Shareholders of KOSDAQ-listed Lunit have recently participated in the company's recent capital raise, paying-in $150 million to fund its development of "next-generation" products and further expansion in the West.
Meanwhile, the AI cancer diagnostics solutions provider obtained its third 510(k) clearance from the United States Food and Drug Administration.
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In a company disclosure,...
Singapore-based medtech Aevice Health has received undisclosed funding from venture capitalist East Ventures for its expansion in Southeast Asia.
It has also announced that its flagship product, the smart wearable stethoscope AeviceMD, has been given a 510(k) clearance by the United States Food and Drug Administration.
AeviceMD is part of the AeviceMD Monitoring System, a patient management...
U.K.-based digital health tech company Huma has received FDA 510(k) Class II clearance for its configurable disease-agnostic Software as a Medical Device platform, which includes the company's cardiovascular risk score algorithm.
The company, which received EU MDR Class IIb certification just three months ago, obtained FDA clearance in partnership with Health Canada through the FDA's joint eStar...
Dozee scores 510(k) for AI contactless sensor for RPM
Indian medical device company Dozee has received the United States Food and Drug Administration's 510(k) clearance for its proprietary contactless sensor for remote patient monitoring.
The Dozee sensor sheet, which is placed under a hospital bed mattress, captures micro-vibrations from patients using Ballistocardiography. These vibrations are...
Singular Health scores 510(k) for 3D DICOM viewer software
ASX-listed medical technology firm Singular Health Group has received a 510(k) clearance from the US Food and Drug Administration for 3Dicom MD.
The software-as-a-medical device allows medical practitioners to collaboratively visualise standard CT/MRI and PET scans in 2D and 3D in real time. It also has built-in voice and text chat and...
Singapore clears VUNO's AI software for fundus analysis
South Korean medical AI firm VUNO has recently obtained a medical device certification from Singapore's Health Sciences Authority for its AI-based fundus analysis software.
The VUNO Med-Fundus AI analyses images of the fundus, which is the back part of the eye, to provide findings necessary for the diagnosis of retinal diseases. It can...
CardieX files 510(k) for dual blood pressure, arterial health monitor
Australia-listed health tech firm CardieX has filed a 510(k) premarket submission with the US Food and Drug Administration for its dual blood pressure and arterial health monitor.
Called the CONNEQT Pulse, the health monitor features CardieX's FDA-cleared SphygmoCor technology which measures central blood pressure to obtain...
111 to build a disease management platform with Bayer
Chinese healthcare platform 111 has expanded its existing partnership with global drug maker Bayer Healthcare Co.
The two companies first entered into a strategic partnership last year in September to market innovative drugs and healthcare products for chronic disease management. A digital platform was also built to provide online pharmacist...
Long-term data on ambulatory monitoring patches. Scientists from the Scripps Research Translational Institute and Johnson & Johnson have unveiled three-year study data for iRhythm Technologies' Zio wearable ambulatory monitoring patches at this year's American Heart Association Scientific Sessions. The mSToPS study examined 1,738 participants who were a mean age 73.7 years at the time of...
The past couple of days have seen a handful of artificial intelligence algorithms for radiology imaging analysis receive 510(k) clearances from the FDA. Two of these, from Quantib and Ezra, are focused on the relatively untouched area of prostate cancer screening, while a third, from Aidoc, targets incidental pulmonary embolism.
Quantib's software delivers an in-workflow assessment of prostate...
