FDA Slaps Medtronic with Warning Letter

Medtronic said it received a warning letter from FDA earlier this month after an inspection that concluded in July related to a recall of the company's MiniMed 600 series insulin infusion pump, and a remote controller device for MiniMed 508 and Paradigm pumps. The warning letter focuses on the inadequacy of specific medical device quality system requirements at the company's Northridge, CA facility in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.

New Medtech Accelerator to Launch in 2022

Proxima Clinical Research, a contract research organization based at the Texas Medical Center, plans to launch its own accelerator program early in the new year. Dubbed M1 MedTech, the accelerator will take on a limited number of companies in each cohort and offer a hands-on approach to helping founders advance their companies and technologies. For now, M1 MedTech will function as an accelerator focused on more involved Class II and III medical devices. As the program continues to grow, the team plans to build out an even more extensive incubator focused solely on Class III medical devices.

And in case you missed our last Medtech in a Minute report...

Medtronic Hugo Scores Health Canada License

Medtronic hit a major milestone in surgical robotics last month when it received a CE mark for the Hugo robotic-assisted surgery (RAS) system. Now, the company's Canadian subsidiary has received a Health Canada license for the Medtronic Hugo RAS system for use in use in urologic and gynecologic laparoscopic surgical procedures, which make up about half of all robotic procedures performed today.

BD 'Seals' Another Deal

BD has been quite acquisitive this year. The company's latest move on the M&A trail is for surgical sealant maker Tissuemed. Leeds, England-based Tissuemed's lead product, Tissuepatch, is a sealant technology that bonds to tissue to help control internal bleeding or prevent leaks from surgical incisions. The technology's thin, flexible and transparent composition that is ready to use out of the package makes it ideally suited for a range of surgical sealant applications.