Breakthrough

Fifth Annual 6sense Breakthrough Customer Event Showcases Revenue Impact of AI

Retrieved on: 
Thursday, October 19, 2023
Marketing, Advertising, Communications, Technology, Artificial Intelligence, History, Pressure, Breakthrough, Intelligence, AI, GTM, Organization, Sales

In his opening keynote, Jason Zintak, CEO of 6sense, shared the history of the company’s decade-long experience bringing AI and data together to revolutionize how B2B companies grow revenue.

Key Points: 
  • In his opening keynote, Jason Zintak, CEO of 6sense, shared the history of the company’s decade-long experience bringing AI and data together to revolutionize how B2B companies grow revenue.
  • Viral Bajaria, CTO and Co-founder of 6sense, spoke about the transformative impact of AI as revenue teams now have the intelligence and technology to uplevel and scale their GTM strategies.
  • The event also crowned the winners of the 2023 Breakthrough Awards, which highlighted outstanding customer achievements across eight categories.
  • Winners were selected based on organizational impact, platform knowledge, and creative use of 6sense Revenue AI™ for measurable outcomes.

ZKR Orthopedics announces FDA Breakthrough Device designation for the LIFT Implant Technology

Retrieved on: 
Monday, October 9, 2023
Osteoarthritis, Incidence, Pain, Cartilage, Food, Hope, Obesity, Knee, Prevalence, Mutation, Stair climbing, FDA, Swelling, PEEK, IDE, Orthopedic surgery, Exercise, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Degenerative disease, Pharmaceutical industry, Medical device

KENTFIELD, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that its LIFT implant technology has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • KENTFIELD, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that its LIFT implant technology has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
  • The LIFT implant is designed to decrease pain, improve function, and delay or eliminate the need for knee replacement.
  • The LIFT system includes trial spacers, a PEEK implant, titanium bone screws, K-wires, and a proprietary positioning instrument.
  • Under the program, ZKR Orthopedics will receive prioritized review and accelerated interaction with the FDA throughout the premarket review phase.

Too hard basket: why climate change is defeating our political system

Retrieved on: 
Sunday, October 1, 2023
Zero, Vaccine, Intergenerationality, World, Uncertainty, Private sector, The New Daily, Conversation, Food, Breakthrough – National Centre for Climate Restoration, Life, Face, Liberal Party, Curse, Coalition, The Conversation, Office of National Assessments, Chalmers, Hope, Anger, Center, Goal, COVID, Second, Carbon, Government, Science, Stomach, Dependent and independent variables, Disaster, ONI, Climate change, Flood, Shadow, Population, Risk, Water, Time, Breakthrough, Climate, Weather, Liberal, Coral reef, Renewable energy, Risk management, Hunting, Labour

When I was first asked to write an opening piece in The Conversation’s series on climate change and the energy transition, I wanted to say no.

Key Points: 
  • When I was first asked to write an opening piece in The Conversation’s series on climate change and the energy transition, I wanted to say no.
  • It may already be too late to save the world as we know it.
  • Or should I write “be under threat” instead of “likely be gone”, to soften the story?
  • The focus on rising temperatures itself makes the future seem more benign than it’s likely to be.

The Albanese government’s softly-softly response

    • In his 2023 Intergenerational Report Treasurer Jim Chalmers included climate change as one of the five major forces affecting future wellbeing.
    • It’s one among many, and the emphasis is on the economic opportunities and jobs offered by the energy transformation.
    • Chief Climate Councillor Tim Flannery said:
      Climate dwarfs everything else in this report.
    • In The New Daily, Michael Pascoe asked, “What is Albanese hiding?
    • The Labor government’s response to the greatest emergency we face seems set on slow, as if we have time for an incremental response with little disruption to daily life and it’s OK to keep subsidising fossil fuels and approving new gas and coal projects.

Government can and must act

    • All this after four decades of neoliberalism in which both the federal and state governments have surrendered capacity to the private sector.
    • But as the COVID crisis showed us, when faced with an emergency our governments can act decisively and put the lives of people ahead of the interests of business.
    • A report from the Centre for Independent Studies claimed voters born after 1996 were the most progressive since the Second World War.
    • As the electoral weight shifts away from the old baby boomers Labor’s federal future is likely to be as a minority government with support from Greens and independents who will demand bolder action.

Why we struggle to face facts

    • Elliot from “Burnt Norton”, the first of his “Four Quartets”:
      Go, go, go, said the bird: human kind

      Cannot bear very much reality.

    • Time past and time future

      What might have been and what has been

      Point to one end, which is always present.

    • Time past and time future What might have been and what has been Point to one end, which is always present.

FDA Grants Breakthrough Device Designation to SeaStar Medical’s Selective Cytopheretic Device for Cardiorenal Syndrome

Retrieved on: 
Friday, September 29, 2023
Partnership, University, Heart failure, Heart, SCD, Food and Drug Administration, Center for Biologics Evaluation and Research, National Institutes of Health, Bangladesh Technical Education Board, AKI, Trial of the century, Șaeș, Acute kidney injury, PMA, MD, Patient, Multiple organ dysfunction syndrome, Cardiorenal syndrome, Breakthrough, Heart transplantation, LVAD, SeaStar, ICU, FDA, NIH, Food, Pharmaceutical industry, Research

The Breakthrough Device Designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.

Key Points: 
  • The Breakthrough Device Designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.
  • This is only the ninth Breakthrough Device Designation granted by the FDA’s Center for Biologics Evaluation and Research (CBER) since the program’s inception in 2015.
  • “Cardiorenal syndrome is seen in the most severe cases of heart failure and is associated with a very poor prognosis,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We believe the SCD represents a novel, innovative and transformative approach to treating hyperinflammation in severely ill patients with chronic heart failure.

FDA Grants Breakthrough Device Designation to Gravitas Medical for Neonatal Patients Requiring Enteral Feeding

Retrieved on: 
Wednesday, September 27, 2023
Medicine, Gastrointestinal tract, Food and Drug Administration, Stomach, Incidence, Patient, SAN, Gravitas, Diagnosis, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Food, Pharmaceutical industry, Medical device

SAN FRANCISCO, Sept. 26, 2023 /PRNewswire-PRWeb/ -- Gravitas Medical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Entarik, the innovative Gravitas Feeding Tube System. This milestone signifies a major step forward in advancing neonatal healthcare by providing expedited access to this revolutionary technology for patients in need.

Key Points: 
  • Gravitas Medical announces U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Entarik, the innovative Gravitas Feeding Tube System.
  • SAN FRANCISCO, Sept. 26, 2023 /PRNewswire-PRWeb/ -- Gravitas Medical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Entarik, the innovative Gravitas Feeding Tube System.
  • Entarik is designed to aid, in conjunction with institutional protocols, qualified operators (medical professionals) in the placement of the Gravitas Enteral Feeding Tube into the stomach of neonatal patients requiring enteral feeding.
  • Jorgen Hansen, CEO of Gravitas Medical, expressed enthusiasm about the Breakthrough Device designation, stating, "The Breakthrough Device designation promises to accelerate the introduction of Entarik for neonatal patients."

SpineX Receives NIH SBIR Phase II Award for SCiP Clinical Trial in Children With CP

Retrieved on: 
Tuesday, September 26, 2023
Research, Medical Devices, Children, Neurology, Clinical Trials, Health Technology, Biotechnology, Consumer, Health, Science, US Foods, SBIR, Spinal cord, SCIP, Clinical trial, CP, Multimedia, Brain, Bangladesh Technical Education Board, Small Business Innovation Research, Cerebral palsy, Breakthrough, Small business, Movement disorder, FDA, NIH, Food, Safety, Pharmaceutical industry

These funds will go towards completing a pivotal clinical trial to test the efficacy and safety of our proprietary SCiP™ device in children living with Cerebral Palsy (CP).

Key Points: 
  • These funds will go towards completing a pivotal clinical trial to test the efficacy and safety of our proprietary SCiP™ device in children living with Cerebral Palsy (CP).
  • In investigational studies, SCiP technology has demonstrated the ability to treat the root cause of CP through spinal cord neuromodulation.
  • “We are honored to receive Phase II funding through the SBIR program,” says Kara Allanach, Director of Product at SpineX.
  • SpineX plans to begin recruiting participants for the SCiP pivotal trial in the first half of 2024 and is aiming to launch SCiP therapy in the US market in 2026.

MCRA Assists Ceribell with Obtaining FDA Breakthrough Device Designation, FDA Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device

Retrieved on: 
Monday, September 25, 2023
CMS, NTAP, Marketing, Software, Food and Drug Administration, MCRA, Market access, Clarity, Clinical trial, Hospital, Digital health, Patient, Physician, Machine learning, ESE, EEG, Quality assurance, Neurology, Diagnosis, Digital, ICU, FDA, Breakthrough, Food, Medical device, Policy, Computer security

MCRA's Neurology and Digital Health regulatory teams played a key role in successfully achieving both the Breakthrough Device Designation and clearance of the 510(k) premarket notification for Ceribell's ClarityPro device.

Key Points: 
  • MCRA's Neurology and Digital Health regulatory teams played a key role in successfully achieving both the Breakthrough Device Designation and clearance of the 510(k) premarket notification for Ceribell's ClarityPro device.
  • In addition, MCRA's Reimbursement, Health Economics, and Market Access team provided Ceribell with valuable insights, analyses, and strategic guidance on the NTAP application.
  • Raymond Woo, CTO of Ceribell said, "Ceribell feels extremely fortunate to have partnered with MCRA on ClarityPro as well as other projects.
  • The FDA Breakthrough Device program is itself relatively new, and the CMS NTAP alternative pathway for breakthrough devices is an even more recent development.

Zai Lab Obtains Breakthrough Therapy Designation for Efgartigimod Alfa Injection (Subcutaneous Injection) in Patients with Chronic Inflammatory Demyelinating Polyneuropathy in China

Retrieved on: 
Monday, September 18, 2023
SC, Safety, Policy, Breakthrough therapy, Quality of life, Medicine, ECI, Autoimmunity, HKEX, Chronic inflammatory demyelinating polyneuropathy, Patient, Risk, National Medical Products Administration, Breakthrough, Immunoglobulin G, CDE, International development, Biology, Center for Drug Evaluation and Research, NMPA, Infection, Autoantibody, Pharmaceutical industry, Rare-earth element, CIDP, Neuroscience

SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
  • The Breakthrough Therapy Designation for efgartigimod SC was supported by data from both global and Chinese patients enrolled in the ADHERE study.
  • “We have seen how efgartigimod SC can meaningfully improve and stabilize disease symptoms in these patients.
  • Existing treatment options are quite limited, and problematic given the general reliance on long-term steroid or chronic immunoglobulin therapy.

Department of Energy Awards Xcel Energy up to $70 Million for Long Duration Energy Storage

Retrieved on: 
Friday, September 22, 2023
Technology, Other Energy, Utilities, Oil, Gas, Coal, Alternative Energy, Energy, Batteries, Nuclear, U.S. Department of Energy, Office of Inspector General, Xcel Energy, Minnesota Department of Commerce, Form Energy, Ministry of Energy, Minnesota Public Utilities Commission, Electricity, DOE, Primary energy, Comanche, Sherburne County Generating Station, Wind, Commerce, Inflation Reduction Act of 2022, Form, Colorado Public Utilities Commission, Weather, Breakthrough, Sherburne County, Minnesota, Renewable energy, Construction, Becker

Xcel Energy announced today that it has received a grant of up to $70 million from the U.S. Department of Energy (DOE).

Key Points: 
  • Xcel Energy announced today that it has received a grant of up to $70 million from the U.S. Department of Energy (DOE).
  • The award will partially fund two long duration energy storage systems in Minnesota and Colorado.
  • Each demonstration-scale system will be a 10 megawatt/1,000 megawatt-hour iron-air battery developed by Massachusetts-based Form Energy.
  • The long duration energy storage systems will strengthen the grid against day-to-day and week-to-week variability of renewable energy.

INBRAIN Neuroelectronics Announces FDA Breakthrough Device Designation for Its Graphene-Based Intelligent Network Modulation Platform

Retrieved on: 
Tuesday, September 19, 2023
Neurology, FDA, Medical Devices, Health, Health Technology, BCI, Multimedia, Steel, Carbon, Biomarker, Science, DBS, BDD, Neuropsychiatric Disease and Treatment, Stanford University School of Medicine, Patient, Subthalamic nucleus, STN, Neuro, Breakthrough, Pharmaceutical industry, Medical imaging, Medical device

, a health-tech company dedicated to developing the world’s first intelligent graphene-neural platform, today announced that its Intelligent Network Modulation System has been granted Breakthrough Device Designation (BDD) from the U.S. Food & Drug Administration (FDA) as an adjunctive therapy for treating Parkinson’s disease.

Key Points: 
  • , a health-tech company dedicated to developing the world’s first intelligent graphene-neural platform, today announced that its Intelligent Network Modulation System has been granted Breakthrough Device Designation (BDD) from the U.S. Food & Drug Administration (FDA) as an adjunctive therapy for treating Parkinson’s disease.
  • The thinnest material known, yet stronger than steel, graphene’s unique combination of electrical and mechanical properties makes it ideal for neurotechnology innovation.
  • “Breakthrough device designation from the FDA signifies the potential of the INBRAIN neural platform to further improve the lives of patients with Parkinson’s disease,” said INBRAIN Neuroelectronics Clinical Affairs Head Dan Gnansia.
  • “INBRAIN’s new generation of ultrathin graphene-based high resolution interfaces and associated network platform may vastly improve the precision, efficiency and efficacy of DBS and closed-loop or adaptive modulation.