Report: Q3 medical device recalls down 39%

Medical device recalls have declined 39% for the third quarter, settling at 167, the lowest quarter the US has seen since the fourth quarter of 2011, according to a new Stericycle Expert Solutions report. Recalled units were up, however, rising 1% to 68 million which positioned it higher than 16 of the last 19 quarters, […]

Who got picked for FDA’s digital health pre-cert pilot?

FDA has announced the names of the companies selected to participate in its digital health pre-cert pilot – a first-of-its-kind program aimed to revolutionize digital health regulation in the U.S. Dr. Scott Gottlieb, FDA’s commissioner, announced the nine participants of FDA’s digital health software precertification pilot program (FDA Pre-cert) last week during his keynote address at the

Should the medical device industry pay user fees to CMS?

Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA? That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by

FDA seeking to prevent medical device shortages from hurricanes

The U.S. FDA has been seeking to prevent shortages of medical devices and other products after disruptions caused by Hurricanes Harvey, Irma and Maria. “These storms have hit hard in areas where there are a significant number of farmers, food distributors, and medical product manufacturers, including Houston, Florida, and now Puerto Rico and the U.S.

FDA’s medical gas guidance offers clarity to manufacturers

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]

Webinar: How late 2017 has changed medtech

This webinar was presented live on Wednesday, October 11, 2017. Click below to watch on demand.       When it comes to news out of the U.S. government: one word could sum up what it means for the medical device industry: “uncertainty.” It was true at the start of 2017. And it is even

FDA cuts could threaten medtech innovation: Here’s why

The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advisers (MCRA). Glenn Stiegman, MCRA Innovation is a vital element of success for medical device companies. More than 6,500 U.S. companies are developing technologies that improve patient outcomes. This represents a

FDA to pilot new high-risk PMA for medical devices

The FDA is readying a pilot program to try and improve the pre-market approval process for high-risk medical devices later this month. The federal safety watchdog is seeking nine companies to participate in its Premarket Approval Application Critical to Quality program beginning Sept. 29 and running to either Dec. 31, 2018, or until nine PMAs […]

FDA releases final guidance on medical device interoperability

The FDA this week released final guidance on interoperability in medical devices as more and more healthcare related electronics connect to the Internet of Things. “As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange information and use information that […]

How to work with the new FDA

Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH. Lisa Olson, RCRI Scott Gottlieb has now settled into his role as FDA’s new commissioner and is putting his stamp on the agency. Interestingly, he has started with some very specific points of focus that have bubbled to

Medical device regulation: How it’s changing in the U.S. and Europe

Mary Beth Ritchey, RTI Health Solutions This is a busy year for medical device regulation in the United States and Europe. U.S. medical device regulation legislation In the U.S., the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) is due to expire Sept. 30. A new bill including updates for medical devices has

Serious medical device recalls nearly doubled in Q2

Medical device recalls at the Class I level were up 88% during the second quarter of 2017, and the major culprit was quality issues involving device part malfunctioning, according to a new report from Stericycle ExpertSolutions. Quality played a significant role among the 15 serious medical device recalls during the second quarter, partly because it encompasses such

5 medtech funding insights you need to know

Venture capital funding isn’t what it used to be for medical device startups, but there are actually reasons to feel optimistic about medtech funding. That was the big takeaway from a four-expert panel at DeviceTalks Minnesota last month. (The next DeviceTalks is Oct. 2 in Boston.) Charlie Whelan, director of transformational health consulting at Frost & Sullivan,

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Here are the top 5 medtech stories of mid-2017

The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from

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Why U.S. first may be the new medical device development strategy

Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the U.S. market first. That seemed to be a major takeaway from panels on regulation and reimbursement at Healthegy’s Medtech Conference, held last week in Minneapolis. “We’re actually going to be doing more early clinical work with the FDA,” said Stacey Pugh, vice