Medtech in a Minute: InnoSIGN Splits from Philips, MDUFA V, and More

Quickly catch up on the latest medtech news from FDA, Philips, and others.

Amanda Pedersen

March 28, 2022

2 Min Read
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FDA Releases MDUFA V Details

Details surrounding the proposed fifth iteration of the medical device user fee amendments (MUDFA V) have been made public. Under the proposed measure, FDA would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding, for a total of up to $1.9 billion to further improve performance if specified goals are met. FDA said this funding would provide critical resources to its medical device review program. The agency said it will hold a virtual public meeting April 19 to obtain comments on the medical device user fee amendments.

InnoSIGN Separates from Philips

InnoSIGN has completed its spinout from Philips with the help of an $8 million financing. The new company was formed around the OncoSIGNal pathway activity profiling technology. The OncoSIGNal technology is mRNA-based tests that measure the activity of signal transduction pathways in cancer and immune cells to predict how patients will respond to targeted drugs.

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

GE Launches Digital Health Platform

GE Healthcare has introduced the Edison Digital Health platform, a vendor-agnostic hosting and data aggregation platform with an integrated artificial intelligence (AI) engine. The platform is being developed to enable hospitals and healthcare systems to effectively deploy clinical, workflow, analytics, and AI tools aimed at the improvement of care delivery, the promotion of high-efficiency operations, and the increase of revenue growth, while also supporting reduction in the IT burden that typically comes with installing and integrating apps across the enterprise.

Verily's Prostate Cancer Collab

Verily is working with Lumea, a digital pathology specialist, to improve prostate cancer pathology. The agreement brings together Verily’s artificial intelligence algorithms and Lumea’s end-to-end digital pathology platform with the objective to develop products that can diagnose, prognose, and guide prostate cancer therapy selection with improved objectivity and efficiency.

Dexcom for the CGM Win

One of medtech’s most anticipated devices has won approval in Europe. Dexcom received a CE mark for its G7 continuous glucose monitoring (CGM) system for people with diabetes over the age of two, including pregnant women. The company also plans to roll out an updated CGM algorithm this year.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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