IDE

ASE’s VIPack™ Enables Innovational AI Devices Through Advanced Interconnect Technology for Chiplets

Retrieved on: 
Wednesday, March 20, 2024
Semiconductor, Engineering, Technology, Manufacturing, Artificial Intelligence, Hardware, IO, AP, SOC, Integration, Artificial intelligence, TAIEX, IDE, AI, Senior, Marketing, IP, Creativity, Chiplet, Corporation, Printed circuit board

This interconnect extension advances roadmap capabilities from a chip-on-wafer interconnect pitch of 40um to 20um through advanced microbump technology.

Key Points: 
  • This interconnect extension advances roadmap capabilities from a chip-on-wafer interconnect pitch of 40um to 20um through advanced microbump technology.
  • As the chiplet design approach accelerates, ASE’s advanced interconnect technology allows designers to consider innovative, high density chiplet integration options where there might normally be chip IO density limitations for true 3D layered IP block considerations.
  • ASE’s microbump technology allows for a reduction in pitch from 40um down to 20um using a new metallurgical stack.
  • Fine pitch interconnect capabilities enable a 3D integration capability as well as a higher density for high IO memory considerations.

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Retrieved on: 
Tuesday, April 2, 2024
Chronic kidney disease, DCB, Kidney disease, Patient, Arteriovenous fistula, IDE, Sirolimus, Quality of life, Trial of the century, Fistula, Clinical trial, Kidney, AVF, PMA, US FDA, Safety, Food, FDA, Health, Pharmaceutical industry

Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

Key Points: 
  • Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
  • The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.
  • This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V.
  • With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients' lives worldwide.

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Retrieved on: 
Tuesday, April 2, 2024
Chronic kidney disease, DCB, Kidney disease, Patient, Arteriovenous fistula, IDE, Sirolimus, Quality of life, Trial of the century, Fistula, Clinical trial, Kidney, AVF, PMA, US FDA, Safety, Food, FDA, Health, Pharmaceutical industry

Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

Key Points: 
  • Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
  • The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.
  • This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V.
  • With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients' lives worldwide.

Spineart Secures more than CHF20 Million in Convertible Financing Following Completion of BAGUERA®C IDE Studies Enrollment

Retrieved on: 
Monday, March 18, 2024
Patient, Surgeon, Multimedia, Research, Investment, IDE, Enabling, Safety

GENEVA, March 18, 2024 /PRNewswire/ -- Spineart, a global spine specialist working with surgeons to accelerate the adoption of cutting-edge technologies, has successfully raised a CHF20 million convertible financing.

Key Points: 
  • GENEVA, March 18, 2024 /PRNewswire/ -- Spineart, a global spine specialist working with surgeons to accelerate the adoption of cutting-edge technologies, has successfully raised a CHF20 million convertible financing.
  • The funding comes on the heels of the completion of enrollment in the two BAGUERA®C IDE studies, underlining Spineart's commitment to advancing spinal surgery through large scale investments in research and development.
  • Approximately CHF16 million of the funding was contributed by existing shareholders and employees, with the remaining portion sourced from new investors, above the CHF20 million initial target, with the company exercising its over-allotment allocation option.
  • "We are thrilled to announce the successful closure of our CHF20 million convertible financing round, which underscores the confidence and support of our investors in Spineart's vision and innovative technologies," said Jerome Trividic, CEO of Spineart.

Global and China Automotive RISC-V Chip Industry Research Report 2024: Customized Chips May Become the Future Trend, and RISC-V will Challenge ARM

Retrieved on: 
Friday, March 15, 2024
ISA, Research, Certification, IO, SOC, Memory, Veyron, Qualcomm, Computing, Threshold, Electronics, RISC, Internet, IATF, ARM, IDE, Software, Architecture, IP, SiFive, Ecosystem, X86, NXP, Patent, Family, CPU, Economics, UCIe, ICT, Video game

DUBLIN, March 14, 2024 /PRNewswire/ -- The "Automotive RISC-V Chip Industry Research Report, 2024" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, March 14, 2024 /PRNewswire/ -- The "Automotive RISC-V Chip Industry Research Report, 2024" report has been added to ResearchAndMarkets.com's offering.
  • In contrast, ARM and X86 are not only complicated in instruction set development, but also difficult to obtain authorization to modify instruction sets.
  • In terms of customization, it enables designers to create thousands of potential customized processors, thus speeding up the time to market.
  • In the past, automotive chips were mainly based on ARM or private architectures of some European chip companies.

Google Cloud Announces New Generative AI Advancements for Healthcare and Life Science Organizations

Retrieved on: 
Tuesday, March 12, 2024
CIO, Fact, MEDITECH, Oscar Health, Health, Google Cloud, Organization, Innovation, FHIR, Responsibility, Partnership, SVP, Health care, Classification, Health information management, IDE, AI, Electronic health record, MD, Medscape, MBA, HIPAA, World Health Organization, HDE, Cancer, Hallucination, Launch, API, Condition, EHR, Language, Machine learning, HCA Healthcare, Telus Health, Expanse, CAQH, Medical device

ORLANDO, Fla., March 12, 2024 /PRNewswire/ -- Today at HIMSS24, Google Cloud announced several new solutions to help healthcare and life sciences organizations enable interoperability, build a better data foundation for their businesses, and deploy generative AI (gen AI) tools to improve patient outcomes.

Key Points: 
  • These search and question-answering capabilities now integrate with MedLM , Healthcare Data Engine (HDE) and Cloud Healthcare FHIR APIs , making it easier for healthcare and life science organizations to build the data analytics and AI solutions needed for next era health systems.
  • Configurable cloud APIs: Healthcare application developers can integrate the medically-tuned search directly into the clinician workflow tools using configurable cloud APIs.
  • "Not all generative AI is created equal, and in healthcare, the stakes are particularly high," said Aashima Gupta, global director for Healthcare Strategy & Solutions, Google Cloud.
  • For more information on these technology advancements for healthcare and life sciences, stop by the Google booth #2512 at HIMSS24 , and please contact your Google Cloud sales team to learn more.

Devart Announces Top Three Bestselling Product Lines of 2023 

Retrieved on: 
Monday, March 11, 2024
G2, Acquisition, SQL Server, MySQL, SQL, Growth, HTTPS, IDE, GUI, Enterprise, ODBC, MariaDB, Data, Video game

Prague, Czech Republic, March 11, 2024 (GLOBE NEWSWIRE) -- Devart, a leading provider of database management software, announces its most performing product lines of 2023.

Key Points: 
  • Prague, Czech Republic, March 11, 2024 (GLOBE NEWSWIRE) -- Devart, a leading provider of database management software, announces its most performing product lines of 2023.
  • In 2023, Devart launched a brand new strategy for all product lines, prioritizing the enhancement of product quality, customer experience, and international expansion.
  • The dbForge for SQL Server product line showed 19.6% growth in new orders last year, followed by ODBC Drivers and dbForge Studio for MySQL.
  • Devart CEO Dmytro Nikolaenko comments: "The results demonstrate the effectiveness of Devart's diversified product portfolio and our ability to offer optimal solutions to our customers.

InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 6, 2024
CMS, Pi, Growth, Radiology, IDE, State university system, CAD, Buffalo, PMA, MDR, TEL, Medical device regulation, Health, Stroke, CAS, TCAR, EPS, EFS, Thomas Jefferson University, European, Carotid artery stenosis, Myocardial infarction, CE marking, Vascular disease, Thrombectomy, Clinical trial, Medicaid, NPS, CEA, Good Samaritan Hospital, Stenosis, Risk, Blood vessel, Medicare, Death, Stent, Patient, Medicine, NSPR, Pharmaceutical industry

TEL AVIV, Israel and MIAMI, March 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • Fourth Quarter 2023 and Recent Developments:
    Generated record CGuard revenue in the fourth quarter 2023 of $1.76 million, a 71.6% increase over the fourth quarter of 2022.
  • Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of 74.5%.
  • Financial Results for the Fourth Quarter Ended December 31, 2023
    For the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022.
  • Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter of 2022.

NeuroPace Announces Record Full Year 2023 Revenue of $65.4 Million

Retrieved on: 
Tuesday, March 5, 2024
Hemispherectomy, Project, Investment, FDA, Telephone, Growth, IDE, RNS, Conference, Responsive neurostimulation device, EEG, Webcast, Patient, United, Epilepsy, Idiopathic generalized epilepsy, Pivotal, CARE, Video game

MOUNTAIN VIEW, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Total revenue in the fourth quarter of 2023 grew 41% to $18.0 million, compared with $12.8 million in the fourth quarter of 2022, and increased 10% compared with $16.4 million in the third quarter of 2023.
  • R&D expense in the fourth quarter of 2023 was $5.4 million compared with $5.1 million in the same period of 2022.
  • SG&A expense in the fourth quarter of 2023 was $13.2 million compared with $13.6 million in the prior year period.
  • Loss from operations was $27.2 million in 2023, including $9.6 million of stock-based compensation, compared with $40.8 million in 2022.

Nuwellis, Inc. Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024
Diuretic, Operating cost, Absorption, FDA, Growth, SCD, Cirrhosis, IDE, SeaStar, Nephrology, Webcast, Patient, Pediatrics, CRRT, CRRC, THT, Research, PIK, Pharmaceutical industry

Fourth quarter pediatric revenue grew 35% year over year; 28% increase in utilization and a 49% increase in console sales.

Key Points: 
  • Fourth quarter pediatric revenue grew 35% year over year; 28% increase in utilization and a 49% increase in console sales.
  • Gross margin was 54.4% for the fourth quarter of 2023, compared to 56.9% in the prior-year period, a decrease of 250 basis points.
  • Selling, general and administrative expenses for the fourth quarter of 2023 were $3.6 million, compared to $4.7 million in the prior-year period.
  • Total operating expenses for the fourth quarter of 2023 were $5.0 million, a 15% decrease compared to $5.9 million in the prior-year period.