Medical Blog

3M Partners with Ford to Help Further Accelerate COVID-19 Response

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...

COVID-19: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

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

Ultrasound Could Facilitate COVID-19 Diagnosis

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...

Virtual Roundtable to Focus on Using Precision AM to Fight COVID-19

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

Breakthrough in Coronavirus Research Results in New Map to Support Vaccine Design

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...

Covid-19 Diagnostic Based on MIT Technology Might Be Tested on Patient Samples Soon

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...

FDA Adds More Dates for Town Halls for COVID-19 Test Developers

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...

COVID-19: FDA Expands Remote Patient Monitoring

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...

COVID-19: FDA Issues Diagnostic Emergency Use Authorization; Expedites Availability of Diagnostics

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

Senator Calls for Use of Defense Production Act to Mobilize Manufacturing for Coronavirus Tests

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

FDA Suspends Foreign and Domestic Inspections Due to Coronavirus

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...

From the Editor - The 2019 Products of the Year

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...

From the Editor - Is FDA Making Progress or Still a Victim of Too Few Resources and Too Little Power?

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

From the Editor — Building an Improved Network for Connected Medical Devices

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...

From the Editor — Most Medical Device OEMs Not Ready to Comply with 2020 EU Regulation

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...

FDA Launches Pilot Program to Advance Innovation in EtO Sterilization

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 — 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...

Flex Boston Innovation Center: Taking Products from Sketch to Scale

Staying relevant in the medical device industry requires operating “with real-time information, comprehensive capabilities, and a global physical infrastructure to deliver speed, scope, and scale to keep pace in this rapidly changing market.”

From the Editor — From Wearables to the Surgical Suite: The Future of Electronic Skin

With increasing investments in R&D to develop self-healing, comfortable monitoring systems, a recent report indicates that electronic skin is gaining...

From The Editor — What Manufacturers Want Most

Manufacturers are focused on improving their design processes far more than on improving their design tools, according to a recent study.

Fighting the Opioid Crisis: Researchers Present Breakthrough Tool in Upcoming Webinar

“Opioid abuse, misuse, and addiction has become one of the most profound public health crises facing the U.S. today,” says Jeffrey Shuren, FDA, CDRH....

Latest Patent Trends Favor Patentees — What Device Makers Need to Know

Medical device companies have challenged thousands of patents using the Patent Trial and Appeal Board’s (PTAB) administrative adjudication system. Introduced in 2012,...

From the Editor — Digital Health: Lessons Learned So Far from FDA’s Test Phase

The test phase of FDA’s Software Precertification (Pre-Cert) Program has hit its halfway point. The agency has released an update on its progress and the...

From the Editor — FDA Moves to Increase Transparency of Medical Device Reporting

In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of...

From the Editor — Outlook Mostly Upbeat for Healthcare Deals Next Year

Political uncertainty will be the biggest factor that could upend healthcare transactions according to a recent Merrill InsightTM poll of global mergers and...

From the Editor — Permanently Repealing the Device Tax to Protect Medical Innovation

A new house bill is set to end the medical device tax once and for all. H.R. 2207 was introduced in April — it’s goal to permanently repeal the...

From the Editor — Spurring Innovation of Brain-Computer Interface Devices

Spurring Innovation of Brain-Computer Interface Devices FDA is continuing to encourage innovation in novel areas — the latest being novel brain implants, often...

From the Editor — Reimagining Digital Health Devices: FDA’s New Precertification Model

When digital devices and technologies became the rule rather than the exception, FDA had to rethink its regulatory framework and evaluation process...

From the Editor — Giving the 510(k) Pathway a Much-Needed Makeover

Making changes to a regulatory process is usually difficult, slow, and often painful — after all, it involves lots of bureaucracy and many “cooks in the kitchen.” But...