The FDA 3rd Party Service Report – With Apologies to Firesign Theater G. Wayne Moore, B.Sc., MBA, FASE 5/8/18 If you have never heard of the comedy troop known as Firesign Theater you owe it to yourself to go to YouTube and listen to this album – often described as the funniest comedy album ever created. … Continue reading
3rd Party Repair and the FDA Report G. Wayne Moore, B.Sc., MBA, FASE 4/10/18 After my participation as invited faculty at AIUM’s annual scientific sessions in NYC, I jumped in a cab to catch a flight from Newark to Washington DC for the MITA Board of Directors meeting where Dr. Scott Gottlieb, the FDA Commissioner, was … Continue reading
“When to Replace my Ultrasound Transducer: The Good, the Bad, and the Ugly” G. Wayne Moore, B.Sc., MBA, FASE 3/13/18 I am very excited to be an invited lecturer, along with co-Authors Dr. Jim Zagzebski and Dr. Timothy Bigelow, at this year’s AIUM annual conference in New York City. This 90-minute session, held on Wednesday … Continue reading
No, they are not the same thing Wayne Moore, B.Sc., MBA, FASE 2/13/18 Unfortunately, over the last almost two years of the FDA initiated 3rd party service discussion, a number of people in this debate, who by the way ought to know better, have tried to conflate the FDA’s AIAT (assembly, installation, adjustment, and testing) … Continue reading
In addition to our world-class probe repair offerings, Acertara can now offer new Philips and Philips recertified probes with extended warranty. The list includes: Call the main office at 303-834-8413 or email us at Acertara_Cares@acertaralabs.com for a quote. About Acertara: Acertara Acoustic Laboratories, located in Longmont, … Continue reading
My Prediction G. Wayne Moore, B.Sc., MBA, FASE 1/09/18 Over the past 12 months I have received emails and phone calls literally every week from Industry folks, 3rd Party Service providers, and HTM professionals regarding my take on what the FDA might do concerning the 3rd Party service issue. So, in honor of the New … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE – CEO, Acertara Acoustic Laboratories gwmoore@acertaralabs.com 11/14/17 The hot-button issue at RSNA was artificial intelligence (AI); AI/Machine learning. In fact, Google was at the RSNA for the first time in an area of the Hall called the “Machine Learning (ML)Showcase (MLS).” The Google booth was the hub of a … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE – CEO, Acertara Acoustic Laboratories, gwmoore@acertaralabs.com 11/14/17 I am frequently asked by HTMs what I would recommend as a general strategy to follow when troubleshooting failures in ultrasound systems. Given how complex contemporary ultrasound systems can be it is a great question. With ultrasound systems, regardless of manufacturer, I … Continue reading
Acertara Labs recently expanded their testing and repair capabilties on Philips X5-1 xMatrix ultrasound transducers for both the explora and compact connectors. Repair capabilties include cosmetic repairs, lens replacements, CW mitigation, retermination, and complex electrical repairs. Call the main office at 303-834-8413 or email us at Acertara_Cares@Acertaralabs.com for your probe repair needs! Acertara … Continue reading
Draft Guidance for Marketing Clearance of Diagnostic Ultrasound Systems and Transducers G. Wayne Moore, B.Sc., MBA, FASE 10/10/17 Inertia is a tough customer. I learned this lesson almost 15 years ago when we had our first paper on transducer degradation and the effect of dead elements on image quality published in the Journal of Diagnostic … Continue reading