Medical Devices
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Win McNamee / Staff via Getty Images
Advamed CEO welcomes Dr. Oz as Trump’s pick to lead CMS
Scott Whitaker said Mehmet Oz knows firsthand the impact of medical technologies on disease prevention and treatment. Oz holds a patent on Abbott’s Mitraclip heart device.
By Susan Kelly • Nov. 20, 2024 -
Win McNamee/Getty Images via Getty Images
Trump nominates Dr. Oz to oversee Medicare, Medicaid as CMS head
On Truth Social, President-elect Donald Trump said Oz, who is best known for his eponymous TV show, would take on the “illness industrial complex.”
By Sydney Halleman • Nov. 20, 2024 -
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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 -
Courtesy of Medtronic
Medtronic’s ablation sales slowed by PFA supply issues
CEO Geoff Martha said the business did not meet internal growth expectations last quarter due to third-party supply issues that have now been resolved.
By Ricky Zipp • Nov. 19, 2024 -
Permission granted by Abbott
Abbott opens plant in Ireland to boost Libre 3 sensor production
More than 800 people will be employed at the plant, which will make more Libre sensors than any of the company’s other facilities.
By Nick Paul Taylor • Nov. 19, 2024 -
Courtesy of Boston Scientific
Boston Scientific’s Watchman could be new option for patients post ablation: study
The trial compared the stroke prevention device for left atrial appendage closure to blood thinners in people who underwent cardiac ablation for AFib.
By Susan Kelly • Nov. 18, 2024 -
Courtesy of Johnson & Johnson
The PFA race is heating up. Here’s where the market stands after J&J’s approval.
Boston Scientific, Medtronic and J&J are moving quickly to secure their place in the fast-growing pulsed field ablation space as new devices and heart imaging technology hit the market.
By Susan Kelly • Nov. 18, 2024 -
Courtesy of Getinge
FDA warns providers on Getinge devices tied to 17 serious injuries
Getinge recalled endoscopic vessel harvesting devices after receiving 18 complaints in four months. The FDA added the devices to its shortages list following the recall.
By Nick Paul Taylor • Nov. 18, 2024 -
Courtesy of Boston Scientific
Boston Scientific closes $3.7B Axonics deal after lengthy review
Boston Scientific announced the acquisition in January, but the review dragged on after the Federal Trade Commission requested more information.
By Ricky Zipp • Nov. 15, 2024 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher eliminating 160 jobs, closing Massachusetts facility
A facility in Lexington will close, and smaller numbers of people will be laid off at plants in Cambridge and Plainville.
By Nick Paul Taylor • Nov. 15, 2024 -
Rebecca Noble via Getty Images
Trump nominates RFK Jr. to lead HHS
The nomination of a prominent vaccine skeptic to the head of the nation’s largest healthcare program is expected to alarm some public health experts.
By Sydney Halleman • Nov. 14, 2024 -
Stock via Getty Images
FDA breakthrough device decisions rebound after recent declines
The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the downward trend seen as the COVID-19 pandemic eased.
By Nick Paul Taylor • Nov. 14, 2024 -
Retrieved from GE Healthcare on November 14, 2024
GE Healthcare’s head-only MRI scanner cleared by the FDA
The system is designed to shorten scan times, which may be better for people who struggle to stay still or have claustrophobia, and to detect more subtle abnormalities.
By Nick Paul Taylor • Nov. 14, 2024 -
Photo illustration: Shaun Lucas/Industry Dive; Getty Images
Haemonetics to close California facility, lay off 75 people
Over the past year, Haemonetics has reshaped its product portfolio through restructuring and M&A, adding devices used in cardiology procedures.
By Susan Kelly • Nov. 14, 2024 -
Permission granted by Sequel Medtech
Dean Kamen, insulin pump pioneer, wants to shake up diabetes tech
Kamen and Sequel Medtech CEO Alan Lotvin say they are offering greater precision in insulin delivery with new pump technology in the Twiist device.
By Elise Reuter • Nov. 13, 2024 -
Photo by MART PRODUCTION from Pexels
Livanova hits sleep apnea trial goals, plans FDA filing
Leerink analysts said the results were largely in line with outcomes in a trial of Inspire Medical’s rival device but cautioned that Livanova may have a hard time breaking into the sleep apnea market.
By Nick Paul Taylor • Nov. 13, 2024 -
Courtesy of Johnson & Johnson
J&J’s Ottava surgical robot to begin clinical trial after FDA nod
With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging Intuitive Surgical’s da Vinci system.
By Susan Kelly • Nov. 12, 2024 -
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 -
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
