Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 410 Medical.
Keeping you up to date on recent developments in diagnostics, including: Intensive care scoring systems outperform miRNA in sepsis diagnosis; Report: AI falls short of potential in health care; Angiopoietin trouble can lead to lymphedema.
Spurred by reports of biopharma executives exercising stock options in conjunction with announcements about COVID-19 vaccine developments and government contracts, U.S. lawmakers want to close the loopholes that make such actions legal.
Fitbit Inc. and Apple Inc. picked up the pace in their race to put health monitoring apps on wrists everywhere with Fitbit gaining 510(k) clearance from the U.S. FDA for its new ECG app for the Fitbit Sense and Apple revealing the blood oxygen sensor built into its Series 6 watch this week. The new apps join a growing array of technological advances that permit wearable devices to track and record a range of health metrics.
Advanced diagnostics startup Coremap Inc., which is developing a technology capable of identifying the drivers of atrial fibrillation (AF), scooped up $10.5 million in a series A financing led by Qure Ventures. The funds will be used to accelerate product development and future regulatory submissions. Founded in 2016, the Burlington, Vt.-based company has raised nearly $12 million to date.
A Sept. 16 Senate hearing revisited the Trump administration’s response to the COVID-19 pandemic, and the CDC took the opportunity to post a vaccine distribution plan. CDC director Robert Redfield advised the committee, however, that sufficient quantities of vaccine to cover everyone in the U.S. might not be available until the third quarter of 2021, adding that now is the time to stand up a distribution network for a vaccine that will require cold-chain storage.
RSS
