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US FDA recently granted Cognoa’s autism diagnostic device a Breakthrough Device designation to accelerate its efforts to get the first FDA-cleared medical device for the early diagnosis of autistic spectrum disorder (ASD) to market. The average age of ASD diagnosis is about four years old, but extensive clinical research has shown that earlier diagnosis of ASD can improve outcomes over the child’s lifetime. Cognoa’s system is intended to allow primary care physicians to diagnosis ASD in the children as young as 18 months.
The venous thrombectomy market has historically been under-served, especially compared to the arterial thrombectomy space, because the venous clots are more challenging to remove mechanically. But Galway, Ireland-based Vetex believes their technology, which combines a grasping and rotating action, will become the first-choice treatment for removal of large, difficult-to-remove venous clots in patients with venous thrombo-embolism, without the need for thrombolytic drugs.
Silicon Valley-based start-up Univfy has developed a machine-learning platform that helps in vitro fertilization clinics better predict the chances of IVF success for individual couples, and, with that, improve access to IVF treatment and financing. For 2019, Univfy hopes to use machine learning to expand its current capabilities from improving a couple's access to a clinic's refund program to coaching and breaking down other cost barriers.
Start-Up Spotlight 2018: Biosensors, Hemodynamic Monitor, Catheter-Based Technologies, And Big Data Shine Brightest
The most widely-read 2018 Start-Up Spotlight profiles pointed to a diversity of reader interest -- biosensors, catheters, and AI and big data.
A new hearing aid lets users enjoy the full range of normal hearing frequencies, activated by a contact lens on the eardrum. The hearing aid from Earlens Corp. also provides audio gain without feedback. In October, the company completed an $87m round of financing, which will help launch its next-generation hearing aid, which employs magnetic induction for further hearing refinement.
After making its Korean IPO debut, Korean-American medtech startup Neofect Inc. hopes to bring its gamified rehabilitation solutions to more stroke and spinal injury patients in the US. The company developed the Rapael Smart Glove, an AI-driven device that combines video gaming and hand-motion exercises to help stroke patients use their hands again. Neofect's new NeoMano glove for stroke and spinal injury patients will makes its market debut in 2019.
Aria CV hopes to address pulmonary hypertension, a potential devastating condition that currently has few treatments, with a unique balloon device that requires no power supply, battery, pump, or synchronization. See what Aria CEO John Scandurra said about it here.
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