Shineco Inc.’s subsidiary Changzhou Biowin Pharma received marketing approval from China’s NMPA for its test device that can complete a diagnosis of acute myocardial infarction in five minutes. The five-minute cardiac test relies on a combination of three major cardiac markers that can detect cardiac troponin I, myoglobin and heart fatty acid binding protein in a single test.
A committee of the U.S. House of Representatives met to review the Medicare coverage procedure for innovative drugs and devices, an event that seemed to gin up support for legislation that would help to streamline those processes. The problem for drug and device makers, however, may be that the Centers for Medicare & Medicaid Services
continues to labor under a flat appropriations picture that is eroding daily thanks to inflation.
Organox Ltd. raised £25 million (US$33 million) in a funding round that will allow the company to expand its operations in the U.S. on the back of significantly increasing demand from transplant centers, Oern Stuge, executive chairman, at Organox told BioWorld. The Oxford, U.K.-based company which makes systems to preserve and transport livers for transplant is also preparing for its eventual listing on Nasdaq, he added.
With a bruising battle with its largest investor barely behind it, Masimo Corp.’s preliminary second quarter results came in nearly $100 million below consensus, putting management in an even tougher position now that it has two new investor-aligned board members. Share price plunged from $147.16 to $110 following the after-hours announcement on Monday. By the closing bell on Tuesday, shares had recovered modestly to $117.73.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neuronetics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accustem, Beckman Coulter, Emeritusdx, Fresenius Medical, Fujirebio, Glaukos, H.U. Group, Icecure Medical, Medicinália Cormédica, Radius XR.
The False Claims Act (FCA) has generated billions of dollars in fines each year in the U.S., and Atlanta-based Nextgen Healthcare Inc., is the latest to find itself on the wrong end of a whistleblower lawsuit based on the FCA. The U.S. Department of Justice reported that Nextgen will hand over $31 million to settle allegations that the vendor of electronic health records (EHR) not only misrepresented the capabilities of its software, but also paid kickbacks to physician providers to use its software, a pair of violations that have dinged the company’s finances and its reputation.
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