Gish Consulting LLC

New medical device software draft guidance just released by FDA. This topic came up last week with a client in our consulting practice. #FDA #medicaldevice #regulations #regulatoryaffairs #patientsafety #productsafety

🔎 Meet the #MetaBrainTeam! 🔬 @CNRsocial_’s @IeiitC will implement #BrainModels and run simulations led by Marta Parazzini, and #Cnr_Imm will develop new ultrasound strategies for #BrainStimulation, led by Dr. @maiolo_luca. Find out more: meta-brain.eu/news/cnrs-cont… #metabrain_eu

A collaboration between @HHS_TechPolicy, @TheABFM, & @UCSF delivered new data that sheds light on physicians’ experience with #interoperability. Our blog post digs into the new measurement approach that produced the data: healthit.gov/buzz-blog/inte…

During the 05 September virtual meeting of the IAF and @ILAC_official Joint Executive Committee, attendees discussed current action items, key decisions and relevant topics regarding the formation of GLOBAC. #accreditation #meetings

🚀 Exciting News for Pharma & Med Device companies! Gain visibility and unlock B2B connections with bit.ly/3ZcuDHG, a feature-packed supply chain directory. Pre-register for a FREE or paid listing. #BioVendors #B2BInnovation #pharma #meddevice

"Now you see it, now you don't: the strange world of disappearing Special Issues at MDPI." deevybee.blogspot.com/2024/09/now-yo…

Do you struggle with writer's block? Join us next week for our next live webinar with Ben Riggs and lean how finding your writing focus can help improve your confidence as a writer and your writing’s clarity. Register now: hubs.ly/Q02NTkbP0 #medicalwriting #medicalwriter

Join us for a webinar on the key differences in clinical data requirements for #medicaldevices in the EU vs. US. Experts Sean Smith & @MedtechDavid will share insights, real-world examples, and compliance strategies: bit.ly/3Tkrim9

Largest prospective study of #LongCovid in children and teens with 3-year follow-up thelancet.com/journals/eclin… by @LaCampo4 and colleagues —significant, long-lasting impact —increased risk of autoimmune diseases —reduction of risk with vaccination/boosters, especially among teens

Personal news: I'm joining the policy team as STAT's FDA reporter. I'll still cover the regulation of medical devices, but will also be focused on the agency as a whole. Excited to meet more folks in the space! Send tips to lizzy.lawrence@statnews.com statnews.com/2024-stat-inte…

Senior doctor: "By the way, the patient is a big donor." Sir, I don't care if the patient is a big donor, a little donor, or owes the hospital money they can't pay. Every one of my patients receives the same high-quality care, no matter what their bank account shows.

FDA Guidance Encourages Companies To Include Patient Preferences In Submissions bit.ly/3MAZjLs

On Thursday, October 24, the @US_FDA will host a webinar to discuss our Total Product Life Cycle (TPLC) approach to the oversight of in vitro diagnostic products (IVDs). Learn more: fda.gov/medical-device…

In an opinion piece for @statnews, nearly every living former @CDCgov director argues that to limit CDC's mandate to infectious diseases — as some GOP Congressfolk espouse — would endanger the health of Americans. statnews.com/2024/09/05/cdc…

What slows or speeds brain aging? This is just 1 of 10 recent papers in today's @Nature nature.com/articles/d4158… This one along with the others are reviewed in the new Ground Truths, link in my profile

MDMA recently shared our comments on cyber reporting requirements with @CISAgov as they continue to develop their final rule for stakeholders.  medicaldevices.org/news/677369/MD…

In this episode of the DeviceTalks Weekly Podcast, Host @MedTechTom interviews Todd Powell, CEO and president of @reflexionmed, maker of a smart #radiotherapy system used to combat cancer. LISTEN HERE: devicetalks.com/ceo-powell-exp… #medtech #oncology #cancer #RadiationTherapy

CDRH is pleased to announce organizational changes within the Center for Devices and Radiological Health (CDRH) to help strengthen and better position the Center to meet our mission to protect and promote the public health. fda.gov/medical-device…

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Bausch + Lomb and its subsidiary, Synergetics, Inc. is recalling certain lots of I-Pack Injection Kits after being unable to verify that the products were fully sterilized. fda.gov/medical-device…

The DEFoGD Challenge seeks artificial intelligence (AI) models to identify and predict freezing of gait (FoG) events related to #ParkinsonsDisease. Top performing #AI models from Phase 1 will advance and be evaluated against validated FoG data in Phase 2.

JAMA Today: COVID-19 doubles the risk of children developing Type 1 diabetes. jamanetwork.com/journals/jama/…