FDA greenlights OrthAlign’s handheld Lantern Hip navigation system
OrthAlign has expanded its portfolio of Lantern handheld navigation systems by securing a 510(k) clearance from the US Food and …
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Medtronic shares dip after FDA tags insulin pump recall as Class I
The US Food and Drug Administration (FDA) has issued a Class I tag to Medtronic’s recall of its MiniMed insulin …
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NHS launches study of newborn blood test to detect 200 rare conditions
England’s National Health Service (NHS) has kick started a study which will screen up to 100,000 newborn babies for over …
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FDA clears FluMist nasal influenza vaccine for self-administration
The US Food and Drug Administration (FDA) has given the green light for market clearance to AstraZeneca’s nasal spray vaccine …
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WHO approves Abbott’s mpox test for emergency use
The World Health Organization (WHO) has approved Abbott Molecular’s mpox diagnostic test, Alinity m MPXV assay, for emergency use. This first …
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Myriad and Ultima to study UG 100 sequencing platform for genomics clinical tests
Myriad Genetics has announced a collaboration with Ultima Genomics to evaluate the potential of the UG 100 sequencing platform and …
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Amphix Bio obtains FDA breakthrough device status for bone regeneration product
Amphix Bio has received a breakthrough device designation from the US Food and Drug Administration (FDA) for its drug-device combination …
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Microbix receives EU accreditations for diagnostic products
Life sciences manufacturer Microbix Biosystem has announced upgrades to its European Union (EU) regulatory compliance for its diagnostic assay quality …
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IoT Medical Device Companies & Manufacturers
The increase in demand for wearable devices that measure various health parameters such as heart rate, oxygen levels, blood pressure …
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Homecare Companies for the Medical Device Industry
Homecare companies and medical devices help in improving patient health outcomes and add value to the health system by facilitating …
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Positrigo announces CE mark for NeuroLF PET system
Zurich-based nuclear medical imaging device firm Positrigo’s positron emission tomography (PET) system, NeuroLF, has acquired market authorisation from the European …
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Elucid scoops FDA approval for AI cardiovascular risk diagnostic
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Elucid’s PlaqueIQ, an AI-powered image analysis software designed …
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Medical Device Cybersecurity Companies, Solutions & Services
Digitally compatible medical devices are at risk of cyberattacks, which can interfere with how they operate, harm patient health or …
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Owkin and AstraZeneca to develop AI tool for breast cancer testing
Owkin has announced a partnership with AstraZeneca to create an AI gBRCA pre-screening solution designed to identify mutations in breast …
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FDA approves BioIntelliSense’s BioButton wearable for patient monitoring
BioIntelliSense has received approval from the US Food and Drug Administration (FDA) for its BioButton Multi-Patient wearable and BioDashboard system …
