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Boston Scientific recalls blood-blocking agent linked to 2 deaths
Seven injuries and 11 incidents were also associated with the safety issue.
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‘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.
Updated April 17, 2024 -
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."
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Lilly obesity drug shows benefit in sleep disorder study, pointing to new use
Positive data for Lilly’s medicine tirzepatide in sleep apnea are the latest signal the benefits of GLP-1 agonists could extend beyond diabetes and weight loss.
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Files taken from Orasure systems in cybersecurity incident
Orasure believes it has contained the incident and “preserved the integrity of its core financial and operational systems.”
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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.
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‘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?
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Solventum appoints Shirley Edwards to board of directors
The 3M spinoff highlighted Edwards’ expertise in mergers and acquisitions and corporate governance as an asset.
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GE Healthcare imaging CEO to resign
Jan Makela plans to leave the company in July to join another firm.
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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.
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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.
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Exact Sciences names Aaron Bloomer CFO
The executive will succeed Jeff Elliott, who said in January he would step down due to personal reasons.
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Roche to distribute Prenosis’ AI sepsis detection tool in US
Roche will make the tool available as part of its Navify Algorithm Suite, a collection of medical algorithms the company has validated.
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European Commission approves Illumina’s proposed Grail split
Selling Grail to a third party would free Illumina of the need to capitalize the company, but the buyer would need the commission’s approval, analysts wrote.
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Q&A
Abbott’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.
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Roche scores FDA breakthrough status for Alzheimer’s blood test
The plasma assay is intended to aid in finding amyloid pathology, a biomarker of Alzheimer’s disease.
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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.
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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.
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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.
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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.
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Illumina CFO steps down amid executive shakeup
Ankur Dhingra, who worked with Illumina’s CEO at Agilent Technologies, is joining the genome sequencing company to replace Joydeep Goswami.
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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.
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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.
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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.
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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.