Our recent FDA 510(k) clearance

Greetings,

It continues to be an exciting time at BioSig Technologies.  As many of you know, we recently received 510(k) clearance for our first product, PURE EP System, from the U.S. Food and Drug Administration (FDA). A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as — that is, substantially equivalent to — a legally marketed device.

Receiving this clearance is a significant milestone in the Company’s development as a market leader within the medical technology sector and a huge step toward the commercialization of our PURE EP System.

BioSig’s noninvasive PURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. 

To date, we have successfully performed 12 pre-clinical studies at Mayo Clinic in Rochester, MN and one at Mount Sinai Hospital in New York, NY. We hope that our novel technology will eventually lead to improvements in ablation outcomes and time savings for the hospitals.  

The Company is excited to move into this new era of opportunities. I would encourage anyone who is interested in our Company and our products to review some of these exceptional articles published about us last week:

MassDevice: https://www.massdevice.com/biosig-wins-fda-nod-for-pure-ep-system/ 

DAIC: https://www.dicardiology.com/product/biosig-technologies-announces-fda-510k-clearance-pure-ep-system

FierceMedTech: https://www.fiercebiotech.com/medtech/fda-clears-biosig-system-for-high-fidelity-heart-rhythm-exams

FDAnews: https://www.fdanews.com/articles/188018-fda-grants-510k-clearance-to-biosigs-cardiac-signal-device

LA Business Journal: http://labusinessjournal.com/news/2018/aug/14/biosig-tech-gets-federal-green-light-sell-medical-/

MPO Mag: https://www.mpo-mag.com/contents/view_breaking-news/2018-08-14/fda-oks-biosigs-pure-ep-system-for-electrophysiology/

Kind Regards,

Ken Londoner
Chairman & CEO
BioSig Technologies, Inc.


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