The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts guidance agenda for FY 2021; Third-party 510(k) review report posted; NIOSH testing flunks more imported filter masks; OIG says Cedars-Sinai billed for non-compliant bariatric surgeries.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Livmor, Sanuwave, See-Mode Technologies.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Federal Circuit declines to overturn lower court ruling for Medtronic; FDA stands pat on biotin interference threshold in final guidance; CMS adds to telehealth list.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aferetica, Cytosorbents, New World Medical.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA taking adcomm nominations; HHS, DoD ink deal with Cue Health; NTAP town hall set for Dec. 15-16.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cefaly Technology, Crossbay Medical, Fh Ortho, Immersivetouch, Micro Medical Solutions, Sonivie.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Medicare overpaid for facet-joint injections; FDA posts IIE policy for non-COVID tests.

The U.S. FDA has several years of experience with computational modeling (CM) for medical device design and testing; however, the movement toward a policy has wanted for a solid body of data on which to base a guidance.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cartiheal, GE Healthcare, Varian.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters.