Epidarex Capital secured more than $145 million in commitments in the first close of its fourth fund to invest in early stage therapeutics and medical device companies. The new capital will support up to 15 companies, across the U.K. and U.S., which are focused on oncology, cardiovascular, autoimmune and neurological conditions.

Beta Bionics posts strong results in inaugural public company year

Beta Bionics Inc. reported its first annual results as a public company today showing strong uptake of the iLet tubed insulin pump and plenty of opportunity in both the type 1 and type 2 diabetes markets. Its competitor, Tandem Diabetes Care Inc., also demonstrated increased patient growth and profitability.

FDA warns makers of HIV tests about test collection kits

The U.S. FDA’s Center for Biologics Evaluation and Research has posted four warning letters to makers of HIV sample collection kits, declaring that these kits are in violation of the regulation due to a lack a 510(k) or a PMA. While the warnings are specifically directed toward these kits, the recipients of the warning letters also operate the labs where those tests are conducted, facilities that are now legally out of bounds where FDA regulation is concerned.

FDA says TAP program a big hit to date, but key indicators await

The U.S. FDA’s device center has posted a report on the so-called TAP program, stating that the metrics available to date suggest the program is a rousing success. Still, there are a few key indicators that have not yet had time to emerge – such as product approvals and clearances, but those data points won’t emerge for another year or more.

Also in the news

4DMedical, Abanza, Bluejay Diagnostics, Burl Concepts, EIB, Hyperfine, Imgine Devices, Implantica, Myriad, Nanalysis, Neotech Products, Outset Medical, Qiagen, Quibim, Reveal Genomics, Robocath, Samantree Medical, Siemens Healthineers, Spine Innovation, Tempus, Turbett Surgical, Voxcell