Glaukos Corp. received a green light from the FDA for its Iprime device for the delivery of viscoelastic fluid during ophthalmic surgery, which could help the company to recover some of the revenue lost by cuts to reimbursement for its minimally invasive glaucoma surgery (MIGS) product, Istent. A launch date has not been announced. Read More
Jelikalite Corp. has received a breakthrough device designation from the FDA for its wearable neurostimulation device Cognilum. The home-based system aims to reduce symptoms of moderate to severe autism spectrum disorder in pediatric patients aged 2 to 6 years. The designation was based on the results of a double-blind, placebo controlled clinical trial of 30 pediatric patients with moderate to severe autism, which showed the technology can significantly improve symptoms. Read More
Space travel has known effects on human health and biology. Some, such as loss of bone density, are well understood, while others, like inflammation, are not. Now, organ-on-a-chip maker Emulate Inc. is conducting experiments on the International Space Station U.S. National Laboratory (ISS-NL) aimed at revealing clues to how the brain functions in microgravity. Read More
University of California San Diego engineers have developed tiny 2D sensors that pop up to become a 3D assemblage of microscopic sensors for directly measuring the movement and speed of electrical signals inside the heart. According to nanoengineering professor Sheng Xu, the nanotechnology has enormous implications for heart doctors anxious to better diagnose and treat arrhythmia, heart attack and other diseases. Read More
A homegrown company in Pakistan has developed a multi-grip bionic arm that aims to mimic the movement of real limbs while costing a fraction of what prosthetic arms normally cost. Anas Niaz and Ovais Qurshi founded Karachi-based Bioniks Pte. Ltd. in 2018 to developed efficient and low-cost robotic prosthetic limbs. Read More
New hires and promotions in the med-tech industry, including: Agenda, Caris Life Sciences, Collagen Matrix, Elekta, Singular Genomics, Stimwave Technologies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Actome, Atila Biosystems, Avita, ICU Medical, Qiagen. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Glaukos. Read More