Abbott Laboratories received the CE mark in Europe for the Tactiflex Duo ablation catheter, sensor enabled, to treat patients with atrial fibrillation. The first commercial cases using Tactiflex Duo, a dual energy device that uses radiofrequency and pulsed field energy, were completed in the EU this week.

Wlanholding CEO says it may be too early to trust AI in health care

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 remains issues with the quality and reliability of the data underpinning these systems, as well as the viability of their business model. For now, AI should only be a supportive element of health care but trust in these tools will grow over the next decade, Werner Lanthaler, founder and CEO of Wlanholding, told BioWorld.

Rakuten closes $100M series F round, teams with Lotte Biologics

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. Proceeds will fund the company’s phase III Eclipse study of ASP-1929/pembrolizumab, which is enrolling patients from the U.S., Taiwan, Japan, Ukraine and Poland. Based on the results, San Diego-based Rakuten is targeting BLA submission to the U.S. FDA in 2028.

FY 2025 a banner year for US False Claims Act recoveries

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 healthcare cases. Perhaps of equal significance, however, is the fact that FCA cases for cybersecurity considerations will continue to trend upward, a particularly salient source of risk for med-tech firms.

Medicare improper payment rate down in FY 2025

The U.S. Centers for Medicare & Medicaid Services reported Jan. 15 that the estimated volume of improper payments for Medicare fee-for-service care in fiscal 2025 was $28.83 billion while the number for Medicare managed care was in excess of $23 billion. The agency said both figures fall below the 10% benchmark for more concerted focus on improper payments, but embarrassments such as the skin substitutes problem demonstrate that the Medicare program is still exceptionally vulnerable to fraud and abuse.

Med-tech gainers and losers for Jan. 12-16, 2026

The top 10 med-tech stock gainers and losers for the week.

Holiday notice

BioWorld’s offices were closed in observance of Martin Luther King Jr. Day in the U.S. No issue was published Monday, Jan. 19.

Also in the news

Abbott Labs, Aorticlab, Avanos Medical, Boehringer Ingelheim, Brainomix, Cepheid, Emboline, G Square, Genesis Innovation Group, Illumina, Levee Medical, Major Medical Devices, Orlucent, Serres, Siemens Healthineers, Tricares, VSI, Vygon