Strata Oncology Inc. has inked an agreement with newcomer Elevation Oncology to ramp up patient identification and enrollment for the latter’s phase II CRESTONE study evaluating the use of seribantumab in patients with recurrent, locally advanced or metastatic solid tumors of any origin that have a neuregulin-1 (NRG1) gene fusion. Read More
Bone fracture repair startup Curvafix Inc. has secured $10.75 million in a series B round led by Sectoral Asset Management with participation from existing investors, including Delta Dental Washington Seed Fund, as well as board members. The company will use the proceeds to complete the RESTORE clinical trial of its U.S. FDA-cleared Curvafix intramedullar rodscrew and to scale up for commercial launch later this year or in 2021. Read More
Interludes of classical music. Little kids talking in the background. Unmuted mics as panelists multitask. Gurgles of “underwater” sound. Periods of silence as speakers forget to unmute. And then the technical problems – lots of them. Such are the challenges of addressing a virtual FDA advisory committee in the time of COVID-19. Read More
The U.S. FDA has put a considerable amount of emphasis on patient perspectives regarding medical devices in recent years, the subject of a recent webinar hosted by the Medical Device Innovation Consortium (MDIC). One of the speakers on the webinar, Carrie Kuehn, of Evidation Health of San Mateo, Calif., said that not only do device makers have a trove of valuable data at their fingertips with patient preference data, but also that the FDA’s message is, “if patients say something, we want to hear about it.” Read More
Hong Kong – Korea’s Ministry of Food and Drug Safety (MFDS) is looking to establish an international common set of guidelines for AI medical devices after its election to the first Chair of Artificial Intelligence Medical Devices (AIMDs) at a meeting of the International Medical Device Regulators Forum (IMDRF). Read More
PARIS – Inheart SAS completed its first funding round of $4.2 million to improve cardiac arrhythmia treatment using medical imaging, artificial intelligence and digital simulation. This fund round was led by Elvia Partners SAS, a Parisian investment fund managed by Xavier Lazarus specializing in deep tech, and Aquitaine Science Transfer, a company accelerating technology transfer, from the University of Bordeaux. Read More
New hires and promotions in the med-tech industry, including: Axim Biotechnologies, Guardion Health Sciences, Nuclera, Suralign Holdings, Teckro. Read More
Med-tech firms raising money in public or private financings, including: Cytosorbents, Genetic Technologies, Histogen, Procisedx, Profound Medical. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Colonaryconcepts, Sengine Precision Medicine, Teleflex. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Channel Medsystems, Lifesignals, OralDNA Labs, Paige. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed, Centurion Medical Products. Read More
Keeping you up to date on recent developments in oncology, including: Artificial intelligence plus dual-stain testing beats cytology for cervical cancer detection; Protein degradation system targeted to KRAS; Preventing T-cell rejection; Beating cytokine toxicity one layer at a time. Read More
