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MedWand™ Receives FDA 510(k) Clearance

News Alert! JULY 26, 2022 – MedWand™ Receives FDA 510(k) Clearance: Now Commercially Available | Source/Credit: https://www.medwand.com/press.html

Evaluation Kit, Mobile Clinic, and Remote Clinic Now Commercially Available

Multi-Sensor Device & Software Platform Enables Remote Clinical Exams

FOR IMMEDIATE RELEASE

Tuesday, July 26, 2022

(Rancho Santa Margarita, CA and Las Vegas, NV) – MedWand Solutions, Inc. is pleased to announce the company’s award winning MedWand device has received FDA 510(k) clearance. Transforming the current capabilities of telemedicine, MedWand will initially offer three product configurations including: the MedWand Evaluation Kit, the MedWand Mobile Clinic, and the MedWand Remote Clinic.

“I am happy to share that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the MedWand,” shared MedWand CEO and Co-Founder, Robert Rose. “As a company dedicated to advancing access to quality healthcare, we are proud to offer our innovative solutions to medical facilities worldwide to help lower operating costs, improve health equity, and ultimately save lives.”

Immediately available is the MedWand Evaluation Kit, priced at $2,495 USD, includes a MedWand device, and an Android OS medical tablet that is pre-configured with VirtualCare application software and private access to the cloud based VirtualCare telemedicine platform. This Evaluation Kit allows potential end-users to perform clinical evaluation of the MedWand device itself and explore advanced telemedicine workflows enabled by the VirtualCare platform.

The company is also accepting orders and production slot reservations for their MedWand Mobile Clinic and Remote Clinic configurations. Both Clinics will be available for purchase under Capital Expenditure (CapEx) with supplemental monthly service fee, and all-inclusive Service-as-a-Subscription (SaaS) models. Under SaaS the Mobile Clinic is available for as little as $100/month. To request a private demonstration or volume purchase quotation please visit www.medwand.com/contact.html.

“When it comes to medical diagnostics, clinical accuracy is not just important, but critical, and MedWand’s goal has always been to be the most clinically-dependable telemedicine device in the world,” shared Samir Qamar, MD, Co-Founder and Chief Medical Officer. “With FDA clearance, clinicians and patients everywhere can trust MedWand’s vitals and remote examination tools, and experience telemedicine on an entirely new level.”

Transforming the traditional understanding of telemedicine, MedWand combines multiple clinically accurate vitals sensors with a multi-purpose Ultra-HD resolution camera into one, handheld, lightweight device. Data collected can include core temperature, blood oxygen saturation, and pulse rate, heart, lung and abdominal auscultations, electrocardiogram*, and high definition otoscopic, oropharynx, and dermatoscopic exam images. Through approved 3rd party Bluetooth peripherals, the MedWand Mobile and Remote Clinics can also seamlessly capture blood pressure, glucometer, spirometry, and weight data.

MedWand’s VirtualCare software connects MedWand devices to existing Electronic Medical Record (EMR) and Practice Management / Hospital Information Systems (PMS/HIS). By accepting externally scheduled appointments from the host PMS/HIS, and exporting captured vitals data to the patient’s EMR, MedWand delivers a unique combination of video consultation, live monitoring, and remote clinical-grade vitals capture. MedWand also provides a platform for future AI based vitals data analysis to enable cost efficient and comprehensive telemedicine services for medical facilities worldwide.

For more information on MedWand visit www.medwand.com. To schedule a private demonstration or to request a formal product quotation please contact MedWand at www.medwand.com/contact.html

*Electrocardiogram feature is available in select countries, currently awaiting US FDA 510(k) clearance.

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About MedWand Solutions, Inc

MedWand Solutions, Inc. delivers digital healthcare technologies that enhance the accessibility and quality of healthcare services for clinicians and patients, regardless of location. MedWand was created by a team of physicians and engineers to enhance the quality and accessibility of health care services regardless of physical location. The company offers advanced telemedicine solutions for multiple applications that include hospitals, remote clinics, nursing homes, schools, and workplaces

SOURCE: https://www.medwand.com/press.html

Media Contact: Victoria Elder, PR Director, MedWand Velder@medwand.com, 949-239-9220

Categories: DPC News

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