Medical Devices: Page 111
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Boston Scientific sales not yet back to growth as Watchman hit compounds COVID-19 impacts
The medtech is aiming for organic revenue growth in Q4 after falling 5.7% in Q3. CEO Mike Mahoney said estimating the remaining procedure backlog and new patient funnel "remain a challenge" and vary by business and region.
By Nick Paul Taylor • Oct. 28, 2020 -
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 -
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Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
Retrieved from Abiomed/BusinessWire on April 30, 2020
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 -
Retrieved from Pixabay.
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 -
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 -
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 -
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
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