Confidence in working with Chinese biopharma companies has dropped by 30% to 50% for U.S.-based life sciences companies, with Chinese contract development and manufacturing organizations the hardest hit, according to a recent LEK survey of global life sciences companies on the impact of the pending U.S. Biosecure Act.

Pulse Biosciences Inc. received U.S. FDA breakthrough device designation for its Cellfx cardiac surgery system with surgical clamp for ablation of atrial fibrillation. The Cellfx system uses nanosecond pulsed field ablation technology to deliver durable, continuous transmural ablation.

Endoron Medical Ltd. raised $10 million in its series A funding round to accelerate clinical validation work on its catheter-based endostapling system, Aortoseal, which repairs abdominal aortic aneurysms. The round was led by Sofinnova Partners, with participation from the European Innovation Council Fund.

The U.S. Medicare draft prospective payment system for end-stage renal disease encodes a few changes that will cheer industry, including a provision that would increase patient access to pharmaceuticals that are available only in oral form.

The U.S. FDA warning letter to AG Essence Inc., a maker of wound care products, raised the question of whether the the company’s Banda product line is a drug or a device, although the FDA’s device center was the issuer of the warning letter. However, the company told ioWorld that it sees its offerings as homeopathic products rather than as drugs or devices, suggesting that this product jurisdiction scrum is far from over.

In the first six months of 2024, the med-tech industry raised $13.84 billion, a 29% increase from the $10.75 billion collected during the first half of 2023. While May saw a significant $5.05 billion raised, the monthly total decreased to $1.14 billion in June.