In collaborating with Novo Nordisk A/S, privately held Aspect Biosystems Ltd. entered its biggest ever deal that could bring in more than $2.6 billion while advancing its 3D, bioprinted tissue therapeutics technology. The two companies will collaborate to develop up to four diabetes and/or obesity products, a Novo specialty, using implantable bioprinted tissues to replace, repair or supplement human biological functions. The initial target will be type 1 diabetes.
Braintale SAS unveiled an updated version of its digital biomarkers platform with new features including advance options for patient monitoring. This version is also CE-marked under the new EU Regulation, MDR 2017/745. The company said this latest version of Braintale-care sees important improvements for all users, with superior security and usability alongside additional available biomarkers. “This significant enrichment allows deployment of our platform to a growing number of customers for the benefit of patients and people in the industry,” Jean-Baptiste Martini, chief technology officer of Braintale, told BioWorld.
Getinge AB received U.S. FDA premarket approval (PMA) for its Icast covered stent system, which has been used by clinicians for 20 years under the brand name Advanta V12. Icast is designed to treat patients with iliac arterial occlusive disease, a type of peripheral arterial disease where atherosclerosis narrows and blocks peripheral arteries.
The U.S. CMS has a few changes in mind for the new technology add-on program (NTAP) for fiscal year 2024, including a proposal to allow manufacturers to apply for an NTAP payment only after the sponsor has filed a completed premarket application with the FDA. Perhaps more significantly, the deadline for FDA approval would also be moved up earlier in the calendar year, from July 1 to May 1, a change that could eliminate a year of NTAP eligibility for a significant number of products.
Becton, Dickinson and Co. (BD) tackled the persistent issue of missed vessels for intravenous (IV) placement with the goal of enabling hospitalized patients to have a ‘one-stick stay.’ The Prevue II system uses the BD Cue needle tracking-enabled system, which offers a high-quality ultrasound image of the needle trajectory in conjunction with real-time needle depth markers.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Moximed, R2 Technologies, Reach Neuro.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Artera, Advanced Cooling, Attune Medical, Bone Biologics, Bristol Myers Squibb, Dermtech, Discovery Life Sciences, Foundation Medicine, Glooko, Hedia, Illumina, IMA Group, Neovasc, Reachbio Research, Shockwave Medical.
RNA editing in schizophrenia (SCZ)-associated genes was decreased in postmortem brains of individuals of European descent, according to a study from the University of California, Los Angeles (UCLA). The scientists obtained the RNA editome from SCZ brains to detect the sequence changes in their RNA and observed hypoediting in noncoding regions related to mitochondrial function, such as the mitofusin-1 (MFN1) gene.
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