Medical

Inside the OEM: Johnson & Johnson

For more than 130 years, Johnson & Johnson has been synonymous with healthcare.

Renamic Neo Offers Complete Wireless Connectivity to Implants

Tiotronik’s Renamic Neo communicates with a medical device implanted in a patient, such as a pacemaker, ICD, or implantable cardiac monitor.

Movano Health to File First FDA Submission for Smart Ring’s SpO2 and Heart Rate Data

Movano Health, Pleasanton, CA, has announced successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the...

Ensuring Regulatory Compliance by Digitizing Change Control in Life Sciences Product Development

Medical device manufacturers face constant changes coming from both internal and external sources.

Finding a Manufacturing System Upgrade to Match In-House Innovation

Radiation medicine pioneer Elekta is growing fast. In anticipation of regulatory changes requiring more documentation and labeling, the company implemented a...

Boston Scientific Receives FDA Clearance for EMBOLD Fibered Detachable Coil

Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its EMBOLD™ Fibered Detachable Coil, a device that is...

From the Editor - FDA Catalog of Tools Helps Accelerate Device Development

FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.

New Regulations, New Timelines: How Chemistry Changed in Response to ISO 10993-18:2020

Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.

Medical Device Usability Requirements: Changes to IEC 62366

The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.

Are You Ready for the Next UDI Deadline?

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...

Medical Devices: LIFE after the EUA

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...

EU MDR Economic Operators: Sharing Compliance Duties across the Supply Chain

A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."

FDA Authorizes First COVID-19 Test for Patient At-Home Sample Collection

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...

FDA Creates New Program to Expedite Development of Coronavirus Treatments

The U.S. Food and Drug Administration (FDA) has established new program specifically geared toward expediting the development of potentially safe and effective...

From the Editor - FDA Launches eSTAR: Voluntary Electronic Submission Program for 510(k)s

FDA has kicked off a new voluntary electronic submission program for 510(k)s.

FDA Expedites Review of Diagnostic Tests to Combat COVID-19

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...

FDA Issues Emergency Use Authorization for Ventilators

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...

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...

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)...

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...

Ask the Expert – Ralph Bright on the Power of Power Cords

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.

Preparing for MDR? Don’t Overlook the Analytical Evaluation Threshold

Medical device manufacturers have a big challenge in preparing for their regulatory device submissions for 2020. In addition to the European Union’s new Medical Device...

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 — 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...

A Fast, Simple Sampling Method for Characterizing Volatile Organic Compounds Emitted from Medical Devices

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

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...

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...