MedTech News
.................... by Andrew Celentano

Gut microbes help set the body’s inflammatory response to vaccination
Vaccination is one of the most important tools for preventing infectious diseases and protecting public health. However, immune responses after vaccination vary dramatically from person to person: If you give many people the exact same vaccine, some will experience side effects such as fever and flulike symptoms while others feel fine.

Okami Medical Receives FDA Expanded Indication for LOBO Vascular Occluder in Peripheral Veins
Okami Medical has announced that the U.S. Food and Drug Administration (FDA) has granted an expanded indication for its LOBO Vascular Occlusion System.

Wearable tech gives women ‘proof their pain is real’
Women struggling to secure answers for suspected endometriosis and PMOS could be given stronger evidence of their symptoms through wearable technology shaped by its founder’s own lived experience. WombWise, founded by Edinburgh Napier University graduate Emily Youngs, has been crowned winner of the Create Change Challenge at the Converge Awards.

Viome Launches CancerDetect® Pancreatic, Built For Early Pancreatic Cancer Detection
BELLEVUE, Wash., Oct. 8, 2026 /PRNewswire/ — Viome PRO, the clinical division of Viome Life Sciences, today launched CancerDetect® Pancreatic, a blood test that looks for pancreatic ductal adenocarcinoma by measuring the enzyme activity associated with the disease. In Viome’s blinded validation, the test detected 86 percent of stage I and II cancers with 90 percent specificity, a performance aimed squarely at the early stages where treatment can still change the outcome. The test is ordered by a physician, drawn as a routine venous sample, and processed in Viome’s CLIA-certified laboratory.

Sonorous wins FDA IDE for pulsatile tinnitus stent pivotal trial initiation
Sonorous’ FDA IDE approval follows its BosSTENT’s receipt of FDA breakthrough device designation in February 2026.

Argus Cognitive’s paediatric autism diagnostic secures FDA clearance
Argus’s Neurora tool is intended to complement clinicians’ professional judgement rather than serve as a standalone diagnostic for autism.

FDA grants de novo nod to handheld ER cardiac implant identifier
BridgeSource Medical obtained de novo clearance from the FDA for its handheld cardiac implant identifier, designed to help emergency department clinicians quickly identify a patient’s hardware brand.

New genetic insights could help detect hearing loss earlier
A team of hearing specialists at Vanderbilt Health analyzed thousands of data samples in the institution’s BioVU biobank to understand genetic susceptibility of sensorineural hearing loss, which is caused by damage to the inner ear. Their study is published in JAMA Otolaryngology-Head & Neck Surgery.