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Medical Receives Breakthrough Device Designation Articles & Analysis: Older
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The medical device industry is undergoing a transformative period marked by groundbreaking innovations and advanced materials. As healthcare continues to evolve, the need for devices that enhance patient outcomes while ensuring safety and reliability is more critical than ever. Among the various materials used in medical device design, polytetrafluoroethylene (PTFE tubing) has emerged as a ...
As an organisation, we receive surgical images from a variety of specialities from surgeons all over the world. We are very grateful for this: it helps us to continuously develop medical devices designed for the need surgeons have, as well as confirming that the designs we have launched perform as intended. The images form a library of knowledge and education, and we have recently donated some ...
Congratulations to the ONWARD team for the incredible progress they are making in the field of neuroengineering! In recent days, numerous media have reported the news of a great advance for science, and especially for all those people with spinal cord injury and their medical and caregiver teams. The ONWARD team has developed an epidural electrical stimulation system using electrodes placed ...
Cenorin, a healthcare company providing solutions for medical device reprocessing and waste stream reduction, announces the availability of its new 50 Series advanced drying systems. These new models offer in-demand features and benefits that help healthcare reprocessing teams achieve drying compliance while also improving throughput and workflow. Three widely recognized ANSI/AAMI guidance ...
Little Rock, AR – NuShores Biosciences LLC (NuShores), founded and based in Little Rock, Arkansas, announced today that Mr. Sam Monk has accepted the position of Regulatory and Quality Manager and will move to Little Rock from the Seattle area. Mr. Monk will work closely with C-level management, research scientists, manufacturing, and our Quality and Regulatory team and services providers ...
TEMPE, Ariz., March 09, 2022 (GLOBE NEWSWIRE) -- Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry today announced top-tier recognition for three executives, ...
GRAND RAPIDS, Mich., March 14, 2022—Shoulder Innovations LLC., (SI), a leading innovator in the development of shoulder replacement systems, announces the FDA Clearance of their latest component of the InSetTM Total Shoulder System, the InSetTM Stemless Humeral System. The InSetTM Stemless implant is the latest addition to the innovative and integrated InSetTM system, which already includes ...
NeoTherma Oncology (NTO) announces they have expanded their leadership team with key senior staff who will advance the development and commercialization of the VectRx System. NTO’s new additions include: Ken Belt, Chief Engineer: Ken will lead RF design, and has 48 years of experience in the medical device field with extensive experience in MRI coil and phased array engineering. ...
TEMPE, Ariz., Feb. 07, 2022 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced that it has settled its longstanding patent infringement and antitrust ...
Strengthens Align digital platform with major installed base milestones including 12M Invisalign patients, 68K iTero scanners, and 47K exocad software licenses 2021 total revenues up 59.9% to a record $4.0 billion, operating margin of 24.7%, in line with guidance 2021 revenue growth for the second half was 30.5% compared to 2020, at high-end of 20% to 30% target, in line with guidance 2021 ...
ClinCheck Live Update for 3D controls enables real-time ClinCheck treatment plan modifications that improve practice productivity significantly, while also improving quality of treatment plans Invisalign Practice App provides mobile integration with the Invisalign Doctor Site (IDS) and enables doctors to manage their practice at their fingertips. Invisalign Personalized Plan (IPP) ...
TEMPE, Ariz., Jan. 03, 2022 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced that it will report fourth quarter and 2021 financial results on ...
TEMPE, Ariz., Dec. 21, 2021 (GLOBE NEWSWIRE) -- Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry today announced a $1 million donation to the American Association ...
HOLLAND, Mich., August 23, 2021 — Shoulder Innovations Inc, a leading innovator in the development of shoulder replacement systems, announced today that they have received FDA clearance for their InSet™ Reverse Shoulder Arthroplasty System. ...
BaymatobTM, a MedTech company founded by a Sydney mother after her own traumatic birth experience, has developed a world-first labour monitoring device that has achieved US Food and Drug Administration (FDA) Breakthrough Device Designation. This sets Baymatob’s game changing maternal diagnostic tool called OliTM on an streamlined and supported path toward regulatory approval. Oli seeks to ...
Neuros Medical, Inc., announced today that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel High-Frequency Nerve Block system as an aid in the management of chronic intractable pain of the lower limb of adult amputees. The FDA ...
Nalu Medical, Inc. (“Nalu”), a California-based company that has successfully miniaturized neurostimulation implants for chronic intractable pain management indications, announces its Nalu micro-Implantable Pulse Generator (mIPG) was named the Implant and Tissue-Replacement device Gold Winner at the 2021 Medical Design Excellence Awards (MDEA). The MDEA is a prestigious award that ...
HOLLAND, Mich., May 10th, 2021 – Shoulder Innovations (SI), an emerging leader in the development of shoulder replacement systems, announced today that it has signed an exclusive license agreement for Genesis Software Innovation‘s “GSI“ PreView Shoulder™ Arthroplasty Planning Software, which recently achieved FDA 510(k) clearance. This clearance is the first ...
Quasar Medical Devices, LLC is pleased to announce the expansion of our North American Commercial Headquarters in Minnetonka, Minnesota. This expansion strengthens Quasar’s global presence, allowing for a continued focus on supporting North American customers. Located in one of the key medical device clusters, Quasar Medical Devices USA will bring additional commercial support to existing ...
C4 Imaging LLC, an early-stage medical device company, has completed its latest round of financing, which included a significant institutional component. Institutional investment was led by Stoneworth Financial, LLC, a Houston based investment banking group. Proceeds will be used for growth capital, targeted at accelerating clinical adoption of C4 Imaging’s portfolio of FDA cleared products ...