Aidoc Medical Ltd.'s Care AI foundation model secured 11 new U.S. FDA-cleared indications for use in emergency department triage. Now, with 14 total cleared indications enabling comprehensive evaluation and prioritization of abdomen CTs in a single workflow, Aidoc Care can help health systems identify critical findings more quickly and mitigate delays caused by overcrowding and imaging backlogs.

The U.S. FDA’s final rule for regulation of lab-developed tests is now a part of regulatory litigation history, but Scott Whitaker, CEO and president of the Advanced Medical Technology Association, said that while Congress is still considering LDT legislation, any new legislation may differ substantially from previous bills.

Investors continue to pour capital into AI-driven health care technologies, from drug discovery and diagnostics to personalized medicine and clinical decision-support tools. However, there remain issues with the quality and reliability of the data underpinning these systems, as well as the viability of their business model.

Rakuten Medical Inc. raised $100 million in a series F round to support late-stage clinical development of ASP-1929, its Alluminox-derived photoimmunotherapy being tested with Keytruda (pembrolizumab) as a first-line treatment for recurrent head and neck cancer.

The U.S. Department of Justice said recoveries under the False Claims Act in fiscal year 2025 reached a record of more than $6.8 billion, more than 80% of which came from health care cases.

The U.S. Centers for Medicare & Medicaid Services announced Jan. 15 that the estimated volume of improper payments for Medicare fee-for-service care in fiscal 2025 was nearly $29 billion while the number for Medicare managed care was in excess of $23 billion.

As the momentum and interest in brain-computer interface (BCI) technologies continue to accelerate, Merge Labs has emerged with an investment from OpenAI in its seed round. Merge Labs says it plans to develop next-generation BCIs capable of interacting with the brain at high bandwidth, integrating with advanced AI, and doing so in ways that are safe and accessible to everyone.

The Centers for Medicare & Medicaid Services has cracked open its coverage policy for transcatheter aortic valve replacement devices a second time, and a wide range of stakeholders are providing feedback. Where the agency will land on questions such as the need for continued evidence development is difficult to predict, however, given that the agency is hearing anything but unanimity on the question.

The U.S. FDA has endorsed ISO 14971 for risk management for medical device manufacturers, but there’s nothing compulsory about industry’s use of this standard. Nonetheless, Sarah Moore, principal program lead at NSF, told BioWorld that adoption of 14971 is still the most seamless way to demonstrate proper risk management practices to FDA field investigators, given that the alternative is almost always more work for both sides during facility inspections.

Boston Scientific Corp. looked ready to keep steamrolling down the acquisition path, carrying the momentum from last year, with the news that it is acquiring Penumbra Inc., a company that makes devices for interventional therapies to treat vascular conditions such as stroke and aneurysm, for a whopping $14.5 billion.