The FDA this week finalized a list of 1,003 Class II medical devices that will no longer require 510(k) clearances. The list was drafted and published in March as part of the 21st Century Cures Act, looking to decrease the regulatory burden on the FDA and decrease costs for medical device companies. Included on the […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Bigfoot Biomedical’s CEO talks disruption in diabetes management tech
Bigfoot Biomedical is a highly competitive player in medtech’s race to develop an artificial pancreas. The 50-person company has made rapid progress towards developing a smart, automated insulin delivery system since its beginnings in 2014. Just yesterday Bigfoot announced that it is partnering with Abbott, bringing together Abbott’s FreeStyle Libre glucose monitoring tech and Bigfoot’s insulin […]
Report: MDUFA will relax med device malfunction reporting rules
Updated headline from ‘adverse events’ to ‘malfunctions’ after receiving clarity on the wording of the MDUFA agreement from AdvaMed. The newly House-passed medical device FDA user fee agreement could allow medical device makers to delay reporting malfunctions, according to a New York Times report. While makers would still be required to quickly report injuries or […]
Mallinckrodt wins orphan drug status for long-acting muscular dystrophy therapy
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that the FDA granted orphan drug status to its long-acting cosyntropin acetate formulation, MNK-1411, for the treatment of Duchenne muscular dystrophy. In August last year, the FDA approved the company’s request to fast track its investigational new drug application for the therapy. Get the full story at our sister site, Drug […]
Avita to seek PMA for ReCell burn indication, considers making US operations hub
Avita Medical (ASX:AVH) today released an update on its future plans, saying it it intends to submit an application to the FDA for Premarket Approval for its ReCell device for use in patients with severe burns and that it’s considering making the US its center of operations. The ReCell device is designed to use the patient’s […]
Philips wins FDA nod for BlueControl psoriasis treatment device
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its BlueControl wearable light therapy designed to treat mild psoriasis. The Amsterdam-based company’s BlueControl is designed as a rechargeable, wearable device which can be comfortably used on the arms, legs, elbows and knees using adjustable straps. The company won CE Mark approval in the European […]
FDA panel recommends approval for gene-altering cancer treatment
An FDA advisory panel yesterday recommended approval for Novartis‘ (NYSE:NVS) CAR-T gene therapy. If approved, it would be the first ever treatment of its kind on the market. The panel voted unanimously, 10-0, to recommend that the FDA give its official nod. The company’s therapy genetically alters a patient’s own cells to fight acute lymphoblastic leukemia. Get […]
Milestone Scientific appoints new CEO following FDA nod | Personnel Moves – July 13, 2017
Milestone Scientific (NYSE:MLSS) said this week that it appointed Daniel Goldberger to the company’s corner office. Leonard Osser, who previously served as CEO, is slated to remain on the board and will continue to serve as director of Milestone’s China operations. The appointment comes on the heels of the FDA’s decision to grant Milestone’s CompuFlo epidural […]
US House passes medical device user fee agreement
The US House of Representatives today passed a bill to reauthorize the FDA’s medical device user fee program, alongside a prescription drug, generic drug and bio similar programs through 2022. Newly appointed FDA commissioner Scott Gottlieb applauded the passage, saying it was a “timely reauthorization key for FDA, patients,” on Twitter after the bill passed. […]
VR play Saebo wins FDA nod for SaeboVR rehab system
Medical virtual reality company Saebo said today it won FDA clearance for its SaeboVR virtual activities of daily living rehabilitation system designed to engage neurological clients in physical and cognitive functional tasks. The Charlotte, N.C.-based company said the software is the 1st-of-its-kind, and was grounded in research from National Institutes of Health sponsored research which […]
First cell and gene therapy for osteoarthritis approved in Korea
Maryland-based TissueGene said today that Invossa, which it touts as the world’s first cell and gene therapy for degenerative arthritis, won approval from the Korea Ministry of Food and Drug Safety. Invossa is designed to treat osteoarthritis of the knee through a single intra-articular injection. Get the full story at our sister site, Drug Delivery Business News.