Medtronic (NYSE:MDT) announced today that it appointed Lidia Fonseca to its board of directors as an independent director. Fonseca, who serves as EVP and chief digital and technology officer at Pfizer, will become a director effective today. She will serve on the board’s Compensation Committee and Science and Technology Committee. “We are thrilled to welcome […]
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Another Medtronic HVAD recall is serious
A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving HeartWare Ventricular Assist Device pumps still implanted in patients. The FDA today designated a Medtronic recall involving the HVADs as Class I, the most serious level. It’s the second Class I recall designation for the HVADs this […]
FDA clears Medtronic’s ligament augmentation system for spine surgery
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance and breakthrough device designation for its LigaPASS 2.0. According to a news release, LigaPass is the first and only FDA-cleared device with an indication for ligament augmentation in spine surgery. The company designed the LigaPASS 2.0 ligament augmentation system due to its positive impact on […]
FDA designates new Medtronic HVAD pump implant recall as Class I
Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death. The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 […]
Medtronic announces new chief medical officer for neuromodulation unit
Medtronic (NYSE:MDT) this week announced that it has appointed Dr. Ashwini Sharan as its neuromodulation operation unit chief medical officer. Sharan will be responsible for shaping the strategic direction of the Fridley, Minnesota-based company’s innovation and clinical evidence plans and help guide physician, society and education engagements. He will also serve as a medical advisor […]
Real-world data backs Medtronic’s next-gen MiniMed 780G insulin pump
Medtronic (NYSE:MDT) announced positive real-world data supporting its next-generation MiniMed 780G insulin pump system. Results from real-world analyses in Europe and Chile, along with clinical data, were presented by Medtronic at the American Diabetes Association (ADA) 82nd Scientific Sessions in New Orleans. According to a news release, the MiniMed 780G advanced hybrid closed loop system, designed with […]
FDA clears integration of Medtronic’s monitoring platforms with GE Healthcare’s Carescape
Medtronic’s (NYSE:MDT) Microstream capnography (CO2) and Invos regional oximetry (rSO2) platforms can now be integrated with GE Healthcare’s Carescape. The two companies announced today that they received FDA clearance and CE mark approval for the integration of Medtronic’s Microstream and Invos technologies for perioperative and ICU care on the GE Healthcare Carescape precision monitoring platform. According […]
FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota–based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. According to a news release, […]
Needham & Co. downgrades Medtronic, Zimmer Biomet shares
Needham & Co. Senior Research Analyst Mike Matson today downgraded his rating of Medtronic (NYSE:MDT) and Zimmer Biomet (NYSE:ZBH) shares to Hold, while Boston Scientific (NYSE:BSX) got an upgrade to Buy. MDT shares were down more than 1% to $97.98 apiece in morning trading, a day after Q4 earnings that missed The Street sent the […]
‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems
Medtronic CEO Geoff Martha today said a “catastrophic explosion” in Medtronic’s supply chain for packaging and a shortage of resins were the biggest issues hurting the company’s fourth-quarter performance. Fridley, Minnesota-based Medtronic (NYSE:MDT) reported about $350 million less in sales than analysts were expecting for the quarter, which ended April 29. Martha said about 75% of […]
Medtronic ‘hopeful’ on FDA clearance for next-gen diabetes tech in FY 2023
The Medtronic (NYSE:MDT) diabetes business sputtered in the fourth quarter but could be bolstered by a major regulatory nod this year. The Fridley, Minnesota-based company saw revenues for its diabetes arm fall by 7.7% year-over-year in the fourth quarter amid overall misses on both sales and adjusted earnings per share compared to Wall Street’s expectations. […]
