The device center is responding to a provision in the FDA Safety and Innovation Act, passed last summer, which explicitly prohibits FDA from disapproving an IDE solely because the agency does not believe the study could support approval or clearance.
The device center says it plans to re-issue its draft guidance on the investigation device exemption process in response to recently enacted restrictions from Congress.
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Freenome plans to file for US FDA approval of its blood-based screening test for colorectal cancer mid-year. If cleared, the test would rival Guardant Health’s Shield, the first FDA-cleared blood test for primary screening of colorectal cancer. Exact Sciences is also in the race to bring a blood-based colorectal screening test to market.
A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.
Health tech is at the forefront of the women's health sector, securing 38% of venture capital in 2024. However, panelists at the Anglonordic Life Science Conference held 3 April asserted that a successful therapeutic breakthrough is key to gaining investor confidence and accelerating venture capital.
Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.
Enovis has named veteran medtech leader Damien McDonald as its new CEO effective 12 May as the orthopedic company reaffirms first-quarter 2025 revenue guidance of between $555m and $563m. Medtech Insight spoke with Tim Czartoski, Enovis’ president of US surgical and global product and enabling technologies, about the firm’s growth strategy and innovation plans.
Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.
The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.
