Companies that have brought products through US FDA's current cardiac device review office will come across many of the same review managers in the newly forming Office of Cardiovascular Devices, which will also include a few compliance and surveillance officers on the leadership team. The new office will sit within the device center's nascent "total product lifecycle" Office of Product Evaluation and Quality.
A new cross-functional cardiovascular device office within US FDA will be managed principally by current cardiac device review leaders, along with some current compliance and surveillance officers. Senior FDA staffer Matthew Hillebrenner unveiled the structure and leadership team members of the new cardiac office at the annual CRT conference in Washington, DC, on March 6.
The changes are part of the device center's efforts to stand up the new Office of Product Evaluation and Quality,...
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
