Medtronic plc said Monday that it has expanded its limited site release of its new radial artery access portfolio. Acquired from Rist Neurovascular Inc. last year, the portfolio includes the Rist 079 Radial Access guide catheter and Rist Radial Access selective catheter. Dublin-based Medtronic completed its acquisition of privately held Rist Neurovascular in August 2020 for an undisclosed sum – the eighth in a series of tuck-in deals the med-tech behemoth has undertaken since January 2020. Read More
Illumina Inc. and Sequoia Capital China are collaborating to launch a startup ecosystem in China. The Sequoia Capital China Intelligent Healthcare Genomics Incubator, Powered by Illumina, will support life sciences startup companies in the field of genomics. Illumina for Startups will offer sequencing systems and reagents, lab space in China, and expertise. Sequoia Capital China will provide investment and business guidance. Read More
TORONTO – Kardium Inc. has secured US$115 million in private money to accelerate commercial growth in Europe of a mapping and ablation system for atrial fibrillation (AF), and conduct a clinical study for FDA approval of the system. Led by Fidelity Management & Research Co. LLC, this funding tranche follows a US$40 million investment in Kardium in 2018 driven by T. Rowe Price Associates Inc., which also invested this time around. Read More
The U.S. FDA’s safer technologies program, or STeP, may seem uncontroversial, but agency staff said on a Feb. 1 conference call that the program could be delayed by the change in administration at the White House. This is possibly an artifact of the Biden administration’s Jan. 20 executive order (EO) that applies a freeze to federal agency activities for 60 days, an EO that could affect a wide swath of federal agency activity. Read More
LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Althea UK and Ireland, Ambu, Ascensia, Avails Medical, Cadwell Industries, Cardiovascular Systems, Chansu Vascular Technologies, Circularity Healthcare, Earlysense, Fuse Medical, Hillrom, Innova Medical Group, Laborie Medical Technologies, Mayo Clinic, Orthovestments, Roche, Seegene, Senseonics, Setpoint Medical, Urotronic. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galderma, Soliton. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA unveils policy concerns for 2021; NRC seeks nominees for medical isotopes adcomm; Senators: More protection needed for genomic data; Veterans’ genomic data put at risk; DNA sequencing claims struck down. Read More
Keeping you up to date on recent developments in cardiology, including: Registry data suggest invasive procedures may be omitted in some cardiac arrest patients; Cryoablation beats medical management for some AF patients; Aetna deems certain leadless pacing experimental. Read More
