Precision medicine holds exciting promise for the medical device industry as it offers a range of solutions within diagnostics, digital devices and imaging, which could transform patient care, delegates heard at the LSX World Congress in London. However, there are a range of challenges ahead, including the population of clinical data, getting past the inertia of physicians and making it easier to run clinical studies.

U.S. Medicare coverage of products for leg and foot ulcers has undergone a second review in less than a year thanks to pushback from stakeholders after the August 2023 issuance of proposed non-coverage policies for more than 100 cell and tissue-based products.

Royal Philips NV has come to terms over class-action litigation in which plaintiffs alleged that particulate matter in continuous positive airway pressure (CPAP) machines has proven harmful to their health, bringing the matter to a $1.1 billion conclusion. Despite the 10-figure sum, news of the April 29 settlement sent the company’s share prices up by roughly a third in early morning trading, suggesting that investors had already baked their expectations of the settlement into their thinking about the company’s future.

In what represents its first patenting, PBSF Inc. filed for protection of brain monitoring and neuroprotection strategies for infants at high risk on a large scale.

The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.