FDA has approved BioMerieux Inc.’s THxID BRAF kit, a companion diagnostic test that will help determine if a patient’s melanoma cells have BRAF V600E or V600K gene mutations. The diagnostic was approved May 29 along with GlaxoSmithKline Inc.’s Tafinlar and Mekinist drugs for patients with advanced or unresectable melanoma, the most serious type of skin cancer. Approximately half of melanomas arising in the skin have a BRAF gene mutation, FDA says. FDA’s approval of the THxiD BRAF test is based on data from clinical studies that support the Tafinlar and Mekinist approvals. Samples of patients’ melanoma tissue were collected to test for the mutation.
New Products In Brief
FDA clears skin-cancer companion diagnostic. Medtronic announces two AAA-related approvals. OrbusNeich launches dual-therapy stent outside the U.S. More new products.
More from Archive
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
More from Medtech Insight
Diabetes company Insulet announced that former longtime J&J executive Ashley McEvoy will succeed Jim Hollingshead as president and CEO effective today. Analysts applauded the appointment, noting McEvoy’s strong background in medtech and diabetes.
Medtech Insight sat down with Jared Bunch, chair of AF Center of Excellence Task Force, at HRS 2025 to discuss the newly HRS released framework for Afib Center of Excellence and get his perspective on the role industry could play to help clinicians improve patient outcomes.
Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.