Regulatory & Quality

Medtronic Grapples with Even More HeartWare Problems

Apr 16, 2021

In addition to a previously reported HeartWare-related recall, Medtronic is also recalling HeartWare battery cables, data cables, adapter cables, and controller 2.0 Ports.

Understanding Regulatory Expectations for Combination Products

Apr 15, 2021

Experts from WuXi AppTec Medical Device Testing answer a few questions about submitting combination products for regulatory approval.

One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain

Apr 15, 2021

Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the new medical device regulation (EU MDR), according to a recent survey. These results come one year after the regulation’s postponement...

Medtronic Recalls Several Heart Devices Due to a Battery Problem

Apr 14, 2021

Medtronic is recalling seven of its implantable cardioverter defibrillators and cardiac resynchronization therapy devices due to an unexpected and rapid decrease in battery life. FDA said there have been 444 complaints about the devices, and 264...

iRhythm Discontinues Zio XT in Medicare Segment Due to Reimbursement Cuts

Apr 13, 2021

The rates posted by Novitas Solutions, a Medicare Administrative Contractor, are higher than the rate set in late January, but still considerably lower than the reimbursement rate iRhythm was previously receiving for its wearable heart monitoring...

Medtech in a Minute: FTC Crosses Swords with Illumina, Hologic's Shopping Spree Continues, and More

Apr 09, 2021

Pressed for time? Here's the medtech news you need most, in one minute or less.

Back to Basics: FDA to Host Workshop for Device Industry

Apr 07, 2021

Need to brush up on your regulatory knowledge? FDA will host a free workshop April 13 on two topics related to the CDRH Standards and Conformity Assessment Program.

Medtech in a Minute: FDA Moves on COVID-19 and STD Testing

Apr 02, 2021

Pressed for time? Here's the medtech news you need most, in one minute or less.

FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test

Mar 31, 2021

The ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections, expert says.

6 COVID-19 Tests Impacted by Viral Mutations

Mar 30, 2021

FDA has provided information on specific molecular tests impacted by viral mutations, and recommendations for those tests.

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