The U.S. Securities and Exchange Commission (SEC) has reopened an investigation into Elon Musk's brain-computer implant company Neuralink, according to a letter Musk posted on X penned by his attorney and directed at SEC chair Gary Gensler.
Musk also mocked the SEC in a post saying it was "just another weaponized institution doing political dirty work."
The letter, published on Dec. 12, also...
MobiHealthNews asked executives from across the digital health industry – in places from Fortune 500 companies to emerging startups – to share their biggest takeaways from 2024. Their responses highlight a diverse range of perspectives and insights.
In part one of this two-part series on the biggest takeaways of the year, explore executives' thoughts on key trends, including the growing focus on...
Safety-focused large language model company Hippocratic AI has been issued its first patent by the U.S. Patent Office, which includes the company's LLM innovations incorporated into its safety-focused LLM built with a constellation architecture dubbed Polaris.
Hippocratic AI's generative AI solution focuses on nondiagnostic healthcare tasks such as medication onboarding and monthly reconciliation...
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...
