Sinaptica Therapeutics Inc. received a U.S. FDA breakthrough device designation for its electromagnetic therapy for Alzheimer’s disease. Sinaptistim-AD combines neurostimulation, brain wave monitoring and artificial intelligence (AI) to address the cognitive and functional decline in patients with the neurological disorder. Read More
Axoft Inc. emerged from stealth mode with an $8 million seed round led by The Engine, the Massachusetts Institute of Technology’s venture spinout for early-stage tech startups. The funds will be used to conduct preclinical studies and scale up prototypes of its supple brain implant technology. Read More
Tianjin Usights Ophthalmology Technology Co. Ltd.’s ophthalmic fiberoptic microcatheter system has been approved by the NMPA for marketing for minimally invasive glaucoma surgery (MIGS) in China. Tianjin, China-based Usights claims this is the first homegrown products for MIGS in China that has been approved. Read More
Radiopharm Theranostics Ltd.’s phase II F-18 Pivalate positron emission tomography trial in brain metastases saw positive results with high uptake regardless of the origin of primary tumors, showing that Pivalate could be used to monitor brain metastases. Read More
The value of med-tech mergers and acquisitions, as well as deals, fell in the third quarter, although 2022 remains a standout year. M&As are at a five-year high, while deals are second only to 2019, in terms of overall value during the first three quarters. The volume of M&As are behind 2021, but deal volume this year remains on top. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Premia Spine, Seekin, Theranica Bio-Electronics, Vascular Dynamics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AMC Health, Bioskryb, Cooper Genomics, GE, Genoscreen, Heart Test Laboratories, Heartsciences, Icecure Medical, Illumina, Nanovibronix, Olleyes, Pronia Medical Systems, Revamp Medical, Rosies Base, Spinecraft, Tobii, Transformativemed, Virinx. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genetika+, Medtronic, Sinaptica. Read More