3D Systems Inc. acquired Volumetric Biotechnologies Inc. as part of its plan to expand its organ bioprinting program. The deal entails a $45 million upfront payment with an additional $355 million linked to meeting milestones “planned between now and 2035, and aligned with key points in the development process,” Volumetric President and CEO Jeffrey Graves told BioWorld. Houston-based Volumetric has focused on building replacement organs through bioprinting and created an approach that produces complex vasculature using light-based bioprinting. Read More
The world of artificial intelligence (AI) regulation is still in its infancy, but a number of agencies are nonetheless keen on harmonization for at least some of this policymaking task. The FDA announced recently that it has joined with Health Canada and the U.K. Medicines and Healthcare Products Regulatory Agency to develop a series of 10 guiding principles for good machine learning practices (GMLP), thus answering one of the key questions facing developers of these algorithms. Read More
Tilak Healthcare SAS has received €7 million (US$8.08 million) from investors to push commercialization of its mobile game and vision monitoring platform, Odysight. The CE marked class I device is prescribed by ophthalmologists to remotely monitor age-related visual impairment and includes daily visual tests to stimulate cognitive and visual abilities. A rollout of the mobile game has already commenced in France. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking comments from industry on mandatory reporting of medical device averse events by health care facilities, and the agency also published comments on a consultation on patient information to be provided with devices. As part of the recent overhaul of Australia’s medical device regulations, the TGA released an action plan for medical devices in 2019 that explored whether it should be mandatory for health care facilities to report adverse events and safety problems with devices to the TGA. Read More
TORONTO – Imaging company Moleculight Inc. has launched a new point-of-care, wound imaging platform intended for multiple U.S. health care settings and has also inked a deal with a U.S. distributor to ensure it gets there. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Finvasia, Gini Health, Heartflow, International Clinics Group, Nanox Imaging, Numares. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Detect, Renovia. Read More
