Medical Devices: Page 91
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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 -
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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 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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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 -
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At an 'inflection point,' Smith & Nephew predicts faster growth will follow current challenges
CFO Anne-Françoise Nesmes said there is a procedure backlog from COVID-19 but added that the "new variants of COVID are a reminder of how difficult it is to predict the timing of the recovery."
By Nick Paul Taylor • Dec. 20, 2021 -
Permission granted by Johnson & Johnson
Q&AJ&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 -
Sarah Silbiger via Getty Images
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 -
3 medtech markets poised to thrive in 2022 despite renewed COVID-19 pressures
While the emergence of the omicron variant is muddying next year's medtech outlook, analysts have identified three niches within the sector best positioned to successfully weather the continued strains on the healthcare system.
By Susan Kelly • Dec. 15, 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 -
Roundup: Baxter completes $10.5B Hillrom acquisition
Wall Street analysts have questioned the price and strategic fit of the deal, which is the largest medtech buy so far in 2021.
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 -
Sarah Silbiger via Getty Images
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 -
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Sponsored by RQM+Canada regulations news for medical devices and IVDs
The new Canadian requirement for summary reports goes into effect on 18 Dec. 2021. Learn how to leverage your PSUR for an efficient submission.
By Nancy Morrison, RQM+ • Dec. 13, 2021 -
Edwards sees double-digit 2022 sales growth boosted by another TAVR jump
The cardiac device maker estimated 12% to 15% growth next year for transcatheter aortic valve procedures. During its annual investor conference, Edwards also updated future growth projections for key markets.
By Ricky Zipp • Dec. 9, 2021 -
Sarah Silbiger via Getty Images
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 -
Permission granted by The Boldt. Co.
Study finds surgery volumes bounced back after 2020 COVID-19 shutdown, confirming medtech sales trends
Confounding factors such as healthcare staffing shortages caused the delta variant headwind to drag on — and, now, rapidly increasing inpatient volumes are leading U.S. hospitals to once again delay surgical procedures.
By Nick Paul Taylor • Dec. 9, 2021 -
Thomas Barwick via Getty Images
Study links cochlear implants to new bone formation, long-term residual hearing loss
Ultra-high spatial resolution CT detected new bone formation in two-thirds of the patients within four years of implantation, which adversely affected their long-term hearing preservation, according to a study in the journal Radiology.
By Nick Paul Taylor • Dec. 8, 2021 -
Implantable cardioverter defibrillators are underused in women, racial minorities: study
The proportion of people who received an ICD rose from 11.6% in 2003 to 17% in 2014, according to the Mayo Clinic study. However, that overall figure masks differences between patient groups.
By Nick Paul Taylor • Dec. 8, 2021 -
Tandem Diabetes Care targets 1M customers by 2027
The insulin pump maker expects to triple its installed units over the next five years behind new product launches and capturing market share as use among Type 1 and Type 2 patients is projected to take off.
By Ricky Zipp • Dec. 7, 2021 -
Sarah Silbiger via Getty Images
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 -
Insulet Omnipod 5 release
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 -
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Sponsored by Avail MedsystemsCan medical device reps have a healthy work-life balance and a growing career? Yes and yes.
Medical device reps face long work days and extensive travel schedules, but technology is changing the way they do business.
Dec. 6, 2021 -
Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
NuVasive resumes US shipments of titanium-based orthopaedic devices, gets FDA thumbs up
The agency voiced its support for the reintroduction of the Precice products, telling healthcare providers that the availability of the devices is in the best interests of patients as the benefits outweigh the known risks.
By Nick Paul Taylor • Dec. 2, 2021 -
EU finalizes implementing regulation for Eudamed medical device database
The European Commission has provided a framework for the basic operation of the system, slated for a May 2022 launch, including how to access it, what it will do in the event of a database malfunction and IT security measures.
By Nick Paul Taylor • Dec. 2, 2021
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