US FDA Proposes Biggest Mammography Rule Change In 20 Years
US FDA wants to make significant changes to how mammographers interact with patients in terms of the information they share about the procedure and standards they will have to follow. The issue specifically addresses scenarios where patients with denser breast tissue may not be fully informed about the accuracy of their mammography tests. If the agency's proposal moves forward, it will be the biggest regulatory change for the mammography industry in more than two decades.
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American Society Of Breast Surgeons Releases First Mammography Screening Guidelines
In a move which conflicts with guidelines from other organizations, the American Society of Breast Surgeons released its first mammography screening guidelines, recommending among others, annual screenings for women starting at age 40.
FDA’s 2020 Device Budget Would Focus On Safety, Cybersecurity, Bringing Medtech 'Home'
US FDA intends to use device-center dollars in its fiscal year 2020 budget on medical product safety, bolstering cybersecurity, device oversight modernization, and an initiative called “Bring Medtech Manufacturing Home,” among other priorities.
Market Intel: Breast Imaging Market Driven By AI, Technological Innovation
The global market for breast cancer imaging and biopsy technologies is expected to reach $5.8bn by 2022, a CAGR of 5.9%, driven by innovation technologies and machine-learning tools that serve as "second readers" to help radiologists triage images and find cancers. Many radiologists believe that mammography will remain the most widely used screening tool, but that digital breast tomosynthesis will ultimately become the gold standard. Here's a close look at the overall breast imaging and biopsy market, highlighting different modalities and key players, and offering the real-world use perspective from three radiologists at Kaiser Permanente, San Diego.