Device

SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration

Retrieved on: 
Friday, January 26, 2024

SS Innovations received acknowledgement of this pre submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17, 2024.

Key Points: 
  • SS Innovations received acknowledgement of this pre submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17, 2024.
  • The CDRH is responsible for regulating firms who manufacture, repackage, relabel, or import medical devices sold in the United States.
  • In addition, CDRH regulates medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems and ultrasound equipment.
  • SS Innovations Founder, Chairman and Chief Executive Officer, Dr. Sudhir Srivastava, commented, “The filing of our pre-submission application with the CDRH is a pivotal step for SS Innovations, and provides an opportunity for us to gather feedback in an interactive meeting with the FDA prior to our planned 510(k) premarket submission for the SSi Mantra™ Surgical Robotic System.

Modular Devices Invests In Flow Cleanrooms & Supply and Technical Air Products

Retrieved on: 
Thursday, January 25, 2024

Modular Devices ( www.modulardevices.com | www.portable-cleanroom.com ), a leading provider of mobile and modular cleanroom solutions and medical imaging equipment labs, and portfolio company of O2 Investment Partners ( www.o2investment.com ), announced today that it has partnered with Flow Cleanrooms ( www.flowcleanrooms.com ) and Technical Air Products ( www.technicalairproducts.com ).

Key Points: 
  • Modular Devices ( www.modulardevices.com | www.portable-cleanroom.com ), a leading provider of mobile and modular cleanroom solutions and medical imaging equipment labs, and portfolio company of O2 Investment Partners ( www.o2investment.com ), announced today that it has partnered with Flow Cleanrooms ( www.flowcleanrooms.com ) and Technical Air Products ( www.technicalairproducts.com ).
  • Dustin Deckrow, President of Flow Cleanrooms, commented, “The partnership with Modular Devices came at an opportune time as we are looking to rapidly expand our operations to better serve our customers.
  • There are other strategic opportunities we will continue to explore, and we are excited to see what the future holds.”
    Mark Koers, CEO of Modular Devices, noted, “The addition of Flow and TAP significantly increases Modular Devices’ cleanroom product and service offering.
  • The addition of Flow and TAP marks the second and third investment for Modular Devices in 2023 and the fourth investment since 2022.

Analog Devices Appoints Richard C. Puccio, Jr. as Executive Vice President and Chief Financial Officer

Retrieved on: 
Thursday, January 25, 2024

Analog Devices, Inc. (Nasdaq: ADI ) today announced that Richard C. Puccio, Jr. will join the company on February 5, 2024 as Executive Vice President and Chief Financial Officer.

Key Points: 
  • Analog Devices, Inc. (Nasdaq: ADI ) today announced that Richard C. Puccio, Jr. will join the company on February 5, 2024 as Executive Vice President and Chief Financial Officer.
  • In this role, Mr. Puccio will set ADI’s financial strategy and lead the company’s global finance operations.
  • View the full release here: https://www.businesswire.com/news/home/20240125388539/en/
    Analog Devices appoints Richard C. Puccio, Jr. as Executive Vice President and Chief Financial Officer (Photo: Business Wire)
    ​“Rich brings tremendous experience and capability from his more than three decades of leading financial advisory and high-growth business operations activities in complex technology sectors, and this makes him a great addition to ADI’s leadership team.
  • Mr. Puccio earned his AB in Economics from Harvard University and his MBA from Boston University.

CES 2024 Spotlight: Kepler's Humanoid Robot Launch Gains International Recognition

Retrieved on: 
Monday, January 22, 2024

LAS VEGAS, Jan. 22, 2024 /PRNewswire/ -- Kepler Exploration Robot Co., Ltd. ("Kepler") unveiled its groundbreaking Kepler Forerunner series of general-purpose humanoid robots ("Kepler Humanoid Robot") at the 2024 Consumer Electronics Show (CES) in Las Vegas.

Key Points: 
  • LAS VEGAS, Jan. 22, 2024 /PRNewswire/ -- Kepler Exploration Robot Co., Ltd. ("Kepler") unveiled its groundbreaking Kepler Forerunner series of general-purpose humanoid robots ("Kepler Humanoid Robot") at the 2024 Consumer Electronics Show (CES) in Las Vegas.
  • The showcase marked Kepler's first participation in a major global exhibition following the official launch of its humanoid robots.
  • The Kepler Humanoid Robot garnered immediate attention from numerous professional visitors at the event, including several of the industry's most respected experts.
  • Debo Hu, Co-founder and Vice President of Kepler, personally introduced the line-up of guests to the Kepler Humanoid Robot.

Regu(AI)ting Health: Lessons for Navigating the Complex Code of AI and Healthcare Regulations

Retrieved on: 
Wednesday, January 24, 2024

Authors: Stephanie Wong, Amber Ezzell, & Felicity Slater As an increasing number of organizations utilize artificial intelligence (“AI”) in their patient-facing services, health organizations are seizing the opportunity to take advantage of the new wave of AI-powered tools. Policymakers, from United States (“U.S.”) government agencies to the White House, have taken heed of this trend, [?]

Key Points: 


Authors: Stephanie Wong, Amber Ezzell, & Felicity Slater As an increasing number of organizations utilize artificial intelligence (“AI”) in their patient-facing services, health organizations are seizing the opportunity to take advantage of the new wave of AI-powered tools. Policymakers, from United States (“U.S.”) government agencies to the White House, have taken heed of this trend, [?]

McDermott Boosts FDA Practice With Five Lawyer Team

Retrieved on: 
Tuesday, January 16, 2024

WASHINGTON , Jan. 16, 2024 /PRNewswire/ -- International law firm McDermott Will & Emery welcomes a new five lawyer US Food and Drug Administration (FDA) team to its Healthcare Practice Group.

Key Points: 
  • WASHINGTON , Jan. 16, 2024 /PRNewswire/ -- International law firm McDermott Will & Emery welcomes a new five lawyer US Food and Drug Administration (FDA) team to its Healthcare Practice Group.
  • "We have long sought to expand and bolster our existing FDA team by adding industry-leading practitioners like Jamie and Paul," said Jerry Sokol , global head of Healthcare at McDermott.
  • The practice was also recognized by Chambers as "Healthcare Team of the Year" in 2010, 2013, 2017, 2019 and 2022.
  • And adding Paul in San Francisco allows us to extend our already robust FDA practice coast to coast," said Doug Carsten , global head of McDermott's global Life Sciences Practice Group.

Direct Source Connects Retailers with Innovative Technology at NRF: Retail’s Big Show 2024

Retrieved on: 
Monday, January 15, 2024

Direct Source , the leading retail technology consultant and integrator, has unveiled the latest in retail technology and will be showcasing solutions at NRF: Retail’s Big Show in New York City January 14-16, booth #5839.

Key Points: 
  • Direct Source , the leading retail technology consultant and integrator, has unveiled the latest in retail technology and will be showcasing solutions at NRF: Retail’s Big Show in New York City January 14-16, booth #5839.
  • "We're thrilled to engage with retailers at NRF 2024,” said Brad Fick, president of Direct Source.
  • Leveraging their comprehensive product knowledge, Direct Source’s technology experts analyze each retailer’s business goals, future technology needs and pain points to create the optimal in-store experience.
  • For more information about Direct Source’s complete retail solutions, visit: www.directsource.com or visit booth #5839 at NRF: Retail’s Big Show.

Analog Devices Deploys SambaNova Suite to Facilitate Breakthrough Generative AI Capabilities at Enterprise Scale

Retrieved on: 
Wednesday, January 10, 2024

Analog Devices, Inc. (Nasdaq: ADI ), global semiconductor leader, and SambaNova Systems , makers of the only purpose-built, full-stack AI platform, announced that ADI is deploying SambaNova Suite to spearhead its global AI transformation, making AI pervasive enterprise-wide.

Key Points: 
  • Analog Devices, Inc. (Nasdaq: ADI ), global semiconductor leader, and SambaNova Systems , makers of the only purpose-built, full-stack AI platform, announced that ADI is deploying SambaNova Suite to spearhead its global AI transformation, making AI pervasive enterprise-wide.
  • “The SambaNova Suite solution offers a quicker way for ADI to deploy generative AI enterprise-wide with global impact.
  • We’re delighted to be working together.”
    SambaNova Suite is the first full stack, generative AI platform, from chip to models, for the enterprise.
  • "Seeing generative AI moving beyond experimentation to enterprise use cases signals the next wave of market maturity has begun."

Mark Koers Appointed CEO of Modular Devices in 2024 Leadership Transition

Retrieved on: 
Tuesday, January 9, 2024

Modular Devices , a nationwide leader in mobile imaging and cleanroom solutions, announces a pivotal leadership transition as Greg Mink steps down as CEO, passing the baton to Mark Koers, effective January 1, 2024.

Key Points: 
  • Modular Devices , a nationwide leader in mobile imaging and cleanroom solutions, announces a pivotal leadership transition as Greg Mink steps down as CEO, passing the baton to Mark Koers, effective January 1, 2024.
  • Mark Koers, previously serving as Chief Revenue Officer, shared his appreciation with the Modular Devices team in an end-of-the-year letter.
  • Expressing excitement about the upcoming year, Koers outlined strategic plans and his vision for Modular Devices as the newly appointed CEO.
  • “Greg’s leadership and vision have taken Modular Devices to where it is today.

Settlement Administrator Angeion Group Announces Proposed Settlement in In Re Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Litigation Class Action

Retrieved on: 
Thursday, January 11, 2024

PHILADELPHIA, Jan. 11, 2024 /PRNewswire/ -- A proposed Settlement of Economic Loss Claims has been reached in a U.S. class action lawsuit against Defendants Philips RS North America LLC ("Philips RS"), Koninklijke Philips N.V., Philips North America LLC, Philips Holding USA, Inc., and Philips RS North America Holding Corporation (collectively, the "Philips Defendants"), related to CPAP, BiPAP and ventilator devices sold in the United States between 2008 and 2021 that Philips RS recalled beginning in June 2021.  Plaintiffs in this lawsuit allege that the particular type of noise-reducing foam used in the recalled devices was defective. The Settlement is intended to resolve Economic Loss Claims only and does not affect or release any claims for personal injuries or medical monitoring relief.

Key Points: 
  • If You Paid For A Philips CPAP, BIPAP, Or Ventilator That Was Recalled By Philips RS North America LLC Beginning in June 2021, A Class Action Settlement May Affect Your Legal Rights.
  • Plaintiffs in this lawsuit allege that the particular type of noise-reducing foam used in the recalled devices was defective.
  • The Settlement is intended to resolve Economic Loss Claims only and does not affect or release any claims for personal injuries or medical monitoring relief.
  • You may be eligible to receive a payment if you paid for a Philips Respironics CPAP, BiPAP, or Ventilator that was recalled.