Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.

Abionic SA received U.S. FDA 510(k) clearance for its in vitro diagnostic Capsule pancreatic stone protein (PSP) sepsis test. Produced by the pancreas and immune cells, PSP provides an early biomarker for sepsis that could push back detection of deadly condition by 24 to 48 hours.

GT Metabolic Solutions Inc. received U.S. FDA clearance for its Magdi bariatric surgery system. The system uses magnets to create side-to-side duodeno-ileal anastomosis without cutting intestinal tissue or leaving foreign materials in the body permanently.

Ngenebio Co. Ltd. launched a precision diagnostic panel called Oncoaccupanel RNA in South Korea Oct. 29 as a test to detect oncogenic fusion genes commonly found in solid tumors.

The U.S. FDA cleared Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system, which combines digital monitoring capabilities and hypothermic perfusion technology to preserve donor kidneys during transportation.

Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition.

The Medical Information Working Group again took up a question regarding U.S. FDA-regulated speech, citing the agency’s new misinformation draft guidance as an example of a piecemeal approach to regulated speech.

Remote monitoring for patients with implanted cardiac electrophysiology devices may finally be coming of age in the U.K. thanks to a review of these systems by the National Institute for Health and Care Excellence.

The EU's regulatory crisis continues to roil relations between Brussels and stakeholders in the health care sector, and the European Parliament reacted with a message to the European Commission to revise the Medical Device Regulation.

The U.K.'s Medicines and Health Care Products Regulatory Agency posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K.