Medical Devices: Page
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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 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
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 -
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 -
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 -
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 -
Getty Images
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 -
Sarah Silbiger via Getty Images
FDA extends deadline for comments on role of digital health in diabetes detection
The agency is seeking answers on how digital health technologies could be used in the detection of prediabetes and Type 2 diabetes.
By Nick Paul Taylor • Jan. 31, 2024 -
Getty Images
The top medtech trends in 2024
Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.
By MedTech Dive Staff • Jan. 31, 2024 -
Permission granted by Agilent
Agilent, Incyte to partner on companion diagnostics
The collaboration comes after Agilent restructured and sold its liquid biopsy unit.
By Elise Reuter • Jan. 30, 2024 -
Permission granted by ShockWave
Shockwave Medical names Renee Gaeta CFO
Gaeta is filling the vacancy created by Dan Puckett, who retired from the position this week.
By Nick Paul Taylor • Jan. 30, 2024 -
Getty Images
Deep Dive4 heart device trends shaping the medtech sector in 2024
Medtronic, Boston Scientific and J&J are among the medtech companies advancing treatments in cardiac care for when medicines are not enough.
By Susan Kelly • Jan. 30, 2024 -
Permission granted by Vicarious Surgical
Vicarious Surgical hires former Olympus leader as president
The appointment comes less than three months after a downsizing at the surgical robot maker.
By Susan Kelly • Jan. 30, 2024 -
Courtesy of Boston Scientific
What to watch for as Stryker, Boston Scientific and BD post earnings this week
The next round of results follows reports from J&J, Abbott and Intuitive, all of which signaled a solid end to 2023.
By Nick Paul Taylor • Jan. 29, 2024
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