Boston Scientific announces strategic investment in MiRus LLC
Agreement includes exclusive option to acquire novel, balloon-expandable transcatheter aortic valve made with proprietary rhenium alloy
FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
FDA Commissioner Marty Makary says, one-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness.
FDA Expands AI Capabilities: Launches ELSA and Completes HALO Data Platform Consolidation
The agency launched Elsa 4.0, an upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.
Roche acquires PathAI to transform AI-driven diagnostics
PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities, according to the company Roche, will complement the company’s digital pathology portfolio to drive laboratory efficiency.
Trump Planning to Fire FDA Commissioner Marty Makary
Top administration officials have become increasingly convinced Makary has to go because, in addition to months of turmoil, complaints from some in the pharmaceutical industry have continued to mount, people familiar with the matter said.
Medtronic’s Updated Mitral Valve, Mosaic Neo, Gets FDA approval
Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally Invasive Cardiac Surgery (MICS) and robotic cases.
Sonire Therapeutics Initiates First U.S. Clinical Study of Ultrasound-Guided HIFU Therapy for Pancreatic Cancer
SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach
Edwards Lifesciences Shares Ten-Year Pivotal Data Supporting Long-Term Durability of Resilia Tissue
Edwards announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue.
Johnson & Johnson Enters Agreement to Acquire Atraverse Medical
The deal would fold the FDA-cleared Hotwire system, and the team behind Farapulse, into J&J’s expanding cardiac ablation business.
enVVeno Medical Receives FDA IDE Approval for Non-Surgical Replacement Venous Valve
The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.