Michael Barbella, Managing Editor07.16.22
New device reprocessing standards drove the bulk of MPO website traffic this week, as cybervisitors flocked to the site to learn more about a regulatory roadmap being shared by the Association of Medical Device Reprocessors. The organization has published “Global Regulatory Standards for ‘Single-Use’ Medical Device Reprocessing and Remanufacturing,” a tool to help Notified Bodies, Ministries of Health, and regulatory authorities of medical devices to unlock the benefits of reprocessing for hospitals and health systems worldwide. The report includes all known regulations, standards, and guidances that govern the practice of reprocessing (known as remanufacturing in Europe), worldwide.
Runner-up to the reprocessing roadmap was an exclusive contribution from Sweetch CEO Yoni Nevo on leveraging SaMD (software as a medical device) and digital therapeutics (DTx) to help patients with chronic conditions adhere to their treatment programs. "SaMD and DTx solutions are promising, but they are only truly effective when their engagement with patients is precise and personalized," Nevo writes. "It is insufficient for an SaMD or DTx solution to prompt a patient to take their medication when they are driving, or to go for a walk when they are in a meeting. For apps to be effective, they need to hyper-personalize the patient’s experience."
Also garnering page views this past week was FDA authorizations for—coincidentally (or not)—AI-based MRI software and a digital therapeutic. Philips won FDA 510(k) clearance for its SmartSpeed artificial intelligence (AI)-powered MR acceleration software, while Renovia earned the agency's clearance for its leva pelvic health system as a first-line treatment for chronic fecal incontinence (FI) in women. leva was granted FDA breakthrough status in 2021 and had previously been FDA-cleared to treat stress, mixed, and mild-to-moderate urinary incontinence (UI) in women. leva helps women strengthen pelvic floor muscles, including the puborectalis, which acts as a “sling” around the rectum and vagina and contributes directly to FI. The prescription digital therapeutic (PDT) guides woman through pelvic floor muscle training (PFMT) via a small vaginal motion sensor and smartphone app. It requires five minutes of training a day.
Philips' AI reconstruction algorithm, meanwhile, is used at the MR signal’s front end to remove the noise and preserve details while enabling k-space data consistency check for trustworthy AI. It increases resolution up to 65% and achieves up to 3 times faster scanning times compared to conventional MR scans.
Medtronic's partnership with CathWorks attracted website traffic as well. The company is investing up to $75 million and co-promoting CathWorks’ FFRangio system in the United States, Europe, and Japan, where it’s currently available. In a separate agreement, Medtronic was given the option to acquire CathWorks once certain undisclosed milestones are met.
Runner-up to the reprocessing roadmap was an exclusive contribution from Sweetch CEO Yoni Nevo on leveraging SaMD (software as a medical device) and digital therapeutics (DTx) to help patients with chronic conditions adhere to their treatment programs. "SaMD and DTx solutions are promising, but they are only truly effective when their engagement with patients is precise and personalized," Nevo writes. "It is insufficient for an SaMD or DTx solution to prompt a patient to take their medication when they are driving, or to go for a walk when they are in a meeting. For apps to be effective, they need to hyper-personalize the patient’s experience."
Also garnering page views this past week was FDA authorizations for—coincidentally (or not)—AI-based MRI software and a digital therapeutic. Philips won FDA 510(k) clearance for its SmartSpeed artificial intelligence (AI)-powered MR acceleration software, while Renovia earned the agency's clearance for its leva pelvic health system as a first-line treatment for chronic fecal incontinence (FI) in women. leva was granted FDA breakthrough status in 2021 and had previously been FDA-cleared to treat stress, mixed, and mild-to-moderate urinary incontinence (UI) in women. leva helps women strengthen pelvic floor muscles, including the puborectalis, which acts as a “sling” around the rectum and vagina and contributes directly to FI. The prescription digital therapeutic (PDT) guides woman through pelvic floor muscle training (PFMT) via a small vaginal motion sensor and smartphone app. It requires five minutes of training a day.
Philips' AI reconstruction algorithm, meanwhile, is used at the MR signal’s front end to remove the noise and preserve details while enabling k-space data consistency check for trustworthy AI. It increases resolution up to 65% and achieves up to 3 times faster scanning times compared to conventional MR scans.
Medtronic's partnership with CathWorks attracted website traffic as well. The company is investing up to $75 million and co-promoting CathWorks’ FFRangio system in the United States, Europe, and Japan, where it’s currently available. In a separate agreement, Medtronic was given the option to acquire CathWorks once certain undisclosed milestones are met.