Medical Devices: Page 34
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adamkaz via 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 -
JohnnyGreig via 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 -
Jolygon via 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 -
Patrik Stollarz / Staff via Getty Images
Philips stops selling sleep, respiratory devices in US due to FDA consent decree
The order is now being finalized ahead of its submission to a U.S. court for approval.
By Nick Paul Taylor • Jan. 29, 2024 -
Sarah Silbiger via Getty Images
Absolutions receives FDA breakthrough designation for abdominal wall closure device
The device is designed to reduce the risk of hernia by distributing suture tension over a large area of tissue.
By Nick Paul Taylor • Jan. 26, 2024 -
Stock via Getty Images
Globus lays off Nuvasive employees after merger
More than 150 positions in California were cut in January, according to a state notice reviewed by MedTech Dive.
By Elise Reuter • Jan. 26, 2024 -
Sascha Steinbach via Getty Images
How Masimo forced Apple to redesign its smartwatches
In a long-running patent dispute, Masimo has compelled the tech giant to remove the pulse oximetry function of certain Apple Watches.
By Susan Kelly • Jan. 26, 2024 -
Courtesy of Cook Medical
Cook Medical sells ear, nose and throat devices to C2Dx
The transaction completes Cook’s divestiture of its otolaryngology, head and neck surgery product lines.
By Nick Paul Taylor • Jan. 26, 2024 -
Permission granted by Abbott
Abbott gets approval for new rechargeable deep brain stimulation system
The decision comes just weeks after Medtronic received approval for its latest rechargeable device.
By Elise Reuter • Jan. 25, 2024 -
Sara Silbiger via Getty Images
FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain
The reorganization establishes new divisions at the Office of Strategic Partnerships and Technology Innovation to account for its growth since 2019.
By Nick Paul Taylor • Jan. 25, 2024 -
Courtesy of Intuitive Surgical
Robot reveal: Intuitive submits 510(k) for next-generation system
The new surgical robot will have 10,000 times the processing power of the current da Vinci model, CEO Gary Guthart said on the company’s fourth-quarter earnings call.
By Susan Kelly • Jan. 24, 2024 -
Courtesy of Abbott
Abbott says all four segments stronger than pre-pandemic
CEO Robert Ford said investing in its base business using COVID-19 testing revenues was “absolutely the right strategy.”
By Elise Reuter • Jan. 24, 2024 -
Carl Court via Getty Images
European Commission proposes delays for IVDR to prevent supply disruption
Officials are planning to give manufacturers another 31 months to get tests certified under the In Vitro Diagnostic Medical Devices Regulation.
By Nick Paul Taylor • Jan. 24, 2024 -
3M on track to complete healthcare spinoff in first half of 2024
The healthcare leadership team will share more details as the completion of the transaction approaches.
By Nick Paul Taylor • Jan. 24, 2024 -
Courtesy of Edwards Lifesciences
Edwards risks TAVR market share slip amid challenges from Abbott, Boston Scientific: survey
Cardiologists predicted Edwards’ market share may erode slightly in the next two years, according to a survey commissioned by Leerink Partners.
By Nick Paul Taylor • Jan. 23, 2024 -
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Deep DiveOrthopedics leaders watch procedure backlog, new technologies in 2024
J&J, Medtronic and Smith & Nephew executives and orthopedic surgeons said they expect more procedures to move outpatient, while questions about pricing and procedure backlogs loom over the medical technology industry.
By Elise Reuter • Jan. 23, 2024
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