Medtronic plc, of Dublin, has gained CE-marking approval for its Minimed 780g system, a next-generation closed-loop insulin pump for people with type 1 diabetes between the ages of 7 and 80 years old. The advanced hybrid closed-loop system (AHCL) features an advanced autocorrection algorithm and Bluetooth connectivity. Read More
The patent lawsuit between Merck & Co. and Microspherix LLC began when the latter sued Merck for infringement of patents for brachytherapy in Merck’s implantable contraceptive device, but Merck was unable to prevail in an inter partes review (IRP) or in an appeal of the IPR at the Court of Appeals for the Federal Circuit. After wading through questions about purported prior art, Merck failed to persuade the two courts that Microspherix’s non-provisional filing had strayed too far from the written description of the related provisional, thus handing Microspherix a win against its much larger rival in the market for drug delivery with microspheres. Read More
The U.S. FDA granted San Diego-based Illumina Inc. an emergency use authorization (EUA) for the first COVID-19 diagnostic test that uses next-generation sequencing (NGS). In addition to diagnosing infection with SARS-CoV-2, the COVIDSeq test can help researchers track mutations in the coronavirus. Read More
Partners Adaptive Biotechnologies Corp., which is based in Seattle, and Redmond, Wash.-based Microsoft Corp. have started sharing an open database that details the immune response in COVID-19 patients with researchers and public health officials. The project is analyzing thousands of de-identified patient blood samples submitted from institutions around the world and is dubbed ImmuneCODE. Read More
HONG KONG – India has been slowly easing restrictions on the export of its med-tech products, giving hope to domestic manufacturers looking to meet global demand for their output. “We are pleased to share that many of the routine IVD diagnostic kits falling under HSN code 3822 have been removed from export restrictions and a few specific items related to COVID-19 testing retained,” Rajiv Nath, the forum coordinator for the Association of Indian Medical Device Industry (AIMED), told BioWorld recently. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Berry Genomics, Biospherix, Dariohealth, Genetron, Hawkeye Systems, Htg Molecular Diagnostics, Nanotronics, Patientsafe Solutions, Personalis, Royal Philips, Sexton Biotechnologies, Sorrento Therapeutics, Terramera, Thermo Fisher Scientific. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Establishment Labs, Medtronic. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Lucid Diagnostics, Moleculight, Palmetto GBA, Pavmed. Read More
Keeping you up to date on recent developments in diagnostics, including: Sickle cell still greatly undiagnosed; Cardiac imaging for heart strain in infants with lung infections; C12orf49 is new lipid metabolism gene. Read More
