Boston Scientific has launched DirectSense, a tool used during cardiac ablation procedures to track the effects of radiofrequency energy to help reduce the risk of complications and over-ablation.
The FDA has given emergency use authorization to Stryker Sustainability Solutions for its N95 decontamination system. The system uses vaporized hydrogen peroxide and cannot be used to decontaminate respirators that contain cellulose-based materials.
The FDA has given emergency use authorization to Abiomed for its Impella RP, a temporary heart pump that can be used to treat COVID-19 patients who experience right heart failure.
Aytu BioScience received emergency use authorization from the FDA for its COVID-19 IgG/IgM test cassette. Approximately 1.4 million tests are available for sale in the company's warehouse, Aytu stated.
European regulators have given CE-IVD mark approval to Mobidiag for its Amplidiag COVID-19 and Novodiag COVID-19 PCR tests. The Amplidiag test can deliver results within 3 hours, while the Novodiag can deliver results within an hour.
Healgen Scientific received emergency use authorization from the FDA for its COVID-19 IgG/IgM Rapid Test Cassette that can deliver results within 10 minutes. The company said the test has an 87.9% sensitivity and 100% specificity for IgM antibodies, and a 97.2% sensitivity and 100% specificity for IgG antibodies.
The FDA added Pfizer's antidepressant drug Zoloft and generic sertraline to the list of drugs in short supply amid a spike in demand as the pandemic takes a toll on mental health. Generic-drug companies that make sertraline said they have had difficulty securing enough of the active pharmaceutical ingredient used to make the drug, while Pfizer makes its own API but said some bottles and formulations are in short supply.
LabWare has entered an exclusive agreement with Tangen Biosciences to distribute the latter's GeneSpark point-of-care instrument with LabWare's SARS-CoV-2 portable disease surveillance kit. The deal's other terms were not disclosed.
Medtronic is making temporary changes to its extracorporeal membrane oxygenation technology's indications to allow COVID-19 patients experiencing acute respiratory or cardiopulmonary failure to use the devices in an ECMO circuit for more than six hours. The devices that can be used to treat patients are the Affinity CP adapter, Affinity centrifugal blood pumps and the Bio-Console 560 extracorporeal blood pumping console with accessories.
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