Boston Scientific’s SCS leads linked to 1,081 serious injuries in FDA alert
The US Food and Drug Administration (FDA) has issued an alert over Boston Scientific’s recall of a lead kit used …
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FDA rallies HRT manufacturers amid US-wide estradiol patch shortage
The US Food and Drug Administration (FDA) has started working with six drug-device manufacturers involved in the production of transdermal …
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WHO greenlights Cepheid’s Ebola diagnostic amid ongoing Bundibugyo outbreak
Cepheid’s haemorrhagic fever panel has become the fourth diagnostic for detecting the Bundibugyo (BVD) Ebola virus strain to receive an …
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Globus Medical’s Excelsius3D imaging system receives CE mark
Globus Medical has secured the CE mark for its Excelsius3D imaging system, clearing the way for commercial sales of the …
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HR HealthCare rolls out Liv catheter for female self-catheterisation
US-based HR HealthCare has launched the Liv Pre-lubricated Intermittent Catheter, a device developed to support women managing their bladder health …
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FDA clears Heartvue’s cardiac image evaluation software
Heartvue.ai’s machine learning–powered software for cardiovascular magnetic resonance image (MRI) evaluation and analysis has secured US Food and Drug Administration …
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Podcast: A Q4 preview from Medical Device Network
Summer is officially behind us and we're turning our attention to Q4. Here's a sneak peek of what we have …
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IVL adoption grows, but consistency remains the real test
Intravascular lithotripsy (IVL) is moving into routine interventional cardiology practice, but adoption is still shaped by practical constraints. IVL uses …
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Elucid raises $55m to advance cardiovascular diagnostic portfolio
Elucid has raised $55m to further develop its artificial intelligence (AI)-based cardiovascular imaging platform and support preparations for the anticipated …
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FDA clears Hamamatsu NanoZoomer S20MD and S540MD slide scanners
Hamamatsu Photonics has received 510(k) approval from the US Food and Drug Administration (FDA) for its NanoZoomer S20MD and NanoZoomer …
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PixCell Medical and Inter Medico to distribute HemoScreen across Canada
PixCell Medical has entered the Canadian market through a new distribution agreement with Inter Medico, following the granting of a …
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Flosonics awarded $70m BARDA contract for wearable’s advance into trauma care
Flosonics has won a contract worth up to $70m from the US Department of Health and Human Services’ (HHS) Biomedical …
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Inside Huawei’s next health play: turning wearables into medical research
Huawei’s health ambitions are moving beyond the smartwatch. At the European Society of Cardiology Congress (ESC) in Munich, the Chinese …
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Vara nets first CE mark for autonomous AI breast cancer screening tool
Vara has secured a European CE mark for an autonomous, artificial intelligence (AI)-powered breast cancer screening triage tool – marking …
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Health Canada issues licences to Fujirebio’s Lumipulse assays
HU Group Holdings’ wholly owned subsidiary Fujirebio has received Class II Medical Device Licences from Health Canada for its Lumipulse …
