Endostart s.r.l. received U.S. FDA 510(k) clearance for Endorail, a magnetic balloon system which helps resolve intestinal looping and facilitates the efficiency and safety of colonoscopy procedures. The approval is an “important milestone” for the company as it will allow Endostart to bring its technology to the U.S. market to empower physicians, Alessandro Tozzi, co-founder and CEO of the company, told BioWorld. Read More
Noze Inc. is hot on the trail of tuberculosis with its Diagnoze hand-held system that can detect the disease by its smell. The company, formerly known as Stratuscent, received additional support from the Bill & Melinda Gates Foundation to fund a study evaluating a breathalyzer designed to detect tuberculosis in high-burden countries. Read More
Exact Sciences Corp. reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus. Read More
Boundless Bio Inc. got a lukewarm welcome on Nasdaq after pricing its IPO of 6.25 million shares at the midpoint price of $16 per share, raking in about $100 million in gross proceeds to advance its pipeline of ecDNA-driven drugs targeting oncogene-amplified tumors.
In what represents its first patenting, Austin, Texas-based Slipstream Solutions LLC is seeking protection for systems and methods for treating fluid stasis (e.g., edema) that employ an airstream to move static fluid to natural drainage areas such as lymph nodes or ducts. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Isotopia Molecular Imaging, Synaptive Medical. Read More
