The FDA has banned electrical stimulation devices sometimes used to treat self-harm and aggression in people with intellectual or developmental disabilities. The agency, which rarely bans medical devices, proposed the ban on the devices in 2016 because they present “an unreasonable and substantial risk of illness or injury to the public.” Some people’s intellectual or developmental […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Report: FDA promise of 1 million coronavirus tests this week unattainable
The FDA grossly overestimated the number of coronavirus diagnostic tests that would be available this week as well as U.S. laboratories’ capacity to process them, according to a report in the New York Times. FDA commissioner Stephen Hahn told reporters on Monday that the agency’s decision allowing private labs to make their own tests would […]
FDA authorizes industrial respirators for use during coronavirus
The FDA has authorized the use of certain industrial respirator masks for healthcare workers during the coronavirus outbreak. The N95 disposable filtering facepiece respirators have been approved by the National Institute for Occupational Safety and Health (NIOSH) as non-powered air-purifying particulate respirators. Healthcare workers will be allowed to use these, including those that have passed […]
Advanced Bionics recalls certain cochlear implants due to hearing degradation
Advanced Bionics announced a voluntary recall of the initial version of its HiRes Ultra and Ultra 3D cochlear implant devices due to a decrease in performance experienced by some recipients. The company has experienced recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of Feb. 11, in […]
Masimo gains FDA clearance for new respiration rate measurement system
Masimo (NSDQ:MASI) said today that the FDA has granted 510(k) clearance to its continuous RRp (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters. With this clearance, both continuous and spot-check RRp are now available in the U.S., supported in a variety of pulse oximetry sensors and […]
Companion Medical wins FDA nod for InPen diabetes management system
Companion Medical announced that it won FDA clearance for its InPen bolus calculator for fixed dosing and meal estimation in diabetes management. The new bolus calculator is designed to account for the user’s current glucose level and active insulin to remove the guesswork from insulin dosing. Companion Medical touts the system as the first of its […]
CryoLife wins CE Mark for ascending aortic prosthesis
CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for the On-X ascending aortic prosthesis (AAP) for treating native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. The approval allows for resumed distribution of the On-X AAP in Europe, as the product has been off the market there since late […]
Coronavirus spurs FDA plea for stricter oversight of medtech manufacturers
FDA chief Stephen Hahn yesterday called on Congress to require medtech manufacturers to notify the agency of impending device shortages or supply-chain disruptions. The request is part of President Trump’s budget and has taken on new urgency with the spread of the coronavirus worldwide. The FDA does not have the same authorities for medical device […]
Ibex wins CE Mark for AI-powered cancer detection software
Ibex Medical Analytics announced today that it won CE Mark approval for its artificial intelligence-powered Galen Prostate software for identifying suspected cancer on prostate core needle biopsies. Tel Aviv-based Ibex touts its Galen prostate solution as the first-ever AI-based software for cancer detection used in routine clinical practice, and it is already deployed in pathology […]
Baxter wins FDA nod for next-gen staple-line reinforcements
Baxter (NYSE:BAX) announced today that it received FDA 510(k) clearance for the new generation of its Peri-Strips Dry with Veritas collagen matrix (PSDV) staple-line reinforcement material. The “PSDV with secure grip” is now available with peel-and-secure technology. Baxter touts the new generation of the product as two times faster in preparation when compared to the previous […]
Pavmed gains FDA breakthrough nod for esophageal pre-cancer test
Pavmed (NSDQ:PAVM) recently announced that its Lucid Diagnostics subsidiary has received FDA breakthrough device designation for its EsoGuard esophageal DNA test. The test uses esophageal samples collected using Lucid’s 510(k)-cleared EsoCheck cell collection device from certain patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD). EsoGuard and EsoCheck are designed to […]