Medical Devices: Page 115
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Courtesy of Abbott, PRNewswire
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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 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 -
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 -
Courtesy of Boston Scientific
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 -
Jacob Bell/MedTech Dive
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 -
Courtesy of Medtronic
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 -
J&J US device unit returns to growth, potential bellwether for medtech Q3 earnings
A double-digit rise in interventional sales was offset by ongoing headwinds in parts of the orthopaedic and surgery franchises.
By Nick Paul Taylor • Oct. 13, 2020 -
De Novo-winning devices often lack effectiveness data, analysis shows
A JAMA Internal Medicine analysis of 63 devices reviewed via FDA's premarket pathway for novel technologies found one-fifth weren't evaluated in pivotal studies.
By Nick Paul Taylor • Oct. 13, 2020 -
TCT 2020: Abbott devices, TAVR systems headline late breaker lineup
The five-day Transcatheter Cardiovascular Therapeutics event kicked off Wednesday.
By Susan Kelly • Oct. 12, 2020 -
Cancer testing drives 2020 medtech IPO surge after slow start
A flurry of activity began in June, including from China-based Burning Rock and Genetron and U.S.-based Progenity.
By Nick Paul Taylor • Oct. 12, 2020 -
Courtesy of AdvaMed
5 key exec insights from 2020's MedTech Conference
Top leaders from Abbott, BD, Medtronic, Stryker and Zimmer Biomet shared the latest on the industry's recovery during the pandemic and thoughts on where it goes from here.
By Maria Rachal • Oct. 9, 2020 -
Fresenius sees COVID-19 driving dialysis device growth, eyes home care strategy
Execs at the company, which upped production of machines by 230% in response to the crisis, laid out plans at an investor day Thursday.
By Nick Paul Taylor • Oct. 9, 2020 -
Medtronic shares early data TAVR works in low-risk bicuspid patients
Authors of the short Medtronic-sponsored trial, published in JAMA Cardiology, suggest the valve may be free of problems that caused early studies of the device in bicuspid disease to report worse in-hospital outcomes.
By Nick Paul Taylor • Oct. 8, 2020 -
Avail raises $100M to let medtech reps remotely oversee surgeries
The Series B funding comes weeks after Smith & Nephew claimed to be the first orthopaedics company to use the telemedicine service.
By Nick Paul Taylor • Oct. 8, 2020 -
Steris inks $850M deal for Key Surgical adds to medtech M&A wave
CEO Walter Rosebrough gave a nod to current low interest rates but said Steris had been looking at this potential transaction "for years, not months."
By Susan Kelly • Oct. 7, 2020 -
'Tragedy' if FDA doesn't extend COVID-19 lessons beyond pandemic, Shuren says
Device head Jeff Shuren acknowledged the regulatory paradigm for medical devices is more than 40 years old and "not well suited for many modern-day technologies," speaking at AdvaMed's Virtual MedTech Conference.
By Greg Slabodkin • Oct. 7, 2020 -
Analysts predict Zimmer Biomet M&A in 2021 to speed growth
The medtech is likely to initially target private orthopaedic companies worth up to $300 million, Needham analysts specified. The spine and dental businesses, meanwhile, could be on the chopping block.
By Nick Paul Taylor • Oct. 7, 2020
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