Philips: Compounds in recalled devices 'not typically' associated with long-term health risks

Despite further testing, the company did not change its guidance for physicians or patients, which was given due to the recall of millions of sleep apnea and ventilator machines.

By Ricky Zipp • Updated Dec. 23, 2021

FDA seeks feedback on 180-day notice period for termination of COVID-19 EUAs

The agency's plan is intended to avoid supply disruptions while moving back toward the regulatory requirements of routine operations.

By Nick Paul Taylor • Dec. 23, 2021

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

CDRH warns review timelines will remain extended in 2022 as pandemic pressures continue

The FDA's Center for Devices and Radiological Health expects "a gradual transition back toward normal review timelines" next year as COVID-19 has delayed traditional work.

By Nick Paul Taylor • Dec. 22, 2021

Biden stresses need for additional testing supply, plans to distribute 500M free rapid COVID-19 tests

"We have to do more. We have to do better — and we will," President Joe Biden acknowledged on Tuesday, as a surge in omicron cases has put added stress on America's already strained test supply.

By Greg Slabodkin • Updated Dec. 22, 2021

Most COVID-19 medical device EUAs lack documented supporting data: JAMA

The use of "low-quality data" is reasonable at the start of a crisis but FDA should consider raising the standard of evidence after multiple products come to market, according to the authors of the study.

By Nick Paul Taylor • Dec. 21, 2021

EU finalizes staggered rollout of IVDR, removing near-term threat to diagnostic supply

MedTech Europe welcomed the adoption of the amended transitional provisions, which it said mitigate "the immediate and urgent risk" of disruption.

By Nick Paul Taylor • Dec. 21, 2021

FDA warns about Log4j cybersecurity vulnerabilities in medical devices

The bugs in Apache's Java-based open source logging library could potentially allow unauthorized users to remotely impact the safety and effectiveness of device functionality, according to the agency.

By Greg Slabodkin • Dec. 20, 2021

J&J device chief on company split, omicron surge, robotic surgery

Ashley McEvoy is confident that 2022 will not be as bad as the first or second year of the COVID-19 pandemic, even as the omicron variant drives cases up, but adds that "we're not out of the woods yet."

By Ricky Zipp • Dec. 20, 2021

Roundup: Omicron variant's impact on COVID-19 tests

As the variant of concern continues to spread worldwide, FDA and test makers have scrambled to assess whether the performance of diagnostics are affected by omicron's viral mutations. Here's what we know so far.  

Updated Dec. 29, 2021

Getinge intra-aortic balloon pump recall tied to 1 death, 71 complaints

The Class I recall, initiated due to a risk that leaking fluid could shut down the heart assist device, is the second in recent months for the pump after reports of defective batteries in a small number of units.

By Susan Kelly • Dec. 17, 2021

Federal COVID-19 aid fueled huge jump in national health spending last year

The pandemic accounted for major changes in who paid for healthcare as job losses spurred changes in coverage types, while people deferred care and spent less out of their own pockets.

By Shannon Muchmore • Dec. 16, 2021

FDA in update says 2 COVID-19 tests fail to detect the omicron variant

Diagnostics from Applied DNA Sciences and Meridian Bioscience are not able to detect omicron, causing false negative results, according to the agency, while Tide Laboratories has fixed the problem with its test.

By Greg Slabodkin • Updated Dec. 29, 2021

Medtronic's stock price falls nearly 9% following FDA warning letter

The medtech giant’s stock continued to drop following the Wednesday announcement, while insulin pump rival Tandem Diabetes Care’s was boosted by roughly 9.5% when the market closed Thursday.

By Ricky Zipp • Updated Dec. 17, 2021

Medtronic's Covidien initiates ventilator recall due to manufacturing error

Puritan Bennet 980 series ventilators can become inoperable during use, according to the FDA recall database. The agency labeled the recall a Class I event, the third such classification for the product since 2015.

By Ricky Zipp • Updated Dec. 14, 2021

Neurostimulator to treat stroke fails to gain FDA advisory panel support

The panel questioned whether modifications in the pivotal trial for the device from BrainsGate, a company that attracted early investment from Boston Scientific and J&J, could have compromised the study.

By Susan Kelly • Dec. 13, 2021

FDA seeks comment on 3D printing of medical devices at hospitals, doctor's offices

The agency's discussion paper lays out the benefits and challenges of creating 3D-printed devices in healthcare settings as well as a potential approach for regulatory oversight.

By Greg Slabodkin • Dec. 13, 2021

FDA floats independent contractor to track MDUFA hiring following medtech pressure

The agency made the offer during the Medical Device User Fee Amendments V meetings in response to industry negotiators who want a clearer picture of how the program uses the money it receives.

By Nick Paul Taylor • Dec. 9, 2021

Senate passes legislation to avoid Medicare cuts for providers in year-end sprint

Groups like the American Hospital Association came out in support of the legislation, which would mitigate some of the cuts set to soon take effect.

By Rebecca Pifer • Updated Dec. 10, 2021

Senate passes bill to delay 2022 Medicare rate cuts for hundreds of lab tests

Senators late Thursday passed an end-of-year package that will delay the 15% cuts for nearly 600 tests slated to kick in next month. Passed by the House on Tuesday, the bill must still be signed by President Joe Biden to become law.

By Greg Slabodkin • Updated Dec. 10, 2021

Cancer treatments lead latest FDA breakthrough device designations

The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.

By Nick Paul Taylor • Dec. 7, 2021

Thermo Fisher, Verily on FDA list of COVID-19 tests affected by omicron variant

The agency's list focuses on coronavirus diagnostics impacted by S-gene dropout, an occurrence that is most commonly associated with Thermo Fisher Scientific's TaqPath test kits.

By Nick Paul Taylor • Dec. 6, 2021

Congress passes on delay to Medicare rate cuts for lab tests, for now

The American Clinical Laboratory Association wants lawmakers to push off 2022 cuts for nearly 600 lab tests. A stopgap bill late last week did not include a reprieve, but Cowen analysts are optimistic a legislative fix will be found.

By Greg Slabodkin • Dec. 6, 2021

Insulet's Omnipod 5 insulin pump cleared by FDA after months of delays, sending shares up 9%

The clearance better positions Insulet to compete with rival Tandem Diabetes Care, and comes while Medtronic's diabetes group is managing multiple product safety problems.

By Susan Kelly , Ricky Zipp • Updated Jan. 28, 2022

Device recalls jumped 36% in Q3, first quarterly increase since 2020: report

The primary reasons for recalls in the quarter were software issues, which have been the leading causes in 21 of the last 22 quarters, according to Sedgwick's November U.S. product recall index.

By Ricky Zipp • Dec. 3, 2021

Biden orders private health insurers to cover COVID-19 home tests

Test makers such as Abbott, BD and Quidel could see demand increase as costs for consumers are reimbursable. The White House is also doubling distribution of free at-home tests to uninsured and underserved communities.

By Nick Paul Taylor • Dec. 3, 2021