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X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.
Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.
X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.
FDA reports the action marks the first consent decree of permanent injunction against a firm or grower for violating public safety standards under the Produce Safety Rule enacted under the Food Safety Modernization Act of 2011.
"Streck is excited about this milestone for Cell-Free DNA BCT," said Product Manager Joel Lechner. "We have always known that Cell-Free DNA BCT is the best tube for customers who are concerned about pre-analytical variation, but De Novo IVD status solidifies Cell-Free DNA BCT as a truly novel collection tube."
The opioids offered for sale include products such as tramadol and oxycodone. These are prescription drugs that have significant risks of addiction, abuse and misuse, which can lead to overdose and death, and should only be used under the supervision of a licensed health care provider.
FDA notes the findings come as we mark today’s premarket review submission deadline, a milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by the FDA.
The study begins on the heels of a recent Breakthrough Device Designation issued by the FDA for the Intrepid TTVR System. The Intrepid TTVR system is an investigational device worldwide.
Clarity Pharmaceuticals Executive Chairman Dr. Alan Taylor commented, "We are very excited to have received the RPDD status for the diagnostic application of SARTATE™ in children with neuroblastoma. This comes shortly after Clarity has been granted RPDD for the treatment of neuroblastoma with 67Cu-SARTATE™ for the therapeutic application, announced on the 3rd of June 2020."
The BreviTest SARS-CoV-2 IgG Test detects the presence of SARS-CoV-2 specific IgG antibodies in plasma or serum using only 3μl of sample. Reliable results are available in 10 minutes. A positive test result indicates prior exposure to the virus and potential immunity.
Fujifilm Sonosite creates point-of-care ultrasound systems and medical informatics solutions along with transducers and accessories that can help physicians improve time-to-diagnosis, patient outcomes, procedural efficiency, and workflow.
PQ Bypass advises physician access to this device can now be expedited as a result of this designation by the FDA Breakthrough Device Program, which is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
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