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 Peri-Strips Dry 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 […]
CHF Solutions wins FDA nod for Aquadex SmartFlow pediatric indication
CHF Solutions (NSDQ:CHFS) announced today that it received FDA 510(k) clearance for its next-generation Aquadex SmartFlow console for use in adult and pediatric patients weighing 20 kg or more. Eden Prairie, Minn.–based CHF Solutions said it submitted an application for clearance for the next-generation console last month, having previously offered its Aquadex FlexFlow system that wasn’t […]
LivaNova beats on Q4 earnings, misses on revenue
LivaNova (NSDQ:LIVN) shares took a slight dip today on fourth-quarter results that beat the consensus projections for earnings but came up short on revenue. The London-based medical device company posted losses of -$143.2 million, or -$2.96 per share, on sales of $287.6 million for the three months ended Dec. 31, 2019, for a 32% bottom-line gain […]
FDA recommends limiting use of power morcellators
The FDA today recommended that laparoscopic power morcellators, which have been implicated in the spread of cancer, be limited to use with certain tissue containment systems and only in premenopausal women under 50 years of age. Power morcellators were used for 20 years to laparoscopically remove benign tumors of the uterus, known as fibroids, by mincing them. […]
Tytek Medical recalls TM-317 PneumoDart pneumothorax needles
Tytek Medical issued a recall for its PneumoDart pneumothorax needles for air removal during life-threatening situations like lung trauma or collapse. According to an FDA news release, the recall, which Tytek Medical initiated on Nov. 18, 2019, is now considered a Class I recall, the most serious kind. The PneumoDart needle is designed to remove […]
Abilitech aims to arm people with independence
Some have dubbed Abilitech’s device “a wheelchair for the arms.” Its machined aluminum exoskeletal arm and breathable cloth vest use a spring counterbalance system and a “living hinge” that spreads the load, making it — and the arm — feel weightless. Nancy Crotti, Managing Editor Rob Wudlick brushed his teeth on his own recently for […]
BD warns on some ambulatory syringe pumps
Becton Dickinson (NYSE:BDX) issued a field safety notice in the United Kingdom to warn on an issue with its T34 and T34L (T60) ambulatory syringe pumps. The company was alerted to an issue with the syringe pumps that could cause risk of under-infusion and/or alarm failure, according to the notice published today. Get the full story at our […]
FDA is unable to conduct medical device plant inspections in China
The FDA is unable to conduct medical device plant inspections in China because of the U.S. State Dept.’s travel advisory amid the coronavirus outbreak, the agency said in a statement today. While the FDA is unable to conduct inspections, it plans to rely on tools such as import screening, examinations, sampling and import alerts, along […]
Fresenius to launch a mechanical ventilators alternative in U.S.
Fresenius (NYSE:FMS) announced today that it has achieved a 510(k) clearance for its Novalung system — which reduces or eliminates the need for mechanical ventilation by pumping a person’s blood through an oxygenator for gas exchange. Fresenius boasted that the Novalung is the first extracorporeal membrane oxygenation (ECMO) system cleared to provide more than six hours […]
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