Medical Devices

Medical device security continues to be casualty of hospital-medtech divide

FDA says manufacturers and hospitals are both responsible for protecting devices from growing cybersecurity threats. However, experts say healthcare providers carry a much heavier load.

By Greg Slabodkin • Dec. 1, 2021

Cyber playbook sets out strategies for modeling threats to medical devices

The FDA-funded guide arrives against a backdrop of calls from the agency for the medtech industry to step up its threat modeling throughout the device lifecycle in order to strengthen cybersecurity and patient safety.

By Nick Paul Taylor • Dec. 1, 2021

Explore the Trendline➔

COVID-19 diagnostics surge as industry prepares for spike in at-home testing

With strong demand once again for rapid at-home coronavirus tests, medtech companies are looking beyond COVID-19 to sell over-the-counter and direct-to-consumer diagnostics for other diseases. 

By MedTech Dive staff

FDA updates eSTAR ahead of expanding filing template for De Novo submissions

The platform has been available for manufacturers to voluntarily submit 510(k) submissions since September 2020. The agency will start accepting De Novo applications when a final rule takes effect early next year.

By Nick Paul Taylor • Nov. 30, 2021

4 takeaways from Medtronic's latest earnings report

The medtech giant on Tuesday discussed a wide range of issues impacting the company, from whether procedure volumes rebounded in November to the chances of it spinning off non-core or underperforming business units.

By Nick Paul Taylor • Nov. 24, 2021

Roundup: COVID-19 surge, hospital labor shortages, supply chain issues hit medtechs in latest earnings

After the industry began recovering in the first half of the year, top companies reported that the delta variant surge put a drag on businesses last quarter.

Nov. 23, 2021

Medtronic blames revenue miss on COVID-19 resurgence, hospital staffing shortages

CEO Geoff Martha said the medtech was hit in its second quarter by pandemic-related challenges that weighed on procedure volumes, particularly in the U.S.

By Greg Slabodkin • Nov. 23, 2021

FDA beats 2021 facility inspection target but big pandemic-driven backlog remains

The update features evidence of progress at the device division, with fewer application decisions delayed solely because of pending facility inspections or assessments.

By Nick Paul Taylor • Nov. 23, 2021

Rise of TAVR increased overall aortic valve replacement, improved outcomes: study

The growth of transcatheter procedures has driven a 60% increase in aortic valve replacement and cut one-year mortality in older adults, according to data published in the Journal of the American College of Cardiology.

By Nick Paul Taylor • Nov. 23, 2021

Latest breakthrough device designations go to brain-computer interface, exo-suit

Regulatory privileges were awarded to Blackrock Neurotech's brain-computer interface, designed to assist immobile patients with performing activities, and ReWalk Robotics' exo-suit, which is intended to help stroke patients walk. 

By Nick Paul Taylor • Nov. 22, 2021

New iRhythm CEO talks Medicare pricing, larger medtech competitors, international markets

"I think the near-term noise is something that we'll work through, but the underlying technology has never been questioned," Quentin Blackford told MedTech Dive.

By Ricky Zipp • Nov. 19, 2021

Stryker dismisses robotics threat from J&J, Zimmer with bullish forecast

CEO Kevin Lobo said during Thursday's analyst day that the company is "poised and ready to pounce" if valuations fall as Stryker looks to leverage M&A in long-term growth plans.

By Nick Paul Taylor • Nov. 19, 2021

Medtronic leadless pacemaker flagged by FDA for safety risks

The agency said in a letter to healthcare providers that cardiac perforations associated with Medtronic's Micra device are more likely than traditional pacemakers to be associated with serious complications, such as death.

By Nick Paul Taylor • Nov. 18, 2021

TAVR uptake in US cities tied to race, ethnicity and income: JAMA study

ZIP codes with higher proportions of Black, Hispanic and socioeconomically disadvantaged patients have lower rates of transcatheter aortic valve replacement procedures, according to an analysis of Medicare claims data.

By Nick Paul Taylor • Nov. 18, 2021

MCIT breakthrough device payment pathway included in Cures 2.0 bill

Lawmakers on Tuesday introduced a revised MCIT proposal in the next version of the 21st Century Cures Act, following last week's repeal of the final rule by CMS. Industry groups AdvaMed and MDMA both back the legislation.  

By Nick Paul Taylor • Nov. 17, 2021

Siemens Healthineers projects revenue jump fueled by Varian double-digit sales growth

The medtech expects its $16.4 billion Varian acquisition to post annual sales growth from 2023 to 2025, leading it to forecast accelerating revenue rises.

By Nick Paul Taylor • Nov. 17, 2021

Globus in takeover talks with NuVasive to boost spine portfolio: reports

Truist Securities and Piper Sandler analysts said the deal is unlikely. J.P. Morgan cautioned that earlier orthopaedic takeovers struggled to generate returns.

By Nick Paul Taylor • Nov. 16, 2021

What does J&J's split mean for the medical device business?

Analysts agree that shedding the consumer health group will help boost pharma and medical device growth. The healthcare giant's move follows two key medtech breakups announced in 2021: GE and Zimmer.

By Ricky Zipp • Nov. 16, 2021

BD's $2B annual M&A war chest, connected care devices at heart of growth plan

Evercore ISI analysts said the targets and messaging were consistent with expectations, while J.P. Morgan questioned why it is taking BD longer than its peers to return margins to pre-pandemic levels.

By Nick Paul Taylor • Nov. 15, 2021

FDA questions safety of Philips replacement foam for recalled devices

The agency has asked Philips Respironics to conduct more safety testing on the sound abatement foam at the center of the sleep apnea and ventilator device recall, but did not recommend that patients stop using the machines.

By Susan Kelly • Nov. 15, 2021

FDA panel finds need for surveillance of devices from Endologix, Medtronic and others

Experts convened earlier this month by FDA warned the risks of routine use of Endologix's current endovascular graft device outweigh the benefits.

By Nick Paul Taylor • Nov. 15, 2021

Biden nominates Robert Califf to return as FDA head

If confirmed, the cardiologist would return to lead an agency taxed by a heavy COVID-19 workload and a backlog of initiatives back-burnered amid the pandemic.

By Ned Pagliarulo , Jonathan Gardner • Updated Nov. 12, 2021

J&J splitting medical device, pharma units from consumer health brands

The industry giant and mainstay of corporate America will separate its consumer health business from its drug and medical device units, which will retain the J&J brand. 

By Ben Fidler , Ned Pagliarulo , Ricky Zipp • Updated Nov. 12, 2021

After another successful quarter, diabetes tech players look ahead to key product launches

Dexcom's new G7 CGM system is expected to gain CE mark clearance in Q4, and Insulet's Omnipod 5 insulin pump is on track for FDA clearance and a limited launch by the end of the year.

By Ricky Zipp • Nov. 11, 2021

Siemens software vulnerabilities potentially put millions of medical devices at risk

A U.S. cybersecurity agency issued an alert about the vulnerabilities which could allow hackers to disrupt the operation of anesthesia machines and bedside monitors from multiple manufacturers.

By Nick Paul Taylor • Nov. 11, 2021

Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

By Nick Paul Taylor • Nov. 10, 2021