Aerobiotix announced today that it received FDA 510(k) clearance for its Aerocure-MD medical air purification system. Miamisburg, Ohio-based Aerobiotix’s Aerocure-MD platform received FDA labeling to destroy microorganisms in the air by exposure to ultraviolet radiation and also remove particles in from the air via HEPA filtration, according to a news release. Aerocure-MD is designed for […]
510(k)
FDA clears Theranica device for adolescent migraines
Theranica announced today that the FDA has granted expanded clearance for the use of its Nerivio acute migraine treatment device by people 12 years and older. The use of the device in the treatment of adolescents is supported by a study recently published in Headache. According to the study, 28 of 39 (71%) of the adolescent participants using […]
DePuy Synthes lands FDA clearance for Velys robotic knee system
Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes announced that it received FDA 510(k) clearance for the Velys system. Velys is a robotic-assisted system designed for use with the Attune total knee system and its cleared indications for use and it will become part of the broader Velys digital surgery platform of connected technologies, according to a news […]
These medtech stocks performed the best in 2020
While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while […]
Abbott gains FDA clearance for rapid concussion test
Abbott (NYSE:ABT) announced today that it received FDA 510(k) clearance for its rapid handheld traumatic brain injury (TBI) blood test. According to a news release, the test is designed to help clinicians assess individuals with suspected mild TBIs, including concussions. The test runs on Abbott’s handheld i-STAT Alinity platform, with results provided within 15 minutes after […]
FDA clears Rapid Medical steerable neurovascular guidewire
Rapid Medical announced today that it received FDA clearance for its Drivewire guidewire for aiding in treating vascular diseases. Yokneam, Israel-based Rapid Medical’s Drivewire (known as Columbus outside the U.S.) is designed to allow physicians to control the direction and shape of the guidewire’s tip while it is inside the vessel, allowing for navigation in […]
Biotronik wins FDA clearance for cardiac monitor sensor
Biotronik today announced FDA clearance of its Vital Data Sensor, designed to identify body temperature increases potentially associated with fever, as part of its new Biomonitor IIIm injectable cardiac monitor (ICM). Biomonitor IIIm contains integrated sensors designed to measure patient activity, heart rate and body temperature. The new sensor gives physicians access to daily reports […]
Avenda Health focal laser ablation system wins FDA clearance
Avenda Health today received FDA 510(k) clearance for its focal laser ablation system. The image-guided focal laser ablation system is designed to ablate soft tissue in a physician’s office. It features a laser needle and thermal optical sensor to target and treat soft tissue while minimizing the impact on healthy tissues. “We purposely designed our […]
FDA allows Medtronic to integrate high-speed drills into Mazor robotic system
Medtronic (NYSE:MDT) announced today that FDA has cleared the integration of Midas Rex high-speed drills — as well as utilization of navigated interbody features — into the Mazor Robotic Guidance System. FDA clearance for the integration into the robotic spine surgery system came sooner than expected, according to Medtronic. “Operating rooms are very complex environments, and […]
FDA clears Think Surgical’s second-gen robotic knee surgery system
Think Surgical announced today that FDA has granted 510(k) clearance for the second generation of its TSolution One total knee application. The TSolution One is an active robot for total knee replacement; it includes fully automated bone preparation and provides surgeons a choice of implant options. The newly-cleared version of the system features includes an […]
Alaris remediation could cost BD up to $244M
Becton Dickinson (NYSE:BDX) in its most recent fiscal year set aside $244 million to cover future product remediation costs, including the company’s work to fix its problematic Alaris infusion pumps. The Franklin Lakes, N.J.–based company has had shipments of the pumps on hold since early this year, when FDA called for a comprehensive 510(k) submission to […]
