Picard Medical to Begin Rollout of FDA-Cleared Accessory for its SynCardia Total Artificial Heart
Picard Medical, Inc. (PMI)
Company Research
Source: GlobeNewswire
TUCSON, Ariz., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems, LLC, maker of the world’s first total artificial heart approved by both the U.S. Food and Drug Administration (FDA) and Health Canada today announced that it would begin to incorporate an additional design component of an FDA-cleared accessory, CPC1 “Connector Covers”, into its SynCardia Total Artificial Heart (STAH) design that is intended to provide comfort during daily activities while reinforcing system safety and reliability. Specifically, the CPC Connector Covers will offer an extra layer of protection over the metal release buttons that are found on the STAH CPC connectors which externally connect SynCardia Drivers to the two pneumatic drive cannulas of the STAH ventricles. The rollout is expected to be incorporated into standard clinical practice for patients in the U.S. beginning January 15, 2026. “Patient safety and
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- Picard Medical: FDA-Approved Artificial Heart, But Ramp-Up Remains Uncertain [Seeking Alpha]Seeking Alpha
- Picard / SynCardia Featured on the Cruxx of MedTech PodcastGlobeNewswire
- SynCardia and Hydrix Enter into Development Collaboration to Advance the Emperor, SynCardia’s Next Generation Total Artificial HeartGlobeNewswire
- Picard Medical Announces Conference Participation During J.P. Morgan Healthcare Conference Week [Yahoo! Finance]Yahoo! Finance
- Picard Medical Announces Conference Participation During J.P. Morgan Healthcare Conference WeekGlobeNewswire
PMI
Sec Filings
- 1/13/26 - Form 8-K
- 1/13/26 - Form 8-K
- 1/12/26 - Form S-1
- PMI's page on the SEC website