FDA's increasingly popular de novo classification pathway for moderate-risk devices that have no predicate accounted for five marketing go-aheads last month, four of which were for in vitro diagnostics.
[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out our Approvals Tracker.]
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.
Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?
Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?
“Infectious disease should be treated in the community, not in hospitals,” Alex Batchelor, Pictura Bio CEO, told Medtech Insight at the Anglonordic Life Science Conference on 3 April in London.
AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.
Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?
