Industry News
Medical Device Industry News
Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA
Genio is a different approach to hypoglossal nerve stimulation (HGNS). Genio offers patients a leadless, fully-body MRI compatible, non-implanted battery solution, powered and controlled by a wearable.
FDA Approves PYZCHIVA ® (ustekinumab-ttwe), Samsung Bioepis’ Biosimilar to Stelara
“The FDA approval of PYZCHIVA as a biosimilar to Stelara is an important milestone for patients living with inflammatory conditions, as biosimilars can offer more choice and access to biologic treatments,” said Byoung In Jung,
Valneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ ®
IXCHIQ ® is the world’s only licensed chikungunya vaccine available to address this unmet medical need. In accordance with the International Recognition Procedure (IRP)3, Valneva has also submitted a Marketing Authorization Application (MAA) to the
OSE Immunotherapeutics Announces Publication of Preclinical Efficacy Results with Lusvertikimab in Acute Lymphoblastic Leukemia in the Journal ‘Blood’
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concludes: “We are very pleased with this publication on Lusvertikimab in ‘Blood’, a high-level journal within the field of hematology whose manuscripts are reviewed by prominent specialists.
LIfT BioSciences Appoints Antonin (Tony) de Fougerolles as Chairman of its Board of Directors
Alex Blyth, Chief Executive Officer of LIfT BioSciences commented: “On behalf of LIfT’s Board of Directors, I am pleased to welcome Tony to the Company as Chairman. Tony has extremely relevant experience, having played a
Study: Private Equity Acquisitions in Cardiology on the Rise
“Policymakers and clinicians have raised concern about the growing presence of private equity in other medical specialties. Although cardiology is an attractive target for private equity firms, little is known about the number and types
Wondering How to Prevent Running Injuries? Here’s What You Need to Know
To prevent running injuries, you must be proactive—understanding your body, choosing the right equipment, and adjusting your training program.
Bio-Rad Launches Celselect Slides 2.0 to Advance Rare Cell and Circulating Tumor Cell Enrichment for Cancer Research
“CTCs are rare — as low as only 1–10 can be found per milliliter of blood — however, CTC enumeration and analysis offers valuable insight into tumor heterogeneity and disease progression,” said Stephen Kulisch, Vice
UltraSight Joins Butterfly Garden to Expand AI Real-Time Guidance Across Point of Care Ultrasound Devices
“We are thrilled to partner with UltraSight to bring their AI guidance software to Butterfly devices in an effort to mitigate the pressing issue of sonographer shortages, among other workforce challenges, impacting medical communities around
Neuromod Partners with 14 New US Tinnitus Clinics to Expand Availability of FDA Approved Lenire
Lenire has become the most in-demand tinnitus treatment device in America since the device was awarded a De Novo FDA Approval Grant in 2023. Neuromod Devices, creators of Lenire, is operating a phased expansion to
Assessing Industry Impact of FDA’s LDT Final Rule
The recent final rule that recognizes LDTs as regulated medical devices is being met with questions, scrutiny, and legal action.
VenoStent Completes $20 Million Series A with $4 Million Investment from Norwest Venture Partners
VenoStent builds on Momentum with New $3.6 Million NIH SBIR Grant to fund U.S. clinical trial of breakthrough medical device showing promise in improving dialysis patient outcomes.
PE-based Piezoelectric Film Cost-effective Alternative to PVDF
The novel technology developed by Sabic researchers reportedly doubles properties of commercially available piezoelectric polymers.
Zeiss Unveils New Arivis Pro 4.2 Version
The arivis Pro 4.2 introduces advanced AI-powered segmentation tools, enhanced 3D analysis capabilities, and seamless handling of massive datasets.
Medasense & Nihon Kohden Pen Distribution Agreement
The partnership will introduce the Medasense nociception monitor to the Japanese market, pending regulatory approval.
Exploring the Pros and Cons of the PillCam for Endoscopy
The field of gastroenterology has seen significant advancements in diagnostic tools over the years, with one of the most revolutionary being the PillCam. This small, swallowable capsule contains a camera that captures images of the
Sovato Touts Successful Remote RAS Procedures Over 500 Mile Distance
After the preclinical tests, the company said surgeons reported a high degree of confidence with performing the remote procedures using its Sovato Platform.
Laudio Expands Work With Children’s National Hospital to Include Nurse Educators
“Setting nurses up for success, supporting them effectively, and ultimately retaining them requires increasingly proactive, comprehensive strategies,” said Tom Hills, EVP of Client Engagement at Laudio. “We are excited to welcome nurse educators at Children’s
PharmaEssentia Completes Patient Enrollment for Phase 2b EXCEED-ET Trial in Essential Thrombocythemia and Phase 3b ECLIPSE-PV Trial in Polycythemia Vera
"Myeloproliferative neoplasms, including ET and PV, are chronic blood diseases that can impact patients' quality of life and lead to life-threatening complications, including the development of specific types of blood cancers, and PharmaEssentia is committed
Sovato Announces Multiple Successful Remote Robotic-Assisted Procedures Over a 500-Mile Distance with the Use of the Sovato Platform
The Sovato Platform is a first-of-its-kind, comprehensive solution for enabling and orchestrating remote robotic-assisted surgeries and procedures. Sovato brings together the remote surgery ecosystem, including healthcare providers and any RAS system, to deliver the curated