Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA 510(k) clearance for the Scout MD surgical guidance system. Scout MD broadens the South Jordan, Utah–based company’s oncology portfolio. Merit designed the system to enhance the diagnosis and treatment of breast cancer, as well as other soft tissue cancers. The system includes the Scout radar […]
510(k)
FDA clears first over-the-counter fingertip pulse oximeter from Masimo
Masimo announced today that it received FDA clearance for its MightySat Medical over-the-counter fingertip pulse oximeter. The company says that the regulatory nod makes MightySat Medical the first and only FDA-cleared medical fingertip pulse oximeter available over the counter (OTC), direct to consumers without a prescription. Irvine, California-based Masimo powers its OTC pulse oximeter with […]
Wandercraft wins FDA clearance for exoskeleton for people with spinal cord injuries
Wandercraft announced today that it received FDA clearance for its Atalante X exoskeleton for individuals with spinal cord injuries (SCIs). The FDA granted clearance for people with SCIs at levels T5 to L5 to utilize the self-balancing robotic exoskeleton technology. The system enables those with limited mobility to stand up and walk again. Wandercraft says […]
FDA clears 5008X hemodialysis system from Fresenius Medical Care
Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system. The company said this marks a step toward bringing a new standard of care in dialysis therapy to the U.S. Bad Homburg, Germany-based Fresenius can now begin U.S.-based clinical evaluations and user studies ahead of a broad launch in 2025. […]
Philips wins FDA nod for latest IntelliVue patient monitor software including Sounds alarm package
Philips announced today that it received FDA 510(k) clearance for its latest IntelliVue patient monitor software. The latest IntelliVue technology includes several new solutions, including the Philips Sounds alarm package. This clearance means the alarm package now has availability in the U.S. and more than 200 countries worldwide. Philips worked with clinicians and sound experts […]
Intuitive seeks FDA clearance for its next-gen da Vinci 5
Intuitive Surgical has submitted for FDA 510(k) clearance of its next-generation da Vinci 5 multiport surgical robot. The da Vinci 5 will join Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the […]
FDA clears SnoreLessNow mandibular advancement device
SnoreLessNow announced today that the FDA granted 510(k) clearance for its over-the-counter dental device. Known as SomniFit-S in Europe, the Anti-Snore Mouth Guard+ reduces snoring by positioning the jaw gently forward. It allows for increased airflow and eliminates airway obstruction by tissues inside the mouth, requiring no masks, hoses or electronics. Swiss manufacturer Oscimed SA […]
FDA clears Kallisio’s 3D-printed oral insert for radiation therapy
Kallisio recently announced that the FDA has cleared its 3D-printed Stentra, used to protect head and neck cancer patient’s healthy tissue during radiation therapy. Stentra is fabricated of bio-compatible nylon materials (nylon ISO 10993-1), using 3D SLS printing technology. Baltimore-based Kallisio says Stentra directs radiation to the target tumor area while reducing the harmful impact […]
FDA clears AI-based lung analysis software from Thirona
Thirona announced today that it received FDA 510(k) clearance for the latest update of its AI-based LunQ clinical software. LungQ 3.0.0 utilizes AI to automatically segment the pulmonary segments and subsegments in the internal anatomy of the lung. The analysis includes the identification of structures like lobes, segments, subsegments, airways and fissures. It analyzes the […]
FDA clears stereotactic guidance system from ClearPoint Neuro
ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system. Solana Beach, California–based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand. SmartFrame OR offers stereotactic guidance for placing and operating instruments or devices […]
Zeta Surgical wins expanded FDA nod for mixed reality navigation system
Zeta Surgical announced today that the FDA granted it a special 510(k) clearance for expanded software functionality. The Zeta cranial navigation system’s special clearance applies to enhanced software features and compatibility with additional accessories. Zeta Surgical’s mixed reality (MR) system initially received FDA clearance in September. The Zeta cranial navigation system provides surgeons with GPS-like […]