fda

medical device FDA’s New Digital Health Report

To update health care providers, patients, and developers about some of the risks and benefits surrounding software products, the FDA released a report based on impact to patient safety, health benefits and risks, and best practices.
Pamela Rentz
medical device FDA Updates Cybersecurity Recommendations for Medical Devices

Because of the rapidly evolving nature of cybersecurity threats and risks, the U.S. Food and Drug Administration recently released a draft of updated premarket cybersecurity recommendations on how device manufacturers can better protect their products and proactively address security.
Pamela Rentz
eye retina scan FDA Reviewing Guidelines for AI and Health Care

Artificial intelligence is projected to revolutionize health care and make high-quality medical treatment more accessible and affordable. While 3D-printed donor organs may still be on the horizon, AI tools to detect strokes, diagnose diabetic retinopathy, and help identify wrist fractures are already here.
Pamela Rentz
doctor using tablet FDA Pilots Program to Pre-Certify Digital Health Software

As healthcare undergoes a digital transformation, how can the traditional regulatory process keep pace? The FDA recently announced the initial participants in a pilot program that will pre-certify digital health tech companies that meet quality standards for software design, validation, and maintenance.
Pamela Rentz
FDA Won’t Regulate “Low Risk” Medical DevicesIt’s expected that a product such as a left ventricular assist device that helps maintain the pumping ability of a heart comes under the scrutiny of the FDA. But should wearables for healthcare that simply record heart rates and sleep cycles be regulated as medical devices?
Pamela Rentz
Heart-to-Heart Security Proposed for Implanted Medical DevicesLike any wireless device that can be accessed remotely, implanted medical devices are vulnerable to hacking. The FDA acknowledged that embedded medical devices are a potential target for cyber security breaches and issued a warning to device manufacturers. Pamela Rentz looks at a proposed solution.
Pamela Rentz
FDA Urges Medical Device Makers and Hospitals to Increase SecurityCybersecurity incidents reported involving some medical devices have prompted the U.S. Food and Drug Administration to issue stern warnings to medical device manufacturers and health care facilities to ramp up safeguards. Pamela Rentz highlights the latest FDA recommendations.
Pamela Rentz
Is the FDA Ready to Regulate Mobile Medical Apps?With the growing adoption of mobile technologies for health care delivery, the FDA has proposed regulating mobile medical applications. Even though the FDA issued preliminary guidance in 2001, final guidance has not yet been delivered.
Pamela Rentz