Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.
Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.
X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.
X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.
Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.
"The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues," said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE™ Pivotal trial. "With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker."
NanoDrop has received clearance in the United States as the inaugural blood-lancing device available for over-the-counter use on the upper arm. This development is poised to revolutionize the consumer testing market and decentralized clinical trials within the realm of at-home healthcare.
"Receiving Fast Track designation is a significant milestone in addressing the high unmet medical need for PSC, and it will facilitate the efficient development of LB-P8 by enabling close communication with the regulatory authority," said Jiyoung Ahn, Head of Clinical Development, LISCure. "By having enhanced communication with the regulatory authority, we will expeditiously bring forward a novel therapy option in an area with limited available treatments."
SetPoint Medical notes acceptance into the TAP Pilot will help expedite regulatory and patient access pathways for a first-of-its-kind therapeutic approach for people with relapsing-remitting multiple sclerosis.TAP Pilot acceptance follows Breakthrough Device Designation announcement for the treatment of RRMS.
Elixir Medical advises the DynamX BTK System for the treatment of BTK vessels impacted by CLTI broadens the use of the novel bioadaptor platform technology beyond the treatment of coronary artery disease
Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management.
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