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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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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Jul 07,2022

Renovia’s breakthrough tech gets FDA OK for new incontinence indication

The US FDA has given Renovia’s Ieva pelvic health system the green light to be marketed as a first-line treatment for chronic faecal incontinence (FI) in women. The 510(k) clearance comes less than nine months after the technology, designed for home use, was granted FDA breakthrough device status. leva is already cleared and being commercialised as a treatment for stress, mixed and mild-to-moderate urinary incontinence (UI) in women.

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Nov 29,2022 TOP STORY

FDA clears Apple Watch app for tracking Parkinson’s from H2o Therapeutics

H2o Therapeutics announced recently that the FDA cleared its prescription mobile app, Parky, for monitoring Parkinson’s disease. Ankara, Turkey–based H2o’s Parky app monitors symptoms including tremors and dyskinesia in real-time through the Apple Watch. In addition, the tool allows users and medical professionals to share meaningful and reliable data.

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Jul 30,2021

Biofourmis Earns FDA Breakthrough Device Designation for Digital Therapeutic for Heart Failure

Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).

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Aug 17,2021

Swing Therapeutics lands FDA breakthrough designation for fibromyalgia platform

Digital therapeutics (DTx) startup Swing Therapeutics has been granted FDA Breakthrough Device Designation for its smartphone-administered fibromyalgia management program. Swing’s 12-week DTx uses acceptance and commitment therapy (ACT), forms of cognitive behavioral therapy (CBT) that help patients accept factors outside of their control and focus on making internal changes. The program includes daily learning lessons and interactive sessions that help users understand their circumstances and develop skills to manage their condition.

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