Michael Barbella, Managing Editor01.20.24
So much for CPAP's glitches being put to rest.
ResMed is the latest company to wrestle with issues related to continuous positive airway pressure (CPAP) machines, as evidenced by a Class 1 recall of its AirFit and AirTouch CPAP masks over potential magnetic interference with the masks’ magnets near some implants and devices in the body. The AirFit and AirTouch masks have magnets on the lower headgear straps and frame connections of CPAP masks to make them more comfortable to wear. Under certain circumstances when the magnet is less than two inches from certain implants and devices, interference can occur and disrupt their function or position, according to ResMed. The company is recalling all CPAP masks with magnets to update the labels, as well as add more warnings and information to guide safe usage when using masks with magnets. So far, ResMed has reported six injuries due to the magnetic interference issue, with no reports of death.
Not surprisingly, ResMed's Class I recall was the top traffic driver on MPO's website this past week, far outpacing regulatory news from Pleural Dynamics and MTF Biologics, a personnel update from Excelitas Technologies, and promising clinical study data from Medtronic. The medtech behemoth enticed cybersurfers to the site by sharing promising four-year results from the Evolut Low Risk Trial. Study results showed the Medtronic Evolut transcatheter aortic valve replacement (TAVR) system delivered exceptional outcomes and sustained valve performance, proven by significantly better hemodynamics than surgical aortic valve replacement (SAVR).
Though it trailed well behind ResMed's recall news, Pleural Dynamics still amassed significant pageviews for gaining FDA 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System, a fully implantable automatic effusion shunt powered by normal breathing and designed for continuous symptom relief. MTF Biologics followed suit with FDA investigational device exemption approval to begin a clinical study to confirm the safety and effectiveness of FlexHD Pliable for implant-based breast reconstruction.
ResMed is the latest company to wrestle with issues related to continuous positive airway pressure (CPAP) machines, as evidenced by a Class 1 recall of its AirFit and AirTouch CPAP masks over potential magnetic interference with the masks’ magnets near some implants and devices in the body. The AirFit and AirTouch masks have magnets on the lower headgear straps and frame connections of CPAP masks to make them more comfortable to wear. Under certain circumstances when the magnet is less than two inches from certain implants and devices, interference can occur and disrupt their function or position, according to ResMed. The company is recalling all CPAP masks with magnets to update the labels, as well as add more warnings and information to guide safe usage when using masks with magnets. So far, ResMed has reported six injuries due to the magnetic interference issue, with no reports of death.
Not surprisingly, ResMed's Class I recall was the top traffic driver on MPO's website this past week, far outpacing regulatory news from Pleural Dynamics and MTF Biologics, a personnel update from Excelitas Technologies, and promising clinical study data from Medtronic. The medtech behemoth enticed cybersurfers to the site by sharing promising four-year results from the Evolut Low Risk Trial. Study results showed the Medtronic Evolut transcatheter aortic valve replacement (TAVR) system delivered exceptional outcomes and sustained valve performance, proven by significantly better hemodynamics than surgical aortic valve replacement (SAVR).
Though it trailed well behind ResMed's recall news, Pleural Dynamics still amassed significant pageviews for gaining FDA 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System, a fully implantable automatic effusion shunt powered by normal breathing and designed for continuous symptom relief. MTF Biologics followed suit with FDA investigational device exemption approval to begin a clinical study to confirm the safety and effectiveness of FlexHD Pliable for implant-based breast reconstruction.