Industry News
Medical Device Industry News
How Otis Boykin’s Invention Put the ‘Pace’ in Pacemakers
Trivia Tuesday: The pacemaker would not be what it is today without what critical contribution from Otis Boykin?
Foldax Spells Out Regulatory Plans for Tria Surgical Heart Valve
The Salt Lake City, UT-based company will seek approval in India first and then bring the technology to the U.S.
Medline Reaps FDA Ire in Class I Endotracheal Tube Recall
The company has been under FDA spotlight since its link to the China plastic syringe manufacturing safety communication was announced earlier this year.
VitaFlow Liberty ™ Granted EU CE-MDR Mark
Jeff Lindstrom, President of CardioFlow, stated, "The certification of VitaFlow Liberty by the CE regulatory body under MDR, is a testament to CardioFlow's world-class R&D, quality, and clinical capabilities. This recognition will expedite the global
Philips Zenition 90 Motorized receives FDA 510(k) Clearance
“During complex procedures, it’s vital to be able to rely on surgical imaging systems. As clinicians navigate their way through challenging anatomy, the priority is to quickly visualize small anatomical details while limiting X-ray dose,”
Neuromod’s FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus
The Lenire Device is the first bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) Contract. It can be prescribed when appropriate by a trained healthcare clinician for the treatment of tinnitus.
Surgical Suction Instruments Market to Hit USD 503 Million by 2029, Driven by 6.1% CAGR
The global surgical suction instruments market is projected to reach USD 503 million by 2029, growing at a CAGR of 6.1% from USD 375 million in 2024, driven by increasing adoption of minimally invasive surgery
Gyrolab Generic Anti-AAV Kit to Support Gene Therapy Development | Introduced by Gyros Protein Technologies
The Gyrolab Generic Anti-AAV Kit supports identification of pre-existing immunity that may interfere with the efficacy of AAV-based gene therapy delivery.
Awards Recognize Unsung Heroes in Sterile Medical Packaging
This year’s superstars in sterile awareness work tirelessly — often behind the scenes — to ensure patient safety and prevent healthcare acquired infections or HAIs.
Getinge Sevoflurane Vaporizer Recall Gets Class I Rating
The device was recalled after the company reported potential exposure to hydrogen fluoride.
Teleflex Arrow FiberOptix and UltraFlex (IAB) Catheter Kits Recall Identified as FDA Class I
The company, along with its subsidiary Arrow International, recalled the devices after finding that a manufacturing error had the potential to cause the catheter’s balloon to become overtwisted.
5 Things We’re Talking About in June
Your quick visual roadmap for the hottest medtech topics in June 2024.
Venus Medtech VenusP-Valve Completed First Implantation in IDE Pivotal Clinical Study in U.S.
The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT
Pfizer Reports | ELREXFIO ™ Shows Median Overall Survival of More Than Two Years in People with Relapsed or Refractory Multiple Myeloma
“These compelling overall survival data support the clinical benefit ELREXFIO has already demonstrated and its potential to be a transformative treatment option for people with multiple myeloma,” said Roger Dansey, M.D., Chief Development Officer, Oncology,
Updated Phase 2 CAPTIVATE Study Results
“After more than five years, the CAPTIVATE study findings confirm the sustained benefit of the fixed duration combination of ibrutinib and venetoclax as a first-line treatment for patients living with CLL, including in those with
Editas Medicine Reports New Safety and Efficacy Data from the RUBY Trial of Reni-cel in 18 Patients with Sickle Cell Disease | Presented at the European Hematology Association (EHA) Annual Congress
“These data confirm the observations from our prior clinical readouts and further support our belief that reni-cel has the potential to be a best-in-class and clinically differentiated, one-time, durable medicine that can provide life-changing clinical
Innovent Biologics Delivers Oral Presentation on Clinical Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Advanced Non-small Cell Lung Cancer and Other Solid Tumors at the 2024 ESMO Virtual Plenary
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "IBI363, as a first-in-class molecule, represents Innovent's continuous innovation and advancement in the immunotherapy field. Starting from molecular design, the unique approach of α bias with
Sphere Fluidics Awarded Gold Accreditation by Investors in People
Dale Levitzke, CEO of Sphere Fluidics, expressed his pride in the achievement: "Receiving the Gold Investors in People Award is a significant milestone for Sphere Fluidics. It recognizes the dedication and hard work of our
Opthea Limited Successfully Completes Placement and Institutional Component of Entitlement Offer Raising A$171.5 million (US$113.2m¹)
“We appreciate the strong support from our shareholders, and from new investors, who share our belief that sozinibercept has the potential to transform patient outcomes with superior vision gains, which continues to be a significant
InduPro Announces $85 Million Series A Financing
InduPro notes the financing will support the advancement of the first expected clinical product candidate targeting cancer tissue based on the proximity of co-targeted pairs, from preclinical development to an expected IND filing in Q4