Zimmer Biomet's transformation over the past five years is one of the best medtech turnaround stories in recent history. Now, the CEO responsible for righting the ship is ready for a new voyage - and so is the company. Bryan Hanson stepped down abruptly last week to lead 3M’s healthcare spinoff.
It was a big news week for Medtronic. The company kicked the week off on a high note with an earnings report that shows Medtronic's diabetes business is making a comeback. Then came news of Medtronic's global pilot program with Cydar Medical using Cydar's AI technology. And finally, an FDA advisory committee shot down Medtronic's renal denervation technology, raising concerns about efficacy and benefits versus risk.
GE Healthcare launched its Vscan Air SL handheld wireless ultrasound imaging system designed for use in rapid cardiac and vascular assessments to accelerate diagnoses and treatment decisions. The device features the company’s SignalMax and XDclear imaging performance technology, designed to enable high levels of penetration, resolution, and sensitivity with a single crystal transducer technology.
And in case you missed our last Medtech in a Minute report...
An two-month FDA inspection of Integra LifeSciences' Boston, MA manufacturing facility has resulted in a warning letter. This comes as no surprise given the company's earlier announcement that it has halted production and initiated a global recall of all products made at that facility. A company spokesperson told MD+DI the company will not resume production at the Boston, MA facility until it has addressed FDA's concerns and are "confident the facility meets the strictest regulatory and product quality standards." This is anticipated to be complete by the end of the calendar year, the spokesperson said.
Medtronic has issued a recall on certain Mahurkar triple lumen hemodialysis catheters due to occlusion in the tip of the catheter's center lumen. Medtronic said it discovered the problem during routine manufacturing related testing and the company has reported no confirmed complaints, adverse events, or deaths related to the issue. The company said the occlusion was caused by excessive MDX, a silicone-based lubricant used to coat the catheter tip.
Microbot Medical recently announced it has signed a manufacturing agreement with Medimor to advance the commercialization of its Liberty Robotic Surgical System. Liberty is a single use endovascular surgical robotic system designed to streamline endovascular procedures.