Berkshire Biomedical Announces Acceptance of 510(k) Premarket Submission of Computerized Oral Prescription Administration™ (COPA) System

Innovative Virtual Care and Prescription Drug Administration Plot Designed to Serve Sufferers and Suppliers in Digital Effectively being Platform

DALLAS, Jan. 21, 2021 /PRNewswire/ — Berkshire Biomedical, LLC (“Berkshire” or “the Firm”), a privately-held digital health company putting in place a revolutionary virtual care and Intended Individual prescription drug management machine, this day launched that the Firm’s 510(okay) utility to the U.S. Meals and Drug Administration (FDA) for pre-marketing clearance of the Computerized Oral Prescription Administration (COPA™) Plot used to be permitted for overview.

“The 510(okay) submission is the fruits of our imaginative and prescient to construct a instrument and machine to remotely red meat up medication supply with the skill to video show Intended Individual adherence to prescribed therapy, and to talk all of this info support to suppliers,” mentioned Thomas M. Rouse, Founder and Chairman of the Board of Berkshire Biomedical. “Developed over four years by world class hardware and software program engineering teams along with leading scientific technology alternate experts, the COPA Plot, with its innovative means to personalized, prescription drug supply, is expected to be a disruptive technology that can red meat up the transformation to virtual care.”

“The acceptance of this submission is a a will deserve to comprise milestone for Berkshire as we reach the COPA Plot in opposition to regulatory clearance with the unprejudiced of bringing this customized prescription drug management machine to sufferers and suppliers short of a virtual care solution for some distance away drug therapy supply. Plans for commercialization are underway and we are working on scaling industrial manufacturing and assessing varied strategic marketing plans to red meat up the COPA Plot’s commence. In tandem, we are rising discussions with means strategic partners and are very encouraged by the high level of preliminary interest in and red meat up for our virtual care drug supply machine,” added Mr. Rouse.

“The COPA Plot used to be designed to toughen affected person wellness by addressing the intersection of two unmet needs in this day’s healthcare supply machine: medication adherence and the increased test for virtual care choices to snort medication and healthcare companies at the point of care. Right here is incredibly crucial ought to you accept as true with about this day’s virtual setting and the continuing need for surveillance of medicines in a diversity of indications equivalent to addiction management, persistent disaster management and psychological health components to name a few. Besides, the machine provides a document of adherence and the skill to supply true-time knowledge supply that is unrivaled—a doable recreation-changer for sufferers, physicians and caregivers,” acknowledged Colonel (ret) Geoffrey Ling, M.D., Ph.D., Professor of Neurology and Attending Neuro-Serious Care Doctor at the Johns Hopkins Scientific Institutions; a Professor of Neurology and the founding father of the Heart for Militia Scientific Neurosciences at the Uniformed Companies University of the Effectively being Science (USUHS) and a member of the Advisory Board for Berkshire Biomedical.

In regards to the Computerized Oral Prescription Administration (COPA™) Plot
The COPA™ Plot is currently beneath pattern as a virtual care and prescription drug supply machine that is pioneering the usage of biometrics technology in a hand-held instrument that is cloud-essentially based totally totally, HIPAA compliant and makes use of a cell instrument-enabled database management machine (DBMS).

The COPA Plot is meant to be used as an lend a hand to scientific suppliers in simply about managing therapeutic regimens for sufferers within the dwelling or hospital. The machine provides a approach for the affected person’s prescribed medicines to be saved in a supply unit; for a scientific provider to remotely time desk the affected person’s prescribed medicines; to supply notification to the affected person when the prescribed medicines are due to be taken; to liberate the prescribed medicines into the mouthpiece, on the affected person’s repeat; and to supply to the scientific provider a historical previous of the tournament.

The COPA Plot’s patented technology provides exact, neatly timed and consistent dosage of prescribed, liquid, oral drug regimens. It aspects enabled, twin biometric controls including fingerprint and dentition recognition to substantiate the Intended Individual earlier than doling out the prescription drug, which enhances security, security, and drug adherence. The COPA Plot integrates mobile technology for true-time usage knowledge sequence, which permits physicians to video show affected person habits and manufacture dosage adjustments. It is also enabled with a cloud-essentially based totally totally knowledge storage and analytics machine that will most probably be disseminated to licensed physicians, pharmacists, and caregivers to extra red meat up scientific selections.

About Berkshire Biomedical, LLC
Berkshire Biomedical, LLC is a privately held healthcare choices provider taking into consideration impacting lives by leveraging technology to supply a boost to scientific outcomes and toughen affected person wellness. The Firm’s lead product beneath pattern, the (COPA™) Plot, is designed to contend with the intersection of two fundamental needs within the healthcare supply machine: virtual care supply the usage of technology combined with knowledge and medicine self-administration and adherence.

Founded and funded by a personnel of skilled monetary and scientific technology executives, Berkshire Biomedical intends to verify gigantic alternatives in scientific markets, drug purposes, and companies that tackle the commercialization and knowledge analytics of the instrument in expose to maximise the COPA Plot’s impression within the virtual care and scientific technology sectors.

Extra knowledge about Berkshire Biomedical and the COPA Plot will most probably be found at www.berkbiomed.com.

CONTACT:

Barry R. Dunn
Vice President – Corporate Pattern
Berkshire Biomedical, LLC
bdunn@berkbiomed.com

Anne Marie Fields
Managing Director
Rx Communications Community, LLC
afields@rxir.com

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SOURCE Berkshire Biomedical, LLC

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