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 […]
Medical device tax: What we talk about when we talk about job losses
For going on 5 years now, opponents on both sides of the fight over the medical device tax have engaged in a rhetorical war about the number of jobs that will be lost to the levy.
Zoll lands Japanese OK for R Series monitor/defibrillator
Zoll Medical said today that it won Shonin approval from the Japanese Ministry of Health, Labor & Welfare for its R Series combination monitor and automated external defibrillator.
Zoll makes another buy, nabs German life-support systems company
Massachusetts-based Asahi Kasei (TYO:3407) subsidiary Zoll Medical touted its 2nd acquisition this month, this time nabbing assets of German-based Lifebridge Medizintechnik.
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