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Author: JALEX Medical

RTsafe, with collaboration from JALEX Medical, gets 510(k) FDA clearance for Personalized PseudoPatient™.

By JALEX Medical
July 31, 2018 Category: Press Releases

For the first time in the US, therapists can safely simulate and verify an individual radiotherapy treatment cycle before exposing the patient suffering from brain cancer to potentially harmful radiation. The PseudoPatient dosimetry phantoms, built from real patient anatomical data, combine proven expertise in medical physics with highly accurate 3D printing technology for radiotherapy treatment. JALEX Medical partnered with the Greek based company in 2017 as their United States based regulatory consultants. RTsafe came to Ohio via the SelectUSA program, which is a division of the United States Chamber of Commerce aimed at bringing medical device companies to the United States. JALEX Medicals president, Jennifer Palinchik, participated as a featured speaker and mentor during the Cleveland event. Its exciting to see the continued advancements that are being made in the medical industry with 3D printing, and the PseudoPatient device is yet another example of brilliant forward thinking

American Association of Neurological Surgeons - New Orleans, LA

By JALEX Medical
April 30, 2018 Category: Events, Featured

JALEX Medical will be attending the 86th annual meeting for the American Association of Neurological Surgeons, this yeartitled Neurosurgery: The Privilege of Service. The educational program for the 2018 AANS Scientific meeting will include the presentationof scientific date in general and subspecialty sections as Oral Presentations, Rapid-fire Oral Presentations and E-posters. If your organziation may be in need of design or regulatory development assistance, contact JALEX Medical today. Jennifer Palinchik, President of JALEX Medical would like to meet with you personally while at AANS.

Jennifer Palinchik, Panelist for Cleveland State Women in Leadership Symposium

By JALEX Medical
April 10, 2018 Category: News, Events, Featured

Tuesday, April 10th, President of JALEX Medical invited to participate at the Women in Leadership Symposium.

American Academy of Orthopedic Surgeons - New Orleans, LA

By JALEX Medical
March 06, 2018 Category: Events, Featured

March 6-10, 2018 JALEX Medical will be attending the Annual meeting for the American Academy of Orthopaedic Surgeons, which is expected to host more than 30,000 attendees including Academy Fellows, AAOS members, international guests as well as allied medical professionals and exhibitors. Attendees will have the opportunity to learn about the latest industry trends and medical advancements in educational sessions. Stop by our booth to talk to JALEX Medical about your device design, regulatory affairs, or quality systems needs. Event Information

JALEX Medical First Quarter Newsletter

By JALEX Medical
January 26, 2018 Category: Newsletters

First Quarter Newsletter

PRESS RELEASE - Omnia Medical: First PEEK-OPTIMA HA Enhanced Vertebral Body Replacement System to enter US-market

By JALEX Medical
December 08, 2017 Category: Press Releases, News

US FDA 510(k) clearance paves the way for an innovative orthopaedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes.1-3 Thornton Cleveleys, United Kingdom, December 7, 2017 Omnia Medical VBR has been granted the first US FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced polymer, from Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. This advancement was the result of a three-way collaboration: orthopedic implant company Omnia Medical partnered with JALEX Medical on product development and regulatory activities and with Invibio Biomaterial Solutions, who pioneered medical PEEK. Robert Gewirtz, MD- Neurosurgeon, Columbus, Ohio, comments on the innovative orthopedic product: Omnia Medical VBR is an intuitive device that is easy for the surgeon to use, and the benefits of hydroxyapatite incorporated

North American Spine Society (NASS) Annual Conference - Orlando, FL

By JALEX Medical
October 25, 2017 Category: Events

October 25-28, 2017 JALEX Medical will be exhibiting at the North American Spine Society conference. NASS is the place to hear the latest information, innovative techniques and best practices with renowned spine care professionals from around the world. The Annual Meeting delivers dynamic and challenging educational programs, outstanding exhibitions and the chance to network and build relationships with celebrated spine professionals. Stop by our booth to talk to our experts to see how JALEX Medical can get your project or concept to market quickly and efficiently. Event Information

Congress of Neurological Surgeons Annual Meeting - Boston, MA

By JALEX Medical
October 07, 2017 Category: Events

October 7-11, 2017 JALEX Medical will be attending the Congress of Neurological Surgeons Annual Meeting in Boston. The CNS Annual Meeting is the premier forum for learning about cutting-edge procedures, approaches, and technologies in the field. This years theme, Transformation Celebration, challenges the traditional ways of thinking and celebrates the many accomplishments of neurosurgeons from around the world. Event Information

Becker's Spine, Orthopedic and Pain Management Conference - Chicago, IL

By JALEX Medical
June 22, 2017 Category: Events

Beckers ASC Review, Beckers Spine Review, and ASC Communications attracts attendees and speakers that are among the smartest people in the ASC industry today. This conference takes discussion and thinking to the highest levels, focusing on the orthopedic, spine and pain management surgeons, administrators, and owners and operators of ambulatory surgery centers. Event Information

Annual Ohio Foot and Ankle Medical Association Seminar - Columbus OH

By JALEX Medical
June 08, 2017 Category: Events

The Ohio Foot and Ankle Medical Associations educational mission is to purposefully advance the art and science of podiatric medicine by providing the highest quality of didactic and clinical learning experiences. This seminar includes a variety of instructional sessions aimed at significantly enhancing patient care, treatment protocols and practice efficiency. Event Information

Jennifer Palinchik, Moderator for AD & M Panel in Cleveland

By JALEX Medical
March 30, 2017 Category: News

Read the Plastics Today article about a panel discussion on medtech-related 3D printing at the Advanced Design and Manufacturing Conference in Cleveland moderated by Jennifer Palinchik. Plastics Today Article

Crains Cleveland Business Nominates Jennifer Palinchik

By JALEX Medical
March 15, 2017 Category: News

Jennifer Palinchik, President of JALEX Medical, has been honored along with a group of inspiring female leaders by Crains Business Cleveland for its Women of Note program. Nomination Press Release

SelectUSA selects JALEX Medical of Northeast Ohio

By JALEX Medical
March 08, 2017 Category: News

March 8th, 2017 - Jennifer Palinchik, President of JALEX Medical, will speak to how global market inventors bring innovative medical device products to the United States market, specifically Northeast Ohio. SelectUSA Press Release

JALEX Medical Hires New Director of Business Development

By JALEX Medical
February 15, 2017 Category: News

JALEX Medical has appointed Lisa A. Bartos as Director of Business Development. In this role, she will serve as a member of the Biomedical Design and Regulatory Innovation team involved in the active recruitment of new business. Read the full article for more details about Lisa and what is on the horizon for JALEX Medical. Lisa Bartos Director of Business Development Announcement

Cures Act could be big win for biomed groups

By JALEX Medical
February 12, 2017 Category: News

Crains Cleveland Business discusses the new federal law that aims to speed up drug approval and increase investment in medical research. The article features members of the medical device and healthcare industry in the northeast Ohio area, including Jennifer Palinchik, President of JALEX Medical. In the article, she discusses the benefits the law could have on the medical device industry and how the FDA reviews and approves new products. Crains Cleveland Business Article

Women in medtech: Making gains but not there yet

By JALEX Medical
January 26, 2017 Category: News

An article by Medical Design Outsourcing discusses the growing role of women in medical and technology fields, and the challenges that are yet to be overcome. JALEX Medical President Jennifer Palinchik is featured and gives her thoughts on having the confidence to advance and working in a male-dominated industry. Medical Design Outsourcing Article

Speed and Production-Equivalency Lead Prototyping Demands

By JALEX Medical
March 04, 2016 Category: News

Jennifer Palinchik is featured in a round-table discussion with BONEZONE (a specialty publishing firm solely focused on the global orthopaedic market) about developments and challenges in new prototyping processes in the orthopaedic field and how to use them efficiently. BONEZONE Article

Gender is not a leadership concern, says biomedical industry's Jennifer Palinchik

By JALEX Medical
December 31, 2014 Category: News

Jennifer Palinchik, President of JALEX Medical, is featured in an article by Smart Business, where she provides her insight into gender in the STEM field, and discusses the people who helped to influence her professional career. Smart Business Interview Article

On The Move: Jennifer Palinchik of Jalex Medical

By JALEX Medical
October 01, 2014 Category: News

Jennifer Palinchik, President of JALEX Medical, is featured on page 45 of the Fall issue of Workforce Diversity for Engineering IT Professionals from Equal Opportunity Publications ( Jennifer gives us her perspective on the additive manufacturing and 3D printing industry and talks about some of her experiences as a woman in the biomedical industry. Workforce Diversity for Engineering IT Professionals - JALEX Featured on page 45

Palinchik Engineers Career Path in Northeast Ohio Biomedical Arena

By JALEX Medical
September 29, 2014 Category: News

Jennifer Palinchik is the President of JALEX Medical LLC. She was featured in the September issue of Medical Device Daily. In this issue, Jennifers background in the medical device industry is detailed, and she gives insight into the 3D printing and additive manufacturing industry and the role it will play in the future of medical devices. Device Daily, September Issue

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