The Latest

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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.”

  Diagnostics

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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.

  Medical Devices

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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?

  Medical Devices

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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.

  Medical Devices

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  GE Healthcare imaging CEO to resign

  Jan Makela plans to leave the company in July to join another firm.

  Medical Devices

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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.

  Clinical Trials

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Diagnostics

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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.

  Legal

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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.

  Medical Devices

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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.

  Diagnostics

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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.

  Digital Health

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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.

  Medical 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.

  Medical Devices

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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.

  Medical Devices

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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.

  Diagnostics

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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.

  Legal

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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.

  Digital Health

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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.

  Medical Devices

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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.

  Medical Devices

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  Exact Sciences’ cancer blood test achieves 51% sensitivity in prospective trial

  Sensitivity for the multi-cancer early detection test rose to almost 64% in the six cancers with the shortest five-year survival rate.

  Clinical Trials

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  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.

  Clinical Trials

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  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.

  Medical Devices

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  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.

  Updated April 5, 2024

  Medical Devices

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