Associated tags: Seizure, Intensive care medicine, EEG, Diagnosis, Oscillation, Patient, FDA, Medical device, Hospital, ICU, ESE, Neurology, NTAP, Pharmaceutical industry, CMS, AI
Locations: PENNSYLVANIA, MOUNTAIN VIEW, CALIFORNIA, UNITED STATES, CA
SUNNYVALE, Calif., April 2, 2024 /PRNewswire/ -- Today, Ceribell, Inc.®, the developer of the first AI-powered point-of-care EEG diagnostic system, announced the appointment of Sean Manni as Senior Vice President of Sales. In this role, Mr. Manni will lead Ceribell's commercial sales organization as it continues to expand its U.S. footprint.
Key Points:
- SUNNYVALE, Calif., April 2, 2024 /PRNewswire/ -- Today, Ceribell, Inc.®, the developer of the first AI-powered point-of-care EEG diagnostic system, announced the appointment of Sean Manni as Senior Vice President of Sales.
- In this role, Mr. Manni will lead Ceribell's commercial sales organization as it continues to expand its U.S. footprint.
- "Joining Ceribell represents a unique opportunity to collaborate with an exceptional leadership and sales team," said Manni.
- Most recently, he served as Vice President, North America Sales at Omnicell, a healthcare service company.
Retrieved on:
Thursday, January 4, 2024
SUNNYVALE, Calif., Jan. 4, 2024 /PRNewswire/ -- Ceribell, Inc.®, the developer of the first AI-powered point-of-care EEG system, announced today that Jane Chao, Ph.D., CEO and Co-founder, will present at the upcoming 42nd Annual J.P. Morgan Healthcare Conference.
Key Points:
- SUNNYVALE, Calif., Jan. 4, 2024 /PRNewswire/ -- Ceribell, Inc.®, the developer of the first AI-powered point-of-care EEG system, announced today that Jane Chao, Ph.D., CEO and Co-founder, will present at the upcoming 42nd Annual J.P. Morgan Healthcare Conference.
- The presentation will take place on Monday, January 8, 2024, at 8:00 a.m. Pacific Standard Time.
FDA,
ESE,
Seizure,
Medicare,
Neurology,
Health,
NTAP,
Centers for Medicare & Medicaid Services,
Hospital,
EEG,
Patient,
Status epilepticus,
CMS,
ICU,
Medical imaging,
Medical device SUNNYVALE, Calif., Oct. 30, 2023 /PRNewswire/ -- Ceribell, Inc.® today announced the commercial release of its new AI algorithm, ClarityPro™, accompanying the availability of potential additional reimbursement for eligible Medicare patients.
Key Points:
- ClarityPro is an AI-based software algorithm within the Ceribell EEG system that analyzes EEG waveforms to diagnose electrographic status epilepticus (ESE).
- It is the first acute care device to be FDA indicated for stand-alone diagnosis.
- Ceribell is dedicated to expanding access to neurodiagnostics, which is essential to improving patient care and outcomes," said Jane Chao, Ph.D.,Ceribell's Co-founder and CEO.
- For additional information about ClarityPro, the FDA Breakthrough Device program, the CMS NTAP program, and status epilepticus, visit https://ceribell.com/ClarityPro .
Mathematics,
Medicine,
Harvard University,
McKinsey & Company,
Hospital,
EEG,
Growth,
AI,
Massachusetts Institute of Technology,
Medical device,
Management,
Neuroscience,
Applied mathematics SUNNYVALE, Calif., Oct. 2, 2023 /PRNewswire/ -- Today, Ceribell, Inc.®, the developer of the first AI-powered point-of-care EEG diagnostic system, announced the appointment of Joshua Copp as Chief Operating Officer. As COO, Mr. Copp will contribute to the business by delivering commercial and strategic guidance as the company scales.
Key Points:
- The 12-year McKinsey & Co. alum will oversee operations at the AI-powered point-of-care neurodiagnostics company
SUNNYVALE, Calif., Oct. 2, 2023 /PRNewswire/ -- Today, Ceribell, Inc.®, the developer of the first AI-powered point-of-care EEG diagnostic system, announced the appointment of Joshua Copp as Chief Operating Officer.
- As COO, Mr. Copp will contribute to the business by delivering commercial and strategic guidance as the company scales.
- "Ceribell stands at the forefront of medical technology, reshaping the landscape of neurodiagnostics," said Mr. Copp.
- Mr. Copp had a 12-year tenure at McKinsey & Company, including four years as a partner.
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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.
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Thursday, August 31, 2023
University,
General counsel,
Business,
Assistant,
Paul Merage School of Business,
Patient,
Ethics,
Growth,
Diagnosis,
AI,
Ferhat Ozcep,
Medical device,
Pharmaceutical industry,
Pfizer SUNNYVALE, Calif., Aug. 31, 2023 /PRNewswire/ -- Ceribell, Inc.®, the pioneer in AI-powered point-of-care neurodiagnostics, today announced Louisa Daniels has joined the medical device company as its General Counsel. In this role, Ms. Daniels will lead the company's legal, governance, compliance, and ethics functions.
Key Points:
- SUNNYVALE, Calif., Aug. 31, 2023 /PRNewswire/ -- Ceribell, Inc.®, the pioneer in AI-powered point-of-care neurodiagnostics, today announced Louisa Daniels has joined the medical device company as its General Counsel.
- Ms. Daniels brings a wealth of experience to Ceribell, with over 30 years in the biopharma industry.
- Previously, she was Chief Legal Officer, General Counsel and Chief Compliance Officer for Recursion Pharmaceuticals, which she helped take public in April 2021.
- Before Recursion, Ms. Daniels was a Vice President and Assistant General Counsel at Pfizer, where she served at various times as Chief Counsel for Global Product Development; Global Commercial Operations, Strategy & Portfolio Management; and Pharmatherapeutics R&D.
Hospice and palliative medicine,
Seizure,
Status epilepticus,
CMS,
NTAP,
Centers for Medicare & Medicaid Services,
Medicare,
Triage,
Patient,
Risk,
ESE,
EEG,
Brain,
Diagnosis,
ICU,
ACNS,
FDA,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Food,
Neurology,
Software,
Pharmaceutical industry,
Medical device,
Health insurance,
Medical imaging SUNNYVALE, Calif., Aug. 3, 2023 /PRNewswire/ -- Ceribell, Inc.® today announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. Centers for Medicare and Medicaid Services (CMS) granted New Technology Add-on Payment (NTAP) for ClarityPro of up to $913.90 per eligible Medicare patient case.
Key Points:
- SUNNYVALE, Calif., Aug. 3, 2023 /PRNewswire/ -- Ceribell, Inc.® today announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE).
- ClarityPro is now the only FDA-indicated device for the diagnosis of ESE in adult patients over the age of 18.
- ClarityPro is also the first and only device to offer NTAP reimbursement for the diagnosis of ESE.
- For additional information about the FDA Breakthrough Device program, the CMS NTAP program, and status epilepticus, visit https://ceribell.com/ClarityPro .
FDA,
AI,
Delirium,
Brain,
Machine learning,
Early stage innovation company,
Patient,
OpenAI,
Seizure,
Risk,
Microsoft,
Hope,
Hospital,
EEG,
Medical device,
Nursing,
Spotify SUNNYVALE, Calif., March 2, 2023 /PRNewswire/ -- Ceribell, Inc., developer of the world's first brain monitor for point-of-care seizure detection, has been named to Fast Company's prestigious annual list of the World's Most Innovative Companies for 2023.
Key Points:
- SUNNYVALE, Calif., March 2, 2023 /PRNewswire/ -- Ceribell, Inc., developer of the world's first brain monitor for point-of-care seizure detection, has been named to Fast Company's prestigious annual list of the World's Most Innovative Companies for 2023.
- Each year, Fast Company's Most Innovative Companies list identifies products, services, and initiatives from around the globe that are poised to have a transformative impact across all sectors of the economy.
- Ceribell joins the ranks of Microsoft, OpenAI, Stripe, Spotify, Seegene, and others that Fast Company has recognized for paving the way for the innovations of tomorrow.
- Ceribell is the first and only device to have received an FDA Breakthrough Designation for the screening and monitoring of delirium.
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Thursday, January 5, 2023
SUNNYVALE, Calif., Jan. 5, 2023 /PRNewswire/ -- Ceribell, Inc., developer of the world's first brain monitor for point-of-care seizure detection, announced today that Jane Chao, CEO and Co-founder, will present at the upcoming 41st Annual J.P. Morgan Healthcare Conference.
Key Points:
- SUNNYVALE, Calif., Jan. 5, 2023 /PRNewswire/ -- Ceribell, Inc., developer of the world's first brain monitor for point-of-care seizure detection, announced today that Jane Chao, CEO and Co-founder, will present at the upcoming 41st Annual J.P. Morgan Healthcare Conference.
- The presentation will take place on Monday, January 9, 2023, at 2:00 p.m. Pacific Standard Time.
Retrieved on:
Tuesday, January 26, 2021
Research,
Pharmaceutical,
Hardware,
Data management,
Medical devices,
Technology,
Hospitals,
Clinical trials,
Science,
Biotechnology,
FDA,
Health,
Drugs,
Psychoactive drugs,
Neurochemistry,
Sedatives,
GABAA receptor positive allosteric modulators,
Chloroarenes,
Epilepsy,
Benzodiazepine,
Status epilepticus,
RSE,
Clinical trial,
Ketamine,
the RAISE Trial,
Status Epilepticus (SE),
the Ceribell Rapid Response EEG System,
Ceribell,
Marinus Pharmaceuticals The study will examine the proportion of participants with RSE who experience status epilepticus cessation within 30 minutes of initiation of IV ganaxolone as well as the rate of progression to IV anesthesia.
Key Points:
- The study will examine the proportion of participants with RSE who experience status epilepticus cessation within 30 minutes of initiation of IV ganaxolone as well as the rate of progression to IV anesthesia.
- The Phase 3 RAISE Trial is a randomized, double-blind, placebo-controlled trial in status epilepticus (SE) patients who have failed benzodiazepines and two or more second line intravenous AEDs.
- If treatment with the first IV AED following benzodiazepines is ineffective, the patient is considered to have refractory SE (RSE).
- Examples of forward-looking statements contained in this press release include, among others, statements regarding our clinical development plans for ganaxolone; our expectations for clinical trial sites for our Phase 3 trial in refractory status epilepticus; the potential safety and efficacy of ganaxolone; and the therapeutic potential of ganaxolone.
