Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.

Laboratory Corporation of America Holdings Inc. agreed to purchase select assets of Bioreference Health from Opko Health Inc. for $237.5 million in a deal slated to close in the second half of 2024. The transaction could be the start of a buying spree for the country’s second-largest independent laboratory testing service provider, as Labcorp management has laid out an acquisition strategy that focuses on higher-growth areas, particularly reproductive and women’s health.

It’s game time for Abbott Laboratories’ 15-minute concussion test now that FDA clearance is in hand. The I-Stat traumatic brain injury cartridge uses whole blood, allowing bedside assessment of patients without lab processing.

The notion of using vacuum pressure on the anterior portion of the human eye as a treatment for open-angle glaucoma might be a clinical novelty, but Balance Ophthalmics Inc. is poised to change that. The company recently won a favorable outcome at a U.S. FDA advisory panel for its Fsyx negative pressure pump for ocular use, although the company is likely to have to drum up a large body of data in post-approval studies, assuming the FDA gives the Fsyx the nod.

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.

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.

Avicenna.AI SAS received clearance from the U.S. FDA for two of its artificial intelligence (AI)-based solutions, Cina-Ipe and Cina-Aspects, which provide for the detection of pulmonary embolism (PE) and the assessment of stroke severity in CT scans, respectively.

The U.S. FDA released two draft guidances in the third week of March 2024, one of which is a modest edit of an existing guidance for pre-submission activities between the agency and manufacturers.