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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galderma, Soliton.
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.
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.
Medtronic plc received U.S. FDA premarket approval of its Diamondtemp Ablation (DTA) system for treatment of patients with recurrent, symptomatic paroxysmal atrial fibrillation. The temperature-controlled radiofrequency (RF) ablation system features industrial-grade diamonds, which provide 200 to 400 times the thermal conductivity seen in conventional ablation and enable more efficient delivery of energy to regions of the heart responsible for the erratic electrical signals underlying atrial fibrillation (AF).
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