Medical Devices: Page 106
-
How much is too much? OIG warns about booze for doctors in medtech speaker programs
"This is a chance to take a hard look and see if it's worth it. The document may signal that some types of practices are just too risky," said Ben Wallfisch, a senior counsel with the Office of Counsel to the HHS Inspector General.
By Kim Dixon • Oct. 1, 2021 -
Andreas Rentz via Getty Images
Bayer posts final analysis of Essure adverse events to FDA
The last report, which is based on social media posts, completes the deal the company made with the agency.
By Nick Paul Taylor • Sept. 30, 2021 -
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 -
MedTech Europe director warns about EU's turbulent switch to IVDR
Oliver Bisazza told the AdvaMed conference this week that while the European Union will "needlessly lose a great deal of tests" in the transition to the In Vitro Diagnostic Regulation, he is confident decision makers will "course correct."
By Nick Paul Taylor • Sept. 30, 2021 -
Alex Wong via Getty Images
CMS defends proposal to nix MCIT pathway, medtechs hold out hope
If the bid to repeal the breakthrough payment rule is finalized, the agency's CMO committed to an alternative pathway that evaluates devices for Medicare patients potentially via clinical trials, outcome registries and real-world data.
By Greg Slabodkin • Sept. 29, 2021 -
Getty Images
FDA medical device regs, safety checks questioned by AMA ethics journal
As it's typically safer to discontinue the use of a drug than an implant, it "might be reasonable" to hold some devices to higher standards, suggests Ariel Wampler, author and plastic and reconstructive surgery physician.
By Nick Paul Taylor • Sept. 29, 2021 -
CDRH's 2021 'reset' shunted again as COVID-19 dominates workload
Jeff Shuren, who spoke during AdvaMed's annual conference, said the heavy coronavirus workload will lead it to miss some MDUFA IV performance metrics.
By Greg Slabodkin • Sept. 28, 2021 -
Sarah Silbiger via Getty Images
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 -
Win McNamee via Getty Images
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 -
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 -
Justin Sullivan via Getty Images
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 -
Getty Images
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 -
Getty Images
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 -
Getty Images
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 -
Getty Images
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 -
Alex Wong via Getty Images
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
Previous
