Med-tech companies often use robotics and artificial intelligence (AI) to transform healthcare systems and improve patient outcomes. However, the current hype around generative AI, such as ChatGPT, and the explosion in the use of data are raising questions around regulation, reimbursement, and whether AI and robotics are the right tools for certain jobs, participants heard at the LSX World Congress in London. Read More
In a draft guidance released May 2, the U.S. FDA provided recommendations for sponsors, investigators and other stakeholders for implementation of decentralized clinical trials (DCTs) to advance research in medical devices, drugs and biologics. This week’s announcement responds to the Food and Drug Omnibus Reform Act, signed into law late last year, which required the agency to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices.” Read More
The FDA gave the greenlight to Route 92 Medical Inc. for its Freeclimb 70 reperfusion system in the treatment of ischemic stroke. The 510(k) clearance includes a Freeclimb 70 aspiration catheter, as well as a Tenzing 7 delivery catheter. Read More
With the COVID-19 public health emergency ending in the U.S. next week, Congress is looking to use the lessons learned from the pandemic to draft a new iteration of the Pandemic and All-Hazards Preparedness Act to ensure the country is better prepared for the next pandemic. Read More
Moleculight Inc. published a study on the impact of skin pigmentation on the clinical diagnosis of wound infection that could have profound implications for implicit or unconscious racial bias among diagnosticians. The paper in the Journal of Racial and Ethnic Health Disparities pointed to lack of clinical training and educational resources on diverse skin tones and of diagnostic tools to address unique clinical attributes of patients with darker skin tones. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cumulus Neuroscience, Norlase, Nucleix. Read More
