Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies.
An easy-to-miss footnote to FDA’s recent 510(k) program draft guidance is attracting the attention of some industry experts as a potential overstepping of agency authority.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.
Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.
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.
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.
Egg Medical is ramping up efforts to expand international sales of its EggNest scatter radiation protection system to shield X-ray procedure room staff without disrupting workflow. Medtech Insight sat down with Bob Wilson, Egg Medical’s CEO, to discuss the various EggNest systems, marketing opportunities and the competitive landscape.
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.
