Mar 19,2024 TOP STORY

Almee Receives Breakthrough Device Designation From the FDA

Alex Therapeutics and Vicore Pharma announced FDA Breakthrough Device Designation status for Almee, a 9-week digital cognitive behavioral therapy (CBT) delivered in a patient-facing tool, to be used as an adjunct treatment of anxiety symptoms related to Pulmonary Fibrosis. Almee has shown effectiveness in reducing anxiety symptoms and improving health-related quality of life in the COMPANION study as reported earlier this year, driving a 2.7-point increase in GAD-7 (generalized anxiety disorder scale) score and a 4.4 improvement in KBILD (King’s Brief Interstitial Lung Disease) score. As next steps, Vicore is seeking to advance Almee in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis.

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Mar 18,2024 TOP STORY

Sequel’s twiist™ Automated Insulin Delivery System Receives FDA 510(k) Clearance

Sequel Med Tech, a company developing insulin delivery technologies, announced its partner, DEKA Research & Development Corp., has received 510(k) clearance from the U.S. FDA for the twiist Automated Insulin Delivery (AID) system powered by Tidepool. The twiist AID system, which will be commercialized by Sequel Med Tech, LLC, is the first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose. Cleared for people ages 6 and up with type 1 diabetes, the twiist AID system offers the capability to address each patient’s individual dosing needs. The twiist system incorporates FDA-cleared Tidepool Loop technology, which enables the system to automatically adjust insulin delivery based on CGM readings and predicted glucose levels.

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Mar 12,2024

Welldoc Announces CE Mark Certification

Welldoc announced that its flagship BlueStar mobile app has received CE mark certification as a Class IIa medical device under the European Union Medical Device Regulation (EU-MDR). This enables the company and their strategic partners to advance digital health solutions in the EU, addressing chronic condition needs that are rising globally. The announcement builds upon Welldoc’s existing 11 FDA clearances for type 1 and type 2 diabetes management capabilities, including advanced insulin dosing calculators. This milestone underscores the company’s continued commitment to the highest standards of quality, while also demonstrating extensive leadership in AI-based digital health solutions. 

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Mar 08,2024 TOP STORY

Dexcom over-the-counter Stelo Glucose Biosensor wins FDA clearance

Dexcom has received FDA clearance for its over-the-counter continuous glucose monitoring (CGM) solution called Stelo, which offers round-the-clock glucose readings directly to smartphones. The wearable biosensor has a two-week battery life and detects normal as well as low or high glucose levels. It's tailored for adults managing diabetes with oral medications or needing insight into lifestyle impacts on blood sugar levels. While not indicated for problematic hypoglycemia, it aims to empower users with actionable insights. Stelo is set for online release in summer 2024.

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Dec 18,2023

NuvoAir’s Air Next Spirometer is Now EU MDR Certified

NuvoAir has received an updated CE mark certification for its proprietary Air Next spirometer, complying with the new European legislation for medical devices. NuvoAir’s long-standing CE mark signified compliance with the Medical Device Directive (MDD). However, to ensure more stringent regulation of medical devices and better safeguard patients, MDD was replaced by the European Medical Device Regulation (EU MDR). In addition to EU MDR, NuvoAir holds the ISO 13485:2016 certification.

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Jan 30,2024

NuvoAir’s Air Next Spirometer is FDA-approved for in-home use

NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) clearance allows Air Next to conduct full spirometry at home, providing extremely valuable clinical data that ensures patients can be monitored continuously. High-quality lung data empowers the NuvoAir clinical team to intervene when changes are detected and provide instantaneous care before lung function deteriorates to the point where hospitalizations are necessary. By achieving 510(k) clearance, the Air Next Spirometer can now be used for ATS 2019-compliant spirometry in clinical trials across the US and Europe.

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Feb 20,2024 TOP STORY

Better Therapeutics Receives FDA Breakthrough Device Designation for Digital Therapeutic Platform Targeting Advanced Liver Disease

Better Therapeutics announced that the U.S. FDA has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH. Better Therapeutics earned breakthrough status based on the outcomes of its LivVita clinical study, which successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device-related adverse events. Results of the study were published in Gastro Hep Advances. Better Therapeutics’ novel form of CBT works by targeting the lifestyle behaviors that are known to cause and/or contribute to the progression of metabolic diseases. The Company’s CBT platform has already demonstrated clinically meaningful outcomes in type 2 diabetes (T2D), leading to the FDA authorization of AspyreRx™ in 2023 as the first prescription digital therapy to deliver CBT as a treatment for T2D.

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Feb 20,2024

Better Therapeutics Receives FDA Breakthrough Device Designation for Digital Therapeutic Platform Targeting Advanced Liver Disease

Better Therapeutics announced that the FDA has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH. Better Therapeutics earned breakthrough status based on the outcomes of its LivVita clinical study, which successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device-related adverse events. Results of the study were published in Gastro Hep Advances. Besides this, the Company’s CBT platform has already demonstrated clinically meaningful outcomes in type 2 diabetes, leading to the FDA authorization of AspyreRx™ in 2023 as the first prescription digital therapy to deliver CBT as a treatment for T2D.

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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.

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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.

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