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Learn about FDA medical device regulations and how to achieve approval. Our news and expert advice provides an overview of regulatory requirements for Class I, Class II, and Class III devices.
Biodegradable Bandage Helps Wounds Heal
Superelastic Metal Alloy Shows Promise in Biomedical Applications
Nanosensor Platform Could Advance Detection of Ovarian Cancer
Implant Allows Amputees to Use Mind to Control Robotic Arm
Inside the OEM: Boston Scientific
As summer 2020 gives way to fall and we continue grappling with unprecedented challenges, healthcare industry efforts persist to ensure that medical supplies are available when and where they are...
Yes, there will be a day when the U.S. EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality, and the FDA regains control of the medical approval process...
In an effort to harness diverse streams of data to understand and respond to COVID-19, the U.S. Food and Drug Administration (FDA) has entered into an agreement with Aetionto...
FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production...
The U.S. Food and Drug Administration (FDA) has authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the...
The U.S. Food and Drug Administration (FDA) has established new program specifically geared toward expediting the development of potentially safe and effective...
Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.
New Liquid Silicone Rubber with Primerless Adhesion to Polycarbonate
Rapid prototyping technologies play an important role in supporting new product development (NPD) by companies that are working to bring novel and innovative products to market. But in advanced industries where products often make use of multiple technologies, and where meeting a part’s exacting tolerances is essential, speed without precision is rarely enough. In such advanced manufacturing—including the medical device and surgical robotics industries — the ability to produce high-precision prototypes early in the development cycle can be critical for meeting design expectations and bringing finished products to market efficiently.
Harnessing the Power of Ultrasonic Precision Cleaning for cGMP Compliance
Is a Medical Robot Really a Robot?
The Journey Toward Intelligent Catheters
Robotics Motion Control: The Complex Relationship Between Movement and Task