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.

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.

Embattled Masimo Corp. disclosed it received a non-binding term sheet offering $850 million to $950 million for a potential joint venture that would include its consumer health products and the Sound United business. In an 8-K filing with the U.S. Securities and Exchange Commission, Masimo said it intends to negotiate for a higher price.

Bob Califf, commissioner of the U.S. FDA, has been laser-focused on misinformation recently, and the agency reissued a 2014 draft guidance that describes an enforcement policy about third-party communications about a drug or device. The draft appears to sidestep at least one major problem with the 2014 edition, but seems to suggest that manufacturers should consider addressing misinformation about an entire class of products.

The pilot version of the U.S. FDA’s advisory program for breakthrough medical device life cycle management was initially limited to cardiovascular devices, but the agency has announced an expansion into other product areas. Going forward, orthopedic, radiological and ophthalmic devices will be eligible for the FDA’s Total Life Cycle Advisory Program, which will aid applicants in obtaining both faster and more trouble-free market access.

Serac Imaging Systems Ltd. is seeing encouraging results from ongoing trials at three sites, which are comparing its Seracam portable hybrid gamma-optical camera for medical imaging to standard of care nuclear medicine imaging, Mark Rosser, CEO of the company, told BioWorld.

The years’ long effort by activist investor Politan Capital Management LP to take control of the Masimo Corp. board of directors and oust Masimo CEO and founder Joe Kiani took a turn for the weird this week as news emerged that Masimo Chief Operating Officer Bilal Muhsin notified the board that he would step down if Kiani were pushed out.

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.