Second Class I recall in a month for Getinge’s troubled Cardiosave IABPs
More electrical failures mean the devices could unexpectedly shutdown, leaving patients without heart pumping-assisted therapy.
18 August 2023
18 August 2023
More electrical failures mean the devices could unexpectedly shutdown, leaving patients without heart pumping-assisted therapy.
The FDA OK follows a clinical study demonstrating significant improvement in symptoms in women with urge urinary incontinence.
FDA identifies a class I recall of Abiomed’s labelling for Impella RP Flex with SmartAssist following of blood clot risks.
The acquisition follows the company's aims of expanding its infrastructure and capitalising on market opportunities.
The VisiRad XR software sends images with AI-detected lesions back to radiologists within their usual viewing setup.
The Nightingale kit and self-collection device enable trial participants to draw their own blood sample from a finger-prick.
Nemaura has filed a PMA with the US FDA for the flexible CGM device.
The test attained an overall performance statistic of 0.94 AUC and 88% accuracy in a study involving two independent cohorts.
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Per GlobalData estimates, the precision and personalized medicine market is expected to achieve a CAGR of more than 43% between 2022 and 2029. The digital transformation of the healthcare industry is driving the market demand. For example, advances in biomarker testing with NGS are improving patient selection, use of AI in identifying trends in big datasets is accelerating the time from drug discovery to commercialization, and the use of Industry 4.0 technologies is improving the quality and efficiency of manufacturing complex drugs such as cell and gene therapies.
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