Medical Devices: Page 58
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Kevin Dietsch via Getty Images
FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech
The head of the agency said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.
By Nick Paul Taylor • May 9, 2023 -
Permission granted by Boston Scientific
Q&AFriday Q&A: Boston Scientific’s De Rosa on the rise of an AFib ‘game changer’
The Switzerland-based vice president of rhythm management for Europe, the Middle East and Africa expects a “massive shift” to pulsed field ablation from other atrial fibrillation treatments.
By Susan Kelly • May 5, 2023 -
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 -
Mark Wilson via Getty Images
Boston Scientific gets DOJ subpoena for documents related to heart monitoring
The disclosure comes as cardiac monitoring device maker iRhythm also said it received a request from the Justice Department.
By Susan Kelly • May 5, 2023 -
HadelProductions via Getty Images
ZimVie will lay off 5% of staff in bid to reduce costs, streamline business
The restructuring, along with reductions in discretionary spending, are expected to save the company $17 million to $20 million by 2024.
By Elise Reuter • May 5, 2023 -
Permission granted by iRhythm Technologies
iRhythm says it received DOJ subpoena regarding company’s ‘products and services’
The company’s shares fell more than 5% after the federal government requested documents.
By Nick Paul Taylor • May 5, 2023 -
Permission granted by Becton Dickinson
BD raises full-year forecasts again, expects Alaris infusion pump approval
The company said revenue increases in a number of its product lines were faster than market growth rates, suggesting it’s gaining share.
By Susan Kelly • May 4, 2023 -
Permission granted by Akili Interactive
Akili shares rise after early data shows video game treatment can improve attention in adults
The company aims to expand its video game-based treatment for ADHD to adults and adolescents.
By Elise Reuter • May 4, 2023 -
Sarah Silbiger via Getty Images
FDA posts draft guidance on studying medical devices in decentralized clinical trials
Analysts at Cowen said the draft could reassure sponsors they can run decentralized trials without complicating approvals.
By Nick Paul Taylor • May 4, 2023 -
Courtesy of Tandem Diabetes
Tandem expects to meet ‘key’ goals even as rival’s device launch may curb short-term sales growth
Tandem claims it has a better insulin pump than Medtronic’s recently approved rival MiniMed 780G device.
By Nick Paul Taylor • May 4, 2023 -
Thermo Fisher plans another round of layoffs in California, as profits fall
The workforce reductions at the scientific instruments maker continue the wave of job cuts affecting the medical device sector in recent months.
By Susan Kelly • Updated May 3, 2023 -
Courtesy of Dexcom
Dexcom proposes $1.1B debt offering to add to existing $2.6B cash reserve
About $189 million of the funds will go toward the repurchase of Dexcom stock and a portion will support other financial transactions, the company said.
By Nick Paul Taylor • May 3, 2023 -
Permission granted by Medtronic
Medtronic’s US diabetes business is floundering. Can the MiniMed 780G rescue it?
The company, sidelined by a warning letter while competitors brought new products to market, is counting on its newest diabetes devices to spur “pent up interest.”
By Elise Reuter • May 2, 2023 -
Masimo suit against Apple over smartwatch trade secrets ends in mistrial
The medical device maker said it intends to retry the lawsuit, as it awaits a decision from the International Trade Commission on a separate investigation into patent infringement claims against Apple.
By Susan Kelly • May 2, 2023 -
Permission granted by Zimmer Biomet
Zimmer Biomet grows revenue, profits, as orthopedic procedures return
CEO Bryan Hanson said “pretty much everything went better than expected” in the first quarter.
By Elise Reuter • May 2, 2023 -
ChooChin via Getty Images
Analyst ‘blown away’ by robot-fueled growth of Stryker’s hip and knee sales
Stryker CEO Kevin Lobo named the Mako robot as a driver of “pretty breathtaking” knee growth outside the U.S.
By Nick Paul Taylor • May 2, 2023 -
Courtesy of Hologic
Hologic, after overcoming chip shortage, starts considering larger M&A deals
The breast health unit “emphatically returned to growth” because of improvements to the supply of semiconductors.
By Nick Paul Taylor • May 2, 2023 -
Permission granted by Medtronic
Medtronic ramps up competition for leadless pacemakers with newly approved devices
Medtronic received FDA approval for the first leadless pacemaker in 2016, but faces a new competitor in Abbott, which got the nod for its own leadless device last year.
By Elise Reuter • May 1, 2023 -
Carl Court via Getty Images
Great Britain proposes allowing CE marks until 2030 to minimize Brexit disruption
The extended timeline to create a new regulatory system in England, Scotland and Wales is intended to prevent medical device shortages.
By Nick Paul Taylor • May 1, 2023 -
HadelProductions via Getty Images
Globus shareholders approve share issuance for $3.1B NuVasive purchase
NuVasive’s shareholders also OK’d the merger agreement, bringing the deal a step closer to closing.
By Elise Reuter • April 28, 2023 -
Courtesy of Dexcom
Dexcom reports ‘growing momentum’ behind G7 launch in first quarter
The CGM launch helped the company add more users than in any other quarter in its history.
By Nick Paul Taylor • April 28, 2023 -
Courtesy of ResMed
ResMed device sales jump 43% as supply constraints ease
ResMed’s CEO said “I know we’ll be able to beat [Philips]” when the rival returns to the market after its recall.
By Nick Paul Taylor • April 28, 2023 -
Courtesy of Illumina
Illumina gets cybersecurity warning from FDA over sequencing software
The vulnerability could result in an attacker gaining control of an instrument remotely and altering genomic data results, the agency said.
By Susan Kelly • Updated April 28, 2023 -
Courtesy of 3M.
3M plans 6,000 layoffs as hospital staffing woes continue to curb procedures
Manufacturing and supply chain “headwinds” hurt operating margins in the first quarter, the company said.
By Peter Green • April 27, 2023 -
Permission granted by Edwards Lifesciences
Edwards Q1 revenue boosted by growth at TAVR unit, surgical structural heart business
The company also said it benefited from improved hospital staffing levels that led to a rebound in procedures.
By Nick Paul Taylor • April 27, 2023 -
Boston Scientific Q1 sales top expectations on ‘healthy’ market demand
As medical procedures pick up pace after the COVID slowdown, the company said it is taking market share in all of its business units.
By Susan Kelly • April 26, 2023
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