Makers of devices for ablation for atrial fibrillation (AF) have struggled at times to overcome clinician skepticism, but a new report in a respected medical journal might persuade some of those cardiologists. A study of nearly 28,000 AF patients in South Korea demonstrated that device therapy yielded lower rates of death and admission for heart failure compared to medical therapy, suggesting that ablation is a valid alternative to medical therapy, at least for patients in Asia.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is pushing back implementation dates for numerous medical device reforms due to delays caused by the COVID-19 pandemic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Conformis, Mainstay Medical, Medtronic, Omnipathology.
PARIS – Stilla Technologies SAS, of Villejuif, France, is supplying a new, cost-effective approach for COVID-19 testing by combining its digital polymerase chain reaction (PCR) technology with the group testing method. “This approach greatly increases testing capacity and meets the highest quality standards,” Rémi Dangla, co-founder and CEO of Stilla Technologies, told BioWorld.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anpac Bio, Beijing Yuan Jian Health Management, Koru Medical Systems, Masimo, Pixium, Seizure Tracker, Tuberous Sclerosis Alliance.
PERTH, Australia – Australia’s largest life science investment fund is pressing the government for an urgent COVID-19 response package to support the country’s AU$170 billion (US$117 billion) life sciences sector that is struggling to survive in a post-COVID-19 ecosystem.
Beverly, Mass.-based Lexagene Holdings Inc. has developed a genetic analyzer with multiplex testing capability that would enable it to determine whether a patient has COVID-19, influenza or another respiratory infection with one sample. The Lx Analyzer uses a proprietary quantitative reverse transcription polymerase chain reaction (RT-qPCR) method to automatically test for up to 27 pathogens simultaneously, all in about one hour.
The potential for neurological complications, including seizures and stroke, is a growing concern with COVID-19 patients. To ensure rapid diagnosis and treatment, Ceribell Inc., a Mountain View, Calif.-based startup, is deploying its cloud-linked, portable electroencephalogram (EEG) device to enable EEG assessments in minutes in emergency rooms and intensive care units.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Antibodiescheck.com, Medakit, Sonrisa Family Dental.
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