MDUFA V talks kick off as FDA grapples with onslaught of COVID-19 submissions

Medtech industry groups broadly expressed a desire to maintain the status quo after FDA Commissioner Stephen Hahn described the strain on agency workers under MDUFA IV as unsustainable.  

By Maria Rachal • Oct. 28, 2020

Neovasc refractory angina treatment faces FDA panel review

The agency's ultimate approval decision on the Canadian company's CE-marked device has important financial implications for the medtech, which saw its revenue plunge and operating loss deepen in the second quarter.

By Susan Kelly • Oct. 27, 2020

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

FDA grants 510(k) to Abiomed's artificial lung, teeing up use in COVID-19

While LivaNova and Medtronic already sell ECMO devices, Abiomed is focusing on a relatively compact design to differentiate the device from the pack.

By Nick Paul Taylor • Oct. 27, 2020

Despite recent rebound, hospitals find admissions still well below pre-pandemic levels

Trends from health systems in New York and California suggest patients may have lost health insurance as a result of the economic fallout from the pandemic

By Ron Shinkman • Oct. 26, 2020

FDA, Philips warn of data bias in AI, machine learning devices

The comments come 18 months after FDA unveiled a yet-to-be-finalized framework for modifying AI/ML-based software as a medical device using real-world learning and adaptation.

By Greg Slabodkin • Oct. 26, 2020

Stryker buyout of Wright poised to pass 1-year mark without closing

CEO Kevin Lobo said last month the $5.4 billion buyout, which has faced antitrust hurdles, was on track to be finalized in early October.  

By Maria Rachal • Oct. 26, 2020

EU notified body designation pipeline points to IVDR bottleneck

An update from the European Commission reveals only a few notified bodies are likely to join the four already designated over the coming months.

By Nick Paul Taylor • Oct. 26, 2020

Medtech Q3 results signal diagnostics boom, mixed bag on device growth

Hologic, BD and Zimmer Biomet are among the medtechs set to add to the growing mass of late summer data points this week.

Updated Nov. 2, 2020

Neuromod devices at the fore in latest FDA breakthrough designations

Liquid biopsies also stand out as an area where U.S. regulators are encouraging development and prioritizing review.

By Nick Paul Taylor • Oct. 23, 2020

Robotic surgery pricier, with no measurable benefit in hernias: Cleveland Clinic trial

Certain procedures with Intuitive's da Vinci took 55% longer than those done laparoscopically, which drove up costs. The findings also punctured the perception that robotic platforms may reduce postoperative pain. 

By Nick Paul Taylor • Oct. 22, 2020

Edwards TAVR sales grow 6% but Q4 forecast disappoints

A resurgence of COVID-19 cases in Europe and parts of the U.S. creates uncertainty about the fourth quarter, execs acknowledged, but noted talks with hospitals suggest widespread global disruption to surgeries is unlikely.

By Nick Paul Taylor • Oct. 22, 2020

Abbott device growth returns as Wall Street queries staying power of COVID-19 test boom

CEO Robert Ford argued that focusing on how coronavirus test demand will evolve "misses the point," touting the longer-term benefits of its now-expanded diagnostic platforms footprint.

By Maria Rachal • Oct. 21, 2020

FDA floats framework to message cybersecurity threats to patients

The proposal, which has the agency and industry sharing responsibility for making the information easy to find, comes as the risks to medical devices continue to grow.

By Nick Paul Taylor • Oct. 21, 2020

Robotic surgery startups help drive Q3 medical device funding over $5B, an all-time high

CB Insights also listed the progress of neuromodulation devices and Medtronic's deals in diabetes and neurosurgery as other highlights.

By Nick Paul Taylor • Oct. 20, 2020

FDA, medtechs envision new era for clinical trials amid COVID-19 shake-up

Medtronic, for example, has faced "very significant delays" in getting products approved as a result of research disruptions, the company's VP of global clinical affairs said during a discussion at TCT.

By Maria Rachal • Updated Oct. 20, 2020

Future of COVID-19 products, device shortages, CDS top CDRH 2021 to-do list

Regulators aim to publish final guidance on five topics and draft documents on another dozen priority areas in the coming year. A few of the goals are carryovers as priorities shifted during the public health emergency.

By Susan Kelly • Oct. 19, 2020

Philips Q3 connected care sales up 42%, but ventilators to decline next year

The company expects the COVID-19 tailwinds, including double-digit growth in patient monitors and ventilators, to extend through the fourth quarter but fall away in 2021.

By Greg Slabodkin • Oct. 19, 2020

Boston Scientific faces TAVR setback vs. Medtronic, 3-year delay to US launch of redesigned valve

The medtech's stock fell 4% on news that its Acurate neo valve did not achieve noninferiority against Medtronic's CoreValve Evolut, and subsequently that the FDA needs more data for a product submission to be successful.

By Maria Rachal • Oct. 16, 2020

Intuitive sees partial Q3 recovery but warns COVID-strained hospital finances continue

Between customers tightening their belts and having first-time competition on the horizon, the longtime robotic surgery leader is rethinking approaches to pricing and M&A.

By Nick Paul Taylor • Oct. 16, 2020

FDA finalizes guidance on nitinol devices, posts biocompatibility draft

The agency has been looking at the alloy, commonly used in stents and heart valves, as part of a broader look at metals that can cause inflammatory or other types of reactions once inside the body.

By Nick Paul Taylor • Oct. 15, 2020

Medtronic pits TAVR device against Edwards Sapien 3, eyes challenge to Abbott's MitraClip

The company appears to be doubling down on structural heart competition with a series of investments in the transcatheter aortic valve replacement and mitral valve repair markets.

By Nick Paul Taylor • Oct. 15, 2020

Medtronic CEO pitches strategy revamp, but Wall Street takes wait-and-see approach

Geoff Martha laid out a new operating model to investors, acknowledging the medtech giant has too often grown "below its markets" and that its market share is "not commensurate with our technology leadership."

By Greg Slabodkin • Oct. 14, 2020

With rivals delayed, Intuitive Surgical extends use of robotic instruments

The program could help expand the da Vinci robot's place in gallbladder removal and hernia repair, as Medtronic and J&J face pandemic-related delays to launching their systems. 

By Susan Kelly • Oct. 14, 2020

Old market, new growth: Medtronic and Axonics competition ups sacral neuromodulation's reach

In a challenging year for elective procedures, Medtronic estimates a key pelvic health market that's grown in the mid-single digits for the last 25 years increased 20% this past quarter.

By Maria Rachal • Oct. 14, 2020

Elective surgeries seen driving Q3 medtech comeback, but can it last?

A robust recovery in medical device procedures is forecast for the third quarter as patients rescheduled, but some analysts are now seeing a leveling off in hospital activity. The flu season also poses a risk going into the winter.

By Susan Kelly • Oct. 13, 2020