Gish Consulting LLC

Achieving sustainable regulatory compliance through creative strategy and performance

[Gish Consulting LLC @GishConsulting]

New medical device software draft guidance just released by FDA.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

[META-BRAIN @MetaBrain_EU]

🔎 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: https://t.co/Pi5eZI8L19

#metabrain_eu

[Office of the National Coordinator for Health IT @ONC_HealthIT]

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: https://t.co/sQUpgM1UdE

[IAF @IAF_Global]

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

[Evergreen Bioscience Innovation Cluster @EvergreenBIC]

🚀 Exciting News for Pharma & Med Device companies! Gain visibility and unlock B2B connections with https://t.co/8IEyI6QYd7, a feature-packed supply chain directory. Pre-register for a FREE or paid listing.

#BioVendors #B2BInnovation #pharma #meddevice

[Retraction Watch @RetractionWatch]

"Now you see it, now you don't: the strange world of disappearing Special Issues at MDPI."
https://t.co/0RhjaufmMe

[AMWA @AmMedWriters]

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: https://t.co/CXU6M9RPU0 #medicalwriting #medicalwriter

[Market Pathways | MedTech Regulatory & Policy @Market_Pathways]

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: https://t.co/5Vkmc31c1D

[Eric Topol @EricTopol]

Largest prospective study of #LongCovid in children and teens with 3-year follow-up
https://t.co/338AFEnoLp by @LaCampo4 and colleagues
—significant, long-lasting impact
—increased risk of autoimmune diseases
—reduction of risk with vaccination/boosters, especially among teens

[Lizzy Lawrence @LizzyLaw_]

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 [email protected]
https://t.co/NVxCYHlw3L

[David Velasquez, MD @davidevelasqu]

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.

[Medtech Insight, Citeline Commercial @Medtech_Insight]

FDA Guidance Encourages Companies To Include Patient Preferences In Submissions
https://t.co/L6GsEBVZ3H

[FDA Medical Devices @FDADevices]

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: https://t.co/VqkOGTbg9B

[Helen Branswell 🇨🇦 @HelenBranswell]

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. https://t.co/ncnRm1I2mn

[Eric Topol @EricTopol]

What slows or speeds brain aging?
This is just 1 of 10 recent papers in today's @Nature
https://t.co/pKnqjLlZV7
This one along with the others are reviewed in the new Ground Truths, link in my profile

[MDMA @medicaldevices]

MDMA recently shared our comments on cyber reporting requirements with @CISAgov as they continue to develop their final rule for stakeholders.  https://t.co/2XWd5ySXgd

[MassDevice @MassDevice]

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: https://t.co/qCW8RNdpBj

#medtech #oncology #cancer #RadiationTherapy

[FDA Medical Devices @FDADevices]

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. https://t.co/4ivbRnqUnI

[FDA Medical Devices @FDADevices]

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. https://t.co/GDvNXJuaLo

[FDA Medical Devices @FDADevices]

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.

[Mike Hoerger, PhD MSCR MBA @michael_hoerger]

JAMA Today: COVID-19 doubles the risk of children developing Type 1 diabetes.

https://t.co/cZYs1vbI8I