Hot off the heels of a $45 million series B financing raise, Activ Surgical Inc. has completed the first clinical trial evaluating its Activinsights augment reality (AR)-based software suite and Activsight imaging module. The safety and feasibility study, carried out with The University of Texas Health Science Center at Houston (UTHealth Houston) is the first of several trials the Boston-based company is planning in 2021.
Asahi Intecc Co. Ltd. is tapping Hexagon Manufacturing Intelligence Inc.’s non-linear structural analysis software, Marc, to develop delivery devices that carry markers to the vicinity of cancers in preparation for endoscopic surgery.
PERTH, Australia – Singular Health Group Ltd. was awarded AU$50,000 (US$37,000) in funding from Australia’s Commonwealth Scientific and Industrial Research Organization’s (CSIRO) Kick-Start program to undertake a research project to develop artificial intelligence (AI)-based tools to automatically design patient-specific cranial implants. The AI will be integrated into Singular Health’s surgical planning software for editing before the cranial implants are 3D printed.
Precision cancer care company Simbiosys Inc. has raised $15 million to accelerate development of its Tumor Scope software platform for management of solid tumors. The application enables oncologists to virtualize cancer tumors and simulate a patient’s response to specific drug therapies by combining artificial intelligence with biophysical simulations. The technology models the impact of drug delivery, drug sensitivity, metabolism and spatial heterogeneity and provides data that can be used to inform individual treatment plans.
TORONTO – Pathway Medical Inc. has raised C$1.6 million (US$1.3 million) in an oversubscribed funding round to expand its evidence-based clinical decision support platform and deliver an enterprise version of its point-of-care technology. The current mobile app uses natural language processing and machine learning to give doctors evidence-based answers to questions on patient diagnosis and treatment.
PERTH, Australia – Australia’s TGA issued new guidance to help device manufacturers better understand new classifications for active medical devices, including software-based medical devices, and clinical decision support software.
Feops SA reported that its Heartguide product has received de novo authorization from the FDA for pre-operative planning of left atrial appendage occlusion (LAAo) with the Boston Scientific Corp. Watchman device. The software platform is designed to help physicians virtually model clinical scenarios with different implant positions and sizes of the Watchman device using digital twin technology based on patient-specific virtual replicas of the heart. It is currently commercially available in the EU, U.K., Canada and Australia for transcatheter aortic valve implantation and LAAo workflows.
TORONTO – Numalogics Inc. has entered a partnership deal with Sawbones Inc. to develop computational modeling and simulation software for small and medium sized orthopedic manufacturers. Adding Montreal-based Numalogics’ computational simulation software to Seattle-based Sawbones’ biomechanical test line is intended to help customers optimize their orthopedic device designs more quickly and efficiently. The software is expected to be market ready in 2022.
Through a series of notifications, India’s drug regulator has classified a new batch of medical devices as well as a range of software used in medical devices according to risk, taking another step to strengthen regulatory oversight and shore up the domestic med-tech sector.
A cloud-based web application for long-term brain monitoring has received a CE mark to support personalized management of neuro-disorders such as epilepsy. Developed by Swiss neuroscience research organization Wyss Center, Epios Cloud displays and reviews electroencephalogram (EEG) recordings made by EEG devices using scalp and sub-scalp electrodes, heart rate and accelerometer measurements.