LifeSignals today announced that it has received FDA 510(k) clearance for its LX1550 multi-parameter remote monitoring platform. Fremont, Calif.–based LifeSignals designed to continuously collect patient physiological data from home and in healthcare settings. Get the full story on our sister site, Medical Design & Outsourcing.
510(k)
FDA clears Stryker biodegradable subacromial balloon spacer
Stryker (NYSE:SYK) this week announced that it received FDA 510(k) clearance for its balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears. Kalamazoo, Mich.–based Stryker designed the InSpace balloon implant to restore the subacromial space without requiring sutures or fixation devices. It has been demonstrated to improve shoulder motion and function, according to the […]
East End Medical wins FDA clearance for transseptal balloon introducer
East End Medical this week announced that it received FDA 510(k) clearance for its SafeCross transseptal radiofrequency (RF) puncture and steerable balloon introducer system. The Miami-based company designed SafeCross to provide a predictable and safe treatment option for electrophysiology and structural heart interventions requiring left atrial access. Get the full story on our sister site, […]
Interventional Systems wins FDA clearance for miniature surgical robot
Interventional Systems announced today that it received FDA 510(k) clearance for its Micromate robot for percutaneous procedures. Kitzbühel, Austria–based Interventional Systems developed Micromate as a table-mounted medical robot for interventional procedures, touting it as the world’s smallest robot for those of the percutaneous kind, according to a news release. Micromate uses a universal instrument guidance […]
Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant
Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology. The Parsippany, N.J.–based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface. Get the full story on our sister […]
FDA clears Masimo wearable thermometer for prescription, OTC use
Masimo (NSDQ:MASI) announced today that it received FDA 510(k) clearance for two uses of its Radius Tº wearable thermometer. Irvine, Calif.–based Masimo clearances for Radius Tº cover both prescription use and over-the-counter use for patients and consumers 5 and older, according to a news release. Radius Tº includes continuously trending temperature measurements and Bluetooth connectivity […]
FDA clears Medtronic patient-specific spinal rods
Medtronic (NYSE:MDT) today announced its UNiD patient-specific rods for its spinal systems won FDA clearance. The UNiD rods are made for use with the medtech giant’s CD Horizon Solera Voyager and Infinity OCT spinal systems, which can be used with the Mazor robotic system. Medtronic designed the rods to be industrially pre-bent before surgery to accurately […]
Avicenna.AI’s triage system get regulatory nods
Avicenna.AI announced today that it received FDA 510(k) clearance and CE mark for its Cina Chest vascular condition triage system. Marseille, France-based Avicenna.AI designed Cina Chest to leverage deep learning algorithms to offer automatic detection and triage capabilities for both pulmonary embolism (PE) and aortic dissection (AD) from CT-scan imaging, according to a news release. […]
Edwards’ low-BP prediction software gains FDA clearance
Edwards Lifesciences (NYSE:EW) has announced that its Acumen hypotension prediction index (HPI) software has received FDA 510(k) clearance. Using data obtained from the Acumen IQ finger cuff, the software uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only […]
iRhythm wins FDA clearances for next-gen Zio monitor, AI capabilities
iRhythm Technologies (NSDQ:IRTC) announced that it received FDA 510(k) clearances for updates to its heart rhythm monitoring tech. San Francisco-based iRhythm’s first clearance came for a new and improved design of its flagship wearable Zio monitor and the second covered updated artificial intelligence (AI) capabilities, according to a news release. The Zio ambulatory cardiac monitoring […]
FDA clears EndoFresh disposable digestive endoscope
EndoFresh today said it received FDA 510(k) clearance for its disposable digestive endoscopy system. The system features a camera system with an all-in-one design, disposable upper GI endoscope and disposable colonoscope, which can be used with the company’s medical display and other peripheral devices for physicians to visualize, diagnose and operate gastrointestinal endoscopy. Get the full […]
