FDA clears Glooko’s cloud-based insulin dosing platform
Glooko has secured US Food and Drug Administration (FDA) clearance for EndoTool IV Cloud, priming the cloud-based insulin dosing platform …
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Butterfly Medical raises $21m in funds for BPH device development
Butterfly Medical has raised $21m in Series C funding for the development and potential commercialisation of its minimally invasive device …
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Biopharma industry endorses Pazdur for FDA commissioner role
With the leadership role of the US Food and Drug Administration (FDA) vacant following Marty Makary’s resignation earlier this week, …
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BlueWind Medical raises $47.8m to advance commercialisation efforts for UUI treatment
BlueWind Medical has raised $47.8m to expand commercialisation of its implantable tibial neuromodulation (iTNM) system for urge urinary incontinence (UUI) treatment. Originating …
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Ardent Health and Fujifilm team up for Synapse enterprise imaging rollout
Ardent Health has partnered with Fujifilm Healthcare to bring Synapse enterprise imaging solutions to its acute care hospitals across six …
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UK health secretary Wes Streeting resigns
UK health secretary Wes Streeting has resigned, citing a ‘loss of faith’ in the Labour party’s leadership under Prime Minister …
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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 …
