The U.S. FDA granted breakthrough device designation for CT-155, a prescription digital therapeutic co-developed by Boehringer Ingelheim GmbH and Click Therapeutics Inc. to treat the negative symptoms of schizophrenia. Designed as an adjunctive to pharmaceutical therapy for schizophrenia, among the most challenging mental health conditions to treat, the PDT is one of several products in the collaboration’s pipeline. Read More

Renovos Biologics Ltd. was granted a U.S. FDA breakthrough device designation for its Renovite BMP-2 (bone morphogenetic protein-2) product, which is designed for interbody spinal fusion. Read More

The U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this regard.

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An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner. Read More

Are there other guidances the U.S. FDA should release as final without going through the draft and public comment process first? That’s one of the questions the FDA wants stakeholders to comment on as it updates its best practices for guidance. Read More

Researchers from three California-based institutions are seeking patent protection for systems, devices and methods that allow brain-controlled limb movement and sensation. Read More

New hires and promotions in the med-tech industry, including: Atricure, Bivacor, Blue Spark, Covalon, Deciphex, Fluidform, Mission Bio, Moximed, Prophase, Quris. Read More

Med-tech firms raising money in public or private financings, including: Ceretype, Nalu, Ok2Standup, Vmocion. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Kuros, Vicore. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptar Digital, Aptargroup, Bruker, Enovis, Gerresheimer, Limacorporate, Tornado Spectral. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocomposites, Ingelheim, Immunexoress, Irhythm, Kuros, Mentice, Renovos, Simbiosys. Read More