Medtronic's PulseSelect is the first pulse field ablation technology to earn FDA approval and the company plans to launch it in early 2024. PulseSelect PFA earned a CE mark in November.
Medtronic appears to have won the race to becoming the first company to launch a pulse field ablation system in the US.
The US Food and Drug Administration approved Medtronic’s PulseSelect pulsed field ablation (PFA) system for the treatment of both paroxysmal and persistent atrial
PulseSelect is the first PFA technology to be approved by the FDA
HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.
