DOJ Files Charges in $2.1 Billion Telemedicine Health Care Fraud Plot September 30, 2019 The defendants allegedly duped Medicare beneficiaries into signing up for unnecessary genetic tests. Read More
Chinese Firm Rapped for Quality Failures September 27, 2019 The company failed to investigate a complaint about a malfunctioning device. Read More
Life Spine Gains 510(k) Clearance for Hinged Laminoplasty System September 27, 2019 The firm is focused on products for minimally invasive spinal surgeries. Read More
FDA Flags Lapses at German Device Facility September 27, 2019 Software used in the firm’s production and quality system was not validated and documented. Read More
European Commission Designates Fifth Notified Body September 27, 2019 European device groups have expressed concerns about the shortage of notified bodies. Read More
Colorado Devicemaker Cited for Lack of Acceptance Criteria September 26, 2019 The investigator said that the firm had no documentation defining the actual acceptance criteria. Read More
Omnia Medical Gets 510(k) Clearance for Cervical VBR System September 26, 2019 The system features a hollow center and holes to accommodate an autograft or allograft. Read More
DiaSorin’s VZV Swab Test Nabs CE Mark September 26, 2019 The diagnostic runs on the company’s Liaison MDX platform. Read More
Abbott’s Recharge-Free Spinal Stimulator Gets FDA Approval September 26, 2019 The device changes pain signals going from the spinal cord to the brain using low doses of mild electrical pulses. Read More
B. Braun Pulls Infusion Pump Sets Over Air Embolization, Contamination Risks September 25, 2019 The company recalled more than 2,500 units. Read More
Personal Genome’s Tissue Complete Assay Gets CE Marked September 25, 2019 The assay also tests for tumor mutation burden. Read More
ProciseDxs Near-Patient Diagnostic Platform Gains CE Mark September 25, 2019 The near-patient platform offers tests that take from two to five minutes. Read More