CMS departures: Deputy Administrator and Chief Operating Officer Ruben King-Shaw is resigning for "personal" and "family" reasons, the agency confirms April 8. Shaw is expected to pursue interests in the private sector. Leslie Norwalk, senior advisor for policy and counselor to the administrator, will assume King-Shaw's duties. In the Coverage & Analysis Group, senior analyst Perry Bridger will be leaving to take on a senior analyst position at Health Strategies Consultancy in Washington, D.C., effective May 12....CMS arrival: William Sullivan is appointed deputy chief medical officer at CMS April 7 and is reporting to Administrator Tom Scully and Acting Chief Clinical Officer Sean Tunis. Sullivan previously served as VP-medical affairs and chief clinical officer for the Eastern Maine Medical Center...
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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.
BD is accelerating transitions of product sourcing for China to avoid tariffs. Historically, products like Vacutainer were exported from Sumter, SC, to China, and Flush was shipped from Columbus, NE.
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.
