Syncardia Systems LLC, of Tucson, Ariz., has petitioned the Centers for Medicare and Medicaid Services (CMS) to drop the coverage with evidence development (CED) mandate for artificial hearts, stating that multiple studies have demonstrated that artificial hearts meet the reasonable and necessary standard. Syncardia said its temporary Total Artificial Heart (TAH-t) should thus be available “unencumbered by the existing requirement for evidence development,” a change that could modestly bolster utilization and sales of these devices. Read More
Zimmer Biomet Holdings Inc., of Warsaw, Ind., reported good news for the fourth quarter, which saw net sales of $2.126 billion, an increase of 2.6% over the prior year period. In terms of geography, the Americas and Asia-Pacific stood out. In addition, the company witnessed strong results globally in its knee and hip businesses. Read More
HONG KONG – Over the weekend, India’s Union Finance Minister Nirmala Sitharaman has imposed a health cess (also known as tax on tax) of 5% on the imports of medical equipment, except those exempted from basic customs duty (BCD). The aim of this development, stated in Sitharaman’s 2020 budget address, is to give impetus to the domestic industry and to generate resources for health services in the country. Read More
At this very early point in the emerging 2019-nCoV outbreak, knowledge about the virus is insufficient to predict what shape that outbreak will ultimately take. But knowledge about the virus is accumulating at remarkable speed, and experience with other viruses is helping to shape the response to the newest coronavirus threat. 2019-nCoV, sometimes called Wuhan coronavirus after its source, is the third coronavirus after SARS-CoV and MERS-CoV with the potential to cause serious illness and death that has emerged since the beginning of the 21st century. Read More
Now that U.S. Health and Human Services (HHS) Secretary Alex Azar has declared a nationwide public health emergency due to the 2019 novel coronavirus (2019-nCoV), HHS is saying it may need more money to help it be as proactive and aggressive as possible in detecting the virus and containing an outbreak. Read More
New hires and promotions in the med-tech industry, including: Arisglobal, Dxterity Diagnostics, Frazier Healthcare Products, Nuvaira, Polarean Imaging, Potero Medical, Sorrel Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Airos Medical, Bactiguard, Baxter, Biosense Webster, Cardiofocus, Contract Medical International, Haraeus Medical Components, Laminate Medical Technologies, Medtronic, Nanospectra, Orthofix Medical, Rhythm AI, Spectral Medical, Staar Surgical, Tissue Regenix, Vigilenz, Virtrial, Wittenstein SE. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Axonics Modulation Technologies, Drawbridge Health, Qiagen, Sky Medical, Soundbite Medical Solutions. Read More
Keeping you up to date on recent developments in oncology, including: New algorithm can distinguish between subtypes in low-grade glioma; Different drivers can turn the wheel in glioblastoma’s vicious cycle; Commercial antibodies underwhelm for studies of PP2A; Foundation awards more than $1M for cancer research; Protons better for sparing cognitive function in pediatric patients. Read More
