Cybersecurity has become one of the fastest-evolving areas of medical device regulation. While the U.S. FDA already requires cybersecurity documentation for many connected medical devices submitted after March 2023, lawmakers are now proposing legislation that could significantly expand FDA's oversight beyond new product submissions. Recently, Senator Tom Cotton introduced the Countering Chinese Cyberthreats for Patients (Countering CCP) Act, a bill that would require the FDA

The U.S. FDA has granted De Novo classification to the Claria System, an innovative medical device developed by Claria Medical to improve tissue containment and removal during minimally invasive hysterectomy procedures. The authorization represents an important milestone—not only for the company, but also for the broader medical device industry. What Is the Claria System? The Claria System is designed to make tissue extraction during minimally invasive hysterectomies safer an

In June 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Huons Co., Ltd. following an inspection of its sterile injectable manufacturing facility in Jecheon, South Korea. While Warning Letters are not uncommon in the pharmaceutical industry, this case stands out because it goes far beyond isolated documentation issues. The FDA concluded that the company's manufacturing systems, laboratory controls, and quality oversight failed to comply with Curren

FDA Medical Device Cybersecurity Guidance: Enforcing Section 524B of the FD&C Act to Secure Connected Devices via Strict SBOM Requirements for Medical Devices As medical devices become increasingly interconnected through hospital networks, wireless configurations, and cloud infrastructure, they face a rising wave of sophisticated digital threats. In response to these vulnerabilities, the U.S. FDA finalized its comprehensive FDA medical device cybersecurity guidance, titled "C

Why Generative AI Medical Devices Face Unique Hurdles Under the Current FDA Regulation on AI Medical Devices Artificial Intelligence is rapidly reshaping healthcare, prompting regulatory bodies worldwide to reevaluate their approval frameworks. While thousands of software functions are currently listed on the official FDA AI-enabled medical devices list, a critical shift is occurring with the emergence of advanced technologies like Generative AI medical devices. Notably, Sout

How the 21 CFR Part 820 Amendment Harmonizes Global Quality Management Systems with the FDA QMSR Final Rule The U.S. Food and Drug Administration has officially enacted one of the most significant modernizations to its medical device quality system regulations in decades. By issuing the highly anticipated FDA QMSR final rule (Quality Management System Regulation), the agency has substantially replaced the long-standing Quality System Regulation (QSR) framework. This massive r

If you find yourself sneezing, sniffling, and constantly reaching for tissues in California, you're not alone.

Groundbreaking technology that will change how heart transplants are done nationwide has now received approval from the U.S. Food and...

The U.S. Food and Drug Administration on Tuesday approved the antiviral Veklury (remdesivir) as the first COVID-19 treatment for young...

The answer to helping kids with "lazy eye" before it's too late could be a hand-held screening device, a new study suggests. Amblyopia...

Engineers at Tufts University have created a first-of-its-kind flexible electronic sensing patch that can be sewn into clothing to...

For older adults, wearable activity trackers may be popular gifts, but they may not be used for very long. While counterintuitive,...

On February 4, 2022, The U.S. Food and Drug Administration (FDA) has posted a recall for a COVID-19 Ag Home Test because there are...

At-home COVID-19 self-test kit users who rely on the U.S. Food and Drug Administration-authorized instructions may not follow the U.S....

On December 27, 2021, the Food and Drug Administration issued a recall for “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)," a...

Wearable electronics that adhere to skin are an emerging trend in health sensor technology for their ability to monitor a variety of...

Fitness trackers can be valuable tools for assessing the quality of life and daily functioning of cancer patients during treatment, a new...

A wearable biosensor may help monitor stress experienced by healthcare professionals, according to a study published in Physiological...

On June 17, 2021, Wren Laboratories, a CLIA-certified laboratory, has been granted an emergency use authorization by the U.S. Food and...