Snapshot from Jul 23, 2026 at 07:00 UTC. For live data and tracking: View Live
Events / Regulatory / Vivos FDA IDE approval for RadioGel
Regulatory regulatory approval

Vivos FDA IDE approval for RadioGel

Analysis based on 6 articles · First reported Jul 06, 2026 · Last updated Jul 06, 2026

Sentiment
30
Attention
2
Articles
6
Market Impact
General
Live prominence charts, article sentiment distribution, and event development timeline available on the Ergen Dashboard
Market Impact

The FDA IDE approval is a positive regulatory step for Vivos, potentially boosting investor confidence and stock price. However, the early-stage study and small patient enrollment limit immediate market impact.

Medical devices Biotechnology Oncology
Event Summary

Vivo (OTCQB: RDGL) received U.S. FDA approval for its Feasibility Investigational Device Exemption (IDE) to initiate a first-in-human clinical study of RadioGel, an yttrium-90-based injectable hydrogel for targeted cancer treatment. The study will be conducted at Mayo Clinic in Jacksonville, FL, enrolling up to five patients with non-resectable papillary thyroid carcinoma. This milestone follows preclinical studies in animals demonstrating safety and efficacy. Vivos plans to advance RadioGel through U.S. regulatory pathway while expanding its IsoPet veterinary product and pursuing international opportunities.

Key Actions
100 United States — Food and Drug Administration approved IDE Vivo
Entities Involved
priv
Vivo
Vivos received FDA IDE approval to begin first-in-human study of RadioGel, a key milestone for its pipeline.
Importance 100.0 Sentiment 60.0
govactor
United States — Food and Drug Administration
FDA approved the IDE application, allowing Vivos to initiate the clinical study.
Importance 80.0 Sentiment 0.0
per
Brad Weeks
Brad Weeks, President of Vivos, commented on the milestone.
Importance 30.0 Sentiment 0.0
per
Mike Korenko
Mike Korenko, CEO of Vivos, expressed excitement about the FDA approval.
Importance 30.0 Sentiment 0.0
per
Darrell R. Fisher
Dr. Darrell R. Fisher, nuclear medicine physicist, provided expert commentary on RadioGel's safety profile.
Importance 20.0 Sentiment 0.0
priv
Versant Medical Physics and Radiation Safety
Versant Medical Physics and Radiation Safety is the affiliation of Dr. Fisher, who commented on the study.
Importance 10.0 Sentiment 0.0
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