Medical Devices: Page 20
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Sarah Silbiger via Getty Images
FDA creates communication ‘super office’ at CDRH
The changes are part of a broader reorganization intended to increase organizational agility and help the agency meet user fee commitments.
By Nick Paul Taylor • July 16, 2024 -
Courtesy of Intuitive Surgical
J&J, Abbott and Intuitive start medtech earnings season
The companies’ financial results will offer a glimpse at the current health of medtech markets.
By Nick Paul Taylor • July 16, 2024 -
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Sitthiphong via Getty Images
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 -
Courtesy of Edwards Lifesciences
Edwards to acquire Innovalve, stake in Affluent Medical
The heart valve specialist said in a federal filing that it expects to pay $300 million in cash for Innovalve Bio Medical when the deal closes.
By Susan Kelly • July 15, 2024 -
Courtesy of Hamilton Medical
Hamilton recalls ventilators that may fail to restart
One death and one injury have been tied to the safety problem, the Food and Drug Administration said in a recall notice.
By Nick Paul Taylor • July 15, 2024 -
Permission granted by Element Biosciences
Element raises $277M to challenge Illumina in sequencing market
The startup claims companies that choose its device over Illumina’s sequencer can save almost $1.5 million in three years.
By Nick Paul Taylor • July 12, 2024 -
Retrieved from Food and Drug Administration.
J&J limits use of Megadyne electrodes due to burn risk
The FDA said 15 injuries have been tied to the use of three models of Megadyne patient return electrodes.
By Elise Reuter • July 12, 2024 -
Sarah Silbiger/Getty Images via Getty Images
FDA finalizes guidance on studying opioid use disorder treatments
The Center for Devices and Radiological Health is aiming to help companies manage challenges such as inaccurate participant reports of drug use.
By Nick Paul Taylor • July 12, 2024 -
Anna Moneymaker / Staff via Getty Images
Deep DiveFDA’s lab developed test rule could be first check on agency’s power post-Chevron
The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.
By Susan Kelly , Elise Reuter • July 11, 2024 -
Courtesy of BD
FDA warns BD blood culture bottle shortage could impact diagnosis
BD said reduced availability of blood culture media bottles due to supplier issues has prevented it from meeting global demand.
By Nick Paul Taylor • July 11, 2024 -
Courtesy of Medtronic
Medtronic recalls endotracheal tubes over blockage risk
The Food and Drug Administration has told healthcare providers to stop using the two affected types of endotracheal tubes.
By Nick Paul Taylor • July 11, 2024 -
Mark Wilson via Getty Images
Federal officials step down from health AI group’s board
HHS officials Micky Tripathi and Troy Tazbaz resigned from their roles as non-voting members of the Coalition for Health AI, an industry group working to create standards for artificial intelligence in healthcare.
By Emily Olsen • July 10, 2024 -
iStock via Getty Images
Roche wins CE mark for its first CGM
The clearance positions Roche to challenge Abbott and Dexcom for the European continuous glucose monitor market.
By Nick Paul Taylor • Updated July 10, 2024 -
Sarah Silbiger via Getty Images
Pulse drops 510(k) plan for PFA device after FDA requests clinical data
Analysts said the AFib device is now unlikely to come to market before late 2026.
By Nick Paul Taylor • July 9, 2024 -
FG Trade Latin via Getty Images
Philips recall of imaging coils tied to 12 injuries
Several models of coils used in MRI scanners were recalled due to the risk of overheating, which can cause serious burns.
By Ricky Zipp • July 9, 2024 -
Courtesy of Masimo
Masimo offered up to $950M for consumer business
Final terms of the deal are still being discussed, and Masimo said it plans to negotiate a higher price.
By Nick Paul Taylor • July 9, 2024 -
saengsuriya13 via Getty Images
Baxter considers sale of kidney care unit to PE firm: WSJ
Carlyle Group could reportedly pay more than $4 billion for Baxter’s Vantive business.
By Elise Reuter • July 8, 2024 -
Permission granted by Becton Dickinson
BD to close Ireland facility, putting 170 jobs at risk
A company spokesperson said the decision follows a recent review and reflects a push to improve operational efficiency.
By Nick Paul Taylor • July 8, 2024 -
Mario Tama / Staff via Getty Images
Masimo employees rally around CEO Kiani as proxy fight looms
Hundreds of healthcare engineers have joined managers to support founder and CEO Joe Kiani as he battles an activist shareholder for control of the company.
By Susan Kelly • July 3, 2024 -
Zorica Nastasic via Getty Images
Alcon buys Belkin Vision for $81M upfront
Alcon will gain access to a laser treatment for glaucoma that it plans to sell in the U.S. by the end of the year.
By Nick Paul Taylor • July 3, 2024 -
Jajah-sireenut via Getty Images
Merit Medical pays Endogastric $105M for acid reflux treatment
Merit expects the device to add around $30 million in annual sales.
By Nick Paul Taylor • July 2, 2024 -
Retrieved from Cardinal Health on July 02, 2024
FDA continues crackdown on plastic syringes made in China
The agency has issued import bans for four manufacturers, and multiple companies have recalled affected syringes. Check out MedTech Dive’s roundup of the news.
By Elise Reuter • July 2, 2024 -
Sarah Silbiger via Getty Images
FDA to expand total product life cycle program
Officials plan to start accepting radiological and ophthalmic medical devices into the program, designed to accelerate medtech innovation, in October.
By Nick Paul Taylor • July 2, 2024 -
Courtesy of BusinessWire/Masimo
Masimo COO says he’ll resign if CEO Kiani is forced out
Activist investor Politan Capital Management is attempting to remove longtime Masimo leader Joe Kiani, claiming the company lacks independent oversight.
By Susan Kelly • July 1, 2024 -
Mario Tama/Getty via Getty Images
Medtech M&A may pick up after mixed start to 2024: analysts
The annual number of medtech acquisitions is on course to slump to its lowest level since 2017, according to Needham.
By Nick Paul Taylor • July 1, 2024 -
Patrik Stollarz / Staff via Getty Images
FDA walks back injury, death reports on recent Philips BiPAP recall
The agency now says 10 injuries and seven deaths are associated with the problem. The updated numbers match figures shared by Philips and are significantly below the original report.
By Elise Reuter • Updated July 11, 2024
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