Australian medical device company DorsaVi saw shares jump approximately 8.6% today after the company announced it had won FDA 510(k) clearance for its ViMove2 muscle activity sensor. The ViMove2 sensor is designed to measure, record and analyze movement and muscle activity in the lower back, and includes Bluetooth communication and a mobile application for both […]
Food & Drug Administration (FDA)
Drugmakers talk competition & innovation with FDA leaders
Drugmakers, payers and patient advocates convened at the FDA’s White Oak campus yesterday to present before a panel of regulatory leaders about competition and innovation in the pharmaceutical industry. The meeting, which was titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” opened with FDA commish Scott Gottlieb, who announced that the […]
Inovio looks to raise $75m in public offering
Inovio Pharmaceuticals (NSDQ:INO) said yesterday that it is launching an underwritten public offering to sell $75 million shares of common stock. The Plymouth Meeting, Penn.-based company said it plans to grant underwriters an option to buy up to $11.3 million additional shares of common stock. Get the full story at our sister site, Drug Delivery Business News.
Guided Therapeutics re-opens FDA discussions seeking LuViva PMA
Guided Therapeutics (OTC:GTHP) said today it re-entered discussions with the FDA about pursuing premarket approval for its LuViva advanced cervical scan device. The Norcross, Ga.-based company said the decision was prompted by “constructive” outcomes from previous meetings with the organization alongside a “perceived more favorable environment for device approvals under the new presidential administration” and a […]
EDAP pulls FDA bid for Focal One, plans to resubmit with new data
Edap (NSDQ:EDAP) said today it withdrew the FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer. The French company said that following “advanced discussions” with the federal watchdog, it plans to submit a new 510(k) application which includes new clinical data. “As mentioned during our last quarterly call, a […]
Corium touts clinical data for transdermal delivery of Alzheimer’s drug
Corium (NSDQ:CORI) touted data today from a pilot bioequivalence study, comparing its Corplex Donepezil transdermal patch to oral Aricept as delivery method for the most commonly prescribed treatment for Alzheimer’s disease. Data from the pilot study demonstrated that Corium’s transdermal patch met the criteria for bioequivalence to oral Aricept, as measured by primary pharmacokinetic endpoints previously […]
T2 Biosystems wins CE Mark for MR-based bacteria detector, closing in on FDA bid
T2 Biosystems Inc. (NSDQ:TTOO) said today it won CE Mark approval in the European Union for its T2Bacteria Panel magnetic resonance-based bacterial detector, and said that it has entered the final stages of its FDA pivotal trial as it seeks 510(k) approval from the agency. The T2Bacteria Panel is designed to run on the company’s T2Dx […]
Voluntis wins regulatory nod to integrate Toujeo insulin with Insulia mobile app
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 […]
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 […]
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 […]