A series A fundraising round lifted the mood at Genetikaplus Ltd. (Genetika+), raking in $10 million, a healthy 33% more than the initial target of $7.5 million. Proceeds from the round will go to fund trials of the Jerusalem-based company’s “brain-in-a-dish” technology for evaluating the best antidepressant for each patient. Greybird Ventures led the round, with participation by Meron Capital, Jumpspeed Ventures and Sapir Venture Partners.
Australia’s TGA provided updates regarding up-classification of several device types, including a number of spinal implants, which will henceforth be regulated as high-risk, class III devices, rather than medium-to-high risk devices (class IIb).
South Korea’s Cgbio Inc. has entered a partnership agreement with Singapore-based NDR Medical Technology Pte. Ltd. to introduce and test an automated needle targeting (ANT)-X system to assist surgeons during minimally invasive surgery. The system will combine artificial intelligence (AI) and medical image processing, based on core technology from NDR Medical.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Haemonetics, Siemens.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aethlon Medical, Caredx, Daxor, Envveno Medical, Eurofins Viracor, Hancock Jaffe Laboratories, PPD, Qiagen, Siemens, Treace Medical Concepts.