Feb 12,2024

Proscia Receives FDA Clearance for Digital Pathology Software Solution

Proscia, a provider of digital and computational pathology solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Concentriq AP-Dx. The digital pathology solution was cleared for the purpose of primary diagnosis, reported the company, adding that it is cleared for clinical use with the Hamamatsu NanoZoomer S360MD Slide scanner in the United States. Proscia’s Concentriq AP-Dx is a comprehensive diagnostic software solution that immerses pathologists in an intuitive experience for viewing, interpreting, and managing whole slide images and helps to drive confidence and efficiency gains. In addition to its 510(k) clearance, Proscia was the first company to achieve CE-IVDR certification to advance primary diagnosis in the European Union. The company also has a product licensed in Canada and cleared in the United Kingdom among other countries.

REGULATORY FDA

#ai/software

#clinical decision support

View Analyst & Ambassador Comments
Go to original news
Feb 09,2024 TOP STORY

Hologic AI-powered cancer screening system wins FDA approval

Medical technology firm Hologic has been granted clearance from the FDA to market its Genius Digital Diagnostics System, powered by the company's Genius Cervical AI algorithm. The digital cytology system–a medical diagnostic tool used to examine cells under a microscope to detect abnormalities or diseases–integrates deep learning-based AI with advanced volumetric imaging technology to aid in detecting precancerous lesions and cervical cancer cells. Cervical cancer screenings typically involve a Pap test, where cervical cell samples are collected at an OB-GYN office and sent to a lab for analysis on glass slides. By digitizing glass slides for analysis through the AI algorithm, the company says the system can enhance sensitivity without compromising specificity and facilitating more timely and effective treatment decisions. Its commercial launch is expected later this year. Its technology is already available in Europe, Australia and New Zealand.

REGULATORY FDA

#ai/software

#clinical decision support

View Analyst & Ambassador Comments
Go to original news
Jan 25,2024

BIOCORP Obtains 510(k) FDA Clearance for SoloSmart®, Sanofi’s Smart Cap for Disposable Insulin Pens

BIOCORP, a Novo Nordisk company based in France and specialized in the design, development, and manufacturing of innovative medical devices, announced that they have received 510(K) clearance from the U.S. Food & Drug Administration (FDA) to market SoloSmart®, Sanofi’s smart medical device that connects SoloStar® insulin pens. Designed, developed, and manufactured exclusively for Sanofi by BIOCORP, SoloSmart is a smart sensor that is directly attached to Sanofi’s SoloStar insulin pen platform, upgrading the pens into connected devices. It offers HCPs an easy way to follow patients in the case of a multitherapy treatment, for instance when using basal and rapid insulins. In addition to SoloSmart's CE marking (Sept 2022), the FDA’s authorization reinforces BIOCORP's technological leadership in the smart pens market. Previously, BIOCORP obtained 510(k) clearance for Mallya first version in December 2022.

REGULATORY FDA

#insulin pen

View Analyst & Ambassador Comments
Go to original news
Jan 17,2024 TOP STORY

FDA Approves First AI-Powered Skin Cancer Diagnostic Tool

The FDA has approved the DermaSensor, the first AI-powered tool to diagnose skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma, at the point of testing and noninvasively. The DermaSensor is a wireless, handheld device that uses spectroscopy technology to examine lesions at cellular and subcellular levels, then analyze those characteristics using an FDA-cleared algorithm. The device was evaluated in the DERM-SUCCESS study which was led by the Mayo Clinic across 22 study centers and enrolled over 1000 patients. The DermaSensor device demonstrated a 96% sensitivity across all 224 types of skin cancers. Further, negative results from the DermaSensor had a 97% chance of being benign across all skin cancers. A companion clinical utility study also investigated the DermaSensor’s usage with 108 physicians. This study found that the device decreased the number of missed skin cancers by half (18% vs 9%). The FDA previously granted breakthrough device designation to DermaSensor in 2021.

REGULATORY FDA

#connected device

#ai/software

View Analyst & Ambassador Comments
Go to original news
Jan 08,2024

Qure.ai's AI-Driven Chest X-ray Solution Receives FDA Clearance for Enhanced Lung Nodule Detection

Qure.ai, a leading global innovator in medical imaging solutions, has announced its 13th FDA clearance for their AI-enabled solutions. Qure’s chest X-ray-based qXR-LN uses artificial intelligence to identify and localize lung nodules, marking another significant milestone for the organization, strengthening its standing as a pioneer in the realm of AI-powered advancements for plain film radiography and medical imaging. This also marks the 6th FDA clearance for Qure’s chest X-ray based solutions. Notably, this is the only FDA-cleared solution for detecting and localizing lung nodules utilizing computer vision to have Radiologists, Pulmonologists and ER physicians as intended users.

REGULATORY FDA

#ai/software

View Analyst & Ambassador Comments
Go to original news
Jan 04,2024 TOP STORY

Click Therapeutics and Boehringer Ingelheim Announce FDA Breakthrough Device Designation for Prescription Digital Therapeutic to Treat Negative Symptoms of Schizophrenia

Click Therapeutics announced that the investigational CT-155 prescription digital therapeutic (PDT), co-developed by Boehringer Ingelheim and Click Therapeutics, has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). CT-155 is a novel software accessible on mobile devices that is being studied for use adjunctive to standard of care pharmaceutical therapy and is designed to treat the negative symptoms of schizophrenia. It is one of multiple digital therapeutics under joint-development by the companies for the treatment of schizophrenia. “Our unique therapeutic approach is on track to be the industry’s first-in-class treatment for the negative symptoms of schizophrenia” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “This designation brings us one step closer to that reality by enhancing our ability to work with the FDA on market authorization and accelerate access to this future treatment option,” said Austin Speier, Chief Strategy Officer of Click Therapeutics. CT-155 is the first investigational PDT developed as part of the collaboration between Click Therapeutics and Boehringer Ingelheim, which has been in effect since September 2020. The collaboration has since expanded to include an additional investigational prescription-based digital therapeutic for use alone and in combination with pharmaceutical therapy to help people with schizophrenia achieve positive clinical outcomes, which was announced in December 2022.

REGULATORY FDA

#pdt

View Analyst & Ambassador Comments
Go to original news
May 16,2023

FDA Authorizes Stanza to Treat Fibromyalgia Symptoms

Swing Therapeutics received De Novo marketing authorization by the U.S. Food and Drug Administration (FDA) for Stanza, the first prescription digital therapeutic for treating fibromyalgia symptoms. Fibromyalgia is a chronic pain condition that affects over 10 million Americans. Current FDA-approved medications, while offering moderate efficacy, are often accompanied by side effects. Treatment guidelines recommend multimodal care that combines medications with non-drug approaches, including Cognitive Behavioral Therapy (CBT) and a specialized form of it called Acceptance and Commitment Therapy (ACT). But access to these non-drug approaches has been extremely limited for most people. Leading up to FDA De Novo granting of Stanza, Swing ran multiple randomized controlled trials and real-world studies, including PROSPER-FM, the biggest device trial ever undertaken for fibromyalgia treatment. Swing has launched Swing Care, a virtual care platform that enables the delivery of personalized, holistic care to patients with fibromyalgia, with Stanza as a treatment option.

REGULATORY FDA

#pdt

View Analyst & Ambassador Comments
Go to original news
Nov 14,2023 TOP STORY

Lunit gets FDA approval for AI cancer diagnosis solution

South Korean medical AI company Lunit announced that its Lunit Insight DBT, an AI imaging diagnosis solution aiding in breast cancer diagnosis, has secured 510(k) pre-market clearance from the US Food and Drug Administration (FDA). This marks Lunit's third FDA approval, joining its AI emergency triage solution Lunit Insight Triage, and the breast imaging analysis tool Lunit Insight MMG. The Lunit InsighT DBT analyses 3D images from digital breast tomosynthesis (DBT) with AI, offering faster and more accurate results than traditional 2D mammography. With FDA approval, Lunit hopes to secure a share of the US market, which represents 65% of global breast cancer screenings, with DBT's widespread adoption.

REGULATORY FDA

#ai/software

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

Empatica's Platform Receives New FDA Clearance for Cardiac Digital Biomarkers

Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today announced US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate. With the addition of pulse and respiratory rate, the Empatica Health Monitoring Platform now includes six FDA-cleared digital biomarkers, among the most offered for use in clinical trials. These are among the 128 digital measures supported by the platform, the largest offering available in a single solution. The Empatica Health Monitoring Platform is a full-stack remote health monitoring and data collection solution for research and healthcare professionals, built on data collected by the company's medical-grade, EmbracePlus wearable.

REGULATORY FDA

#connected device

#digital biomarkers

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