FDA Approves Beyond Air’s LungFit PH for Newborn Pulmonary Hypertension July 7, 2022 LungFit PH is Beyond Air’s first approved nitric oxide generator targeting pulmonary disease. Read More
Radiobotics Gets CE Mark for Its RBfracture Software July 6, 2022 The CE mark was certified by the EU notified body Tüv Süd. Read More
Palette Life Sciences Gets FDA 510(k) Clearance for Barrigel Rectal Spacer July 6, 2022 The spacer is made from non-animal stabilized hyaluronic acid. Read More
Scopio Labs Gains FDA Clearance for Its Hematology Analysis Device July 6, 2022 The digital analysis eliminates the need for additional manual microscopic examination, the company said. Read More
FDA Approves Foundation Medicine’s Companion Diagnostic for Genentech’s Rozlytrek July 6, 2022 As a condition of approval, Foundation Medicine will conduct a post-approval study. Read More
Innova Medical Group Earns CE Mark for Its Rapid Antigen Self-Test for COVID-19 July 5, 2022 Innova’s rapid antigen self-test detects multiple proteins in the SARS-CoV-2 virus. Read More
Stronghold Group Receives 510(k) Clearance for Nitrile Examination Gloves July 5, 2022 The company aims to help relocate the industry that is largely located in countries such as China and Malaysia. Read More
Bosch Healthcare Solutions Gets a CE Mark for Its STI Test July 5, 2022 The test can deliver a positive result in an hour. Read More
FX Receives FDA Clearance for Its FX V135 Shoulder Arthroplasty Platform July 5, 2022 The system gives surgeons the option to use a reverse configuration for the humeral cup. Read More
LumiraDx Gets CE Mark for Two Multiplex Tests That Can Identify COVID-19 July 1, 2022 Results from the two assays are comparable to high-sensitivity RT-PCR tests, the company said. Read More
Proscia’s Concentriq Dx Gets CE-IVDR Mark for Use in Primary Diagnosis July 1, 2022 The digital platform provides “a microscope-like viewing experience in a digital pathology environment,” the company said. Read More
Grifols’s Procleix Plasmodium Assay for Malaria Granted a CE Mark July 1, 2022 The assay will be available in all markets that accept CE mark certification, the company said. Read More