News

The FDA has signed a five-year collaborative research agreement with Dassault Systèmes Vélizy-Villacoublay, France, a world leader in 3D design software, for the development of testing paradigms for insertion, placement, and performance of pacemaker leads and other cardiovascular devices...

A final guidance, “Design Considerations for Devices Intended for Home Use,” issued by the FDA, is intended to assist manufacturers in designing and developing home-use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements.

Here is the latest batch of news from the medical products community. Please click the link for more.

Here is the latest batch of news from the medical products community. Please click the link for more.

Scientists at the National Institute of Standards and Technology, Gaithersburg, MD, in collaboration with the National Cancer Institute and the Radiological Society of North America, have designed and developed image-calibration technology to study the effects of traumatic brain injury (TBI). The...

Here is the latest batch of news from the medical products community. Please click the link for more.

According to a recent report by the Freedonia Group, world demand for disposable medical supplies will increase 6.6 percent yearly to nearly $245 billion in 2018. The upgrading and enforcement of infection prevention standards, coupled with an expanding volume of hospital, surgical, and outpatient...

Here is the latest batch of news from the medical products community. Please click the link for more.

To strengthen the safety of medical devices, the FDA has finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. On October 1, the agency issued a final guidance on the content of premarket submissions for the management of...

The winners of the Create the Future Design Competition were announced this week. The Medical Category winner was the HemeChip for Early Diagnosis of Sickle Cell Disease, designed by a team from Case Western Reserve University, who have created a biochip that can rapidly, easily, and conclusively...

Here is the latest batch of news from the medical products community. Please click the link for more.

Here is the latest batch of news from the medical products community. Please click the link for more.

XPRIZE, the global leader in incentivized prize competitions, announced the 10 finalist teams competing for the $10 million Qualcomm Tricorder XPRIZE, a global competition sponsored by the Qualcomm Foundation for teams to develop a consumer-focused mobile device capable of diagnosing and interpreting a set...

Here is the latest batch of news from the medical products community. Please click the link for more.

Here is the latest batch of news from the medical products community. Please click the link for more.

On August 13, The FDA issued a guidance for industry and FDA staff called “Unique Device Identification System: Small Entity Compliance Guide”. This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s September...

The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and Class II medical devices from premarket, or 510(k),submission requirements. If a device is “exempted from premarket notification,” then the FDA would allow a device that was...

Here is the latest batch of news from the medical products community. Please click the link for more.

UL (Underwriters Laboratories), Northbrook, IL, announced that the FDA has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial...

Here is the latest batch of news from the medical products community. Please click the link for more.

Here is the latest batch of news from the medical products community. Please click the link for more.

Recognizing that the need for effective cybersecurity to ensure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information, the FDA has issued a draft...

The U.S. Food & Drug Administration (FDA) has issued the first phase of its Global Unique Device Identification Database (GUDID): Guidance for Industry on June 11, 2014. To quickly provide industry with information critical to successful use of the GUDID, the FDA is issuing the GUDID Guidance in two...

Here is the latest batch of news from the medical products community. Please click the link for more.

Here is the latest batch of news from the medical products community. Please click the link for more.

Here is the latest batch of news from the medical products community. Please click the link for more.

The FDA has proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.

Here is the latest batch of news from the medical products community. Please click the link for more.

Here is the latest batch of news from the medical products community. Please click the link for more.