Medical Devices: Page 33
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Courtesy of Samsung Electronics
Samsung wins de novo nod for watch that detects sleep apnea
The FDA created special controls that provide a path to market for other developers of over-the-counter devices.
By Nick Paul Taylor • Feb. 14, 2024 -
Getty Images via Getty Images
Invitae files for Chapter 11 bankruptcy
The genetic testing company hopes to keep its employees on payroll as it works through a court-overseen sale.
By Elise Reuter • Feb. 14, 2024 -
Permission granted by Senseonics
Senseonics gains expanded Medicare coverage for implantable CGM
Three Medicare Administrative Contractors will start covering the Eversense E3 CGM for people who only take basal insulin.
By Elise Reuter • Feb. 13, 2024 -
gorodenkoff via Getty Images
Robotic knee replacement revision rate no better than traditional surgery: study
Orthopedics companies such as Stryker and Zimmer Biomet have promoted robotic knee surgery as a more accurate technique.
By Nick Paul Taylor • Feb. 13, 2024 -
kieferpix via Getty Images
Medtech companies lay off thousands in 2024, continuing last year’s trend
With the year drawing to a close, Masimo, Smith & Nephew and Boston Scientific are among the medtech companies to announce job cuts.
By MedTech Dive Staff • Updated Dec. 17, 2024 -
No name give, Prostock-Studio via Getty Images
Masimo finds pulse oximeter is accurate in Black patients with low pulse strength
A recent study, which examined a Masimo device, found low pulse strength and darker skin pigmentation are associated with pulse oximeter errors.
By Nick Paul Taylor • Feb. 12, 2024 -
Courtesy of Abbott Laboratories
FDA meeting document ‘generally supportive’ of Abbott Triclip: analysts
J.P. Morgan analysts noted the agency’s queries on safety but added the document has “simple voting questions” that “all lean towards approval.”
By Nick Paul Taylor • Feb. 12, 2024 -
Permission granted by Illumina
Illumina cut 12% of global staff over past year: CEO
The genomics company, which initiated a fresh round of layoffs last month, expects to finalize its Grail divestiture by the end of June, Jacob Thaysen said Thursday.
By Susan Kelly • Feb. 9, 2024 -
kieferpix via Getty Images
Livanova to lay off 137 people at Pittsburgh facility
A spokesperson said the layoffs are part of the company's plan to shut down its advanced circulatory support business.
By Ricky Zipp • Feb. 9, 2024 -
Courtesy of Fresenius
Fresenius Medical Care brings dialysis technology to US with FDA clearance
The company plans to start a broad market launch next year and push to establish hemodiafiltration as the new standard of care.
By Nick Paul Taylor • Updated March 8, 2024 -
Courtesy of Illumina
Illumina to lay off 111 people at San Diego headquarters
The job cuts, expected by March 12, include senior management positions, scientists and engineers.
By Susan Kelly • Feb. 8, 2024 -
Permission granted by Zimmer Biomet
Zimmer Biomet to cut about 540 jobs
A spokesperson told MedTech Dive that the company will lay off about 3% of its workforce as part of a restructuring.
By Elise Reuter • Updated Feb. 8, 2024 -
Courtesy of Insulet Corp.
Insulet wins CE mark for integration of insulin pump with Abbott CGM
The clearance positions Insulet to sell the integrated Type 1 diabetes product in Europe beginning in the first half of the year.
By Nick Paul Taylor • Feb. 8, 2024 -
Courtesy of Boston Scientific
Boston Scientific’s spinal cord stimulators approved for non-surgical back pain
FDA backing for the Wavewriter SCS systems allows the company to challenge Abbott and Nevro.
By Nick Paul Taylor • Feb. 7, 2024 -
Courtesy of Edwards Lifesciences
How Edwards’ Evoque valve won an early nod from the FDA
The heart valve specialist has the chance to shape a new tricuspid market with the first-of-its-kind device, like it did 20 years ago in TAVR, CEO Bernard Zovighian said.
By Susan Kelly • Feb. 7, 2024 -
Courtesy of Globus Medical
Globus Medical names Keith Pfeil as chief operating officer
Pfeil will remain the company’s CFO, a position he has held since 2019.
By Nick Paul Taylor • Feb. 7, 2024 -
Mario Tama via Getty Images
J&J unveils Varipulse data at AF Symposium
The results compare favorably to data from Boston Scientific and Medtronic, although analysts noted that J&J enrolled younger patients.
By Nick Paul Taylor • Feb. 6, 2024 -
Permission granted by Livanova
Livanova names J&J veteran Vladimir Makatsaria as CEO
Makatsaria spent almost 30 years at J&J, rising to the top of its global Ethicon surgery business.
By Nick Paul Taylor • Feb. 6, 2024 -
Courtesy of Philips
Philips consent decree ‘worst case scenario’ for respiratory business
The company may have to demonstrate years of compliance before it can sell sleep and respiratory products in the U.S. again, experts said.
By Elise Reuter • Feb. 6, 2024 -
Avosb via Getty Images
Nanostring files for bankruptcy protection, explores possible sale
The life science tools company said it is evaluating whether to sell all or part of its business after attracting interest from potential buyers.
By Susan Kelly • Feb. 5, 2024 -
Sarah Silbiger via Getty Images
Hologic wins FDA clearance for AI-enabled cervical cancer screening system
The product creates digital images of Pap test slides and uses an AI algorithm to identify cells for review.
By Nick Paul Taylor • Feb. 5, 2024 -
Wavebreakmedia via Getty Images
FDA panel recommends new standards for pulse oximeters amid bias concerns
Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.
By Elise Reuter • Feb. 5, 2024 -
Retrieved from Food and Drug Administration.
Cardinal Health expands recall of Monoject syringes amid compatibility problems
The company said there have been no reports of patient deaths, but noted there is a risk of serious injury or death.
By Nick Paul Taylor • Feb. 5, 2024 -
Courtesy of Edwards Lifesciences
Edwards receives FDA approval for first transcatheter tricuspid valve replacement treatment
The Evoque valve will serve patients with few treatment options, wrote RBC analyst Shagun Singh.
By Elise Reuter • Feb. 2, 2024 -
magicmine via Getty Images
CVRx names Kevin Hykes as CEO
Kevin Hykes joins the company as it looks to grow the market for its device to improve heart failure symptoms.
By Elise Reuter • Feb. 2, 2024
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