The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices. FDA’s proposal regards the June 2021 recall of millions of certain Philips ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement […]
FDA
FDA signals careful approach in authorizing COVID-19 vaccines in young children
FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June. In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months […]
FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes
The FDA is evaluating the risk of Medtronic (NYSE:MDT) silicone-based electromyogram (EMG) endotracheal tubes following reports of deaths and serious adverse events. The FDA issued the warning last week in a letter to healthcare providers concerning the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes. They are the only silicone-based EMG […]
Medtronic investigates HVAD pump welds after patient deaths
Medtronic (NYSE:MDT) is investigating a new problem with its HeartWare Ventricular Assist Device (HVAD) nearly one year after halting sales and new implantations of the device. Fridley, Minnesota-based Medtronic said it received three complaints of suspected pump thrombosis in patients. Two of the patients died after their heart pumps were exchanged. Medtronic found a malfunction when inspecting […]
Ear-puffing device for migraine treatment wins FDA breakthrough designation
A handheld device that treats migraine attacks with puffs of air in a patient’s ears has been designated a breakthrough device by the FDA. Tempe, Arizona-based Nocira said it is the first company to announce breakthrough device designation for treating migraine attacks in both chronic and non-chronic migraine patients ages 18 and up. The device […]
FDA clears Onera Health’s at-home sleep diagnostic
Onera Health announced today that it received FDA 510(k) clearance for its Onera STS system for polysomnography (PSG) studies. Eindhoven, The Netherlands–based Onera’s patch-based technology aims to transform the outdated, cumbersome and expensive process of traditional sleep testing. Onera said in a news release that its clinical-grade technology can offer an upgrade on the traditional […]
FDA approves Transmedics OCS Heart organ transplant system
TransMedics (Nasdaq:TMDX) announced today that it received FDA premarket approval (PMA) for its OCS Heart system. FDA PMA allows Andover, Massachusetts-based TransMedics to expand the pool of eligible heart donors in the U.S. to organs from donors after circulatory death (DCD). The company had previously received PMA for the OCS Heart system for use with […]
FDA clears four new parameters for Caretaker Medical’s wireless patient monitoring system
Caretaker Medical announced that it received FDA 510(k) clearance for four new hemodynamic parameters for its VitalStream platform. Charlottesville, Virginia-based Caretaker’s wearable, wireless, non-invasive VitalStream platform now has clearance to monitor cardiac output, stroke volume, heart rate variability and left ventricular ejection time. Get the full story at our sister site, Medical Design & Outsourcing.
Recall of Medtronic’s Harmony delivery catheter is Class I
The FDA today announced a Class I recall — the most serious kind — for the Medtronic (NYSE:MDT) Harmony delivery catheter system. Medtronic designed the Harmony transcatheter pulmonary valve (TPV) system for treating a leaky native or surgically repaired right ventricular outflow tract (RVOT). It consists of a transcatheter pulmonary valve and a delivery catheter (the […]
FDA approves Biotronik’s programmer for implanted cardiac rhythm management devices
Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management devices. Lake Oswego, Oregon-based Biotronik designed its Renamic Neo programmer for implanted devices, including ICDs, pacemakers and implantable cardiac monitors. According to a news release, Renamic Neo offers LifeSupport for clinicians to share the programmer screen with or grant […]
DOJ subpoenas Philips over Respironics recall; CEO addresses investigation
Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices. Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial […]