Medical Devices: Page 2
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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 -
Trendline
The EU Medical Device Regulation
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems with continued extensions and outstanding questions still in play.
By MedTech Dive staff -
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
The deal comes just over a week after The Wall Street Journal reported that the companies were discussing a merger.
By Ricky Zipp • Updated April 5, 2024 -
Permission granted by Prenosis
FDA grants de novo nod to AI tool for detecting sepsis
Prenosis CEO Bobby Reddy Jr. told MedTech Dive the company sees third-party validation as important, with the FDA having clarified that certain decision support tools should be regulated as medical devices.
By Elise Reuter • April 4, 2024 -
Permission granted by Eko Health
Eko wins FDA nod for AI to detect sign of heart failure using stethoscope
The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.
By Nick Paul Taylor • April 4, 2024 -
Courtesy of U.S. Food and Drug Administration
Teleflex catheterization kit recall linked to 10 injuries, 1 death
Nearly 335,000 devices were recalled due to safety issues, which may cause damage to blood vessel walls, artery blockage or death.
By Nick Paul Taylor • April 4, 2024 -
Techa Tungateja via Getty Images
Deep DiveAs cyberattacks on healthcare persist, can the FDA’s new device regs hold up?
Revamped regulations to thwart hackers are a big step forward, but issues such as legacy devices and reliance on software patches pose lingering challenges.
By Ricky Zipp • April 3, 2024 -
Permission granted by Baxter
Baxter receives FDA clearance for delayed Novum IQ infusion pump
The clearance ends a three-year back-and-forth with the FDA to get the product to market.
By Nick Paul Taylor • April 2, 2024 -
Permission granted by Abbott
Abbott nets FDA approval for Triclip
The transcatheter tricuspid valve repair device will compete against Edwards Lifesciences’ Evoque system.
By Susan Kelly • April 2, 2024 -
Permission granted by Abbott
Abbott wins FDA clearance for bedside blood concussion test
The clearance is a step towards using the test in non-healthcare settings, such as sporting events, Abbott said.
By Nick Paul Taylor • April 2, 2024 -
Sarah Silbiger via Getty Images
Infutronix pulls infusion pumps from US after nearly 3,700 complaints
The company listed six issues that can cause the pumps to stop infusions and otherwise malfunction.
By Nick Paul Taylor • April 2, 2024 -
Courtesy of 3M.
3M spins out Solventum
The new company will need to work through debt from the spinoff and sole-source arrangements with 3M.
By Elise Reuter • April 1, 2024 -
Permission granted by Politan Capital Management
Masimo faces another proxy challenge from Politan Capital
The activist shareholder seeks two more seats on Masimo’s board, after both candidates it nominated last spring were voted in.
By Susan Kelly • April 1, 2024
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