Medical Devices: Page 42
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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 -
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 -
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 -
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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 -
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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 -
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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 -
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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 -
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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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Usability challenges for at-home devices top ECRI’s 2024 hazards list
The safety watchdog also identified inadequate or onerous device cleaning instructions as the second biggest health technology hazard this year.
By Nick Paul Taylor • Feb. 2, 2024 -
Sara Silbiger via Getty Images
FDA publishes final rule to harmonize quality system requirements with global standard
The agency extended the transition timeline from one to two years, pushing back the effective date to 2026.
By Nick Paul Taylor • Feb. 1, 2024 -
Joe Raedle/Getty Images via Getty Images
Califf backs increased LDT oversight despite industry opposition
At a Wednesday event, the FDA commissioner named the laboratory-developed test proposal as a top priority and addressed questions on AI.
By Ricky Zipp • Feb. 1, 2024 -
Patrik Stollarz / Staff via Getty Images
FDA receives more reports of deaths linked to Philips’ recalled respiratory devices
From the start of July to the end of September last year, the agency received more than 7,000 reports that contained 111 deaths.
By Nick Paul Taylor • Feb. 1, 2024 -
Permission granted by Boston Scientific
Boston Scientific nets Farapulse approval, pushes back US TAVR launch
The device maker disclosed it will start the highly anticipated launch of the AFib ablation device, but approval for its aortic valve replacement implant will have to wait.
By Susan Kelly • Jan. 31, 2024
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