Medical Devices: Page 64
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FDA posts draft guidance on studying medical devices in decentralized clinical trials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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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 -
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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 -
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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 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher reports 9% drop in Q1 revenue, shares slip
The drop in revenue accompanied a 41% decline in net income, with Life Sciences Solutions and Specialty Diagnostics revenue declining by double digits.
By Peter Green • April 26, 2023 -
Permission granted by Insulet
Insulet gets FDA clearance for tubeless pump to eliminate daily shots for basal insulin users
The device, called Omnipod GO, eliminates the need for daily injections for people with Type 2 diabetes, CEO Jim Hollingshead said.
By Elise Reuter • April 25, 2023 -
Courtesy of GE Healthcare
GE HealthCare revenue up in first quarter as a standalone company, but shares drop
Steady demand and supply chain improvements have helped it grow the business, even as inflation and foreign exchange rates pressure its income.
By Elise Reuter • Updated April 25, 2023 -
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Know Labs hopes to advance non-invasive glucose sensor with proof-of-concept test
The company wants to use its Bio-RFID technology for glucose monitoring, and recently showed the device could detect and quantify specific molecules in water.
By Nick Paul Taylor • April 25, 2023 -
Philips says revenue rises 6%, sees €575M in recall-related legal costs
CEO Roy Jakobs expressed confidence in the company’s outlook for the year ahead and said setting aside the funds to resolve a U.S. class action lawsuit was “an important step.”
By Susan Kelly • April 24, 2023 -
ipopba / iStock
Graphene ‘tattoo’ pacemaker senses and treats irregular heart beats in rats
While still in early stages of development, the tattoo material can mold to the heart, unlike the more rigid implanted pacemakers used today, reducing some of the problems with traditional and leadless technologies.
By Nick Paul Taylor • April 24, 2023 -
Courtesy of Medtronic
Medtronic wins FDA approval for long-delayed MiniMed 780G insulin pump
Analysts called the FDA approval a “positive” for Medtronic that “should somewhat aid in a turnaround of its U.S. diabetes franchise.”
By Nick Paul Taylor • April 24, 2023
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