Endolumik's story started a few years ago as the FDA sounded the alarm over the risks of internal surgical staplers. In 2019, the federal agency warned healthcare providers that it had received more than 41,000 medical device reports (MDRs) related to surgical staplers and staples for internal use from 2011 to 2018. Those MDRs tallied more than … [Read more...] about Endolumik’s illuminated device takes a big step for safety
About Jim Hammerand
Junkosha names new US leadership
Japanese fluoropolymer supplier Junkosha today announced new leadership for its U.S. subsidiary. Joe Rowan has retired as CEO and president of Junkosha USA but will remain as an advisor as Mike Winterling takes over as chief operating officer. “Our aim is to be acknowledged as the most responsive partner for specialized high-performance … [Read more...] about Junkosha names new US leadership
How Penumbra’s smart-sucking algorithms and catheters speed up clot removal
Blood loss is a big problem when using aspiration catheters to remove blood clots from patients' veins and arteries. "You suck out the clot, you also suck out the blood," said Sandra Lesenfants, president of the interventional business at Penumbra (NYSE:PEN). Algorithms developed by Penumbra's software team for the company's continuous … [Read more...] about How Penumbra’s smart-sucking algorithms and catheters speed up clot removal
Freudenberg Medical expands medical tubing production to Massachusetts
NEWS RELEASE: Freudenberg Medical Expands Medical Tubing Production to Massachusetts Freudenberg Medical, a global contract design and manufacturing provider to the medical device and pharmaceutical industry, has added custom silicone extrusion and medical and biopharma tube processing to its newest cleanroom manufacturing operation and global … [Read more...] about Freudenberg Medical expands medical tubing production to Massachusetts
FDA hits Olympus with warning letters after factory inspections
The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities. The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations. “Olympus’ highest … [Read more...] about FDA hits Olympus with warning letters after factory inspections
Why Affera’s cardiac ablation technology is worth $1B to Medtronic
Affera started in 2014 with a simple goal that paid off when Medtronic (NYSE:MDT) bought the company for up to $1 billion this year. Achieving that goal, however, took some unconventional and sometimes difficult design choices, Affera founder and CEO Doron Harlev said. Newton, Massachusetts–based Affera's system diagnoses, maps and treats … [Read more...] about Why Affera’s cardiac ablation technology is worth $1B to Medtronic
Abbott imaging catheter recall flagged as Class I by FDA
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That's the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The recall affects … [Read more...] about Abbott imaging catheter recall flagged as Class I by FDA
FDA warns of potential toxic risk from Fresenius hemodialysis machines
The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines. The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K. The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL … [Read more...] about FDA warns of potential toxic risk from Fresenius hemodialysis machines
FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes
The FDA is evaluating the risk of Medtronic (NYSE:MDT) silicone-based electromyogram (EMG) endotracheal tubes following reports of deaths and serious adverse events. The FDA issued the warning last week in a letter to healthcare providers concerning the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced … [Read more...] about FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes
Catheter delivery could enable better brain implants: Synchron’s neuroscience chief explains how
Synchron's catheter delivery could make brain-computer interface technology simpler, safer and more accessible than the leading alternative: open-brain surgery. Officials at Synchron — developer of the catheter-delivered Stentrode brain-computer interface (BCI) implant — believe they're the only BCI company tapping into blood vessels to capture … [Read more...] about Catheter delivery could enable better brain implants: Synchron’s neuroscience chief explains how
