Medical Devices: Page 12
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Sarah Silbiger via Getty Images
FDA sends 2 warning letters after inspecting Chinese syringe manufacturers
One warning letter covers the production of plastic syringes for Cardinal Health.
By Nick Paul Taylor • July 22, 2024 -
Permission granted by Medtronic
Q&A‘Our next frontier is prediction’: Medtronic on AI and heart disease
Stacey Churchwell, who leads the company’s cardiovascular diagnostics and services business, says artificial intelligence is reducing false positives in its insertable cardiac monitors, saving clinicians valuable time.
By Susan Kelly • July 22, 2024 -
Explore the Trendline➔
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 -
Peter Macdiarmid via Getty Images
Dental implant maker Osstem in talks to acquire Zimvie: report
Bloomberg first reported M&A rumors in June when Zimvie was approached about a takeover.
By Elise Reuter • July 19, 2024 -
Courtesy of Intuitive Surgical
Intuitive’s da Vinci 5 robot launch ‘well ahead’ of Wall Street expectations
Early customer feedback on the new robot suggests features such as improved ergonomics and vision technology are helping drive adoption, executives said.
By Susan Kelly • July 19, 2024 -
Stringer via Getty Images
GE Healthcare to buy AI software from Intelligent Ultrasound for $51M
After purchasing Caption Health last year, GE Healthcare plans to add another artificial intelligence acquisition to the company.
By Nick Paul Taylor • July 19, 2024 -
Permission granted by Abbott
Abbott previews PFA, over-the-counter CGM markets
Electrophysiology sales held up against rivals’ launches of pulsed field ablation systems. Meanwhile, Abbott is gauging sales of its first OTC CGMs.
By Elise Reuter • July 18, 2024 -
Ryan David Brown/Getty Images via Getty Images
Deep DiveMedtech firms have cut more than 14,000 jobs in the past 18 months
Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.
By Jasmine Ye Han , Ricky Zipp , Elise Reuter • Updated July 25, 2024 -
Courtesy of Qiagen
Qiagen to cut 175 employees, close Michigan PCR test plant
The layoffs and plant closure are part of a restructuring plan that Qiagen estimates will cost about $400 million.
By Elise Reuter • July 17, 2024 -
Mario Tama via Getty Images
J&J medtech fails to meet growth expectations
CFO Joe Wolk told investors Wednesday that Johnson & Johnson’s medical device business missed the company’s 5%-7% growth forecast in the second quarter.
By Ricky Zipp • July 17, 2024 -
Masimo sues activist investor Politan, postpones annual meeting
The latest turn in the recent drama comes days after proxy advisory firms ISS and Glass Lewis backed two Politan nominees for Masimo’s board.
By Susan Kelly • July 16, 2024 -
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 -
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
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