LONDON – The European Parliament gave its full backing to the emergency measure to delay the Medical Device Regulation (MDR), voting by 693 to 1 in favor of postponing implementation from May 26 this year, to May 26, 2021. The delay will “allow health authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic” by keeping existing procedures in place, the parliament said in a statement. Read More
The COVID-19 pandemic has moved rapidly over the past few weeks, and Ortho Clinical Diagnostics Inc. is doing its part to help during the crisis. To that end, the Raritan, N.J.-based company has worked to successfully secure an emergency use authorization (EUA) for its total antibody assay for COVID-19, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and calibrators. Read More
The U.S. FDA has granted emergency use authorization (EUA) to New Haven, Conn., startup Vent Multiplexor LLC for its emergency rescue co-ventilation device. Developed in collaboration with Yale New Haven Hospital, the Vent Multiplexor enables individualized mechanical ventilation of two adults on a single ventilator – lessening demand for more critical care machines in the ongoing COVID-19 outbreak. Read More
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit. In a letter dated April 18, 2020, the FDA informed Osang of its authorization for the company’s Genefinder COVID-19 Plus Realamp Kit. Read More
In a decision that seems to have yet again roiled the patent subject matter eligibility question, the U.S. Court of Appeals for the Federal Circuit determined that a district court had erred in determining the 7,941,207 patent held by Cardionet LLC, of Conshohocken, Pa., is not eligible for patent protection. Read More
LONDON – The U.K. treasury announced a £500 million (US$622.5 million) COVID-19 bailout plan for research-based startups, which could see the government holding equity stakes in venture capital-backed firms. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytosorbents, Endospan, Fosun Pharma, Foundation Medicine, Genosensor, Osang Healthcare. Read More
Keeping you up to date on recent developments in cardiology, including: Modeling the post-infarct heart; Researchers: Cancer immunotherapy poses threat to heart muscle; Lighting up the path for heart procedures. Read More
