Cochlear

FDA approves Cochlear's Nucleus 8 Sound Processor, smaller, smarter, better connected cochlear implant technology

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Tuesday, November 1, 2022
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LONE TREE, Colo., Nov. 1, 2022 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, receives U.S. Food and Drug Administration (FDA) approval for the Cochlear™ Nucleus® 8 Sound Processor. The Nucleus 8 Sound Processor is now the smallest and lightest behind-the-ear cochlear implant sound processor available in the industry. 1-3 It is also the world's first cochlear implant sound processor ready to provide direct audio connectivity to everyday consumer electronics using the next generation LE Audio technology from Bluetooth®.1-3,#

Key Points: 
  • The Nucleus 8 Sound Processor is now the smallest and lightest behind-the-ear cochlear implant sound processor available in the industry.
  • The Nucleus 8 Sound Processor builds on the direct streaming capabilities available in Cochlear's latest sound processors.
  • In addition to the Nucleus 8 Sound Processor, Cochlear is expanding its Connected Care solutions for Nucleus Implant System recipients.
  • The Nucleus 8 Sound Processor will be commercially available across the United States and Canada by the end of 2022.

Sensorion Announces First Patient Enrolled in Proof-of-Concept Clinical Trial of SENS-401 for Residual Hearing Preservation During Cochlear Implantation

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Wednesday, September 14, 2022
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At the beginning of 2021, Sensorion disclosed positive preclinical data demonstrating that the combination of SENS-401 alongside a cochlear implant helped reduce loss of residual hearing at a frequency located beyond the electrode array.

Key Points: 
  • At the beginning of 2021, Sensorion disclosed positive preclinical data demonstrating that the combination of SENS-401 alongside a cochlear implant helped reduce loss of residual hearing at a frequency located beyond the electrode array.
  • Preclinical studies were undertaken in collaboration with the global leader in implantable hearing, Cochlear Ltd.
    We are very pleased to commence this trial in collaboration with Cochlear, said Graldine Honnet, Chief Medical Officer of Sensorion.
  • With encouraging supporting preclinical data, we believe that SENS-401 has the potential to improve the preservation of residual hearing in patients receiving cochlear implants.
  • Sensorion has entered into a broad strategic collaboration with Institut Pasteur focused on the genetics of hearing.

Avail Reaches Significant Network Expansion Milestone with the Signing of its 50th MedTech Contract

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Thursday, August 4, 2022
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SANTA CLARA, Calif., Aug. 4, 2022 /PRNewswire/ -- Avail, the digital hub of the operating room enabling the medical technology (MedTech) and healthcare industries to work smarter to advance patient care, today announced the addition of a 50th MedTech organization to its telepresence network. With the signing of this contract, the Avail platform is poised to enable hundreds of thousands of people to collaborate, educate, and share surgical and MedTech expertise between operating rooms and remote locations in real time.

Key Points: 
  • With the signing of this contract, the Avail platform is poised to enable hundreds of thousands of people to collaborate, educate, and share surgical and MedTech expertise between operating rooms and remote locations in real time.
  • "With this exciting milestone, the digital evolution of MedTech is well underway.
  • Today, 50 MedTech organizations have contracted with Avail to rethink commercial models, reduce inefficiencies, and enhance the reach and timeliness of collaboration.
  • Avail was founded in 2017 by MedTech veterans with a vision to leverage Silicon Valley technology expertise to evolve the industry and enable MedTech and healthcare to deliver the best care possible.

Osler Diagnostics Appoints Chris Smith as Chairman of the Board and David Berry as a Non-Executive Director

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Monday, March 21, 2022
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Oxford, UK 21 March 2022: Osler Diagnostics (Osler or the Company) is pleased to announce the appointment of Chris Smith as Chairman of the Board of Directors and David Berry as a Non-Executive Director, with immediate effect.

Key Points: 
  • Oxford, UK 21 March 2022: Osler Diagnostics (Osler or the Company) is pleased to announce the appointment of Chris Smith as Chairman of the Board of Directors and David Berry as a Non-Executive Director, with immediate effect.
  • Chris Smith is the CEO of Ortho Clinical Diagnostics (Ortho), a leading global diagnostic company.
  • Chris Smith, Chairman of Osler, commented: I am excited to take on the role of Chairman at such a pivotal time for the Company.
  • David Berry, Non-Executive Director of Osler, added: I firmly believe we are at the precipice of a new era in healthcare.

Sycle, Industry-Leading Practice Management Software Provider, Announces New President

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Thursday, March 17, 2022
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DENVER, March 17, 2022 /PRNewswire-PRWeb/ -- Sycle LLC, the leading practice management solution provider in hearing healthcare, is pleased to announce that Joel Lockwood has been appointed President of Sycle.

Key Points: 
  • DENVER, March 17, 2022 /PRNewswire-PRWeb/ -- Sycle LLC, the leading practice management solution provider in hearing healthcare, is pleased to announce that Joel Lockwood has been appointed President of Sycle.
  • His management experience includes enterprise, start-ups and agency organizations, working with F500 customers as well as small businesses.
  • "We're excited to have Joel on board as President," said Tony Manna, President of Cochlear Americas /Cochlear LTD., Sycle's parent company.
  • It started as an idea to help audiologists better connect with their patients; today, Sycle has evolved into the audiology industry's number one practice management software.

CAI APAC Adds to its Leadership Team

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Tuesday, March 8, 2022
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SYDNEY, March 8, 2022 /PRNewswire/ -- CAI , a global consulting company that provides technical, operational consulting, and project management services to life sciences, data centers, and process manufacturing industries, today announced the promotion of John Wrenn to the APAC leadership team.

Key Points: 
  • SYDNEY, March 8, 2022 /PRNewswire/ -- CAI , a global consulting company that provides technical, operational consulting, and project management services to life sciences, data centers, and process manufacturing industries, today announced the promotion of John Wrenn to the APAC leadership team.
  • Prior to joining CAI, John spent 13 years working in Australia in the Biomedical and medical packaging sectors.
  • His appointment further solidifies our position in the Australian market at the forefront of the data center, pharmaceutical, and biotechnology industries," said Sam Williamson, CAI Vice President for APAC.
  • With the growth of CAI, the projects delivered, and knowledge gained, CAI has the experience to support the Australian Biotech market and provide integrated solutions to drive speed to patient.

DGAP-News: Minimally Invasive Epilepsy Treatment EASEE Receives FDA Breakthrough Device Designation

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Tuesday, February 22, 2022
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Heidelberg, 22.02.2022 - Heidelberg-based Precisis GmbH has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its EASEE brain stimulator.

Key Points: 
  • Heidelberg, 22.02.2022 - Heidelberg-based Precisis GmbH has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its EASEE brain stimulator.
  • Precisis is a medical device company developing minimally invasive neurostimulation methods to free epilepsy patients from their seizures.
  • EASEE, on the other hand, is not only minimally invasive, but the product also allows treatment to be customized to each patient.
  • By classifying EASEE as a "Breakthrough Device," the FDA now also recognizes the potential innovative power of the new treatment method.

Cochlear announces 2022 winners of annual scholarships

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Wednesday, February 2, 2022
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LONE TREE, Colo., Feb. 2, 2022 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced today the winners of the 20th annual Graeme Clark and the 11th annual Anders Tjellstrm Scholarships.

Key Points: 
  • LONE TREE, Colo., Feb. 2, 2022 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced today the winners of the 20th annual Graeme Clark and the 11th annual Anders Tjellstrm Scholarships.
  • The scholarships, named after two pioneers of the hearing implant industry, recognize Cochlear Nucleus Implant, Cochlear Baha System and Cochlear Osia System recipients in the United States and Canada who uphold the Cochlear ideals of leadership and humanity, and demonstrate high academic achievement.
  • The scholarships enable Cochlear hearing implant recipients to further accomplish their goals through education.
  • Cochlear recognizes winners of the 20th annual Graeme Clark and the 11th annual Anders Tjellstrm Scholarships.

FDA approves Cochlear Nucleus Implants for unilateral hearing loss/single-sided deafness

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Tuesday, January 11, 2022
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LONE TREE, Colo., Jan. 11, 2022 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval of Cochlear Nucleus Implants for the treatment of unilateral hearing loss (UHL)/single-sided deafness (SSD).

Key Points: 
  • LONE TREE, Colo., Jan. 11, 2022 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval of Cochlear Nucleus Implants for the treatment of unilateral hearing loss (UHL)/single-sided deafness (SSD).
  • FDA approves use of a cochlear implant from Cochlear for unilateral hearing loss/single-sided deafness.
  • Now with this approval, Cochlear is proud to offer the most hearing implant options available to those with unilateral hearing loss/single-sided deafness through our cochlear implant and bone conduction solutions," said Christine Menapace, MA, Vice President, Clinical Affairs, Cochlear Americas.
  • Cochlear will now support those with UHL/SSD by offering its cochlear implant, the Cochlear Nucleus System, and bone conduction solutions, the Cochlear Osia System and the Cochlear Baha System.

Valencia Technologies Strengthens Leadership Team with Key Appointments

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Monday, November 29, 2021
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VALENCIA, Calif., Nov. 29, 2021 /PRNewswire/ -- Valencia Technologies, a privately held company, today announced the expansion of its leadership team with the appointments of Jerry Schloffman as Chief Commercial Officer, Jim Crines as Interim Chief Financial Officer, Arthur Rasconas Senior Vice President of Operations, and Ann Decker as Vice President of Reimbursement and Health Policy.

Key Points: 
  • VALENCIA, Calif., Nov. 29, 2021 /PRNewswire/ -- Valencia Technologies, a privately held company, today announced the expansion of its leadership team with the appointments of Jerry Schloffman as Chief Commercial Officer, Jim Crines as Interim Chief Financial Officer, Arthur Rasconas Senior Vice President of Operations, and Ann Decker as Vice President of Reimbursement and Health Policy.
  • He joins Valencia from Sycle where he served as President of the Audiology and Hearing Aid Practice Management Software business.
  • Prior to his last role at Cochlear, Mr. Schloffman served as Chief of Clinical Operations at Valencia.
  • Valencia Technologies Corporation ("Valencia"), a private medical technology company located in Valencia, California, designed and manufactured its eCoin device for the treatment of urgency urinary incontinence (UUI).