Medical Product Outsourcing

The Medical University of Graz has enrolled the first patient in Reflow Medical Inc.’s DEEPER CHALLENGE clinical trial, which will investigate early vessel recoil after below-the-knee treatment using the Spur Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon.

Xeltis has surpassed 50% enrollment in its U.S. pivotal trial for aXess, a vascular access device that transforms into a living vessel for reliable hemodialysis access in adults with end-stage renal disease (ESRD). The trial is a prospective, multicenter study evaluating the patency, safety, and performance of aXess in adult ESRD patients who require vascular access for hemodialysis.

Inogen Inc. has appointed Andy Reding to the newly created role of chief operating officer (COO), with responsibility for driving revenue and operational performance, aligning cross-functional priorities, and helping ensure Inogen’s strategy is translated into efficient and measurable outcomes.

DermaSensor, a company pioneering AI-powered skin cancer diagnostic technology, has closed a $4 million Series B extension. The company also launched a community investment round on WeFunder. The new community financing has already garnered over $1 million. It follows the Miami-based company’s $16 million Series B closed in 2025 and brings total investment to $48 million.

The American Medical Association has granted CorVista Health a new Category III Current Procedural Terminology (CPT) code for novel augmentative artificial intelligence (AI) algorithmic analysis of potential coronary artery disease (CAD), pulmonary hypertension (PH), and elevated pulmonary capillary wedge pressure (PCWP).

LUMA Vision has obtained U.S. Food and Drug Administration (FDA) clearance to expand the capabilities of its VERAFEYE procedural intelligence platform for minimally invasive cardiac procedures. The clearance brings 3D anatomy, catheter tracking, and procedural guidance onto one platform, providing real-time anatomical visualization and guidance. VERAFEYE was initially FDA cleared in early 2025.

STAAR Surgical has appointed David Bailey, who served as the company’s CEO from 2001 to 2008, as its next chief commercial officer. In addition to the chief executive role, Bailey served as the Lake Forest, Calif.-based phakic IOL company’s president of International Operations from 2008 to 2011. When he assumed the role, STAAR had a broad portfolio but limited commercial reach.

Siemens Healthineers Molecular Imaging has completed a $43.6 million construction and renovation project at its PET (positron emission tomography) Detector Center in Rockford, Tenn. The project added 40,000 square feet to the 97,000-square-foot campus and renovated an existing 7,500 square feet of space. The Rockford campus is the sole global manufacturing site of the PET detectors that are the cornerstone of Siemens Healthineers PET/computed tomography (PET/CT) scanners.

Yourgene Health (part of the Novacyt Group), has launched the In Vitro Diagnostic Regulation (IVDR)-certified Yourgene Insight DPYD assay, expanding its clinical genetics portfolio across regulated European markets. The launch follows the introduction of the Yourgene Insight DPYD assay as a Research Use Only (RUO) product in May and completes the assay’s regulatory transition to full compliance with the European Union’s IVDR.

Northwell Health’s Feinstein Institutes for Medical Research has received $4.9 million in new multi-year grant funding from the National Institutes of Health (NIH) to tackle two of medicine’s most pressing challenges—acute inflammation and Alzheimer’s disease. These monetary awards will fuel two distinct research projects focused on unraveling fundamental biological mechanisms of both conditions.