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The system’s biggest benefit is the “ability to assess the function of the organ on the device prior to committing to the transplant,” said the principal investigator for the trial that supported the FDA approval. Read More
The system is the latest in the company’s Stratum line, which now includes almost 90 products to treat deformities and fractures in the foot and ankle. Read More
The company will begin marketing the technology in the U.S. in the coming weeks on a limited basis and is planning a national rollout by the end of March. Read More
The FDA has released final guidance detailing the core components of nonclinical testing and clinical trials of benign prostatic hyperplasia (BPH) devices, citing the condition’s prevalence in older male populations. Read More
Quidel is adding one of the world’s largest in vitro diagnostics companies to its already considerable diagnostics portfolio with the $6 billion purchase of Ortho Clinical Diagnostics. Read More
The FDA grants breakthrough device status to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Read More
The first test available on BD’s newly CE-marked MX instrument is the BD CTGCTV2, which detects the three most prevalent nonviral sexually transmitted infections. Read More
High-quality evidence was lacking for most of the COVID-19 diagnostics, medical devices and drugs the FDA has granted Emergency Use Authorization (EUA) since the start of the pandemic, claimed researchers at Israel’s Tel-Aviv University in a provocative analysis in the journal JAMA Internal Medicine. Read More
The FDA is receiving more than 100 applications for pre-Emergency Use Authorization (EUA) meetings and full EUA status for in vitro diagnostics (IVD) each month, so it expects to receive more than 1,000 such submissions in 2022. Read More