USAEUROPEViVE
ABOUTSPONSORSHIPFOUNDATION
Logo Hlth
Logo Hlth
14 Jul 2021 | 01:45 PM GMT
Past Meeting

Masterclass: The regulation of DTx in the US

Participants:

Jason Brooke Attorney & Managing MemberBrooke Consulting
Jason Brooke
Attorney & Managing MemberBrooke Consulting
Jessica Ash Director of Digital Health, R&DOtsukaOther
Other
Jessica Ash
Director of Digital Health, R&DOtsuka
Prayat Shah Co-Founder, VP, Partnerships & AlliancesWellthy Therapeutics
Prayat Shah
Co-Founder, VP, Partnerships & AlliancesWellthy Therapeutics
Uri Goren Head of InnovationMeir Medical Center
Uri Goren
Head of InnovationMeir Medical Center
Zina Manji Founder/Principal, Regulatory StrategistInnopathwayz, LLCLife Sciences, Pharma & Biotech
Life Sciences, Pharma & Biotech
Zina Manji
Founder/Principal, Regulatory StrategistInnopathwayz, LLC

About this Meeting

Regulation is an absolute essential for  DTx companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your DTx product through regulatory pathways in the US? Join us in this Masterclass led by AmalgamRx to learn more about: 

  •  The evolution of the US regulatory regimes for SaMD: FDA Pre-Cert program What should DTx companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?  
  •  FDA Digital Health Center of Excellence (DHCoE): focus and roadmap 
  •  Changes expected in the US regulatory regimes for SaMD in the next 2 years

About Us

HLTH Inc. is a dynamic community delivering unique value to the healthcare industry through a mix of unparalleled global events, inspirational content, and impact-driven initiatives.

USA Event Dates

  • 2026 | HLTH: Nov 15 – 18 | Las Vegas, NV | Register | Sponsor
  • 2027 | ViVE: Mar 14 – 17 | Nashville, TN | Be First to Know | Sponsor
  • 2027 | HLTH: Oct 17 – 20 | Las Vegas, NV
  • 2028 | HLTH: Nov 12 – 15 | Las Vegas, NV

Europe Event Dates

  • 2027 | HLTH Europe: Jun 21 – 24 | Amsterdam | Sponsor
  • 2028 | HLTH Europe: Jun 19 – 22 | Amsterdam

Important Notice on Hotel Scams

Any communication that claims to represent HLTH or any third party offering discounted hotel rooms or attendee lists is NOT AFFILIATED with HLTH and should be considered fraudulent. Please book your accommodations only through HLTH’s official channels to ensure authenticity and security.

© 2026 HLTH, INC. by Hyve Group - All Rights Reserved

About usPrivacy Policy Contact us