Medicrea (EPA:ALMED) said today it won FDA clearance for its IB3D portfolio of 3D-printed titanium interbody devices featuring its AdapTEK technology. The company’s AdapTEK technology is intended to allow surgeons to create interbody devices customized to individual specifications through in-house additive manufacturing techniques. Customization features include different ranges of footprints, lordotic angles, heights, lateral windows and […]
The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic opioids designed to prevent abuse. To date, the FDA has approved 10 of these products, called abuse-deterrent opioids. But, as Gottlieb noted in a statement, […]
European medtech industry group MedTech Europe today said it is seeking “swift action” from national and European Union authorities after the implementation of new regulations, saying that additional resources need to be invested to make sure the regulations are successful. The medtech group published three separate position papers on the matter, calling attention to new […]
The FDA last week approved remote programming adjustments for Cochlear Ltd.‘s (ASX:COH) Nucleus cochlear implant, removing the need for a select group of users to make repeat visits for in-person programming sessions. The newly-cleared remote programming feature is indicated for patients with 6 months of experience with their cochlear implant sound processors and who are […]
Advanced Bionics said late last week it won FDA approval for its HiFocus SlimJ electrode designed for use with the company’s HiRes Ultra cochlear implant. The Valencia, Calif.-based company touts the new electrode as featuring a thin, straight design for easier insertion during procedures and a slim profile to protect the delicate structures of the […]
Medtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology. The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual […]
Orexo (STO:ORX) said today that the European Medicines Agency granted marketing authorization for its Zubsolv rapidly-disintegrating treatment for opioid dependence. The buprenorphine and naloxone sublingual tablet is the first to be approved in Europe with six different strengths, according to the Sweden-based company. Get the full story at our sister site, Drug Delivery Business News.
The FDA has approved Kaleo‘s Auvi-Q epinephrine auto-injector designed to treat life-threatening allergic reactions in infants and small children, according to the privately-held biopharma company. The device, which Kaleo touts as the first of its kind, was given priority review by the FDA. Get the full story at our sister site, Drug Delivery Business News.
The FDA this week laid out guidelines for a new framework it’s implementing for the development and oversight of regenerative medicine products including novel cellular therapies. The framework is laid out through four guidance documents which build on the FDA’s existing regulatory approach and describe more clearly which products are regulated as drugs, devices and […]
From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. […]
Alcyone Lifesciences said yesterday it won FDA 510(k) clearance for its Alivio ventricular catheter and flusher system designed for treating hydrocephalus. The newly cleared Alivio device is designed for the non-invasive retrograde flushing of the ventricular catheter to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid flow in […]