Medtronic plc’s diabetes unit has not received the positive attention lavished on competitors in recent years, but that may be about to change, if its presentations and analysts’ views from the American Diabetes Association 84th Scientific Sessions this weekend provide a good measure. Perhaps most notably, Medtronic’s Mimimed 780G, a hybrid closed-loop automated insulin delivery system that received U.S. FDA clearance in April 2023, posted strong results and could be the catalyst for increased traction of the diabetes franchise. Read More
Results presented at the American Diabetes Association’s 84th Scientific Sessions in Orlando this weekend demonstrated significant reductions in blood glucose and insulin requirements in people with type 2 diabetes using Insulet Corp.’s Omnipod 5 automated insulin delivery (AID) system, providing a solid base for the company’s expansion into a much larger market. Read More
A team of researchers have developed a blood test which uses artificial intelligence to predict Parkinson’s disease in patients up to seven years before symptoms appear. The test, based on the identification of eight biomarkers in the blood, will be able to identify patients who can be treated earlier with therapies to slow down the progression of the disease or even prevent it from occurring. Read More
The recent conviction of Ontrak Inc. CEO Terren Peizer for insider trading was conspicuous on two counts, including that it was the first time such a conviction had been obtained solely for trading conducted under a government-approved insider trading policy. More worrisome for industry, generally, is the case is another example of federal prosecutors’ ever-growing use of data and analytics to root out violations of SEC law. This is a trend that seems destined to grow with advances in artificial intelligence. Read More
The annual U.S. Medicare inpatient rule typically encodes a number of proposed reassignments of procedures between diagnostic-related groups , and the draft rule for fiscal year 2025 proposes several such changes in the area of orthopedic surgeries. The Medical Device Manufacturers Association lauded the proposed changes, arguing that the existing DRG code structure has failed to keep pace with the growing number of procedures for the lumbar spine, not to mention the significant cost differential associated with each. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alcon, Boston Scientific, Endotronix. Read More