Hologic's tomosynthesis: New data presented at Radiological Society of North America conference in Chicago on Dec. 2 shows Hologics' tomosynthesis breast mammography system Selenia Dimensions has a lower recall rate than traditional mammography and can detect tumors in dense breasts. The Selenia Dimensions takes a series of images to show tissue structure in three dimensions, allowing physicians to see an anomaly in breast tissue from multiple angles. Hologic originally expected FDA to approve the PMA for Selenia Dimensions in the second quarter of 2008, but FDA approval for the device was pushed back by a July 30 letter from the agency, requesting additional information (1"The Gray Sheet" Jan. 21, 2008, p. 7). FDA will likely convene an advisory panel meeting to review the PMA. Selenia Dimensions received a CE mark in Europe during the firm's fourth fiscal quarter of 2008. "We continue to see approval as when, not if," Morgan Stanley analyst David Lewis writes in a Dec. 4 report on tomosynthesis. "Focus will eventually turn to the technology, which has garnered considerable physician interest as a revolution versus digital, although concerns on adoption, workflow and applicable market exist.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
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.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
