Medical Devices: Page 109
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FDA starts review after study finds Boston Scientific's Watchman is riskier in women
The agency is working with manufacturers of LAAO devices, a market fought over by Boston Scientific and Abbott, to assess other sources of data before deciding on the next steps.
By Nick Paul Taylor • Updated Sept. 29, 2021 -
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Delta pressure on US hospitals dragged August operations, Kaufman Hall finds
"The August data show we are not out of the woods yet, and hospitals face additional uncertainties as we move into the fall and winter," said Erik Swanson, senior vice president of data and analytics for the consultant group.
By Rebecca Pifer Parduhn • Sept. 28, 2021 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Amid pandemic, medtech R&D, merger activity jumped: EY report
Research and development spending at pure-play medtechs rose to a level last seen before the 2007-2008 financial crisis.
By Nick Paul Taylor • Sept. 27, 2021 -
Quarter of providers saw mortality rates rise after ransomware attacks, survey finds
Only 36% of healthcare organizations said they are effective in knowing where all their medical devices are, while just 35% indicated they know when a device's operating system is at end of life or out of date.
By Rebecca Pifer Parduhn • Sept. 24, 2021 -
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Medtechs face supply chain disruptions from semiconductor shortage: report
The AdvaMed-commissioned survey found all respondents have experienced some level of disruption to their chip supply chain, with delays ranging from two weeks to more than one year.
By Nick Paul Taylor • Sept. 24, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Boston Scientific CEO: 'Unprecedented' shutdown from delta to hit Q3
CEO Michael Mahoney cited a six- to seven-week impact from the variant beginning in August, in line with other warnings from medtechs. He said meeting full-year sales estimates is "still possible."
By Ricky Zipp • Sept. 23, 2021 -
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FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event
The recall comes a decade after Cordis flagged up the potential for marker bands to dislodge into the vascular system when the catheter is stretched.
By Nick Paul Taylor • Sept. 23, 2021 -
Medtronic embolization device hit with another Class I recall, 2 deaths cited
The action expands a 2020 recall of the brain aneurysm treatment and comes five months after the agency approved an updated version of the technology.
By Susan Kelly • Updated Sept. 22, 2021 -
Boston Scientific to spend $269M for remaining stake of Devoro in latest deal
The medtech giant's 2021 M&A spree continues, following deals of $925 million for Preventice Solutions, $1.07 billion for Lumenis' surgical business and $295 million for cardiac ablation device maker Farapulse.
By Ricky Zipp • Sept. 21, 2021 -
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Abbott gets FDA nod, faces uphill climb taking on Edwards, Medtronic in TAVR market
The challenge for Abbott as the newcomer is to take share in a relatively mature market dominated by well-set incumbents, without evidence of superiority.
By Nick Paul Taylor • Sept. 21, 2021 -
UK seeks overhaul of AI, software as a medical device regs
The Medicines and Healthcare products Regulatory Agency is slightly ahead of the FDA, which plans to publish draft guidance for AI and SaMD this year.
By Greg Slabodkin • Sept. 20, 2021 -
Permission granted by Delve
Sponsored by DelveFour ways to win the future of MedTech wearables
As the market for MedTech wearables heats up, new and incumbent companies are eager to capitalize on the trends. But which ones will win? And why?
Sept. 20, 2021 -
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Philip Morris takes control of Vectura amid pushback against acquisition
The tobacco giant has secured investor buy-in despite continued opposition from clinicians and reports that employees of inhaled medicine specialist Vectura are concerned about the change in ownership.
By Nick Paul Taylor • Sept. 17, 2021 -
Carol Highsmith. (2005). "Apex Bldg." [Photo]. Retrieved from Wikimedia Commons.
FTC warns app makers fall under breach notification rule
The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.
By Shannon Muchmore • Sept. 16, 2021 -
Win McNamee via Getty Images
Q&A
Hillrom VP of connected care talks Baxter's $10.5B buy, digital health
The deal, medtech's largest of 2021, is driven by Hillrom's digital health presence. Trey Lauderdale, Hillrom vice president and general manager of care communications, says the Baxter acquisition is validation of their strategy.
By Greg Slabodkin • Sept. 16, 2021 -
Delta patients clog hospitals, spur more procedure delays
Intermountain is the latest system to announce it's postponing elective procedures starting Wednesday at 13 of its hospitals, and expects the pause to last several weeks, CEO Marc Harrison said Friday.
By Hailey Mensik • Sept. 15, 2021 -
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Medtronic-Axonics neuromod IP fight sees another split patent board ruling
The dispute will drag on in the courts after PTAB's final ruling. Medtronic said it will ask a California court to lift its stay.
By Nick Paul Taylor • Updated Sept. 23, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Zimmer latest medtech to warn of delta wave drag in Q3
The company cautioned that delta variant pressures could extend into the fourth quarter. Despite the warning of the impact on the business, Zimmer's stock price was up nearly 5% Tuesday.
By Nick Paul Taylor • Sept. 15, 2021 -
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CMS moves to scrap MCIT rule due to clinical evidence concerns
AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation.
By Nick Paul Taylor • Sept. 14, 2021 -
Deep Dive
Medtechs are boosting DTC investment, but industry still years behind pharma
Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.
By Ricky Zipp • Sept. 14, 2021 -
NuVasive warns of delta hit in Q3 as hospitals once again limit electives
The company's update offers another early indicator that medtechs will likely be hit in the third quarter due to delta variant surges.
By Nick Paul Taylor • Sept. 14, 2021 -
MedTech Europe calls for urgent clarification of EU artificial intelligence proposal
The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.
By Nick Paul Taylor • Sept. 13, 2021 -
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Jefferies lowers medtech outlooks as hospitals project delta pressure into Q4
The investment bank lowered its third quarter outlook for medical device companies with revenues heavily based on surgical volumes, including Boston Scientific, Medtronic and Stryker.
By Rebecca Pifer Parduhn • Sept. 13, 2021 -
Permission granted by iRhythm Technologies
iRhythm announces new CEO, the second since December, amid tumultuous 2021
Quentin Blackford, who is leaving the position of chief operating officer for Dexcom, will officially take over the role on Oct. 4. iRhythm's stock price shot up by over 34% Monday morning following the announcement.
By Ricky Zipp • Sept. 13, 2021 -
Sarah Silbiger via Getty Images
FDA ends summer with fresh batch of breakthrough device designations
Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.
By Nick Paul Taylor • Sept. 10, 2021
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