Acutus Medical announced a realignment of resources and operational downsizing resulting in a 70% workforce reduction. Dr. Shaden Marzouk, the company’s board chair, called the downsizing “hard but necessary steps” in a news release. The company intends to continue to comply with its remaining obligations to Medtronic for the production of left-heart access products. Acutus […]
Medtronic
First U.S. cases performed with Medtronic Affera ablation system
A hospital in Texas announced today that its electrophysiologists completed the first U.S. cases with the Medtronic (NYSE:MDT) Affera platform. EPs at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center performed the procedures with Affera. Dr. Andrea Natale and Dr. Amin Al-Ahmad conducted the first procedure on Nov. 7. A Medtronic spokesperson […]
Medtronic Evolut Pro TAVR demonstrates positive outcomes in study
Medtronic (NYSE:MDT) this week shared new clinical data supporting its Evolut Pro/Pro+ transcatheter aortic valve replacement (TAVR) system. Findings included cusp overlap technique (COT) outcomes from the Optimize PRO clinical study and pooled analysis looking at Evolut Pro patients showing improvement in paravalvular leak (PVL) over time following hospital discharge. Investigators presented the new studies […]
Medtronic to expand GI Genius access with new VA contract
Medtronic (NYSE:MDT) announced today that the U.S. Dept. of Veterans Affaris (VA) awarded a new contract for its GI Genius system. The VA awarded a three-year Indefinite Delivery Indefinite Quantity (IDIQ) contract for GI Genius AI-powered endoscopy units. This results in almost 100 additional unit installations across VA medical centers nationwide. This new contract adds […]
Medtronic acquires articulating instrument maker Fortimedix Surgical
Fortimedix Surgical announced today that it has been acquired by medtech giant Medtronic (NYSE:MDT). “We are pleased to share that Fortimedix Surgical was acquired by Medtronic,” the company wrote on LinkedIn. “A unique opportunity to leverage our articulating instrument technology for application across patient therapies. We look forward to joining Medtronic.” Fortimedix develops proprietary articulating […]
Medtronic wins FDA nod for new InPen app to support launch with Simplera CGM
Medtronic (NYSE:MDT) today announced a regulatory milestone that supports the rollout of its next-generation CGM. Our sister site, Drug Delivery Business News, reports today that the FDA cleared the medtech giant’s new InPen insulin delivery system application. Clearance paves the way for the launch of the company’s smart multiple daily injection (MDI) system. That system includes […]
Breaking: Medtronic expects to submit Hugo surgical robot to FDA in 2025
Medtronic (NYSE:MDT) said today that it expects to submit its Hugo surgical robot to the FDA for urology indications in early 2025. Chair and CEO Geoff Martha said on the company’s second-quarter earnings call that the medtech giant expects a submission in the first quarter of calendar year 2025. On the call, Martha said the […]
Medtronic raises 2025 guidance following Q2 beats
Medtronic (NYSE:MDT) is raising its full-year guidance following strong second-quarter financial results that came in ahead of the consensus forecast. Shares of MDT were down more than 1% to $85.91 apiece in at the opening of trading today. The world’s largest medical device company reported profits of nearly $1.3 billion. That equals 99¢ per share […]
Hexagon Health sues Medtronic for alleged patent infringement of hernia mesh device
Hexagon Health and its founder have filed a lawsuit against Medtronic, alleging patient infringement of a hernia mesh device. The lawsuit, filed in federal court in Delaware, alleges that Medtronic unlawfully incorporated patented designs from Hexagon Health founder Dr. Shirin Towfigh into its Dextile Anatomical Mesh, a device used for inguinal hernia repairs. The suit […]
Medtronic, Recor Medical score renal denervation reimbursement wins
Medtronic and Recor Medical each announced separate Medicare reimbursement approvals for their respective renal denervation (RDN) technologies. Going into effect on Jan. 1, 2025, the approvals could increase patient access to the new hypertension treatments. Medtronic secured a Transitional Pass-Through (TPT) payment under the Medicare Hospital Outpatient Prospective Payment System for its Symplicity Spyral renal […]
Medtronic studies highlight safety, effectiveness of atherectomy
Medtronic (NYSE:MDT) announced results from two studies evaluating the utility of atherectomy for peripheral endovascular interventions. The Total REALITY study retrospectively compared directional atherectomy (DA) versus balloon predilatation prior to drug-coated balloon (DCB) treatment of long, calcified femoropopliteal lesions. The company also released results from a systematic literature review and meta-analysis, including 305 published clinical […]
