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Auxilium’s 3D printer builds medical devices on the International Space Station
Via a collaboration with Nasa, Auxilium has installed a 3D printer on the ISS to test the promise of manufacturing in ...
Patients using diabetes apps can miss critical alerts. Here’s how to make sure you’re getting them
U.S. officials are warning about a potentially life-threatening issue with smartphone apps that help manage diabetes.
MassDevice14h
FDA clears AI 3D head, neck imaging tech from RapidAI
RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.
Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, ...
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
Interesting Engineering19h
US FDA approves first-ever smart glasses with hearing aid for mild to moderate loss
EssilorLuxottica's Nuance Audio Glasses receive FDA clearance for OTC sales in the US, revolutionizing hearing solutions with ...
stockhead1d
Biocurious: EBR Systems is on a ‘glide path’ to FDA approval for its novel heart device
EBR Systems is super confident the US medical gatekeeper will approve Wise, the world's first wireless pacemaker device.
medtechdive1d
Medtronic recall of brain fluid drainage systems linked to 15 injuries
The company will keep the systems on the market but is asking providers to check devices for visible cracks and return ...
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EssilorLuxottica wins FDA clearance and EU approval for OTC audio glasses
EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing ...
JD Supra2d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Medical Device Makers Seek Exemption From Trump Tariffs
Medical device makers including Abbott, Johnson & Johnson and Medtronic want an exemption from Trump tariffs that could hit ...
Trump tariffs could raise medication costs and exacerbate shortages
AdvaMed, the largest medical device association globally, urged the Trump administration to exempt medical products from the ...