Medical Blog

Join the conversation! Medical Design Briefs' Editor Sherrie Trigg provides her take on today’s innovative technology developments and the topics most important to you.

The U.S. Food and Drug Administration (FDA) has made policy changes to respond to the urgent need for even faster testing availability. Although laboratories could use the EUA...

Personal finance company LendEDU has conducted a survey of 1,000 adult Americans in the wake of the Conornavirus pandemic to better understand how the personal...

MIT researchers hope to publish open-source designs for a low-cost respirator that could potentially help Covid-19 patients struggling with critical respiratory problems. The...

A coalition of companies and universities assembled by Stratasys Ltd. (NASDAQ: SSYS) to produce face shields leveraging...

It’s a race against time that some participants liken to Apollo 13, the stricken NASA spacecraft for which engineers improvised an air purification system from...

BCN3D, a manufacturer of 3D printers based in Castelldefels (Barcelona, Spain), has devoted all its technological and manufacturing potential to helping...

Engineers at Binghamton University, State University of New York are stepping up on several fronts to help regional healthcare providers deal with the coronavirus...

The U.S. Food and Drug Administration (FDA) took action May 25, 2020, to make more ventilators available to healthcare personnel in the United States. FDA issued an emergency use...

Abbott has received emergency use authorization (EUA) from the FDA for its molecular test for the identification of SARS-CoV-2, the virus that causes COVID-19. The company is deploying 150,000...

GM and Ventec Life Systems, in cooperation with StopTheSpread.org, the nation’s coordinated private sector response to COVID-19, are collaborating to enable Ventec to increase...

Royal Philips is increasing the production of certain critical care products and solutions to help diagnose and treat patients with the new...

Polymer bushing and wear material manufacturer Vesconite Bearings is standing by to help manufacture ventilators in case the Coronavirus pandemic spirals. Last week,...

Medtronic plc continues to make progress in increasing ventilator production worldwide. The company has increased production by more than 40 percent to date...

3M and Ford are collaborating on specific ways the companies can rapidly combine complementary capabilities and resources to help meet a surge in demand for personal...

The U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other...

Researchers have developed an ultrasound diagnostic protocol for COVID-19. The protocol was developed in the laboratories of UniTrento with collaboration from a dozen clinical teams in Italy as...

Nanofabrica, a manufacturer of 3D printers for precision engineering, invites researchers, doctors, and manufacturers to harness its manufacturing capabilities to develop...

Researchers from The University of Texas at Austin and the National Institutes of Health have made a critical breakthrough toward developing a vaccine for the...

As more Covid-19 cases appear in the United States and around the world, the need for fast, easy-to-use diagnostic tests is becoming ever more pressing. A...

On Wednesday, March 25, 2020 (3–4 p.m. Eastern), the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are...

The Food and Drug Administration (FDA) has issued a new guidance to provide a policy to help expand the availability and capability of noninvasive remote monitoring devices to facilitate...

The U.S. Food and Drug Administration (FDA) has taken two additional significant diagnostic actions during the coronavirus outbreak (COVID-19)...

With the country confronting a shortage of both coronavirus test kits and critical medical equipment, Senator Edward J. Markey (D-Mass.) is...

FDA is postponing most foreign and domestic inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a...

In December, we asked Medical Design Briefs readers to cast their ballot to choose from our 12 Products of the Month the technology they felt was the most significant new introduction to the...

FDA says it is continuing to advance its scientific and technical capabilities, but a recent New York Times editorial says the agency is in...

AT&T is building up its FirstNet network, while also rolling out 5G New Radio — both of which are part of the future of connected of healthcare. FirstNet is a...

Under new rules to market medical devices in the European Union (EU), only 27 percent of respondents said they will be fully compliant with the regulations...

FDA has created a new pilot program for industry to expedite approvals of certain changes to ethylene oxide (EtO) sterilization processes and facilities. In an effort to...

From the Editor : Medical
From the Editor — The Modern FDA: A New Pathway Gets Under Way

As a first step toward implementation of its recently established Safety and Performance Based Pathway for medical devices, FDA is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices:

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