medical devices | TechWell

medical devices

Doctor in a laboratory looking at a slide FDA Explores Review Framework for AI-Based Medical Devices

As more medical devices are developed that employ artificial intelligence and machine learning software that can learn from real-world feedback and adaptation, the FDA announced it is taking steps to explore a new medical device regulatory framework. The goal is creating safe, beneficial, innovative medical products.

Pamela Rentz's picture
Pamela Rentz
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's picture
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's picture
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's picture
Pamela Rentz
FDA Won’t Regulate “Low Risk” Medical Devices

It’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's picture
Pamela Rentz
Heart-to-Heart Security Proposed for Implanted Medical Devices

Like 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's picture
Pamela Rentz
Bionic Arm Changes Lives and Offers Glimpse of the Future

After losing his lower arm to an accident, a man was invited to try out the most advanced prosthetic in the world. The robotic hand uses custom software configurations to let him perform everyday tasks again. This is just the beginning of what can be done in merging technology with the human body.

Beth Romanik's picture
Beth Romanik
January Software Roundup

In this software roundup, we learn that Maryland and Pennsylvania are using software to prevent murders, new software shown at the Consumer Electronics Show underwhelmed some prominent tech pundits, and the Department of Homeland Security recommended disabling Java for a security exploit.

Jonathan Vanian's picture
Jonathan Vanian