Artificial Intelligence Uses in The Healthcare Industry

Artificial manufacturers need to understand the FDA approval process for medical devices and drugs. Physicians need to understand AI uses and patient privacy issues.

FDA Grants Accelerated Approval for a New Alzheimer’s Disease Treatment

The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.

The FDA Transcranial Magnetic Stimulation Approval Process

The FDA has approved Transcranial Magnetic Stimulation (TMS) treatments for depression and obsessive-compulsive disorders. Other treatments may be FDA-approved based on the substantial [...]

Understanding the Medical Device Classification and Approval Process – Part Two

Developers and manufacturers of medical devices need to understand 510 (k) approval of medical devices and other FDA compliance issues.

Understanding the Medical Device Classification and Approval Process – Part One

Developers and manufacturers of medical devices need to understand how FDA classifies the devices and the criteria for approval

Stem Cell Therapies and Clinical Trials

Developers and manufacturers of stem cell therapies need to understand how to conduct clinical trials in order to process FDA investigational new drug (IND) applications.

Stem Cells Therapy Clinic Startups – Legal Compliance Issues

The FDA’s Center for Biologics Evaluation and Research (CBER) regulates stem cell products. Stem cells normally require an investigational new drug application.

Healthcare Compliance Issues for 3D Printing Medical Devices

3D printing is being used for prosthetics, orthodontics, surgical preparation, and other applications. These devices may be subject to FDA regulation, Stark and AKS compliance, and FTC oversight.

Mobile Medical Image Analysis – Part Two

We review in more detail the role of the FDA in the regulation of medical imaging analysis software – whether it’s used as part of a mobile application, laboratory analysis, or for other medical [...]

Medical Image Analysis Software – Part One

New medical imaging software benefits many different types of health practices. Key compliance issues include HIPAA and FDA oversight.