In vitro fertilization business Esco Medical said today the FDA granted 510(k) clearance to its Miri Time-Lapse embryo incubator. The newly cleared Miri TL is designed as a multi-room incubator with a built-in microscope and camera to continuously capture images of embryo development until the embryo is ready to transfer, the company said. “We are […]
510(k)
FDA clears Mauna Kea’s Cellvizio Confocal miniprobes
Mauna Kea (ENT:MKEA) said today it won 510(k) clearance from the FDA for its Confocal miniprobes designed for use with the company’s Cellvizio platform. The newly-cleared Confocal miniprobes are indicated for use in urological and minimally invasive surgical applications along with the near-infared Cellvizio platform, Mauna Kea said. The company touted the regulatory win as its […]
EndoChoice wins FDA 510(k) for Orca endoscope valves, announces multi-product launches
EndoChoice said it won FDA 510(k) clearance for its Orca sterile, single-use air, water and suction valves designed for Olympus 160, 180 and 190 flexible endoscopes, and announced the launch of its 3rd-gen Fuse endoscopy system and RescueNet retrieval device. With the clearance for the Orca valves, as well as previous regulatory wins, EndoChoice will begin sales […]
Biotronik wins FDA nod for Iperia ProMRI HF-T defibrillator
Biotronik said today it won FDA premarket approval for its Iperia ProMRI HF-T cardiac resynchronization defibrillator, which is designed to be compatible with diagnostic magnetic resonance imaging scans. The Iperia line of devices also features remote monitoring with daily automatic transmission and closed loop stimulation designed to adapt heart rate in response to physiological demands, […]
Another FDA win for Synaptive Medical with its ImageDrive Pro
Synaptive Medical said it won FDA 510(k) clearance for its ImageDrive Pro informatics system designed to integrate its existing BrightMatter technology into multiple platforms. The company said the new platform will allow for interoperability across all of BrightMatter’s solutions, including imaging, surgical planning, navigation and automated positioning of high definition optics. BrightMatter gives 3D visuals […]
Potrero wins FDA 510(k) for Accuryn system
Potrero Medical said today it won FDA 510(k) clearance for its Accuryn monitoring system designed to turn urinary catheters into diagnostic tools. San Francisco-based Potrero’s Accuryn critical care monitoring system uses a urinary catheter to deliver real-time, actionable data on urine output, core temperature and intraabdominal pressure, the company said. “Sepsis and acute kidney injury […]
AtriCure wins FDA 510(k) for AtriClip Pro2 LAA device
AtriCure (NSDQ:ATRC) said today it won 510(k) clearance for its AtriClip Pro2 left atrial appendage exclusion system designed to occlude the LAA during minimally-invasive surgical procedures. The AtriClip Pro2 system is designed with an ambidextrous locking and trigger-style clip closing mechanism, the West Chester, Ohio-based company said, as well as handle-based active articulation levers and a […]
Exactech wins FDA 510(k) for Vantage total ankle.
Exactech (NSDQ:EXAC) said today it won FDA 510(k) clearance for its Vantage total ankle designed to treat patients with arthritis in the ankle. The Vantage total ankle is designed for total ankle arthroplasty, with a curved surface talar component and curved talus and anatomic tibia designs, the Gainesville, Fla.-based company said. The device incorporates a press-fit […]
FujiFilm wins 510(k) for Vevo MD clinical ultrasound system
Fujifilm Sonosite (TSE:4901) subsidiary VisualSonics said today it won FDA 510(k) clearance for its Vevo MD ultra high frequency clinical ultrasound system, the company’s 1st offering in the clinical market. The Vevo MD is designed for image resolution down to 30 micrometers, and is compatible with FujiFilm VisualSonics UHF series of transducers capable of operating in […]
Hologic wins FDA nod for Affirm biopsy system, launches in US
Hologic (NSDQ:HOLX) said today it won FDA 510(k) clearance for its Affirm prone biopsy system and launched the platform in the U.S. The Affirm biopsy system is the 1st prone biopsy system to offer both 2D and 3D imaging-guided breast biopsies, the Marlborough, Mass.-based company claims. The device is designed to allow radiologists to target lesions […]
FDA: TransEnterix Surgibot 510(k) does not meet criteria for “substantial equivalence”, shares plummet
Updated to include share prices TransEnterix (NYSE:TRXC) said today that the FDA responded to the 510(k) application for its robotic surgery SurgiBot system, saying that the platform does not meet the criteria for substantial equivalence based on the data and information in the application. Research Triangle Park, N.C.-based TransEnterix claims SurgiBot as the 1st patient-side robotically enhanced laparoscopy […]