Medical Devices: Page 12
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Permission granted by Boston Scientific
Boston Scientific resumes PFA trial in new patient group after pausing enrollment
Boston Scientific expects to complete enrollment in the coming months in the study comparing pulsed field ablation to anti-arrhythmic drugs in patients with persistent AFib, a spokesperson said.
By Susan Kelly • Nov. 12, 2024 -
Win McNamee/Getty Images via Getty Images
Advamed CEO congratulates Trump, stresses need for public policy support
Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the agency’s contentious LDT final rule is challenged in court.
By Ricky Zipp • Nov. 11, 2024 -
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Sitthiphong via Getty Images
TrendlineMedical 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 -
Chip Somodevilla via Getty Images
How the healthcare industry is reacting to a second Trump term
Donald Trump’s first term as president was characterized by significant turbulence for government healthcare programs. Here’s how some of the most influential industry groups responded to the Republican’s reelection.
By Rebecca Pifer • Nov. 11, 2024 -
libre de droit via Getty Images
Inquis raises $40M for pivotal trial of clot removal device
The Aventus thrombectomy system uses technology that tells operators if the device’s tip is in contact with blood, a clot or vessel walls.
By Nick Paul Taylor • Nov. 7, 2024 -
Courtesy of Siemens Healthineers
Siemens Healthineers confident it can cope with Trump tariffs
CEO Bernd Montag said the company is well positioned for a “U.S. versus China situation” that could arise when Donald Trump returns to the White House.
By Nick Paul Taylor • Nov. 7, 2024 -
Permission granted by Politan Capital Management
Masimo, amid leadership transition, targets cost reductions
Executives said the patient monitoring company’s consumer business will likely become a discontinued operation if it is not spun off.
By Susan Kelly • Nov. 6, 2024 -
Courtesy of Ambry Genetics
Tempus AI to buy genetic testing company for $600M
CEO Eric Lefkofsky said the purchase of Ambry Genetics will expand Tempus’ testing portfolio and bring in a fast-growing business.
By Elise Reuter • Nov. 6, 2024 -
Thomas Andreas via Getty Images
Advamed asks CMS to cover extra imaging of dense breast tissue
Many patients with dense breast tissue currently have to pay out of pocket or forgo potentially life-saving additional testing, Advamed said in a letter.
By Nick Paul Taylor • Nov. 6, 2024 -
Courtesy of Medtronic
Medtronic, Recor win CMS transitional payment coverage for renal denervation devices
Patient and physician education is the next challenge to change the treatment paradigm for drug-resistant hypertension, Citi Research analyst Joanne Wuensch said.
By Susan Kelly • Nov. 5, 2024 -
Courtesy of Integra LifeSciences Holdings Corporation
Integra Lifesciences names Mojdeh Poul as CEO
Poul will take over the company in January after spending 11 years with 3M and working at Medtronic and Boston Scientific.
By Nick Paul Taylor • Nov. 5, 2024 -
Courtesy of Boston Scientific
Boston Scientific continues M&A run with Cortex buy
Cortex adds to Boston Scientific’s electrophysiology portfolio amid treatment shifts in the space driven by new pulsed field ablation devices.
By Ricky Zipp • Nov. 4, 2024 -
Wavebreakmedia via Getty Images
Medtronic settles pulse oximetry lawsuit alleging inaccuracies
Roots Community Health has sued 12 other firms, including GE Healthcare, CVS and Walgreens, and called for manufacturers and the FDA to ensure the devices work for everyone.
By Elise Reuter • Nov. 4, 2024 -
iStock via Getty Images
Zimmer licenses NeuroOne brain ablation system
NeuroOne will get $3 million upfront for an exclusive license to distribute its radiofrequency ablation system designed to treat neurological disorders such as epilepsy and Parkinson's disease.
By Nick Paul Taylor • Nov. 4, 2024 -
Permission granted by Johnson & Johnson
J&J Medtech CIO Larry Jones resigns
Jones, who has led connectivity solutions for J&J’s surgical robots, announced his departure on LinkedIn.
By Elise Reuter • Updated Nov. 1, 2024 -
Retrieved from iRhythm on October 22, 2024
FDA clears iRhythm’s second 510(k) in response to warning letter
However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation efforts are further along.
By Susan Kelly • Nov. 1, 2024 -
artJazz via Getty Images
EU posts guidance on ethylene oxide in device sterilization
The document clarifies that EtO falls within the scope of the Medical Device Regulation and the In Vitro Diagnostic Regulation.
By Nick Paul Taylor • Nov. 1, 2024 -
Courtesy of Edwards Lifesciences
Edwards, Medtronic and Inari share trial data at TCT conference
The three medtech firms unveiled new data this week during TCT 2024 in Washington, D.C. Here’s what the results mean for the companies and their device markets.
By Nick Paul Taylor • Oct. 31, 2024 -
Courtesy of Boston Scientific
Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study
Analysts said the findings complicate the outlook for a U.S. launch of Boston Scientific's aortic valve replacement device.
By Susan Kelly • Oct. 31, 2024 -
Permission granted by Zimmer Biomet
Stryker, Zimmer outline different M&A strategies
Stryker CEO Kevin Lobo told investors M&A will be the “number one use of our cash going forward,” while Zimmer Biomet CEO Ivan Tornos emphasized internal product development for growth.
By Elise Reuter • Oct. 30, 2024 -
GussWilder for iStock via Getty Images
Exactech files for Chapter 11, agrees to investor buyout
The filing follows Exactech’s failure to settle product liability claims from about 2,600 patients in response to recalls of orthopedic devices.
By Nick Paul Taylor • Oct. 30, 2024 -
Courtesy of Edwards Lifesciences
Edwards data show benefit of early TAVR over ‘watchful waiting’
Study author Philippe Genereux said the trial data “shatter 60 years of ingrained belief on the treatment for severe aortic stenosis.”
By Susan Kelly • Oct. 29, 2024 -
Courtesy of Abiomed
J&J to seek FDA approval after small-bore Impella heart pump hits trial goal
The company has predicted the narrower Impella ECP will be easier to insert and implant, as well as enable the use of small bore access and closure techniques.
By Nick Paul Taylor • Oct. 29, 2024 -
Courtesy of Boston Scientific
Boston Scientific to close Silk Road Medical headquarters, lay off 138 people
Following its acquisition of Silk Road in September, Boston Scientific said it plans to consolidate the company’s work in Minnesota.
By Elise Reuter • Oct. 28, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips cuts sales forecast after ‘significant deterioration’ in China
CEO Roy Jakobs expects the slump to continue into 2025, driven by China’s anti-corruption measures.
By Nick Paul Taylor • Oct. 28, 2024 -
Retrieved from Hologic on May 23, 2024
FDA advises clinicians to stop using Hologic radiographic markers
Hologic has recalled the Biozorb devices after 188 reports of adverse events in patients who received the implants in breast tissue.
By Susan Kelly • Oct. 28, 2024
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