Podcast: MHRA CEO Lawrence Tallon on the future of medical device regulation in the UK
Since taking over from Dame June Raine as CEO of the Medicines and Healthcare products Regulatory Agency (MHRA) in April …
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Embecta acquires Owen Mumford for $172.6m
Embecta has completed its acquisition of UK-based medical device manufacturer Owen Mumford Holdings in a deal valued at up to …
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Valar Labs hits US first with breakthrough designation for AI bladder cancer test
Valar Labs’ Vesta Bladder Risk Stratify Dx has secured breakthrough device designation from the US Food and Drug Administration (FDA), …
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PainTEQ announces US launch of SI joint implant
PainTEQ has announced the commercial launch of TRAQ, an implant developed for posterior sacroiliac (SI) joint fusion, in the US. The …
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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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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 …
