Medical Devices: Page 21
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FDA creates transparency principles for AI in medical devices
The agency worked with regulators in the U.K. and Canada to determine how key information about machine learning-enabled devices should be communicated.
By Nick Paul Taylor • June 17, 2024 -
Guillermo Spelucin Runciman via Getty Images
Medtech group updates EtO standard for first time in 25 years
The Association for the Advancement of Medical Instrumentation said the changes incorporate new technologies and address industry challenges.
By Elise Reuter • June 14, 2024 -
Explore the Trendlineâž”
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Permission granted by Agilent
Agilent to cut 3% of employees as sluggish lab equipment market persists
An Agilent spokesperson said the layoffs follow job cuts announced late last year amid a slower-than-expected market recovery.
By Susan Kelly • June 14, 2024 -
Sarah Silbiger via Getty Images
Teleflex catheter kit recall linked to 31 injuries, 3 deaths
Teleflex reported 322 complaints about a safety problem that can prevent the balloon from fully inflating.
By Nick Paul Taylor • June 14, 2024 -
Sara Silbiger via Getty Images
Medline pulls thousands of endotracheal tubes due to risk of airway blockage
Medline asked hospitals to immediately identify and destroy any affected devices.
By Elise Reuter • June 13, 2024 -
Kevin Dietsch / Staff via Getty Images
Masimo embroiled in dual DOJ, SEC probes
Masimo will have to juggle the government inquiries while also dealing with an activist investor-led proxy battle.
By Susan Kelly • June 13, 2024 -
Courtesy of Philips
Philips launches stent system to restore blood flow in blocked veins
Philips acquired the device as part of its 227 million euro purchase of Vesper Medical in 2022.
By Nick Paul Taylor • June 13, 2024 -
Fotolia
Kardium raises $104M to develop pulsed field ablation system
Kardium will use the funding to complete a clinical study for pursuing regulatory approvals and build its manufacturing, clinical support and commercial teams.
By Susan Kelly • June 12, 2024 -
SDI Productions via Getty Images
Women underrepresented in trials of high-risk medical implants: study
A median of 33% of study subjects were women, and the figure was significantly lower in cardiovascular trials.
By Nick Paul Taylor • June 12, 2024 -
PeopleImages via Getty Images
Zimmer partners with Think Surgical to launch knee surgery robot
J.P. Morgan analysts said the move is a “low cost way of adding more robotic options” for Zimmer, but they were still unsure about the added value of the partnership.
By Nick Paul Taylor • June 12, 2024 -
Sarah Silbiger via Getty Images
Abbott issues recall for Heartmate system monitor
Abbott’s heart pump system and related products have been part of multiple Class I recalls this year.
By Susan Kelly • June 11, 2024 -
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Vyaire Medical files for Chapter 11 bankruptcy
CEO John Bibb said the move gives Vyaire “breathing room” as the ventilator manufacturer looks to sell its businesses.
By Elise Reuter • June 11, 2024 -
Stringer via Getty Images
GE Healthcare names new leaders of imaging and ultrasound units
Roland Rott will become CEO of GE Healthcare’s imaging business, while Philip Rackliffe will lead a combined ultrasound and image guided therapies segment.
By Nick Paul Taylor • June 11, 2024 -
Permission granted by Abbott
Abbott ramps up over-the-counter CGM race with new sensors
Abbott will launch two over-the-counter glucose monitors in the U.S., competing directly with Dexcom’s Stelo.
By Elise Reuter • June 10, 2024 -
Courtesy of Johnson & Johnson
J&J wins expanded FDA clearance for knee surgery robot
Johnson & Johnson has identified Velys as a product that can help it regain market share from rivals such as Stryker.
By Nick Paul Taylor • June 10, 2024 -
Permission granted by Boston Scientific
Pulsed field ablation to ‘cannibalize’ radiofrequency, cryo: Needham
Boston Scientific is forecast to gain the largest share of the U.S. ablation catheter market in the next 12 months, at the expense of Abbott and J&J.
By Nick Paul Taylor • June 10, 2024 -
Courtesy of Abbott
Abbott wins CE mark for dual-chamber leadless pacemaker
Abbott sees the device as a product that can help its rhythm management business grow 6% to 7%.
By Nick Paul Taylor • June 7, 2024 -
Courtesy of Medtronic
Medtronic recalls neurosurgery navigation system for software error
A problem with the Stealthstation S8 could cause incorrect device placement during surgery. It is the fourth recall of Stealthstation software in the past 12 months.
By Elise Reuter • June 6, 2024 -
Sapien valve performs equally well for small and large aortic annuli, Edwards finds
The analysis adds to a debate about the effectiveness of Edwards versus Medtronic TAVR devices in patients with small aortic annuli, a fibrous ring around the heart’s valve.
By Nick Paul Taylor • June 6, 2024 -
Permission granted by Moon Surgical
Moon Surgical secures FDA nod for commercial soft tissue robot
Moon joins an expanding list of robot makers aiming to compete in a soft tissue surgery market led by Intuitive Surgical.
By Susan Kelly • June 5, 2024 -
Permission granted by ECRI
Q&AStronger oversight of AI needed in medical devices, ECRI CEO says
Marcus Schabacker called for more upfront regulations and postmarket monitoring to better understand how AI features affect patient care.
By Elise Reuter • June 5, 2024 -
Retrieved from Dexcom on June 05, 2024
Dexcom connects G7 CGM directly to Apple Watch in US
Apple Watch and G7 users can now view real-time glucose readings on their wrist, regardless of whether they are carrying an iPhone.
By Nick Paul Taylor • Updated June 7, 2024 -
Courtesy of Illumina
Illumina names Everett Cunningham as chief commercial officer
Cunningham will join Illumina from Exact Sciences to end the six-month search for a permanent leader.
By Nick Paul Taylor • June 4, 2024 -
skynesher via Getty Images
Stryker inks Artelon buyout to join Zimmer in soft tissue space
BTIG analysts said the takeover could serve as a "defensive mechanism against peers who have been growing rapidly in the space.”
By Nick Paul Taylor • June 4, 2024 -
Ethan Miller via Getty Images
Abbott receives FDA OK for over-the-counter glucose monitor
After debuting its Lingo device in the U.K. last year, Abbott can now sell the sensor in the U.S.
By Elise Reuter • June 3, 2024
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