Elcam Medical is the first company in Israel to meet the audit requirements set by MedAccred subscribing members.
Medtronic will invest up to $75 million and immediately begin co-promotion of CathWorks’ FFRangio System for the noninvasive diagnosis of CAD in the U.S., Europe and Japan, where it is commercially available.
An analysis of the HVAD pump implant kit showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly.
The catheter is part of the company’s transcatheter pulmonary valve system.
The Class I recall affects more than 95,000 devices in the United States.
The deal will increase the company’s suite of cardiac ablation products, including mapping and navigation systems.
A capacitor manufacturing assembly error could cause the device to become inoperable.
Part of the research will look at the strength of the supply chain, including its effectiveness in distributing ventilators.
The dynamics of the joint reconstruction devices industry has strengthened with consistent technological improvements, including the adoption of 3-D printing.
FDA also supports the removal of the HeartWare HVAD System from the market.