Medtronic plc’s new Extended infusion set shows the advantages of tending to details. Tubing doesn’t get much respect, but the changes Medtronic made to its set will substantially reduce the burden of disease management for patients with diabetes who use insulin pumps. The Medtronic Extended infusion set can be used for up to seven days, more than doubling the time between changes. The changes also sharply reduced insulin loss, resulting in a 25% reduction in waste of the increasingly expensive medication. Read More
Acotec Scientific Holdings Ltd. obtained marketing approval from the U.S. FDA for its peripheral support catheter Vericor, designed to enhance access to peripheral vessels. Read More
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome approach to validating these systems. However, drug and device manufacturers registered concerns about a lack of clarity in the draft, including 23andMe Holding Co., which said the draft’s references to methods that merely “help to fulfill” validation requirements leave too much gray area to be helpful. Read More
Cardiai Inc. has developed a small, portable monitor that continuously measures patients’ blood pressure (BP) at regular intervals for up to seven days, well beyond the single measurements historically done in a doctor’s office. Read More
The U.S. Department of Health and Human Services (HHS) has issued a bulletin in connection with the Venus ransomware, the latest in a running series of such malware to hit computer systems across the globe. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arterys, Biointellisense, Lumiradx, Mainz Biomed, Metabolon, Neuroquest, Soundbite Medical, Vflo Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeye Health, Roche, Rockfield Medical Devices, Tyber Medical. Read More
