FDA

By Dave Muoio March 13, 2018
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry. “The exponential advancement of digital health technologies presents a...
By Jonah Comstock March 12, 2018
Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016. "Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors (CGM...
By Dave Muoio February 21, 2018
Palo Alto, California-based Cognoa’s machine learning app for pediatric behavioral health has received categorization from the FDA as a Class 2 diagnostic medical device for autism, according to an announcement from the company. By analyzing parent-provided information and videos of a child’s natural behavior, the company’s app uses machine learning to provide an assessment of whether that child...
By Dave Muoio February 20, 2018
Roche’s Accu-Chek Connect Diabetes Management App has hit yet another snag with the FDA. On February 15, the agency issued a Class 2 Device Recall for certain software versions of the app due to a bug that could lead users to self-administer inappropriate doses of insulin. Roche issued an update correcting the bug back in June, and has posted notices on the Accu-Chek website urging users to...
February 15, 2018
Food and Drug Administration Commissioner Dr. Scott Gottlieb released the agency’s budget requests for fiscal 2018 Tuesday, outlining digital health plans for the year. The budget proposed by the Trump Administration would give the FDA $5.8 billion, an increase of $673 million, and would include an additional $190 million for new user fee funding. The requested budget would support the FDA’s...
By Dave Muoio February 14, 2018
The FDA announced yesterday that it will permit marketing of Viz.ai’s Contact, a clinical decision support (CDS) tool that analyzes CT results and highlights cases that may have experienced a stroke. The CDS application was submitted through the agency’s de novo premarket review pathway, and as such creates a new regulatory classification for similar AI-drived platforms to come. The FDA’s...
By Laura Lovett February 6, 2018
Yesterday the Clinical Decision Support (CDS) Coalition released a comment broadly criticizing the FDA’s recent CDS draft guidance, noting that the draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market.  “The resulting overregulation would be to the detriment of patient care,” CDS Coalition Leader...
By Jonah Comstock February 5, 2018
Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone. The clearance is as a prescription, not an over-the-counter device, which means users will have to secure a prescription...
By Laura Lovett February 1, 2018
The road to FDA clearance for medical devices may change radically in the next year.  Last summer, initial discussion began around implementing a pre-certification program for medical device companies, which would allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process....
By Jonah Comstock February 1, 2018
The Apple Heart Study — which began enrollment at the end of November — has now begun data collection, with participants receiving prompts over the weekend to sign informed consent documents and initiate data collection. That document also reveals some new details about how Apple plans to use data collected during the study.  “This study is part of the development of a new investigational device...

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