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).
Medtronic plc is looking to increase market share in pain stimulation with its differential target multiplexed (DTM) therapy, a recharge-free device and its next big disrupter, evoked compound action potential (ECAP). The company is currently developing a closed-loop SCS system for chronic pain following failed back surgery based on ECAP and DTM algorithms.
Medtronic plc reported that the first patient has been enrolled in the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) study its trial evaluating the safety and efficacy of adaptive deep brain stimulation (aDBS) in patients with Parkinson's disease (PD). This type of stimulation is an investigational feature of the Percept PC device that could be enabled if approved.
Corrective and preventive action (CAPA) has a long and difficult history where med tech is concerned. Kathryn Merrill, the global quality/regulatory program director for Medtronic plc, of Dublin, said on a recent webinar that one of the main sources of uncertainty is that many in industry are not clear as to which circumstances dictate that a CAPA should be opened.
Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation (RDN) to treat resistant hypertension. At the same time, the company revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc.
