Medical Devices
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Stock via Getty Images
FDA approves Lumicell’s breast cancer imaging tool
Lumicell developed the technology to enable physicians to detect residual cancer in the breast cavity after surgery.
By Nick Paul Taylor • April 22, 2024 -
Sarah Silbiger via Getty Images
Exactech recalls shoulder devices after initially declining to act
After the FDA issued a public safety notice and sent Exactech a warning letter, the firm agreed to recall shoulder implants due to packaging issues.
By Nick Paul Taylor • April 22, 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 -
Courtesy of Intuitive Surgical
Intuitive’s rollout of new da Vinci 5 robot steals Q1 spotlight
While Intuitive has already placed eight new surgical robots, executives cautioned system placements could be choppy in the coming months.
By Susan Kelly • April 19, 2024 -
Sascha Schuermann via Getty Images
Spinoffs, sales and tuck-ins top medtech deal priorities: Moody’s
After J&J’s $13.1 billion purchase of Shockwave Medical, Moody’s analysts see the potential for other larger pick-ups “if interest rates substantially decrease.”
By Nick Paul Taylor • April 19, 2024 -
Permission granted by Scopio Labs
Scopio Labs wins de novo nod for bone marrow analysis software
Scopio can now add the application to its imaging platforms that allow users to view blood samples digitally rather than under a microscope.
By Nick Paul Taylor • April 18, 2024 -
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 -
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
