TAP

ONWARD® Medical Reaffirms Guidance, Shares 2024 Strategic Priorities, and Releases Unaudited Q4 Financial Highlights

Retrieved on: 
Friday, March 15, 2024
Blood pressure, EUR, BCI, Sale, TAP, Euronext, Spinal cord, ARC, FDA, Movement, SCI, Pharmaceutical industry

The Company expects to launch its investigational ARC-EX Therapy to improve the strength and function of the upper extremities after SCI in the US in Q4 2024.

Key Points: 
  • The Company expects to launch its investigational ARC-EX Therapy to improve the strength and function of the upper extremities after SCI in the US in Q4 2024.
  • Major associated milestones this year include FDA De Novo submission, FDA clearance, and first commercial sale.
  • The Company plans to publish its Full Year 2023 financial statements on April 25, 2024.
  • Net cash outflow in Q4, 2023 was EUR 7.0 million, consistent with the EUR 7.0M cash burn in Q3, 2023.

Registration Opens For Free Event On Navigating Cancer And Employment, Allsup Explains

Retrieved on: 
Tuesday, March 12, 2024
Diagnosis, Social Security Disability Insurance, Employment, Social Security, HR, Career, SSDI, Health, Partnership, Artificial intelligence, Patient, Knowledge, DFS, TAP, Disability, Disclosure, Social, Survivor, Workforce, Digital divide, Workplace, Nursing, Work, AES, Health insurance

This free virtual event brings together cancer patients, survivors, healthcare professionals, employers and advocates to discuss effective management of treatment, recovery and employment for individuals who have cancer.

Key Points: 
  • This free virtual event brings together cancer patients, survivors, healthcare professionals, employers and advocates to discuss effective management of treatment, recovery and employment for individuals who have cancer.
  • “Cancer and Careers exemplifies genuine commitment to aiding those affected by cancer, whether they’re navigating employment during or after their diagnosis,” said T.J. Geist, Allsup Principal Advocate.
  • AES assigns a dedicated case manager to beneficiaries and offers free support and resources through the Ticket to Work Program.
  • The conference is designed to equip attendees with the knowledge and resources needed to manage their careers through the cancer journey successfully.

Tigo Energy Headquarters Receives 90kW of Optimized Solar from Long-Time Installer Partner

Retrieved on: 
Thursday, March 28, 2024
Environment, Commercial Building & Real Estate, Technology, Construction & Property, Other Energy, Software, Building Systems, Alternative Energy, Green Technology, Energy, Cloud, Tigo Energy, CCA, Pressure, Growth, Total quality management, Millicom, Solar Energy Industries Association, TAP, Eye, Safety, TQS, Multimedia, Renewable energy

Tigo Energy, Inc. (NASDAQ: TYGO), a leading provider of intelligent solar and energy software solutions, today announced the installation and commissioning of a rooftop solar system at its headquarters in California.

Key Points: 
  • Tigo Energy, Inc. (NASDAQ: TYGO), a leading provider of intelligent solar and energy software solutions, today announced the installation and commissioning of a rooftop solar system at its headquarters in California.
  • The system was designed and deployed by Tigo installer partner, Laibach Solar , and has averaged 5% Reclaimed Energy since it was commissioned.
  • View the full release here: https://www.businesswire.com/news/home/20240328503393/en/
    The system was designed and deployed by Tigo installer partner Laibach Solar and has averaged 5% Reclaimed Energy since it was commissioned.
  • Tigo is a great partner on our solar mission, and we look forward to many more years of empowering solar with great software and a shared commitment to quality.”
    With the Tigo Energy Intelligence monitoring platform , Laibach Solar and Tigo Energy have full control and visibility over the installation.

SetPoint Medical Accepted into FDA Total Product Life Cycle Advisory Program for Development of its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

Retrieved on: 
Thursday, March 21, 2024
Research, Medical Devices, Neurology, FDA, Genetics, Clinical Trials, Biotechnology, General Health, Health, Science, Vagus nerve, Device, CDRH, Patient, Regulatory affairs, TAP, Remyelination, Clinical trial, Safety, Set, RRMS, Food, Pharmaceutical industry

SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).

Key Points: 
  • SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
  • The FDA’s Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite development and patient access to safe and effective high-quality medical devices upon FDA approval.
  • In October 2023, the FDA expanded the program to include neurological and physical medicine devices.
  • SetPoint's integrated neurostimulation device uses precise vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat autoimmune conditions.

QuantalX Secures Spot in FDA's Prestigious Total Life Cycle Advisory Program (TAP)

Retrieved on: 
Thursday, April 4, 2024
Diagnosis, NPH, Movement disorder, Growth, Cerebrospinal fluid, CSF, Risk, Patient, DSM-IV codes, Stroke, TAP, Doctor of Philosophy, Medtronic, Science, Approximation error, Normal pressure hydrocephalus, Food, FDA, VPS, Dementia, Pharmaceutical industry

NEW YORK, April 4, 2024 /PRNewswire/ -- QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders using the Delphi-MD medical device, announced today its selection to participate in the highly prestigious Total Life Cycle Advisory Program (TAP) initiated by the U.S. Food and Drug Administration (FDA). The program will focus on advancing Delphi-MD's unique Direct Electrophysiology Imaging technology, enabling the early detection of Normal Pressure Hydrocephalus (NPH) disease, with high accuracy rates, and the prediction of patients' response to ventriculoperitoneal shunting (VPS). The TAP program brings together the FDA, major health insurers, healthcare organizations, and industry leaders in a collaborative effort to construct a comprehensive strategy for technologies that can benefit the general population. This strategic framework spans crucial elements, such as value creation in the U.S. market, meticulous preparation for regulatory approval, meaningful engagement with insurers, and the establishment of a robust market presence with customers.

Key Points: 
  • NEW YORK, April 4, 2024 /PRNewswire/ -- QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders using the Delphi-MD medical device, announced today its selection to participate in the highly prestigious Total Life Cycle Advisory Program (TAP) initiated by the U.S. Food and Drug Administration (FDA).
  • "The acceptance into the Total Life Cycle Advisory Program is a truly prestigious and significant opportunity for QuantalX," remarked Iftach Dolev.
  • The Total Life Cycle Advisory Program aims to guide innovative technologies through the entire product life cycle, ensuring regulatory compliance, market adoption, and enhanced positive patient impact.
  • The valuable experience and insights within this program are expected to accelerate QuantalX's market entry and establish a solid foundation for future growth.

Kytopen Announces Launch of Technology Access Program Supported by an Expanded Applications Team

Retrieved on: 
Tuesday, March 26, 2024
MED, Seminal vesicles, Research, Business development, TAP, MSC, CRISPR, Safety, Therapy

and DENVER, March 26, 2024 /PRNewswire/ -- Kytopen Corp., a leader in the development of manufacturing platforms and workflows for advanced therapeutic medicines, announces the launch of the Flowfect® Technology Access Program ("TAP") for early access to partners.

Key Points: 
  • and DENVER, March 26, 2024 /PRNewswire/ -- Kytopen Corp., a leader in the development of manufacturing platforms and workflows for advanced therapeutic medicines, announces the launch of the Flowfect® Technology Access Program ("TAP") for early access to partners.
  • "The Kytopen team is excited and proud to launch our Technology Access Program.
  • Earlier this year, Kytopen significantly expanded its process development and applications team with the hiring of researchers formerly from Artisan Bio, a developer of novel CRISPR editing systems and cell therapies, to support the incoming Technology Access Program partners and development of templated manufacturing processes for emerging non-viral applications.
  • Please reach out to [email protected] to request more information on the Flowfect® Technology Access Program.

ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI™ System

Retrieved on: 
Monday, March 11, 2024
SCI, Paralysis, BCI, FDA, ARC, BDD, Euronext, Risk, TAP, History, Patient, Movement, Medical device

This acceptance follows ONWARD Medical’s announcement last week that its investigational ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration.

Key Points: 
  • This acceptance follows ONWARD Medical’s announcement last week that its investigational ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration.
  • ONWARD Medical is only the second BCI company to be accepted into the program.
  • TAP provides ONWARD Medical with early and frequent strategic engagement from the FDA, patients, providers, and payers to facilitate more rapid development and widespread patient access to safe, effective, high-quality medical devices of public health importance.
  • “We are honored to be one of the first BCI companies included in this important program, which allows for the fastest FDA review times of new medical technology,” said ONWARD Medical CEO Dave Marver.

LYT Proudly Announces Significant Milestones Achieved In Helping To Reduce Traffic Congestion In North American Cities During 2023

Retrieved on: 
Thursday, February 22, 2024
Cloud, TSP, ITS, Algorithm, Thoroughfare, Quality of life, Transport, Pulse, Nextgen, Congestion, TAP, City, Machine learning, Snow, Artificial intelligence, Intelligent transportation system

It harnesses the power of a single-edge device installed in Traffic Management Centers that enables these vehicles to securely speak directly to networked traffic signals in cities through the LYT cloud platform.

Key Points: 
  • It harnesses the power of a single-edge device installed in Traffic Management Centers that enables these vehicles to securely speak directly to networked traffic signals in cities through the LYT cloud platform.
  • The new dashboard provides transit organizations in cities across the U.S. an innovative fusion of data from transit vehicles and traffic lights to showcase how TSP is improving traffic congestion and transit operations.
  • AI promises to streamline traffic flow and reduce congestion for many of today’s busiest roadways and thoroughfares.
  • By integrating everyone’s real-time routing information, cloud-based traffic management systems can now optimize traffic light timing to the true needs of traffic.

Cleerly® Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System

Retrieved on: 
Tuesday, March 5, 2024
Technology, Medical Devices, FDA, Clinical Trials, Health Technology, Cardiology, Software, Health, Artificial Intelligence, Diabetes, Prediabetes, Randomized controlled trial, Physician, Food, Stenosis, MACE, Coronary artery disease, Lung, Splenic infarction, Risk, TAP, CAD, Atherosclerosis, Ischemia, Risk assessment, Metabolic syndrome, Patient, MPH, Medicine, Diagnosis, Heart, CTS, Medical device

Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System.

Key Points: 
  • Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System.
  • The CAD Staging System is a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary atherosclerosis, stenosis and ischemia.
  • The FDA’s Breakthrough Device Designation is granted for technologies that have the possibility to encourage more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases.
  • “This designation from the FDA highlights the critical need for better heart disease risk assessment methods.

N-able Expands Technology Alliance Program, Adding New Vendor Alliances to Open Ecosystem Built for MSPs

Retrieved on: 
Tuesday, February 27, 2024
Networks, Security, Data Management, Technology, Software, Investment, Risk management, Google Workspace, MSP, Collaboration, VPN, QBR, TAP, Software as a service, Ecosystem, Slack, Salesforce, Microsoft, NABL

N-able , Inc. (NYSE: NABL), a global software company helping IT services providers deliver remote monitoring and management, data protection as-a-service, and security solutions, continues to add new vendor alliances to its expanding and enhanced Technology Alliance Program (TAP) , a growing, open ecosystem built for MSPs.

Key Points: 
  • N-able , Inc. (NYSE: NABL), a global software company helping IT services providers deliver remote monitoring and management, data protection as-a-service, and security solutions, continues to add new vendor alliances to its expanding and enhanced Technology Alliance Program (TAP) , a growing, open ecosystem built for MSPs.
  • SaaS Alerts – allows MSPs to detect and automate the remediation of SaaS security threats.
  • Actifile’s platform illustrates the monetary value of current data risks alongside the MSP’s existing cyber security approach and delivers protection against potential financial loss.
  • As part of N-able TAP, vendors are well-positioned to support and strategically engage with the global MSP ecosystem, including ~25,000 MSPs who trust N-able as their partner.