Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant. The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle […]
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Medtronic PulseSelect pulsed field ablation wins FDA approval
The FDA has approved the Medtronic PulseSelect pulsed field ablation (PFA) system, the device developer said today. PulseSelect is the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval. The minimally invasive, cardiac ablation system is indicated for the treatment of […]
Former J&J MedTech head Ashley McEvoy takes board role at consumer goods giant
Less than two months after announcing her departure from Johnson & Johnson MedTech, Ashley McEvoy has taken on a role on the board of Procter & Gamble. In October, the former EVP and worldwide chair at J&J MedTech announced her intention to leave the world’s second-largest medical device manufacturer. Tim Schmid took over the position […]
Ekso Bionics earns Medicare win for exoskeleton tech
Ekso Bionics (Nasdaq:EKSO) announced that the Centers for Medicare & Medicaid Services (CMS) proposed a payment level for its exoskeleton. The Pricing, Data Analysis, and Coding (PDAC) contractor completed its review of the Ekso Indego Personal, approving the use of Healthcare Common Procedure Coding System (HCPCS) Code K1007 to bill Medicare for the device. CMS […]
Calyxo closes $50M funding round to support kidney stone treatment
Calyxo announced that it closed a $50 million Series D financing round to support its CVAC aspiration system for kidney stone removal. Avidity Partners led the round, with existing investors Questa Capital and CRG providing significant participation. Pleasanton, California–based Calyxo’s CVAC system uses irrigation and aspiration to remove kidney stones. The design aims to minimize […]
Integra LifeSciences to buy Johnson & Johnson’s Acclarent and its ENT tech
Integra LifeSciences announced today that it entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech. Acclarent, part of J&J MedTech’s Ethicon unit, enhances Integra’s position in the ear, nose and throat (ENT) treatment market. Integra already offers the MicroFrance line of ENT instruments. The company believes that, upon closing, the deal […]
FDA clears ZimVie and Brainlab spinal fixation combo
ZimVie announced today that the FDA has cleared the use of its Vital spinal fixation system with Brainlab’s Spine & Trauma Navigation. The news comes just nine months after the companies announced a partnership in which Brainlab will provide spine imaging, planning, navigation, and robotic-assisted systems for use with ZimVie implants. The goal is to enable […]
Pulmonary embolism startup Flow Medical raises $2M in friends-and-family round
Flow Medical announced today that it has raised $2 million in a friends-and-family funding round. Chicago-based Flow Medical is developing a new thrombolysis catheter for treating acute pulmonary embolism (PE). The startup said it will use the funding for R&D and regulatory activities. Flow Medical is led by co-founder and CEO Jennifer Fried, the co-founder […]
FDA clears neuro ablation tech from NeuroOne
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that the FDA granted 510(k) clearance to its OneRF ablation system. Clearance makes OneRF the first FDA-cleared, thin-film, sEEG-guided radiofrequency (RF) system capable of recording electrical activity and ablating nervous tissue. The system, which also features temperature control, became the third FDA-cleared device at NeuroOne. It’s the first therapeutic […]
The biggest medtech personnel moves of 2023
The leadership change at Johnson & Johnson MedTech will go down as the year’s biggest personnel move in medtech, barring a December surprise. In October, J&J EVP and J&J MedTech Worldwide Chair Ashley McEvoy announced her resignation from the world’s second-largest device manufacturer. She’s staying on into the first quarter of 2024 while her successor, […]
Microbot Medical is a step closer to an FDA IDE submission
Microbot Medical today announced the successful completion of its pivotal pre-clinical study of its Liberty endovascular robotic surgical system. The study, performed under good laboratory practice (GLP) and essential for the company’s investigational device exemption (IDE) submission, took place under rigorous FDA guidelines. The study involved pigs. In this study, three interventional radiologists performed 96 […]