Zoll Medical announced that it received FDA approval for its Remedē system for conditional use with magnetic resonance imaging (MRI). Chelmsford, Massachusetts-based Zoll designed its Remedē system as an implantable, transvenous phrenic nerve stimulation therapy. It treats adults with moderate to severe central sleep apnea (CSA). Full-body MRI approval applies to all models of the […]
Zoll Medical
Zoll faces lawsuit over data breach
Zoll Medical has been sued in U.S. District Court in Eastern Massachusetts over its recent data breach that involved more than 1 million people. The law firms Sauder Schelkopf (Berwyn, Pennsylvania) and Milberg Coleman Bryson Phillips Grossman (Garden City, New York) filed the suit on March 24. They’re seeking class-action status. The main plaintiff is […]
Zoll data breach affects more than 1 million people
More than 1 million people may have had personal data compromised during a recent hacking of Zoll Medical’s systems. That’s according to a notice that Zoll filed with Maine’s attorney general, one of a number filed with federal and state agencies since the data breach in late January. Operated out of Massachusetts, Zoll is an […]
First patient enrolled in Zoll trial for supersaturated oxygen therapy in heart attack patients
Zoll Medical announced that the first patient enrolled in its AMIHOT III post-approval study for its TherOx supersaturated oxygen (SSO2) therapy. Chelmsford, Massachusetts-based Zoll’s trial will evaluate TherOx for treating the most severe form of heart attack: left anterior descending (LAD) ST-elevation myocardial infarction (STEMI). TherOx is an FDA-approved therapy shown to reduce the size […]
Zoll closes $538M acquisition of Itamar Medical
Zoll Medical announced today that it completed its previously announced $538 million acquisition of Itamar Medical (NSDQ:ITMR). In September, Zoll confirmed its intent to acquire all outstanding shares of Itamar, a developer of non-invasive devices and solutions for the diagnosis of respiratory sleep disorders, at $31 per American Depository Share (ADS), a premium of 50.2% […]
Zoll Medical to acquire Itamar Medical in $538M deal
Zoll Medical announced today that it will acquire Itamar Medical (NSDQ:ITMR) for a total value of approximately $538 million. Chelmsford, Massachusetts-based Zoll will acquire all outstanding shares of Itamar, a developer of non-invasive devices and solutions for the diagnosis of respiratory sleep disorders, at $31 per American Deposiory Share (ADS), a premium of 50.2% over […]
FDA approves Zoll Respicardia’s next-gen Remedē system
Zoll Medical, an Asahi Kasei company, announced today that the FDA has approved its next-gen Remedē EL-X implantable neurostimulation system to treat severe sleep apnea. Zoll acquired the technology through its acquisition of Respicardia in April. Improvements to the new Remedē EL-X include: 40% longer average battery life versus the previous version; Three-fourths the size […]
DTW Podcast: How is Zimmer Biomet waging the ortho data war? Do medical devices carry physics-based biases?
In this week’s DeviceTalks Weekly Podcast, Liane Teplitsky, vice president and general manager of worldwide robotics at Zimmer Biomet, shares her excitement for the burgeoning data business emerging in orthopedics. Teplitsky, an engineer who built her medtech career in cardiac R&D and sales at St. Jude and Abbott, walks us through the interconnected offerings of […]
Zoll Medical acquires Respicardia
Zoll Medical said today that it has acquired Respicardia and its neurostimulation tech for treating sleep apnea. The financial terms of the deal were not disclosed. Respicardia makes implantable neurostimulators to treat moderate to severe central sleep apnea (CSA). The system is FDA approved to treat severe CSA in adult patients with reduced cardiac function. […]
FDA says lay rescuers can use Zoll AED 3 defibrillator
Zoll Medical announced yesterday that its Zoll AED 3 defibrillator received FDA premarket approval (PMA) for use by lay rescuers. Chelmsford, Mass.-based Zoll’s AED 3 defibrillator uses CPR technology with integrated, real-time feedback to deliver guideline-compliant CPR to improve outcomes from sudden cardiac arrest. The company touts its enhanced technology as the first in the […]
Zoll Medical returns HHS funds meant to support health providers
Zoll Medical said today that it’s returning money that it automatically received from the U.S. Department of Health and Human Services’ $50 billion Cares Act Provider Relief Fund. “Although we meet all of the qualifications for the funds we received and could fully comply with the terms and conditions required to keep the funds, we […]
