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

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

Explore the Trendline➔

Top 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

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

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The Medicines and Healthcare products Regulatory Agency is slightly ahead of the FDA, which plans to publish draft guidance for AI and SaMD this year.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

Four 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

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

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

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

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

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

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

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

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

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

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. 9, 2021

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. 8, 2021

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. 7, 2021

Bill 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. 7, 2021

ECRI 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. 3, 2021