The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, other stent graft products in line for FDA panel safety probe; New conditions imposed on vaccine authorization; MRNA vaccine efficacy holds in real world; STIs on the rise in U.S.
The FDA approved the world's first non-surgical heart valve to treat severe pulmonary valve regurgitation, which often affects individuals with congenital heart disease. Medtronic plc’s Harmony transcatheter pulmonary valve system (TPV) improves blood flow to the lungs without open-heart surgery. The device could extend the time before an individual born with heart disease needs open-heart surgery and the total number of such surgeries they have to endure over their lifetime.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA approves Harmony device to treat patients with congenital heart disease.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA seeks nominations for blood products advisory panel; Massachusetts hospital hit for HIPAA access non-compliance; No reports recorded for Medtronic recall; Tillis, Cotton eye patent examiner practice for Section 101 problem.
Medtronic plc obtained the CE mark for its Sensight directional lead system for deep brain stimulation (DBS) for movement disorders and epilepsy, which is designed to be used with the company’s Percept PC DBS device. Percept received U.S. FDA clearance in June 2020 and CE mark in January 2020.
The COVID-19 pandemic has imposed a lot of drag on clinical trials for life science companies, but those companies have also broadened their horizons when it comes to financing their R&D efforts. Jeffrey Ellis and Dennis Howell, of Deloitte, told BioWorld that while these alternative sources of funding are attractive to drug and device makers with a lot of ongoing R&D projects, federal regulators are keeping a close eye on the associated financial reporting, creating a novel regulatory risk for the unwary drug or device maker.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS commits more funds for testing, materials to fight pandemic; Medtronic announces recall of Valiant Navion; Florida man pleads guilty in DME fraud.
Medtronic plc said Monday that it has expanded its limited site release of its new radial artery access portfolio. Acquired from Rist Neurovascular Inc. last year, the portfolio includes the Rist 079 Radial Access guide catheter and Rist Radial Access selective catheter. Dublin-based Medtronic completed its acquisition of privately held Rist Neurovascular in August 2020 for an undisclosed sum – the eighth in a series of tuck-in deals the med-tech behemoth has undertaken since January 2020.
Medtronic plc received U.S. FDA premarket approval of its Diamondtemp Ablation (DTA) system for treatment of patients with recurrent, symptomatic paroxysmal atrial fibrillation. The temperature-controlled radiofrequency (RF) ablation system features industrial-grade diamonds, which provide 200 to 400 times the thermal conductivity seen in conventional ablation and enable more efficient delivery of energy to regions of the heart responsible for the erratic electrical signals underlying atrial fibrillation (AF).
