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The FDA lists 950 AI- and machine learning-enabled devices that are cleared for commercialization. These tools can do everything from detect cardiovascular abnormalities on CT scans to assist nonspecialists in acquiring diagnostic-quality ultrasound images — but there's a problem: only a small fraction are eligible for reimbursement.

Wondering which MR makes and models are generating the most interest among U.S. healthcare providers? We've got analysis derived from data based on over 3,000 symplr customers who submitted MR capital quotes for custom price benchmarking. https://lnkd.in/eVTdnZe4

ISO Avante Health Solutions and its affiliates, (under the banner of Jordan Health Products) have petitioned for Chapter 11 bankruptcy in order to move forward with a sale to private equity firm Staple Street Capital. In other ISO private equity news, DirectMed Imaging is coming under the ownership of Frazier Healthcare Partners.

Molecular imaging and nuclear medicine stakeholders are making the case that proposed policy changes from the FDA could dramatically increase cost and decrease availability for radiopharmaceuticals — and they say no justification for the change has been provided.

The market experts at Signify Research have broken down the economic and political factors influencing ultrasound investment globally, and explain why apprehension is lingering in the imaging segment.

Insiders say that Siemens Healthineers is poised to purchase the diagnostic business of Novartis subsidiary Advanced Accelerator Applications for over €200 million ($224 million), expanding its radiopharmaceutical business into Europe.

GE HealthCare has tapped Amazon Web Services (AWS) as its strategic cloud provider to help it fast-track more generative AI applications for healthcare, giving it?access to computing power and generative AI tools to build and scale its own proprietary generative AI applications.

Supply chain giant Medline Industries may be in the early stages of going public at a $50 billion valuation, which would likely place it among the biggest IPOs of 2025.

Are you following the medical device #righttorepair dispute in Washington? Access to service manuals has taken center stage. ?? ?? Here's some context: The Library of Congress declared manuals exempt from copyright protection under the DMCA. Groups representing OEM interests responded with a lawsuit arguing the decision was unlawful, but failed to convince the court. Then, in appeals court, the ruling was reversed and is currently winding through legal channels. Meanwhile, the FDA has weighed in with a letter stating it supports the exemption as it pertains to device "repair" (but not "device modification"). ISOs and HTMs say they can't do their jobs safely when OEMs withhold service information. OEMs say some service information contains IP / trade secrets and cannot be shared freely. For those of you invested in this argument, is there a common path forward that benefits everyone, and puts patient safety first? Why or why not?