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510(k)

FDA clears Aerobiotix system to clean air inside hospitals

January 25, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: Aerobiotix, FDA

FDA clears Theranica device for adolescent migraines

January 25, 2021 By Nancy Crotti Leave a Comment

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Neurological, Neuromodulation/Neurostimulation, Pain Management, Regulatory/Compliance Tagged With: FDA, Theranica Bio-Electronics

DePuy Synthes lands FDA clearance for Velys robotic knee system

January 20, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Robotics, Surgical Tagged With: DePuy Synthes, Johnson & Johnson, Johnson and Johnson, robot-assisted, Robotic Surgery

These medtech stocks performed the best in 2020

January 15, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: 510(k), Big Data, Business/Financial News, Cardiac Implants, Cardiovascular, Diabetes, Diagnostics, Drug-Device Combinations, Electronic Medical Records (EMR), Featured, Food & Drug Administration (FDA), Funding Roundup, Genomics/Molecular Diagnostics, Health Technology, MassDevice Earnings Roundup, Mergers & Acquisitions, Orthopedics, Regulatory/Compliance, Replacement Heart Valves, Research & Development, Respiratory, Robotics, Software / IT, Structural Heart, Surgical, Wall Street Beat Tagged With: Abbott, Abiomed, coronavirus, COVID-19, Dexcom, Edwards Lifesciences, Hologic, Intuitive Surgical, iRhythm Technologies Inc., Masimo, ResMed, ResMed Inc., Stryker

Abbott gains FDA clearance for rapid concussion test

January 11, 2021 By Sean Whooley

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 […]

Filed Under: 510(k), Diagnostics, Featured, Food & Drug Administration (FDA), Neurological, Regulatory/Compliance Tagged With: Abbott, FDA

FDA clears Rapid Medical steerable neurovascular guidewire

December 22, 2020 By Sean Whooley

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Surgical, Vascular Tagged With: FDA, rapidmedical

Biotronik wins FDA clearance for cardiac monitor sensor

December 16, 2020 By Nancy Crotti

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 […]

Filed Under: 510(k), Cardiovascular, Featured, Food & Drug Administration (FDA), Patient Monitoring Tagged With: Biotronik, FDA

Avenda Health focal laser ablation system wins FDA clearance

December 16, 2020 By Danielle Kirsh

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 […]

Filed Under: 510(k), Food & Drug Administration (FDA), Wound Care Tagged With: Avenda Health

FDA allows Medtronic to integrate high-speed drills into Mazor robotic system

December 16, 2020 By Chris Newmarker

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance, Robotics, Spine, Surgical Tagged With: Medtronic

FDA clears Think Surgical’s second-gen robotic knee surgery system

November 20, 2020 By Chris Newmarker

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), News Well, Orthopedics, Regulatory/Compliance, Robotics, Surgical Tagged With: robot-assisted, Robotic Surgery, Think Surgical, thinksurgical

Alaris remediation could cost BD up to $244M

November 18, 2020 By Chris Newmarker

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 […]

Filed Under: 510(k), Business/Financial News, Drug Pumps, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: BD, becton dickinson

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