AliveCor said yesterday that it won expanded FDA 510(k) clearance indications for its KardiaMobile personal ECG device, now cleared for detecting bradycardia and tachycardia. The Mountain View, Calif.-based company’s KardiaBand is a wrist-worn electrocardiogram device previously cleared to detect atrial fibrillation and normal sinus rhythm. “No other consumer ECG device in the world, can tell […]
Nipro’s Infraredx wins expanded FDA nod for Makoto intravascular imager
Nipro (TYO: 8086) subsidiary Infraredx said today that it won expanded FDA 510(k) clearance for its Makoto intravascular imaging system, now cleared to identify patients and coronary plaques at an increased risk of major adverse cardiac events. The approval came based on results from the Lipid-Rich Plaque study in which researchers explored the ability of intravascular […]
FDA clears Tela Bio’s Restella soft tissue bioscaffolds
Tela Bio said yesterday that it won FDA 510(k) clearance for its Restella reconstructive bioscaffolds, now cleared for use in reinforcing soft tissue in patients requiring soft tissue repair or reinforcement during plastic or reconstructive procedures. The Malvern, Penn.-based company’s tech platform is based on interwoven polymer through layers of biologic tissue in a patented pattern […]
Penumbra VR device wins FDA clearance
Penumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system. The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases. The exercise routines with the […]
FDA clears Gelesis weight-loss hydrogel pill Plenity
Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug. The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without […]
FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix
Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures. The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, […]
Elucent Medical wins FDA nod for EnVisio breast surgery navigation device
Elucent Medical said today that it won FDA 510(k) clearance for its EnVisio surgical navigation system. The Eden Prairie, Minn.-based company said that the EnVisio navigation system is designed for use in conjunction with the company’s SmartClip soft tissue marker during breast cancer procedures. The SmartClip soft tissue marker is an alternative to hook-wire localization […]
Bedfont wins FDA nod for ToxCO carbon monoxide monitor
British medical device firm Bedfont said today that it won FDA 510(k) clearance for its ToxCO breath analysis monitor designed to measure exhaled carbon monoxide to indicate levels of CO in the blood. The newly cleared system is intended for use in triaging cases of CO poisoning as it provides instant results at the point-of-care, […]
Avanos Medical wins FDA nod for ON-Q Bolus pump
Avanos Medical (NYSE: AVNS), which rebranded from Halyard Health last June, said today that it won FDA 510(k) clearance for its ON-Q* with Bolus pump drug infusion device. The Alpharetta, Ga.-based company said that the new ON-Q* with Bolus system features improvements to improve ease of use and reduce postoperative opioid use for pain management. Read the whole story […]
Apyx Medical withdraws Renuvion FDA 510(k) app for dermal resurfacing indication
Apyx Medical (NYSE:APYX), formerly known as Bovie Medical, said late yesterday that it has voluntarily withdrawn the FDA 510(k) clearance application for its J-Plasma/Renuvion device seeking a dermal resurfacing indication. The Clearwater, Fla.-based company submitted a new 510(k) clearance application seeking new indications for the Renuvion system in December. The application came supported by by […]
AngioDynamics wins expanded FDA clearance for OARtrac radiation dose monitor
AngioDynamics (NSDQ:ANGO) said late yesterday that it won expanded FDA 510(k) clearance for its OARtrac radiation dose monitoring system. With the new clearance, the Latham, N.Y.-based company’s OARtrac system is cleared for use with patient-specific, pre-calibrated Plastic Scintillating Detector sensors used during cancer treatments to monitor photon and electron radiation therapy as an adjunct to treatment […]
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