Medical Devices: Page 8
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Permission granted by Becton Dickinson
BD to pay $175M to settle charges of misleading investors on Alaris pump
BD will pay a civil penalty to resolve charges it misled investors about risks associated with sales of its Alaris infusion pump, the Securities and Exchange Commission said.
By Elise Reuter • Dec. 17, 2024 -
Permission granted by Zimmer Biomet
Zimmer receives FDA nod for stemless shoulder implant
The Osseofit devices are intended to match patients’ shoulder bone anatomy and preserve healthy bone in total shoulder replacement procedures.
By Elise Reuter • Dec. 16, 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 -
Courtesy of Medtronic
PFA to surpass radiofrequency ablation in 2025: Citi survey
Pulsed field ablation could soon be used in the majority of electrophysiology procedures to treat atrial fibrillation as Medtronic, Boston Scientific and Johnson & Johnson battle for market share.
By Susan Kelly • Dec. 16, 2024 -
Courtesy of Fresenius
FDA issues first early alert with Fresenius Kabi infusion pump recall
Fresenius Kabi is asking hospitals to remove certain pumps because of the risk of an alarm that could interrupt treatment.
By Elise Reuter • Dec. 13, 2024 -
Permission granted by Augmedics
Augmedics names Paul Ziegler as CEO
Augmedics sells an augmented reality headset that allows spine surgeons to view virtual images of the patient’s bones and surgical instruments inside the body. Ziegler is the former CEO of Viewray.
By Nick Paul Taylor • Dec. 13, 2024 -
Permission granted by Endoquest Robotics
Endoquest robotic system gets FDA OK to launch clinical trial
A pivotal study of the robotic platform in colorectal surgery will begin at five hospitals in early 2025.
By Susan Kelly • Dec. 13, 2024 -
Permission granted by Capstan Medical
Capstan Medical raises $110M for heart valve with robotic system
The startup’s third round of financing includes support from Intuitive Surgical’s venture capital arm.
By Susan Kelly • Dec. 12, 2024 -
Leon Neal / Staff via Getty Images
4 takeaways from the FDA’s first digital health advisory committee
Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology, such as the use of complex models that can change quickly.
By Elise Reuter • Dec. 12, 2024 -
Mario Tama / Staff via Getty Images
Masimo lays off 75 employees in California
Under new leadership, the patient monitoring company is allocating resources to fewer projects as it focuses on market opportunities that address unmet needs, a spokesperson said.
By Susan Kelly • Dec. 11, 2024 -
skynesher via Getty Images
Patterson, a dental products distributor, agrees to $4.1B sale to healthcare investor
Last week, Patterson Companies announced it would seek strategic alternatives after the company’s profit decreased by one-third in its fiscal second quarter.
By Elise Reuter • Dec. 11, 2024 -
Chip Somodevilla via Getty Images
How Trump’s second term will affect the medtech industry
From M&A and tariffs to new health leaders, here are the top issues for the medtech industry to watch during President Donald Trump’s return to office.
By Ricky Zipp • Dec. 10, 2024 -
Permission granted by Vicarious Surgical
Vicarious Surgical CFO William Kelly stepping down in January
Kelly’s departure “does not instill confidence” but shouldn’t affect the robot developer’s timeline to market, said BTIG analyst Ryan Zimmerman.
By Susan Kelly • Dec. 10, 2024 -
Courtesy of Intuitive
Intuitive’s da Vinci beats non-robotic surgeries in cancer meta-analysis
Rates of postoperative complications, readmissions and death were lower after robotic surgeries than laparoscopic and open procedures.
By Nick Paul Taylor • Dec. 10, 2024 -
Just_Super via Getty Images
AI-enabled apps top ECRI’s list of health tech hazards in 2025
Other health tech hazards on ECRI’s annual list include the unmet technology support needs of home care patients, cybersecurity threats and substandard or fraudulent medical devices.
By Nick Paul Taylor • Dec. 9, 2024 -
Elise Reuter/MedTech Dive
Smith & Nephew laying off about 150 employees in Tennessee
The job cuts in Memphis, Tennessee, are part of a turnaround plan that has seen the U.K.-based medical device maker shutter four smaller orthopedics facilities outside the U.S.
By Susan Kelly • Dec. 6, 2024 -
AnkiHoglund via Getty Images
Embecta to cut 125 jobs after ending insulin patch pump
Embecta said its patch pump would require additions to be commercially competitive, and plans to use the funds saved to pay down debt.
By Elise Reuter • Dec. 6, 2024 -
Retrieved from Cleerly on December 06, 2024
Cleerly raises $106M to fund AI-driven heart disease tool
The company has generated evidence that shows its system is better than experts at assessing vessel narrowing, plaque volume and composition.
By Nick Paul Taylor • Dec. 6, 2024 -
Courtesy of Medtronic
Acutus will cut 70% of employees to meet Medtronic obligations
Acutus has now tied two large layoffs to the Medtronic partnership. In November 2023, the firm cut about 160 people to focus on requirements of the manufacturing and distribution deal.
By Ricky Zipp • Dec. 5, 2024 -
Courtesy of EOFlow
Insulet awarded $452M in EOFlow patent fight
A jury found that competitor EOFlow and former executives misappropriated trade secrets for Insulet’s Omnipod insulin pumps.
By Elise Reuter • Dec. 5, 2024 -
Courtesy of Edwards Lifesciences
Edwards expects new TAVR approval in mid-2025 to boost sales
U.S. approval of an expanded indication for transcatheter aortic valve replacement in patients without symptoms is among the growth catalysts Edwards outlined in an investor day presentation.
By Susan Kelly • Dec. 5, 2024 -
Sarah Silbiger via Getty Images
FDA issues final guidance on postmarket updates to AI-enabled devices
By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.
By Elise Reuter • Dec. 4, 2024 -
Violeta Stoimenova via Getty Images
Haemonetics to offload whole-blood business for up to $67M
Selling the assets to Italy’s GVS should help Haemonetics improve its revenue growth and profit margins, analysts said.
By Susan Kelly • Dec. 4, 2024 -
tadamichi via Getty Images
Transmedics appoints Gerardo Hernandez as CFO effective immediately
Hernandez started this week but his predecessor, Stephen Gordon, will continue as a non-executive employee until the end of March and serve as a senior adviser for one year after.
By Nick Paul Taylor • Dec. 4, 2024 -
Permission granted by CMR Surgical
Q&AHow CMR Surgical is taking on robotics’ ‘800-pound gorilla’
“I don't think a monopoly market is healthy,” said CMR co-founder Mark Slack, discussing robotic surgery pioneer Intuitive Surgical’s continuing dominance in the market.
By Susan Kelly • Dec. 3, 2024 -
Courtesy of GE Healthcare
GE Healthcare to buy radiopharmaceutical firm Nihon Medi-Physics
GE Healthcare has identified radiopharmaceuticals as a growth driver for the company and Japan as a key market.
By Elise Reuter • Dec. 3, 2024
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