This week, Abiomed announced a class I recall of Impella heart pumps; the FDA released new device sterilization standards; and Boston Scientific planned a $140m new campus in Minnesota.
The FDA has designated a recall of various Impella Left-Sided Blood Pumps from Abiomed, Inc. as class I, its most serious.
The agency said Abiomed recalled the pumps because the instructions for use (IFU) do not adequately address the precautions clinicians need to take when treating patients who
Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.
The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.
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.
