Building proactive security for healthcare. COO at MedCrypt.
Joined May 2016
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20 Photos and videos
As a part of Greenlight Guru's AI Summit, VP of Services Naomi Schwartz discussed the history of AI/ML regulation at the FDA and methods of approaching cybersecurity for AI/ML devices when submitting to the FDA.
You can watch the full webinar here: bit.ly/3v2sK3g
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We're excited to announce the appointment of Naomi Schwartz as Medcrypt's Vice President of Services!
Naomi's 6.5-year career as a premarket reviewer and consumer safety officer for the FDA will help her expand Medcrypt's FDA Readiness services:
prnewswire.com/news-releases…
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The FDA recently issued final guidance that provided recommendations on medical device cybersecurity and what information to include in premarket submissions. The FDA will be hosting a webinar about this guidance on Nov 2nd.
You can find more info here: bit.ly/478NoN6
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Vidya retweeted
9 Oct 2023
All Americans should be horrified and outraged by the brazen terrorist attacks on Israel and the slaughter of innocent civilians. We grieve for those who died, pray for the safe return of those who’ve been held hostage, and stand squarely alongside our ally, Israel, as it dismantles Hamas. As we support Israel’s right to defend itself against terror, we must keep striving for a just and lasting peace for Israelis and Palestinians alike.
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We're excited to announce Medcrypt won the HLTH Digital Health Award for Patient Safety at the @HLTHEVENT conference. Medcrypt is excited to continue working on innovative medical device #cybersecurity solutions that prioritize patient safety: digitalhealthhub.org/awards/… #HLTH2023
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October is #cybersecurityawarenessmonth, and while this month brings a heightened focus to #cybersecurity it's an ongoing commitment that extends beyond a single month.
Read more from @mikekijewski in @ForbesTechCncl: forbes.com/sites/forbestechc…
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The FDA recently released guidance documents for premarket submissions, the refuse to accept (RTA) policy and eSTAR submissions. Learn more about the latest medical device regulatory news: bit.ly/48Kj0KD
Register for our upcoming FDA webinar: bit.ly/45o1xoa
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What do medical device manufacturers need to understand about the FDA's new guidance? Hear from Medcrypt CEO Mike Kijewski and FDA experts Naomi Schwartz and Seth Carmody as they discuss what this means for MDMs in a new Medcrypt webinar.
Register here: bit.ly/3rtu5ip
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In light of the FDA final premarket guidance, manufacturers must pay close attention to the details outlined in the guidance documents to ensure their submissions are complete and meet regulatory expectations.
Learn how to navigate the FDA: medcryptnews.medium.com/navi…
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Attending HLTH 2023? Medcrypt is hosting a VIP event exclusively for HLTH attendees on Sunday, October 8th. Join us at Top Golf Las Vegas for an evening of drinks, bites, and fun!
Don't miss out! Register today at the link below:
bit.ly/468w2zz
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On September 26th, 2023, the FDA issued an updated final guidance document for premarket medical device submissions.
Medcrypt CEO Mike Kijewski shares his thoughts on the new guidance in a new blog post: bit.ly/3PvZOr7
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In a recent interview with Medtech Insight, Medcrypt's Naomi Schwartz gives her view on how the FDA eSTAR requirements that launch on October 1st will push the industry as a whole in a positive direction.
Read Naomi's full interview here: bit.ly/3OC2C5z
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Vidya retweeted
1 Nov 2022
We are delighted to welcome @MedCrypt to the Anzu portfolio! Congratulations to the team on the $25M Series B. Learn more about their tech in the @TechCrunch piece below. #cybersecurity #venturecapital #Funding
MedCrypt is excited to announce a $25M Series B funding round!
Funds will be used for continued growth and innovation in #medicaldevice cybersecurity and for continued delivery of proactive #cybersecurity solutions. Read the full announcement here: techcrunch.com/2022/11/01/me…
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MedCrypt is excited to announce a $25M Series B funding round!
Funds will be used for continued growth and innovation in #medicaldevice cybersecurity and for continued delivery of proactive #cybersecurity solutions. Read the full announcement here: techcrunch.com/2022/11/01/me…
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Vidya retweeted
25 Sep 2022
This morning, my wife left Orlando, Florida aboard @SouthwestAir flight 1630 (MCO to PHX).
She sat behind this man. She had been attending the Grace Hopper Conference all week and was resting her head on her tray table, trying to sleep a bit.
Let me tell you what happened.
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Thank you for joining our webinar this week where @axel_wirth discussed the fundamental concepts and terms of medical device #cybersecurity. Missed the webinar? Watch the full recording here: youtu.be/S28mg3WIk60
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Join the #cybersecurity terminology webinar with host @axel_wirth on 9/22 at 11AM PT.
We will also introduce some high level concepts that can be applied and are useful to anybody working in #medicaldevice cybersecurity.
Register for to join on 9/22: meet.zoho.com/081comuOB9
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We're pleased to welcome Jamell Pentecost to MedCrypt as the new Senior Director of Product Security Services! Jamell brings over 10 years of product #security and strategy experience.
Read the full announcement: prunderground.com/medcrypt-w…
#cybersecurity #medicaldevices #startups
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Join medical device #cybersecurity expert @axel_wirth in an upcoming webinar to learn about foundational cybersecurity terms and concepts. #Security professionals of all levels are welcome to join on 9/22.
Register for free: meet.zoho.com/081comuOB9
#cyber #securitynews
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Vidya retweeted
1 Sep 2022
Never bring a Brian Kemp to a Stacey Abrams fight.
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