The first filing from Cancerrisk AI Inc. describes their development of a system that uses deep learning to predict future cancer risk from a biopsy image.

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.

The first year of data from the TRISCEND II study of the Evoque tricuspid valve by Edwards Lifesciences Corp. confirm the notion that reduced regurgitation has a big impact on patient well-being. While one-year data support the device’s safety, cardiovascular mortality at one year does not seem to decisively favor the device over medical management.

In what represents the first patenting from Eyecheq Inc., the company is seeking protection for its self-guided eye examination systems which may be mounted in easily movable and transportable kiosks, on tabletop stands, walls or suspended from ceilings.

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.

The contest between the two main classes of antiproliferatives for circulatory system use continues as seen in a presentation at this year’s Transcatheter Cardiovascular Therapeutics.

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.

Atherectomy devices play a key role in dealing with calcified coronary arteries. But a study presented at this year’s Transcatheter Cardiovascular Therapeutics demonstrates that angioplasty balloons made a lot of headway in this clinical area, potentially pushing atherectomy devices into the fringes of routine practice.

Some studies suggest a need for cardiologists to rethink their approach to device implant. However, the TAVR UNLOAD study failed to demonstrate a statistically significant difference between device implant and medical management for patients with aortic stenosis and low left ventricular ejection fraction.

A major increase in the popularity of weight loss drugs, particularly GLP-1s, has created a rivalry with traditional device orientated approaches, but a new technology aims to navigate the space between them.