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Imaging Visualization & Navigation

FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

HistoSonics®, (www.histosonics.com), the manufacturer of the Edison® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for...

October 9, 2023

Surgery and Surgical Robotics

Cadence Announces the Acquisition of ARC Group Worldwide’s Florida Location

Cadence, Inc., a leading provider of design, development, and contract manufacturing services to the medical device, drug delivery, and diagnostics markets, announced today that it has acquired the Florida location of ARC Group Worldwide (arcw.com), a precision manufacturer specializing in Metal Injection...

October 6, 2023

Surgery and Surgical Robotics

Stimdia Medical Inc. Initiates FDA Approved IDE Pivotal Trial to Investigate Impact of Neuromuscular Stimulation on Mechanically Ventilated Patients

Stimdia Medical, a medical device company developing innovative technologies to improve respiratory care, today announced the initiation of its FDA approved pivotal trial to investigate the impact of phrenic nerve stimulation (PNS) on the time to liberate patients from mechanical...

October 4, 2023

Cardiovascular / Cardiology

FDA Grants ExThera Multiple Breakthrough Device Designations for its Seraph® 100 Filter

ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). The...

October 3, 2023

Diagnostics & Healthcare News

Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

Enable Injections, Inc. (“Enable”) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The...

October 2, 2023

Orthopedics and Spine

The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease

ReGelTec, Inc., announced that the U.S. Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. The HYDRAFIL System contains an injectable polymer that is implanted percutaneously via a...

September 29, 2023

Orthopedics and Spine

4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate

4WEB Medical, an orthopedic implant company focused on developing innovative implants that utilize its proprietary Truss Implant Technology™, announced that it has received 510K clearance to market the newest additions to the company’s implant portfolio, the Cervical Spine Truss System (CSTS) Integrated...

September 28, 2023

Cardiovascular / Cardiology

QT Medical® Announces Completion of Series B Financing of $12 Million

QT Medical, Inc., a medtech company focused on cardiac care technology, announced today that it raised $12 million in Series B financing. This funding will accelerate QT Medical’s market penetration, global expansion, product pipeline development, and long-term strategic planning. QT Medical aims to...

September 27, 2023

Imaging Visualization & Navigation

Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Saluda Medical, Inc. (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved MRI conditional...

September 26, 2023