Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Machina Medical, Omnia Medical, Sonomotion, Surgentec, Truvian Health.
Abbott Laboratories received CE mark in Europe for the Tactiflex Duo ablation catheter to treat patients with atrial fibrillation. The first commercial cases using Tactiflex Duo, a dual energy device, were completed in the EU this week.
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.
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