JD Supra6d
CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...
Yahoo Finance27d
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Breakthrough Therapy Designation is generally granted to ... This designation will provide Denali with more intensive FDA guidance, including involvement of senior reviewers, and eligibility ...
Yahoo Finance14d
Spectral AI Provides Update to Investors
DALLAS, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView ® System, which received Breakthrough Device Designation from ...
Business Insider28d
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Breakthrough Therapy Designation is intended to expedite ... This designation provides Denali with more intensive FDA guidance, including involvement of senior reviewers, and eligibility for ...
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Detailed price information for Denali Therapeutics Inc (DNLI-Q) from The Globe and Mail including charting and trades.
Sanara MedTech Inc. Announces Exclusive License and Distribution Agreement with, and Minority Investment in, Biomimetic Innovations Ltd
OsStic® and related technologies represent differentiated solutions that address an estimated 100,000+ procedures in the U.S. annually(1); ...