The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April. The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA panel votes in support of Impulse Dynamic’s cardiac contractility modulation pulse generator
The FDA’s Circulatory Systems Device Panel this week voted in favor of Impulse Dynamics’s Optimizer Smart implantable pulse generator, supporting the company’s premarket approval application seeking clearance for use in patients suffering from heart failure, according to a Healio report. The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency […]
FDA floats changes to De Novo pathway
The FDA this week published a new proposed rule looking to establish procedures and criteria for its De Novo certification pathway. If the rule is finalized, it would establish classifications for new types of medical devices and provide guidelines for the de novo classification process. The proposed rule would also establish requirements for the formatting […]
Medtronic updates software for Puritan Bennett 980 ventilators in FDA-labeled Class I field action
Medtronic (NYSE:MDT) said this week that it released a software update for its Puritan Bennet 980 ventilators in a field action labeled by the FDA as Class I. Class I designations, the FDA’s most serious classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The […]
Pops Diabetes wins FDA clearance for blood glucose monitoring system
Pops Diabetes Care said this week that the FDA cleared its Pops! one blood glucose monitoring system. The Minneapolis-based company’s device can be attached directly to the back of a mobile phone and interacts with the user through a coaching app. The Pops! one system also allows users to review their blood glucose trends and share […]
Subtle Medical wins FDA nod, CE Mark for SubtlePet AI-powered imaging system
Medical imaging tech developer Subtle Medical said today that it won both CE Mark approval in the European Union and FDA 510(k) clearance for its SubtlePET artificial-intelligence-powered positron emission topography imaging enhancement system. The SubtlePET system is designed to enhance images and reduce scanning times to improve overall patient experience during imaging procedures, the Menlo […]
Alimera Sciences wins Health Canada nod for diabetic macular edema implant
Alimera Sciences (NSDQ:ALIM) said last month that it won approval in Canada for its intravitreal implant designed to treat diabetic macular edema. The Iluvien device is a sustained release implant that delivers fluocinolone acetonide and is indicated to treat diabetic macular edema in people who have been previously given corticosteroids and did not have a clinically […]
Edwards wins FDA nod for next-gen HemoSphere platform
Edwards Lifesciences (NYSE:EW) said yesterday that it won FDA 510(k) clearance for its Hemosphere platform with the Acumen suite of decision-support solutions intended for hemodynamic monitoring. The Irvine, Calif.-based company touted that the newly cleared HemoSphere platform is the first to include predictive monitoring for moderate to high-risk surgical patients. The system now includes the […]
Notal Vision snags breakthrough designation for home OCT system
Ophthalmic diagnostic services company Notal Vision said it has won breakthrough device designation for its artificial-intelligence-aided macular degeneration diagnostic device. Privately-held Notal (Manassas, Va.) said its home-based optical coherence tomography (OCT) system was designed to automatically identify intra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD). The Notal Home […]
Axonics bids for FDA approval of sacral neuromod device
Fresh from a $138 million initial public offering, Axonics Modulation Technologies (NSDQ:AXNX) said today that it re-filed yesterday for pre-market approval from the FDA for its r-SNM sacral neuromodulation treatment for urinary and bowel dysfunction. The Irvine, Calif.-based company said it last month withdrew the PMA application it filed in January 2018 after an FDA […]
FDA OKs expanded JenaValve study
JenaValve Technology said today that the FDA approved the expansion of its investigational device exemption trials for the transcatheter aortic valve replacement it’s developing. The JenaValve system consists of the Everdur valve and Coronatix delivery catheter. The FDA decision expands the feasibility study from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or […]