The Food and Drug Administration (FDA) has released its perspective on regulating AI in healthcare and biomedicine, stating that oversight needs to be coordinated across all regulated industries, international organizations and the U.S. government.
The Agency says it regulates industries that distribute their products to the global market, and therefore U.S. regulatory standards must be...
Editor's note: This article has been updated with a quote from iCardio.ai CEO.
Los Angeles-based iCardio.ai has received FDA 510(k) clearance for its artificial intelligence software for interpretation of echocardiography, aimed at offering a comprehensive imaging workflow and autonomous preliminary reporting.
iCardio.ai develops machine learning and deep learning algorithms for the examination...
ASX-listed Echo IQ has obtained regulatory approval in the United States for its AI-driven solution that supports structural heart disease diagnosis.
WHAT IT'S ABOUT
Two years since coming to the US, the company has now received 510(k) clearance from the Food and Drug Administration for EchoSolv AS, which is specifically indicated to support the diagnosis of severe aortic stenosis (a form of...
Radiology genAI unveiled
Harrison.ai has recently introduced a radiology-specific vision language model.
Called Harrison.rad.1, the dialogue-based model can perform open-ended chat related to X-ray images. It can detect and localise radiological findings and generate reports, all with an emphasis on clinical safety and accuracy.
Unlike existing generative AI models trained on general and open-...
Andy Molnar, CEO of the Digital Therapeutics Alliance, has been selected as an industry representative for the FDA's Digital Health Advisory Committee (DHAC).
The FDA established the DHAC to ensure safe and effective regulation of digital health offerings, including AI and machine learning, virtual reality, cybersecurity, patient-generated health data and wearable technologies.
The committee...
The EU AI Act comes into effect today, outlining regulations for the development, market placement, implementation and use of artificial intelligence in the European Union.
The Council wrote that the Act is intended to "promote the uptake of human-centric and trustworthy artificial intelligence while ensuring a high level of protection of health, safety, [and] fundamental rights … including...
The Tandem Diabetes Care t:slim X2 Insulin Pump, which is compatible with glucose monitoring specialist Dexcom's G7 and G6 continuous glucose monitoring (CGM) systems, has been cleared for sale by Health Canada, the department within the government of Canada responsible for national health policy.
t:slim, which holds up to 300 units of insulin, boasts a color touchscreen, a rechargeable battery...
Korean digital health company LifeSemantics has obtained the first approval for an AI-powered solution for skin cancer diagnosis in South Korea.
The company received regulatory clearance from the Ministry of Food and Drug Safety for canofyMD SCAI four months after its application.
The mobile AI technology was developed through the Doctor Answer 2.0 project, which has gathered 30 hospitals and 19...
Infant monitoring specialist Owlet's Dream Sock has received CE Mark certification by the European Union, meeting its required safety and health requirements and paving the way for the device to be sold in Germany, France and the U.K. later this year.
The Dream Sock, which wraps around a baby's foot, is a nonprescription medical pulse oximetry solution for infants aged 1 to 18 months weighing 6...
