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 […]
Asahi Kasei Corp.
Zoll closes Cardiac Science buyout
Asahi Kasei (TYO:3407) subsidiary Zoll Medical said today that it closed its deal to acquire Cardiac Science and its portfolio of automated external defibrillators for an undisclosed amount. Deerfield, Wis.-based Cardiac Science operates in North America, Europe and Asia. The company has installed more than 500,000 units in nearly 100 countries, according to Zoll. “This acquisition […]
Zoll warns on AED Pro defibrillator issue
Asahi Kasei (TYO:3407) subsidiary Zoll Medical this month issued a field advisory for its AED Pro automated external defibrillator after receiving a report that a unit failed during use. Chelmsford, Mass.-based Zoll said its investigation traced the problem to an “isolation breakdown” on an area of the AED Pro’s internal circuit board. “If the isolation breakdown […]
Zoll Medical launches wearable heart failure management system
Asahi Kasei (TYO:3407) subsidiary Zoll Medical announced the launch of and first patient prescription for the Zoll µCor (pronounced “micro core”) heart failure and arrhythmia management system (HFAMS), designed to help clinicians improve outcomes and reduce hospitalizations for heart failure patients with fluid management problems. Zoll HFAMS is an FDA-cleared, patch-based, wireless system that employs […]
Patient deaths prompt renewed warning to heed LifeVest alert
FDA has issued another update to a previous voluntary recall of Asahi Kasei (TYO:3407) subsidiary Zoll Medical‘s LifeVest 4000 wearable automatic external defibrillators following two patient deaths. In January and July 2018, the agency and the company advised patients to contact Zoll immediately for a replacement if their device displays the message: “Call for Service—Message Code 102.” […]
FDA updates on Zoll Medical LifeVest 4000 error 102 issues
The FDA today updated on a previous voluntary recall of Asahi Kasei (TYO:3407) subsidiary Zoll Medical‘s LifeVest wearable automatic external defibrillators over errors that can cause the device to stop functioning, saying the company has initiated new customer training on the device and is working on a software fix. In January, the FDA released a warning and […]
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 […]
Appeals court revives lawsuit over death allegedly linked to Zoll’s LifeVest
Asahi Kasei (TYO:3407) subsidiary Zoll Medical is facing a revived suit alleging that the company’s LifeVest failed to appropriately shock a patient’s heart, resulting in her death. The case was filed by Dennis Godelia, remaining son of deceased Debra Godelia, who died in 2013 after the LifeVest allegedly did not function correctly during a “defibrillation event,” court documents […]
Death prompts warning for Zoll’s LifeVest wearable AED
Asahi Kasei (TYO:3407) subsidiary Zoll Medical and the FDA are warning about an error code displayed by a model of its LifeVest wearable automatic external defibrillator that was involved in a patient’s death. Patients using LifeVest 4000 models who don’t contact the company after the device displays “Call for service: Device has a problem that may […]
Asahi Kasei shuffles the deck at Zoll Medical | Personnel Moves
Japan’s Asahi Kasei Corp. (TYO:3407), which in 2012 paid $2.3 billion to acquire Zoll Medical, is shuffling the deck at the resuscitation device maker. Former CEO Rick Packer, who led Zoll for 13 years before overseeing the merger with Asahi Kasei, was promoted to primary executive officer and charged with building the healthcare business into “a 3rd […]