FDA seeks feedback on draft device shortage guidance

A new document poses a series of questions for industry on the overall design and operation of the policy, and is intended to help manufacturers provide timely information about supply disruptions during public health emergencies.

By Nick Paul Taylor • Jan. 12, 2022

iRhythm stock jumps nearly 28% after Novitas doubles Medicare rates for cardiac monitoring

The new rates give the cardiac monitor maker a boost following a challenging 2021. After a Monday spike, iRhythm's stock price was also up by nearly 9% when the market closed Tuesday.

By Ricky Zipp • Jan. 11, 2022

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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

Insurers will be required to cover 8 at-home COVID-19 tests per month

After proposing the plan in December, the Biden administration on Monday detailed its plan to have insurers cover rapid tests. Health insurance lobby AHIP warned of potential "hiccups in early days" of implementation.

By Nick Paul Taylor • Jan. 11, 2022

Medtronic CEO: Company on track to hit guidance, omicron impact 'uncertain'

Geoff Martha, who spoke on the opening day of J.P. Morgan's healthcare conference, said the medtech is being impacted by both the delta and omicron variants, including ongoing pressure from hospital staffing shortages.

By Ricky Zipp • Jan. 10, 2022

FDA warning letter cites product safety issues in Medtronic diabetes group

The agency was critical of how long Medtronic took to recall certain MiniMed insulin pumps, despite over 57,000 medical device reports being filed with the FDA over more than three years.

By Ricky Zipp • Jan. 5, 2022

Roche, Siemens at-home tests get EUAs as US faces COVID-19 testing shortage

FDA granted emergency use authorizations to the over-the-counter diagnostics under a new accelerated review program. However, the companies may need months to scale up production.

By Nick Paul Taylor • Jan. 4, 2022

iRhythm's Medicare pricing saga defined its 2021

The cardiac monitor maker had a series of setbacks following Novitas Solutions' Medicare rate cut, including a stock free fall and a new CEO resigning after 4 months. Here's our coverage of iRhythm in 2021. 

Dec. 30, 2021

User growth, product delays and a Super Bowl ad: Diabetes tech heads into 2022 after another eventful year

Diabetes tech companies are heading into 2022 with momentum as insulin pump and CGM use climbs and with key product launches on the horizon. Here are MedTech Dive's top sector stories in 2021.

Dec. 28, 2021

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

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