The latest version of legislation for regulatory reform has arrived, and the conventional wisdom may be that the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act will not be passed until the next user fee agreement is codified into law. Nonetheless, Susan Van Meter, executive director of AdvamedDx, told BioWorld that the associated reforms are urgently needed by patients and test developers alike, and there is consequently no need to wait for user fee legislation to pass the VALID Act. Read More
Neuronetics Inc., of Malvern, Pa., has won U.S. FDA breakthrough device designation for its Neurostar transcranial magnetic stimulation (TMS) device for the treatment of patients with drug-resistant bipolar depression. The news comes as the company reported a strong fourth quarter for 2019, with revenue up 11% year-over-year to $17.4 million. Read More
TORONTO – Newpro3D Inc., of North Vancouver, British Columbia, is making its ultra-fast 3D printing technology available to Düsseldorf, Germany-based Henkel AG & Co. KGaA to help it expand into production scale, additive manufacturing of medical devices. Newpro3D’s digital light processing (DLP) system enables its customers to manufacture hard and soft anatomical models used in surgical planning “at record speeds,” said Newpro3D COO Gabriel Castanon, eliminating the slow mechanical processes in more conventional 3D printing techniques. Read More
LONDON – Ibex Medical Analytics is preparing for commercial rollout in Europe after receiving CE-IVD marking for its artificial intelligence (AI) decision support system for automated interpretation of prostate cancer biopsies. Galen Prostate, trained on more than 60,000 samples from multiple institutions, is intended to give a second opinion on digitized slides, following initial assessment by a pathologist. Read More
PERTH, Australia – After more than three years of consultations, Australia’s Therapeutic Goods Administration (TGA) finally has unveiled a new regulatory framework for custom-made and 3D-printed devices that aligns with international standards. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aguair, Anthem, Avricore, Blue Cross, Ehealth Technologies, Enzo Biochem, Labcorp, Mologic, Silk Road Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neuronetics, Stereotaxis. Read More
Keeping you up to date on recent developments in neurology, including: Seismic imaging technology could deliver finely detailed images of the human brain; Scientists monitor brains replaying memories in real time; Drug shows promise in reducing deadly brain swelling after stroke. Read More
