It sounds like European approval of Medtronic’s soft tissue robotically-assisted surgery system, Hugo, could come any day now. “We’re sitting at the tip of our chair waiting for the phone call that the product will be approved,” Medtronic EVP and EMEA President Rob ten Hoedt said Friday. Fridley, Minnesota-based Medtronic (NYSE:MDT) filed for European approval in […]
Medtronic, Johnson & Johnson warn of hospital worker burnout headwind
Medical device manufacturers are worried that the COVID-19 pandemic’s latest wave will make for a tougher recovery in elective procedures after Delta variant cases subside. Top officials from Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ), NuVasive (NASDAQ: NUVA) and Zimmer Biomet Holdings (NYSE:ZBH) recently warned investors of the problem. The concern is that the highly contagious […]
GE warns of supply chain strain well into 2022
Medical device makers and suppliers seeking relief from the global semiconductor shortage will have to hold on a while longer. GE (NYSE:GE) is warning investors that supply and labor shortages are squeezing its Healthcare business this quarter, and that the pressure won’t likely let up in 2021. GE Healthcare’s business “largely is a supply chain […]
CMS aborts launch of MCIT payment program for breakthrough devices
CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs. CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar yesterday — three months before the rule was set to take effect […]
InTRAvent wins FDA 510(k) clearance for Solopass bedside neuro-navigation device
InTRAvent has announced FDA 510(k) clearance of its Solopass system for assisting frontal placement of intraventricular catheters deep within the brain. The Hershey, Pennsylvania-based company said yesterday that it designed the device with 2D and 3D ultrasound imaging, artificial intelligence and trajectory guidance for intraprocedural localization and navigation for external ventricular drain (EVD) placement. Get […]
Medtronic CFO Karen Parkhill honored for financial excellence
Medtronic CFO Karen Parkhill has been named as an outstanding finance executive by the Minneapolis/St. Paul Business Journal in Minnesota. Parkhill is one of 14 individuals who will be honored in the newspaper’s 2021 CFO of the Year awards in November. She was one of two winners in the public company category, joined by Piper […]
Cardinal Health docks executive bonuses over opioid costs
Cardinal Health’s board of directors reduced bonus payouts for CEO Mike Kaufmann and his four top-paid executives due to the cost of opioid litigation. After pressure from investors, Cardinal Health (NYSE:CAH) for the first time has disclosed how its board of directors factored the opioid litigation settlement costs into the pay packages of Kaufmann, Chief […]
Medtronic builds suspense for renal denervation study results
Medtronic’s clinical study of its Symplicity Spyral renal denervation system for hypertension is likely to go down to the wire for inclusion as a late-breaking clinical trial at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference. The highly anticipated results will offer new insight into the Fridley, Minnesota-based medical device manufacturer’s quest to build a billion-dollar […]
Jurors selected in Elizabeth Holmes’ Theranos fraud trial; start date set
The jurors who will weigh the evidence for and against Theranos founder Elizabeth Holmes were sworn in Thursday, setting the stage for the federal fraud trial to finally begin. The twelve jurors — seven men and five women, all residents of California’s Santa Clara County — were selected along with five alternates (two men and […]
Cleveland Clinic reports bionic arm breakthrough
Cleveland Clinic researchers say they’ve developed a bionic system that takes a big step toward restoring natural arm function for patients with upper limb amputations. Upper-limb amputees often have to constantly watch their prosthetics while using them to make corrections in how much grasping force they use, but Cleveland Clinic said patients testing the new […]
Amazon makes moves for a major medical diagnostics play
Amazon (NASDAQ: AMZN) wants to hire key employees to expand its medical diagnostics operations on a global scale, which very well could grow beyond COVID-19 testing. Senior-level job postings offer a glimpse of the notoriously secretive and ambitious tech company’s global aspirations for medical diagnostics. Just this week, Amazon put a call out for a […]