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Philips to Acquire Capsule Technologies Inc.

Royal Philips has signed an agreement to acquire Capsule Technologies Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.

HealthMyne Appoints National Oncology Leader to Board of Directors

HealthMyne, a pioneer in applied radiomics, has announced the appointment of Mimi Huizinga, MD, MPH, FACP, to its board of directors.

MITA Applauds CMS for Creation of Medicare Coverage Pathway for Innovative Medical Technologies

The Medical Imaging & Technology Alliance (MITA), the leading organization and collective voice of medical imaging equipment, radiopharmaceutical, contrast media, and focused ultrasound device manufacturers, today applauded the Centers for Medicare & Medicaid Services (CMS) for its recently issued final rule concerning the Medicare Coverage of Innovative Technology (MCIT) program.

KA Imaging Appoints Seasoned Industry Executives to Key Leadership Positions

Manufacturer KA Imaging has appointed Shawn Campbell as vice president of operations and Robert Moccia as vice president of sales, USA and Canada.

FDA Issues Guidance on Diagnostic Ultrasound Systems and Transducers

The FDA has released a final guidance that provides detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers.

In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).

As before, manufacturers who submit 510(k)s and receive marketing clearance will continue to be exempt from the Electronic Product Radiation Control (EPRC) reporting requirements in 21 CFR 1002.12, for diagnostic ultrasound devices, as described in the notice to industry entitled “Exemption from Reporting under 21 CFR 1002” dated February 24, 1986.

For more information or to view the final guidance, visit https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-clearance-diagnostic-ultrasound-systems-and-transducers.

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