The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.

Huma Therapeutics has been granted Class II clearance from the FDA for its Software-as-a-Medical-Device (SaMD) disease management platform, dramatically expanding the range of services it can deliver.

With initial applications in cardiology, the company offers transformative, cloud-based diagnostic tools, including AccurECG™ 4, an FDA-cleared Class II software as a medical device (SaMD ...

With the usage of AI in medical devices, ethical concerns center on patient health data, safety, and privacy, which adds an ...

Regulating drug discovery and pharmaceutical manufacturing, the FDA ensures the safety and effectiveness of innovative ...

Non-prescription DTx (NPDT) are regulated as SaMD under the FDA’s “enforcement discretion” guidelines. While these NPDT products do not require FDA clearance, they must substantiate their ...

CEL-SCI Announces The Potential Impact On The Clinical Development Of Its Immunotherapy Multikine Resulting From A Recent U.S. FDA Oncologic Drugs Advisory Committee Meeting; Multikine Has Shown ...

The company said it was not yet established that the vaccine had caused the safety event and it was working with the FDA to resolve the pause. "Our goal is to successfully resolve this matter and ...

AiMIFY ™, has received FDA clearance as a Class II software as a medical device (SaMD) for magnetic resonance imaging (MRI) of the brain. This groundbreaking software, exclusively from Bracco ...