Apr 19,2024

Korea approves 2 more DTx for vision improvement, respiratory rehabilitation

The Ministry of Food and Drug Safety in South Korea has granted approval to two new digital therapeutic (DTx) devices, developed by Nunaps and Share&Service. Nunaps VIVID Brain is a mobile application tailored for patients with vision impairments due to brain disorders, offering a 12-week visuoperceptual training program to expand the visual field. Share & Service's EasyBreath, on the other hand, is an eight-week customized respiratory rehabilitation program for individuals with COPD, asthma, and lung cancer, focusing on enhancing aerobic capacity and reducing breathlessness. These approvals mark the third and fourth authorized DTx devices in South Korea, signifying a growing recognition of software-based interventions to prevent, manage, or treat medical impairments or diseases.

REGULATORY

#reimbursement

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

NuvoAir and Cary Medical Management announce partnership to bring high-quality cardiopulmonary care to rural North Carolina

NuvoAir Medical and Cary Medical Management (CMM), a pioneer in transforming traditional primary care into high-performing value-based care clinics, announced their partnership to bring high-quality specialty care to patients in North Carolina. NuvoAir Medical will enable the primary care clinics under CMM’s management to provide in-home and virtual care for patients with complex heart and lung issues including Asthma, COPD, and CHF. NuvoAir Medical will see patients with these conditions through its virtual-first clinic that combines ongoing, empathetic care from a team of specialists with remote monitoring technology to ensure no patient is left behind.

COLLABORATION PARTNERSHIP

#institution

#virtual care

#rpm

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY CE MARK

#connected device

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#connected device

View Analyst & Ambassador Comments
Go to original news
May 11,2023

NuvoAir and Medidata Partner to Advance Clinical Trials with Pulmonary Digital Biomarkers

NuvoAir is excited to share its new partnership with Medidata, a leading digital transformation company in life sciences and the largest provider of electronic data capture (EDC) working across 30K clinical trials worldwide. This collaboration advances the opportunities for studies to capture respiratory endpoints from both at-home and in-clinic settings, improving the participant and study site experience and allowing trials to scale at speed. The Medidata Sensor Cloud Network will now integrate NuvoAir’s suite of connected devices, which can be used in decentralized and hybrid trials across a range of therapeutic areas requiring respiratory endpoints.

COLLABORATION PARTNERSHIP

#connected device

#mobile app

#rpm

View Analyst & Ambassador Comments
Go to original news
Dec 05,2023 TOP STORY

Budget impact analysis of Propeller's digital monitoring platform for COPD

Researchers sought to project the potential savings and costs associated with Propeller’s digital therapeutic platform. The platform passively monitors inhaler medication usage to help healthcare providers identify patients at risk of exacerbations. Using an Excel-based model, researchers conducted a budget impact analysis of Propeller from both commercial payer and Medicare fee-for-service payer perspectives. The estimated number of annual eligible COPD patients for commercial and Medicare was 212,200 and 606,600, respectively. Propeller decreased costs by an estimated $2,475 (commercial) and $915 (Medicare) per enrolled patient. Taking into account estimated reductions in hospitalizations, emergency department visits, and short-acting beta-agonist (SABA) use, the study projected approximately $1.60 and $1.70 per-member per-month savings for commercial and Medicare payers, respectively.

CLINICAL STUDY
View Analyst & Ambassador Comments
Go to original news
Nov 21,2023 TOP STORY

Huma obtains multi-condition Saudi FDA Class C regulatory certification for its configurable SaMD disease management platform

Huma Therapeutics announced today that it has received Saudi FDA Class C certification for a disease-agnostic Software as a Medical Device (SaMD) in Saudi Arabia. Huma's SaMD platform powers digital health pathways through which data are collected from patients for self-management or to be assessed centrally by clinicians. These include remote patient monitoring (RPM) programmes, companion apps, risk assessment tools, dose calculators, algorithms. With the recent attainment of Saudi FDA Class C certification, complementing its existing Class IIb regulatory certification in the EU and Class II 510(k) in the USA, the SaMD platform reaches a new pinnacle in patient care versatility. This achievement enables the platform to monitor patients across all age groups, including infants and those pregnant, and seamlessly integrates with various external devices such as heart rate and blood sugar monitors, and smart inhalers. Beyond facilitating disease self-management for patients, the platform is equipped to aid clinicians in managing critical and serious conditions, including heart failure, COPD, asthma, cancer, rare diseases, pre-/post-op monitoring and more.

REGULATORY SAUDI FDA

#rpm

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

Blackford and contextflow Announce Commercial Partnership to Bring Comprehensive Chest CT Detection Software to Healthcare Providers

Blackford, the pioneering strategic AI platform and solutions provider, and contextflow announced a commercial partnership to bring contextflow’s ADVANCE Chest CT solution to healthcare professionals. Under the partnership, contextflow’s innovative technology will be integrated with Blackford’s advanced enterprise AI platform. Blackford provides healthcare professionals access to an extensive portfolio of medical AI solutions designed to drive clinical efficiency and improve patient outcomes. contextflow’s CE and UKCA marked technology, ADVANCE Chest CT, offers radiologists comprehensive computer-aided detection support for lung cancer, ILD, and COPD patients. The software detects, visualizes and quantifies nodules and lung disease patterns to enhance the speed and quality of radiology reports.

COLLABORATION PARTNERSHIP

#institution

#ai/software

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

Lunit to Implement AI-Powered Chest Screening Solution in Five Major Saudi Hospitals

Lunit announced an expansion of its services in the Kingdom of Saudi Arabia. Under its recent contract, Lunit will deploy its AI solution, Lunit INSIGHT CXR, in five major hospitals across the Kingdom. Lunit INSIGHT CXR is designed to detect the ten most common lung abnormalities, including lung cancer, tuberculosis, and pneumonia. The hospitals that will benefit from this collaboration include: National Guard Hospital Riyadh, King Abdulaziz Medical City, Security Forces Hospital, Al Takhassusi Hospital and Al Moosa Specialist Hospital.

PRODUCT

#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
Subscribe to RESPIRATORY