Nov 14,2017

FDA OKs First Ingestible mHealth Sensor for Medication Adherence

The U.S. Food and Drug Administration announced approval late Monday of Ability MyCite, developed by Proteus Digital Health and Otsuka Pharmaceutical to treat patients with schizophrenia. acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

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Jul 20,2017

DarioHealth Receives U.S. FDA Clearance for Certain Leading Android Devices in the U.S.

DarioHealth today announced that the United States Food and Drug Administration (FDA) has granted Pre-market Notification (510(k)) clearance for the Dario app on certain leading Android smart mobile devices (SMD).

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Dec 06,2016

One Drop Announces FDA Clearance and One Drop | Premium Launch in US, UK, and EU

One Drop today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européene (CE) mark approval for One Drop | Chrome, a beautiful blood glucose monitoring system.

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Dec 22,2015

LabStyle Innovations Receives U.S. FDA Marketing Clearance for the Dario Blood Glucose Monitoring System

LabStyle Innovations Corp. today announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance. The Dario Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

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Jan 26,2023

Tidepool’s automated insulin dosing app for type 1 diabetes gets FDA approval

Tidepool’s automated insulin dosing app has been approved by the US Food and Drug Administration (FDA) to help those who are six years and older manage their type 1 diabetes. Tidepool is a nonprofit organisation and Tidepool Loop is the first app of its kind to receive clearance from the FDA, as well as the first to enable insulin delivery from a compatible Apple watch. Tidepool Loop’s algorithm technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller-enabled pumps to automatically increase, decrease and suspend delivery of basal insulin to the patient based on iCGM readings and predicted glucose values.

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Jan 27,2023

US FDA approves Abbott’s Proclaim XR SCS system to treat Diabetic Peripheral Neuropathy

The US Food and Drug Administration (FDA) has granted approval to Abbott’s Proclaim XR spinal cord stimulation (SCS) system for the treatment of painful diabetic peripheral neuropathy (DPN). The Proclaim XR SCS system can offer DPN patients pain relief, as they often require alternatives to traditional oral medication treatments. After completion of a minimally invasive trial, patients will be implanted with the Proclaim XR SCS device. They will then be able to control their therapy through an Apple device.

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Dec 08,2022

Dexcom G7 Receives FDA Clearance: The Most Accurate Continuous Glucose Monitoring System Cleared in the U.S.

DexCom, Inc. announced today the FDA has cleared the next-generation Dexcom G7 Continuous Glucose Monitoring (CGM) System for people with all Types of diabetes ages two years and older. Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible.

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Dec 08,2022

BIOCORP’s Mallya smart device receives FDA 510(k) clearance

French medical devices company BIOCORP has secured 510(k) clearance for marketing its Mallya smart medical device from the US Food and Drug Administration (FDA). Mallya is a smart sensor that has been designed to be attached directly to insulin pen injectors, converting them into connected devices. It automatically records important treatment information, including selected insulin units as well as the date and time of injection, and transmits the data to a dedicated digital app.

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Nov 05,2019

WaveForm Technologies Inc Awarded CE Mark Approval for Their CGM System

WaveForm Technologies Inc. a wholly owned subsidiary of AgaMatrix Holdings, LLC and developer of novel continuous glucose monitoring products, today announced it has received CE Mark approval for its Cascade Continuous Glucose Monitoring (CGM) system. Commercialization of the product for the European market is anticipated to begin in select countries.

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Jan 01,2022

Blue Note Therapeutics Receives Breakthrough Device Designation for Prescription-only Digital Therapeutic for Acute Myeloid Leukemia

Blue Note Therapeutics, a prescription digital therapeutics company dedicated to easing the burden of cancer and improving outcomes, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for BNT200. BNT200 is a first-of-its-kind prescription-only digital therapeutic to treat anxiety and depressive symptoms in adults with acute myeloid leukemia (AML) who are hospitalized for a regimen of high-intensity induction chemotherapy.

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