Medical Devices: Page 101
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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 -
Courtesy of Abbott
Abbott targets consumer health, aims to turn diabetes success into wearable growth driver
The company is making a play for the wearables market with a line of patches that track the levels of biomarkers such as glucose, ketones and lactate. Abbott's push into the consumer space is part of a broader trend in medtech.
By Nick Paul Taylor • Jan. 7, 2022 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Wall Street backs Stryker-Vocera strategic fit but split on valuation
The nearly $3 billion buy values Vocera at about 11.5 times higher than expected 2022 revenue, leading some analysts to question the overall price.
By Ricky Zipp • Updated Jan. 7, 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 -
Permission granted by The Boldt. Co.
Medtechs brace for hit as hospitals warn of omicron impact on surgeries
Healthcare staff shortages and rising COVID-19 admissions are forcing hospitals to cancel elective surgeries and postpone diagnostic and imaging procedures. BTIG sees as much as a 7% revenue hit for exposed companies.
By Nick Paul Taylor • Jan. 5, 2022 -
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Medtech's biggest deals in 2021 and what to expect next
After dealmaking took off last year following a 2020 lull, market watchers anticipate robust M&A ahead in 2022 as companies pursue faster growth and greater scale.
By Susan Kelly • Jan. 4, 2022 -
Permission granted by iRhythm Technologies
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 -
Sarah Silbiger via Getty Images
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 -
Hospitals clamp down on elective surgeries as COVID-19 surges
Cleveland Clinic, Banner Health and other hospital systems are pausing nonessential procedures, while provider groups issued a joint statement Friday declaring that doctors and nurses are exhausted and heartbroken.
By Susan Kelly • Dec. 22, 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 -
Sarah Silbiger via Getty Images
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 -
Sean Gallup via Getty Images
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 -
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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 -
Praveen Kumar Nandagiri/adobe.stock.com
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
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