Medical Devices: Page 26
-
Brad Barket via Getty Images
23andMe CEO plans to take company private
Anne Wojcicki wants to buy all outstanding shares of the DNA testing firm, which has seen its stock slump in recent years.
By Elise Reuter • April 18, 2024 -
Courtesy of Boston Scientific
Boston Scientific recalls blood-blocking agent linked to 2 deaths
Seven injuries and 11 incidents were also associated with the safety issue.
By Nick Paul Taylor • April 18, 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 -
Patrik Stollarz / Staff via Getty Images
‘An incredible undertaking’: 5 takeaways from Philips consent decree
Under the agreement, the FDA will use rare powers to require repairs, replacements or refunds for recalled respiratory machines.
By Elise Reuter • Updated April 17, 2024 -
Courtesy of Abbott Laboratories
Abbott looks to ‘highly productive’ device pipeline for future growth
CEO Robert Ford highlighted new and upcoming products throughout the earnings call, calling the recently approved Triclip valve a “billion-dollar opportunity."
By Elise Reuter • April 17, 2024 -
Sarah Silbiger via Getty Images
FDA warns Soulaire to stop selling device outside authorized uses
Soulaire marketed its external counterpulsation system to grow new arteries, repair organ dysfunction and treat COVID-19, among other uses, without evidence.
By Nick Paul Taylor • April 17, 2024 -
Permission granted by GE HealthCare
GE Healthcare imaging CEO to resign
Jan Makela plans to leave the company in July to join another firm.
By Elise Reuter • April 16, 2024 -
Courtesy of Johnson & Johnson
‘We think in decades’: J&J’s $30B spending spree may not be over
After Johnson & Johnson has doled out more than $30 billion for Abiomed, Laminar and Shockwave Medical, are more medtech deals on the way?
By Ricky Zipp • April 16, 2024 -
Courtesy of Solventum
Solventum appoints Shirley Edwards to board of directors
The 3M spinoff highlighted Edwards’ expertise in mergers and acquisitions and corporate governance as an asset.
By Nick Paul Taylor • April 16, 2024 -
Courtesy of Abbott
Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths
Biological material can build up and obstruct blood flow in heart failure patients supported by the left ventricular assist devices, the FDA said.
By Susan Kelly • April 15, 2024 -
Courtesy of Edwards Lifesciences
Edwards pushes back on Medtronic’s head-to-head TAVR trial
Edwards Lifesciences and Wall Street analysts questioned the results of Medtronic’s women-focused study, claiming the data are inconsistent with real-world evidence.
By Susan Kelly • April 15, 2024 -
Courtesy of Exact Sciences
Exact Sciences names Aaron Bloomer CFO
The executive will succeed Jeff Elliott, who said in January he would step down due to personal reasons.
By Elise Reuter • April 15, 2024 -
Courtesy of Cook Medical
Cook Medical wins contract to supply implants to US Defense Department
Through the agreement, Cook will provide its Zilver PTX drug-eluting peripheral stent, Zenith aortic endografts and other implantable devices.
By Nick Paul Taylor • April 12, 2024 -
Permission granted by Abbott
Q&AAbbott’s Nadim Geloo on Triclip’s US launch, Edwards competition
The senior medical director for structural heart discussed the Triclip rollout, Edwards’ rival tricuspid treatment and Abbott’s aortic valve clinical trial.
By Susan Kelly • April 12, 2024 -
Justin Sullivan/Getty Images via Getty Images
Osso VR brings surgery training app to Apple Vision Pro
Users can virtually walk through the steps of two orthopedic procedures: total knee replacement and carpal tunnel release.
By Nick Paul Taylor • April 12, 2024 -
Peter Macdiarmid via Getty Images
Steris to sell dental segment for $787.5M
Divesting the business will allow Steris to repay debt and focus on its core markets of healthcare, pharma and medtech.
By Elise Reuter • April 11, 2024 -
Sarah Silbiger via Getty Images
FDA expands import alert to block all plastic syringes from Chinese manufacturer
The agency increased the blockade because Jiangsu Shenli Medical Production failed to meet device quality system requirements.
By Nick Paul Taylor • April 11, 2024 -
Courtesy of Philips
Philips restricted from selling respiratory machines in DOJ consent decree
The agreement, filed Tuesday, also has export restrictions to ensure U.S. patients receive remediated devices in a timely manner.
By Elise Reuter • April 9, 2024 -
Permission granted by Synchron
Synchron launches patient registry to prepare for brain implant trial
The startup, which rivals Neuralink, is developing brain-computer interface technology that lets people control electronic devices hands-free.
By Elise Reuter • April 9, 2024 -
Sittithat Tangwitthayaphum via Getty Images
Robotic knee surgery study revives debate over procedure’s benefits
As robotic assistance gains in popularity, new research has found no advantage over the conventional approach in reducing the need for knee replacement revision surgeries.
By Susan Kelly • April 9, 2024 -
Courtesy of MMI
MMI receives de novo nod for microsurgery robot
Medical Microinstruments said the system could increase the number of physicians who can perform complicated microsurgical procedures.
By Nick Paul Taylor • April 9, 2024 -
Permission granted by Medtronic
Medtronic beats Edwards on valve dysfunction in TAVR study
In a head-to-head clinical trial, Medtronic linked its device to a lower rate of valve dysfunction than Edwards’ rival product in a subpopulation of patients.
By Nick Paul Taylor • April 8, 2024 -
Stock via Getty Images
Physicians ask FDA to revoke approval of DNA test for opioid addiction
Physicians said the test is based “on old genetic studies that have largely been abandoned” and could exacerbate the opioid crisis.
By Nick Paul Taylor • April 8, 2024 -
Courtesy of Beckman Coulter
Beckman Coulter receives FDA warning letter
Inspectors found fault with quality practices at a facility that makes immunoassay analyzer instruments and tests.
By Nick Paul Taylor • April 5, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls thousands of ventilators over fault linked to 8 serious injuries
A problem with the devices can cause patients to receive the wrong amount of ventilation or too little oxygen, the FDA said in a recall notice.
By Nick Paul Taylor • April 5, 2024 -
Mario Tama via Getty Images
J&J to acquire Shockwave Medical for $13.1B
Johnson & Johnson has spent more than $30 billion since late 2022 to bolster its cardiac portfolio, buying up Abiomed, Shockwave Medical and Laminar.
By Ricky Zipp • Updated April 5, 2024
Previous
