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Gastroenterology. What changed.

New drugs and devices in gastroenterology, newest first, each with its bottom line.

As of , Clintelo tracks 3 innovations in gastroenterology: 1 drug (Lynavoy (linerixibat)) and 2 devices (Triton 1 System and SimpleScreen CRC). Each is written from the FDA's announcement or the developer's own release.

Drug IQ in Gastroenterology

Search 1 in Drug IQ
  1. Drug IQFDA approvalLynavoy (linerixibat)Cholestatic pruritus in primary biliary cholangitis · GSKPatients with PBC-related itch have an approved treatment for the symptom for the first time. The average itch improvement over placebo was under one point on a 0-10 scale, and diarrhea was common.

Device IQ in Gastroenterology

Search 2 in Device IQ
  1. Device IQCleared · 510(k)Triton 1 SystemColonoscopy and therapeutic procedures in the colon · Neptune MedicalGastroenterologists may see a robotic option for screening, surveillance and diagnostic colonoscopy, as well as more complex procedures such as EMR and ESD. The evidence so far is a first-in-human study, and the company describes this generation as a step toward commercialization.
  2. Device IQApproved · PMASimpleScreen CRCColorectal cancer screening · FreenomeThe FDA has approved another colorectal cancer screening option for average-risk adults 45 and older that needs only a blood draw, with a US launch by Abbott planned for this fall. A positive result should be followed by colonoscopy, and the test detected few advanced precancerous lesions (13.7% sensitivity) in its validation study.