Medical Devices
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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 -
Sarah Silbiger via 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 -
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Adeline Kon/MedTech Dive
TrendlineHow medtechs are navigating the sales environment through the pandemic
The impact of the pandemic on the industry was far from even, given the diversity of companies in the space — from those that make heart valves to artificial hips and knees to robotics to point of care testing.
By MedTech Dive staff -
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 at 8:55 a.m. -
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 -
Sarah Silbiger via 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The Medicines and Healthcare products Regulatory Agency is slightly ahead of the FDA, which plans to publish draft guidance for AI and SaMD this year.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 -
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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?
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H. Armstrong Roberts via 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&AHillrom 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 -
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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 -
MIND_AND_I/iStock / Getty Images via 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 at 9:19 a.m. -
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 -
Deep DiveMedtechs 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 -
Win McNamee via Getty Images
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 • Sept. 13, 2021 -
Permission granted by iRhythm
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 -
ResMed touts CPAP survival benefits for sleep apnea after HHS doubts therapy efficacy
The ResMed-funded analysis of a French database comes on the heels of a government review finding the evidence does not back a link between continuous positive airway pressure therapy and clinically important outcomes.
By Greg Slabodkin • Sept. 09, 2021 -
Sarah Silbiger via Getty Images
Spine devices, recalls and endovascular stents on FDA's fall meeting lineup
Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning.
By Nick Paul Taylor • Sept. 08, 2021 -
Sarah Silbiger via Getty Images
TransMedics wins FDA nod for donor heart preservation system
Approval for the device comes two months after an FDA advisory panel backed the company's liver preservation system and follows the go-ahead for its donor lung technology in 2019.
By Susan Kelly • Sept. 07, 2021 -
Image courtesy of Vicarious Surgical
Q&ABill Gates-backed Vicarious Surgical targets Intuitive, J&J, Medtronic in abdominal robotic surgery
The robotics startup, with investors including BD, wants to grow sales to $1 billion by 2027. CEO and co-founder Adam Sachs told MedTech Dive legacy robot platforms have fallen short in terms of cost and efficiency.
By Greg Slabodkin • Sept. 07, 2021 -
Permission granted by ECRI
Q&AECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb
Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.
By Ricky Zipp • Sept. 03, 2021
