A medical device can be designated for the De Novo pathway when it offers novel technology with a reasonable assurance of ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

The Millipede88 aspiration catheter. [Image courtesy of Perfuze] Perfuze announced today that it received FDA 510(k) ...

Moby summary of Tenon Medical, Inc.'s Q4 2025 earnings call ...

Thursday, March 19, 2026 at 4:30 p.m. ET Chief Executive Officer — Steven Foster Chief Financial Officer — Kevin Williamson ...

Fourth Quarter 2025 Revenue of $1.5 Million, a 92% Increase Compared to Prior Year ~~ Record Full Year 2025 Revenue of $3.9 ...

Tenon Medical, Inc. (NASDAQ:TNON) Q4 2025 Earnings Call Transcript March 19, 2026 Tenon Medical, Inc. beats earnings expectations. Reported EPS is $-0.22, expectations were $-0.36. Operator: Greetings ...

Q4 2025 Earnings Call March 19, 2026 4:30 PM EDTCompany ParticipantsSteven Foster - CEO, President & DirectorKevin ...

Fourth Quarter 2025 Revenue of $1.5 Million, a 92% Increase Compared to Prior Year ~~ Record Full Year 2025 Revenue of $3.9 Million, a 20% Increase compared to Prior Year, Driven by Strong Second Half ...

Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech” or “Kane”) announces that Frontiers in Antibiotics has published a ...

GE HealthCare completes the $2.3B Intelerad deal to expand AI-driven imaging, boost recurring revenues and strengthen its ...

Instem, a global leader in SaaS solutions for life sciences R&D, today announced a 5-year extension of its Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA).