Nov 06,2023 TOP STORY

Smileyscope Therapy is the First Virtual Reality Device to Receive FDA Class II Clearance for Acute Pain

Smileyscope has made history by becoming the first virtual reality (VR) device to receive FDA Class II clearance for acute pain. This approval recognizes Smileyscope's innovative Procedural Choreography™ technique, which uses positive virtual stimuli to reduce pain and anxiety during medical procedures. With this milestone, Smileyscope aims to revolutionize pain and anxiety management, partnering with hospitals and clinicians globally to enhance patient experiences and improve clinical workflows. FDA clearance included critical, independent evaluation of Smileyscope's patented Procedural Choreography™. Procedural Choreography is Smileyscope's proprietary technique that takes negative real-world stimuli (e.g. a needle) and replaces it with psychologically-preferable positive virtual stimuli (e.g. a friendly fish).

REGULATORY FDA

#virtual reality

View Analyst & Ambassador Comments
Go to original news
Nov 02,2023 TOP STORY

Sibionics wins CE mark for GS1 CGM System

Chinese company Sibionics has obtained a CE Mark for its GS1 continuous glucose monitoring system (CGM), a wearable device that uses an under-the-skin sensor to measure glucose levels in real-time, transmitting the information to a linked handset or mobile phone. The GS1 CGM offers users 14 days of continuous glucose monitoring without the need for frequent calibration. It allows users to transmit glucose data to monitoring devices or mobile apps and generate professional reports.  An additional feature of the system supports data sharing with friends and family and integrates the ProView remote access platform for healthcare providers to monitor and intervene. The GS1 CGM received marketing approval in China in 2021, and the company claims that it is the first blood-glucose meter without the need for finger blood calibration. 

REGULATORY CE MARK

#cgm

View Analyst & Ambassador Comments
Go to original news
Oct 23,2023 TOP STORY

Insulet Announces FDA 510(k) Clearance of the Omnipod® 5 App for iPhone

Insulet announced it has received FDA 510(k) clearance for the Omnipod 5 App for iPhone, making the Company eligible to offer a tubeless automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone. Since its full commercial launch in August 2022 in the United States, the Omnipod 5 Automated Insulin Delivery System has included the option for smartphone control for customers using compatible Android devices. With today’s announcement, the Omnipod 5 Pod will soon be controllable from a compatible iPhone. The Omnipod 5 App for iPhone will launch first with the Dexcom G6 Continuous Glucose Monitoring System integration, with a full market release in 2024.

REGULATORY FDA

#insulin pump

#closed loop

View Analyst & Ambassador Comments
Go to original news
Oct 23,2023 TOP STORY

Lucida Medical's New AI Software for Prostate Cancer Diagnosis Received CE Mark Certification

Lucida Medical Ltd, a Cambridge-based start-up company dedicated to improving cancer diagnosis, has announced Class IIb CE certification for its AI-based prostate cancer detection software, Prostate Intelligence™ (Pi™). Built with leading clinicians and UK NHS hospitals, the CE mark means the software can now benefit patients across Europe. Data presented at the European Society for Urogenital Radiology (ESUR) in September 2023 indicated that Pi™ could help cut undetected cancers to 6% while also reducing avoidable biopsies to 43%. Using AI, Pi™ analyses the MRI and is fully integrated into the radiologist's workflow, targeting key issues of variability, radiologist time, and diagnostic accuracy in prostate cancer. Specifically, Pi™ is intended to be used by radiologists to assess and report prostate MRI studies, by automatically producing 3D segmentations, volumes and risk scores. The company plans to make Pi™ commercially available in the UK and EU in Q1, 2024. Pi™ is not for sale in the US.

REGULATORY CE MARK

#ai/software

View Analyst & Ambassador Comments
Go to original news
Nov 21,2022

Lunit Becomes the First Medical Software Company in Asia-Pacific to Become MDR CE and UKCA Certified

Lunit (KRX: 328130.KQ), a global provider of AI-powered cancer solutions, today announced that its AI solution suite for radiology, Lunit INSIGHT, has received the CE marking under Europe’s newest Medical Device Regulation (MDR). The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe. Among the Lunit INSIGHT suite, two products received the MDR CE and UKCA certifications: Lunit INSIGHT CXR, an AI solution for chest x-ray analysis, and Lunit INSIGHT MMG, an AI solution for mammography analysis.

REGULATORY CE MARK

#ai/software

View Analyst & Ambassador Comments
Go to original news
Sep 21,2023 TOP STORY

Medtronic Diabetes announces CE Mark for new Simplera™ CGM with disposable all-in-one design

Medtronic today announced CE Mark approval for its new all-in-one, disposable Simplera continuous glucose monitor (CGM) featuring a simple, two-step insertion process. The company's newest no-fingerstick sensor does not require over tape and is seamlessly integrated with the InPen smart insulin pen, which provides real-time dosing guidance. Medtronic will begin a phased launch at the European Association for the Study of Diabetes (EASD) 59th Annual Meeting in Hamburg, Germany on Oct. 2-6, 2023. "Despite the rapid adoption of CGM over the past decade, less than 30% of individuals on MDI therapy using a CGM achieve glycemic targets — highlighting a significant unmet need. We're excited to help more people to reach their goals with our advanced algorithm in InPen™ powered by our smallest and most comfortable CGM to-date," said Que Dallara, EVP and President, Medtronic Diabetes. Simplera is indicated for ages 2+ and is not approved by the FDA. Medtronic's automated insulin delivery (AID) system integrated with this next-generation sensor is currently under review for CE Mark and is not commercially available in the U.S. or in Europe.

REGULATORY CE MARK

#cgm

View Analyst & Ambassador Comments
Go to original news
Sep 19,2023

Deep Bio Announces Market Authorization from Swissmedic for DeepDx Prostate, Paving the Way for European Expansion

Deep Bio, a leader in artificial intelligence (AI)-powered cancer diagnostics, announced today that it has obtained marketing authorization from Swissmedic for DeepDx Prostate, its AI-powered prostate cancer diagnostic software. Swissmedic is the Swiss regulatory authority responsible for the authorization and supervision of therapeutic products. With this key approval, Deep Bio is now eligible to launch DeepDx Prostate in Switzerland, marking a significant milestone in the company's plans to expand its footprint in Europe. DeepDx Prostate is an AI-powered software for the assessment of prostate cancer on digital whole slide images of hematoxylin and eosin-stained prostate core-needle biopsies. Deep Bio continues to expand its global reach through partnerships with digital pathology leaders in the US, Europe, and India.

REGULATORY SWISSMEDIC

#ai/software

View Analyst & Ambassador Comments
Go to original news
Nov 30,2021

metaMe Health Receives FDA Clearance for Regulora®, the First FDA-authorized Treatment Specifically for Abdominal Pain Due to Irritable Bowel Syndrome (IBS)

metaMe Health, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for Regulora®, the first FDA-authorized treatment of any kind specifically for abdominal pain associated with irritable bowel syndrome (IBS) in adults. Regulora® is a prescription Digital Therapeutic (PDT) that is self-administered through an Apple or Android smartphone and provides behavioral therapy based on Gut-Directed Hypnotherapy (GDH) through a convenient smartphone app that can be used at home. GDH helps patients with their IBS symptoms by promoting healthier control of digestive tract function and delivering therapy designed to influence pain sensation

REGULATORY FDA

#mobile app

#pdt

View Analyst & Ambassador Comments
Go to original news
Sep 07,2023

alveoair® has received U.S. FDA clearance, marking a significant advancement in respiratory care

alveofit® (Roundworks Technologies Private Limited) is thrilled to announce that its product, alveoair® spirometer, has earned U.S. FDA clearance for distribution in the United States. Specializing in digital therapeutics for respiratory care, the company is committed to delivering affordable and interoperable lung health solutions. This U.S. FDA approval, coupled with strategic partnerships like the one with AstraZeneca, positions alveofit® for broader international expansion, particularly in the U.S. and emerging economies. Dr. Anil Kukreja, VP of Medical Affairs and Regulatory at AstraZeneca Pharma India, praised the FDA clearance as a milestone, highlighting alveofit's role in optimized diagnosis and management of lung disorders such as asthma and COPD.

REGULATORY FDA

#connected device

#spirometer

#mobile app

View Analyst & Ambassador Comments
Go to original news
Aug 23,2023

Welldoc Receives 11th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar

Welldoc today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar . This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation. Welldoc’s latest 510(k) enables BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes.

REGULATORY FDA

#mobile app

#cgm

View Analyst & Ambassador Comments
Go to original news
Subscribe to REGULATORY