The European Union and the U.S. have wrapped up a data privacy framework that covers broad swaths of both economies, including the transmission of clinical trial data across the Atlantic Ocean. Drug and device makers that want to make use of this framework and thus jettison the contractual clause to ensure data privacy may find compliance with this new framework much more efficient in the long run, but will have to do a lot of compliance work on the front end to achieve those efficiencies.

FDA clears Etiometry’s algorithm for neonatal hypercapnia risk

Premature babies face challenges in the neonatal intensive care unit (NICU) as their heart, lungs and neurological system continue to develop outside the womb. Roughly half of neonates born at 26-28 weeks’ gestation experience respiratory distress. These infants often need extra oxygen and help breathing, as well as constant monitoring to ensure oxygen is absorbed and carbon dioxide CO2 is dispelled. To that end, Etiometry Inc. received FDA clearance for its IVCO2 Index, a software tool for use in monitoring risk of hypercapnia – high levels of CO2 in the blood – in NICU patients weighing less than 2 kg.

New geometric deep learning model detects cerebral lesions more accurately

A research time from Leipzig University, the Max Planck Institute and Heidelberg University, all in Germany, devised a new segmentation algorithm for stroke lesions. They used machine-learning models to effect CT image segmentation in the early stages of acute stroke. The research team published their findings on the fully convolutional graph network in July in the Journal of Medical Imaging. “Our proposed model demonstrates the feasibility of using specific geometric deep learning to solve segmentation problems, and performed better than other models evaluated,” Ariel Iporre-Rivas, PhD student at the Institute for Computer Science at Leipzig University and the Max-Planck Institute for Human Cognitive and Brain Sciences, told BioWorld.

Genesis Medtech expands in China with laparoscopic surgical device launch

Genesis Medtech Group received marketing approval from China’s National Medical Products Administration for its laparoscopic surgical device called Artisential, which helps surgeons in precision surgery. The approval not only adds another market in which the device is available but will allow Genesis to expand its reach in China.

Ultromics’ AI solution distinguishes between patients with and without HFpEF 

Ultromics Ltd Echogo Heart Failure system has the ability to detect heart failure with preserved ejection fraction (HFpEF) from a single apical four chamber video clip, according to a study published in JACC Advances. The study follows a consensus statement from American College of Cardialogy which said that although there are now effective therapies to treat HFpEF, there is an increasing urgency for accurate diagnosis as the number of patients with HFpEF is on the rise, accounting for more than 50% of all heart failure cases.

Also in the news

Angiodynamics, Body Vision Medical, Femasys, Grail, Hemosonics, Imperative Care, Mirvie, Opgen, Pacbio, Realm Idx, Roche, Shockwave Medical, Synaptive Medical, Transmedics, Tytocare, Unify Medical, Vicarious Surgical, Voxneuro