Zoll Medical announced today that it received CE Mark approval in Europe for its TherOx SuperSaturated Oxygen (SSO2) therapy system. SSO2 therapy offers interventional cardiologists a treatment beyond percutaneous coronary intervention (PCI) that significantly reduces muscle damage in heart attack patients. Chelmsford, Mass.-based Zoll’s therapy system delivers hyperbaric levels of oxygen directly to damaged heart […]
Zoll Medical wins FDA nod for second-gen TherOx system
Zoll Medical Corp. announced today that it received FDA approval for its second-generation TherOx system for SuperSaturated Oxygen (SSO2) therapy in heart attack patients. The Chelmsford, Mass.–based company’s TherOx system is designed to deliver the SSO2 therapy that has been shown in clinical trials to reduce infarct size (heart muscle damage) in “widowmaker” heart attack […]
Medicare might cover more cutting-edge medtech and pay more for it, too
The Centers for Medicare and Medicaid Services (CMS) said today it wants to give Medicare patients better access to cutting-edge medical devices, and that it’s willing to pay more for them beginning in fiscal year 2020. In its proposed rule, CMS said it might pay more for “certain transformative new devices” for inpatients through a […]
Zoll acquires TherOx
Zoll Medical said today that it acquired TherOx and its acute myocardial infarction treatment. TherOx’s SuperSaturated Oxygen Therapy system delivers a 60-minute infusion of the patient’s super-oxygenated blood to a targeted ischemic area of the heart via a small catheter. The treatment is designed to improve microvascular flow and reduce infarct size following primary coronary […]
TherOx wins FDA approval for SuperSaturated Oxygen therapy
TherOx said today that it won pre-market approval from the FDA for its SuperSaturated Oxygen Therapy system for acute myocardial infarction. Irvine, Calif.-based TherOx touted the PMA as the first heart attack treatment approved to reduce infarct size since the federal safety watchdog OK’d percutaneous coronary interventions. Indicated for patients suffering from left anterior descending […]
Zoll Medical leads debt round for TherOx
TherOx said today it completed a new round of debt financing led by Asahi Kasei (TYO:3407) subsidiary Zoll Medical for an undisclosed amount. Funds from the deal will be used to support the US market introduction and commercialization of the Irvine, Calif.-based company’s SuperSaturated Oxygen Therapy system designed to treat patients with acute myocardial infarction once the system […]
Zimmer Biomet prez, CEO Dvorak unexpectedly resigns | Personnel Moves, July 12, 2017
Zimmer Biomet (NYSE:ZBH) said late yesterday its prez and CEO David Dvorak has resigned from his position at the head of the company, effective immediately, to be replaced on an interim basis by senior VP and CFO Daniel Florin until a permanent successor is named. The Warsaw, Ind.-based company said it is retaining “a leading executive search […]
Bayer taps strategy head Baumann for CEO | Personnel Moves
Bayer (ETR:BAYN) named strategy chief Werner Baumann to replace Marijn Dekkers as CEO today, prompting some industry watchers to speculate that there’s more deal-making ahead for the German firm’s non-pharma markets. Baumann, who’s slated to succeed Dekkers May 1, joined Bayer in 1988 and made a name for himself with the successful integration of rival drugmaker […]
TherOx wins FDA IDE nod for Supersaturated Oxygen therapy
Irvine, Calif.-based oxygenation therapy company TherOx said today it won FDA investigational device exemption approval to test its 2nd-generation Supersaturated Oxygen therapy system for treating acute myocardial infarction. The company’s SSO2 therapy is designed to reduce infarct size by increasing oxygen delivery to heart muscle immediately after the coronary artery has been opened through a […]
