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Jim Hammerand

FDA warns of potential toxic risk from Fresenius hemodialysis machines

May 9, 2022 By Jim Hammerand

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

Filed Under: Plastics, Silicone, Uncategorized Tagged With: dialysis, fda, Fresenius Medical Care

FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes

May 2, 2022 By Jim Hammerand

medtronic-large-updated

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

Filed Under: Plastics, Silicone, Uncategorized

Catheter delivery could enable better brain implants: Synchron’s neuroscience chief explains how

April 12, 2022 By Jim Hammerand

Synchron Stentrode brain-computer interface BCI system catheter delivery

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

Filed Under: Catheters, Implants Tagged With: brain implants, brain-computer interfaces, synchron

Synchron says study shows safety of its brain-computer interface implant

March 30, 2022 By Jim Hammerand

Synchron’s Stentrode device expands inside a blood vessel on the brain to relay motor signals.

Four ALS patients with a Synchron Stentrode brain implant had no serious adverse events one year after their procedure, which allowed the paralyzed patients to control a computer for online shopping, banking and text communication without using their hands or voice for input. New York-based Synchron said this study demonstrated the safety of its … [Read more...] about Synchron says study shows safety of its brain-computer interface implant

Filed Under: Catheters, Implants, Research, Research & Development Tagged With: AUSTRALIAN FEDERAL GOVERNMENT FOUNDATION, DARPA, MOTOR NEURONE DISEASE RESEARCH INSTITUTE OF AUSTRALIA., NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL OF AUSTRALIA, NEURALINK, OFFICE OF NAVAL RESEARCH, synchron, U.S. DEFENSE ADVANCED RESEARCH PROJECTS AGENCY

CoreMap raises $23 million to fund AFib mapping development

February 9, 2022 By Jim Hammerand

CoreMap CEO Sarah Kalil

CoreMap today announced it closed a $20 million Series B financing to accelerate the development of its cardiac arrhythmia diagnostic technology and launch pilot studies. The Burlington, Vermont–based company said it also closed on a $3 million Series A Milestone financing that was part of its $10.5 million Series A in September 2020. In … [Read more...] about CoreMap raises $23 million to fund AFib mapping development

Filed Under: Catheters, Research & Development, Uncategorized Tagged With: afib, coremap

‘Itty bitty’ falloposcope imaging device used inside fallopian tubes for the first time

January 25, 2022 By Jim Hammerand

University of Arizona BIO5 Institute Director Jennifer Barton and her high-resolution falloposcope

After years of development, University of Arizona researchers have captured their first images inside fallopian tubes with a new device that could be used to search for early signs of ovarian cancer. University of Arizona BIO5 Institute Director Jennifer Barton developed the high-resolution falloposcope, which has a diameter of only 0.8 … [Read more...] about ‘Itty bitty’ falloposcope imaging device used inside fallopian tubes for the first time

Filed Under: Endoscopes, Product Development, Research, Research & Development, Uncategorized Tagged With: University of Arizona

Plastics and medical devices: Changes for safety and cost

January 24, 2022 By Jim Hammerand

The move toward polypropylene and polyethylene in medical devices requires new manufacturing and assembly solutions such as ultrasonic and laser welding. Didier Perret, Emerson Plastics are ubiquitous in medical applications thanks to their light weight, durability and flexibility, among other attributes. However, concern has been increasing … [Read more...] about Plastics and medical devices: Changes for safety and cost

Filed Under: Materials, Plastics, Product Development Tagged With: emerson, plastic welding, polycarbonate, polyethylene, polypropylene, PVC

What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains

November 12, 2021 By Jim Hammerand

Medtronic's Symplicity Spyral device is a multi-electrode catheter for renal denervation.

Medtronic (NYSE:MDT) continues clinical trials of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. The hope now is to win FDA approval in 2023. To better understand the technology behind what Medtronic leaders expect to become a multibillion-dollar business, Medical Design & Outsourcing spoke with Jason … [Read more...] about What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains

Filed Under: Catheters, Research & Development, Uncategorized Tagged With: fda, medtronic

Medtronic faces longer road to renal denervation

October 26, 2021 By Jim Hammerand

Medtronic-Simplicity-Spyral-renal-denervation-catheter

Medtronic (NYSE:MDT) will continue the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early. Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular … [Read more...] about Medtronic faces longer road to renal denervation

Filed Under: Catheters, Research & Development Tagged With: fda, medtronic

Study finds single-use bronchoscopes reduce hospital readmission rates by half

October 21, 2021 By Jim Hammerand

Ambu aScope4 single-use bronchoscope

A study of 14,228 bronchoscopy procedures found sterile, disposable scopes reduced readmission rates by more than half. The study, authored by Ambu consultant Dr. Hudson Garrett, analyzed procedures at inpatient hospitals as well as outpatient ambulatory facilities. He found that 3.6 percent of patients treated with a single-use, flexible … [Read more...] about Study finds single-use bronchoscopes reduce hospital readmission rates by half

Filed Under: Catheters, Endoscopes, Sterilization Tagged With: Ambu

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