Lucid Diagnostics has received the CE mark for its EsoCheck esophageal cell collection device, its parent company announced today.
EsoCheck is an FDA-cleared, swallowable balloon capsule catheter that enables a clinician to sample surface cells from the esophagus in a less than five-minute, non-invasive office procedure. Lucid touts EsoCheck as the only such device capable of doing so in an anatomically targeted fashion, without sample dilution or contamination.
Lucid, a subsidiary of PAVmed (NSDQ:PAVM), also sells the EsoGuard esophageal DNA test as a screening tool for early detection of esophageal precancer and cancer in at-risk chronic heartburn patients. As a “General IVD” under Europe’s In-Vitro Diagnostic Medical Devices Directive 98/79/EC, EsoGuard only requires self-certification, which Lucid and its authorized representative expect to complete in the very near future, according to the company.
“This certification represents yet another important milestone in our mission to prevent deaths through the early detection of esophageal precancer and cancer,” said Dr. Lishan Aklog, PAVmed’s CEO and Lucid’s executive chairman, in a news release. “Lucid has already developed strong relationships with European key opinion leaders in esophageal disease who are participating in our pivotal clinical trials. We look forward to leveraging these relationships and proceeding with a commercial launch in select European countries in the near future.”
