Fujifilm Medical Systems U.S.A., a provider diagnostic imaging products and medical informatics solutions, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Gadolinium and Cesium digital X-ray detectors for ...
TauTona, a medical device firm, has obtained 510(k) approval from the US Food and Drug Administration (FDA) and a new patent from the US Patent and Trademark Office (USPTO) for the TauTona tissue injector (TTI), a hand-held adipose tissue ...
Tags: Tautona, Transfer Tool
Iceland-based Kerecis has obtained 510(k) approval from the US Food and Drug Administration (FDA) to market its fish-skin, Omega3, tissue-regeneration technology for the treatment of chronic wounds in the US. The company will market the ...
Tags: Kerecis, PDA, Fish-Skin Technology, chronic wounds
Topera, a US-based medical device company, has announced the US Food and Drug Administration (FDA) 510(k) approval and commercial availability of its FIRMap catheter and RhythmView 3D mapping workstation. For clinicians, the RhythmView 3D ...
Tags: Topera, clinician, firmap catheter, FDA approval
DJO Surgical, a DJO Global company, has reported the first surgical use of its patient-specific shoulder instrumentation, Match Point System, in Reverse shoulder system cases in Australia and Florida. Developed in collaboration with ...
Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for an expanded indication of ear, nose and throat (ENT) procedures for the ENSEAL tissue sealers. The ...
EndoChoice, a US-based medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Fuse gastroscope, which has two cameras and has a 245 degrees field of view. The new gastroscope joins the ...
Tags: Endochoice, Fuse Gastroscope
Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the HARMONIC ACE+ 7 Shears with Advanced Hemostasis (HARMONIC ACE +7). HARMONIC ACE+ 7 is an ...
Medical device company Varian Medical Systems has obtained 510(k) approval from the US Food and Drug Administration for RapidPlan, a radiotherapy treatment planning tool designed to enhance quality, consistency, and efficiency in ...
Dutch multinational engineering and electronics conglomerate Royal Philips has announced the launch of new anesthesia product and two patient monitoring systems. The products include IntelliSave AX700 anesthesia machine and, IntelliVue ...
Integra LifeSciences, an integrated medical technology company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Integra laminoplasty system, a comprehensive set of implants and instruments designed for ...
US-based Maquet Medical Systems has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the VOLISTA surgical lighting system. Incorporating Maquet Medical Systems' Luminance Management Device (LMD) technology, the ...
Tags: Surgical Lighting System
US-based Preventice has obtained CE Mark from the European Commission for its BodyGuardian remote monitoring system for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients. Preventice has developed the ...
Tags: Remote Monitoring System, Medicine
Germany-based company Brainlab has announced that Mobius Imaging, a US-based company, has received 510(k) approval from the US Food and Drug Administration (FDA) to market the Airo mobile intraoperative CT system in the US. Mobius Imaging ...
Tags: Mobius, Mobile Intraoperative
Advanced Catheter Therapies (ACT), a US-based developer of medical devices, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Occlusion Perfusion Catheter, designed to temporarily occlude a specific region ...
Tags: ACT, Occlusion Perfusion Catheter