Voluntis said today its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate Sanofi‘s (NYSE:SNY) Toujeo insulin glargine. The company’s software already works with Lantus and Levemir. The Insulia digital companion is composed of a patient mobile app and healthcare worker web portal. The app gives real-time […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA grants regenerative medicine advanced therapy status to Mallinckrodt’s StrataGraft
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that its StrataGraft regenerative skin tissue won regenerative medicine advanced therapy status from the FDA. The tissue-based therapy is among the first products to be granted the designation. The 21st Century Cures Act, which was passed in 2016, enabled the FDA to give accelerated review approval to products that meet RMAT criteria. […]
CSA Medical wins expanded FDA nod for TruFreeze system
Endoscopic cryo-ablation company CSA Medical said today it won FDA 510(k) clearance for a 3rd spray kit, the rapid AV spray kit, for its TruFreeze system. The Boston-based company’s TruFreeze system is designed as a cryosurgical tool designed for use in dermatology, gynecology, general surgery and to ablate benign and malignant lesions. The newly cleared addition is […]
Whitehouse Labs expands drug delivery device testing capabilities
Whitehouse Laboratories, a division of Albany Molecular Research, said today that it has expanded its drug delivery device testing capabilities to include services for ISO 80369 standards. The 8 standards described in ISO 80369 were designed to prevent connector errors in medical device and drug delivery systems. Whitehouse Labs said that the group’s latest expansion […]
FDA exempts 1,003 Class II devices from 510(k) requirements
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 […]
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 […]