluminescence immunoassay (ChLIA) …
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Rivermark pockets $20m in Series D for late-stage prostate device trial
Wisconsin-based medtech Rivermark Medical has secured $20m in a Series D financing round – supporting the company’s late-stage clinical activities …
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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 …
