The FDA is raising the user fees medical device makers pay for the safety watchdog to review its products by more than 4%. The user fees for fiscal 2016, which begins Oct. 1, 2015 are going up 4.2% over the fiscal 2015 fees for both small businesses making less that $100 million annually and for […]
Food & Drug Administration (FDA)
FDA warns that Hospira Symbiq pumps can be hacked
The FDA today released a safety communication warning about cybersecurity vulnerabilities with Hospira’s (NYSE:HSP) Symbiq infusion system. The Symbiq infusion system can potentially be accessed remotely through a hospital’s network, which could allow for unauthorized changes to the dosage delivered by the pump, according to the federal watchdog. The issue was confirmed by Hospira and […]
Ten Steps to Comply with FDA UDI Requirements
By David Lennarz, Vice President and Co-Founder of Registrar Corp The September 24, 2015 Unique Device Identifier (UDI) compliance date is quickly approaching. Life-supporting and life-sustaining device labelers, as well as most contact and intraocular lens labelers, have only two months left to comply with the U.S. Food and Drug Administration’s (FDA) UDI labeling and […]
Teleflex updates on Q2 earnings, FDA clearances, acquisitions, deals & study data.
Teleflex (NYSE:TFX) yesterday released a slew of new information on the company, including its fiscal 2nd quarter results, new FDA clearances, the acquisition of Australian distributor assets, details on a new group purchase agreement and data from a set of new studies. Teleflex shares slide on Q2 report Teleflex’s shares dropped nearly 5% today after […]
NeuWave wins FDA nod for Ablation Confirmation software
NeuWave Medical said today it won FDA premarket approval for its Ablation Confirmation software, which will be integrated into its Intelligent Ablation system. The new system uses computed tomography which allows physicians to visualize and confirm ablation targets and lesions using images from CT scanners, according to the company. The computer-contolled ablation system also has greater […]
C2 Therapeutics wins 510(k)s for Coldplay cryoballoons
C2 Therapeutics said today it won FDA 510(k) clearances for its Coldplay cryoballoon full ablation system and swipe ablation system. The Redwood City, Calif.-based company’s devices are designed to treat precursors to esophageal cancer known as Barrett’s Esophagus. “The clearance of Coldplay Cryoballoon Full and Swipe Systems is an important milestone in broadening the company’s […]
FDA approves ReShape Medical’s weight loss treatment
Weight loss company ReShape Medical won FDA premarket approval for its ReShape dual balloon system, indicated to facilitate weight loss in obese adult patients, according to an FDA release. The system is designed to be inserted endoscopically into the stomach, where it remains for 6 months to help patients feel full, San Clemente, Calif.-based ReShape […]
UPDATE: Medtronic warns on potential MiniMed pump glitch
Medtronic (NYSE:MDT) is informing customers with a select number of its MiniMed 620G and 640G insulin pumps of an issue with the Bolus screen displaying a bolus amount that is not up to date, according to an FDA report filed last week. Medtronic began notifying customers with the devices on June 19, informing them of an error with […]
NYT op-eds: 21st Century Cures strengthens FDA
The New York Times published 2 letters-to-the-editor supporting the 21st Century Cures act after releasing 2 op-eds slamming the act over the past week. The letters came from Marc Boutin, chief exec of the National Health Council and Stephen Ubl, the chief exec of medical device trade association Advamed. Both responses outlined what the authors […]
FDA Voice: Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs
By: Ben Fisher, Ph.D. At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the U.S., […]
Alphatec reveals FDA warning letter
Alphatec (NSDQ:ATEC) yesterday revealed that it received a warning letter from the FDA over problems at a plant in its home base of Carlsbad, Calif. The July 16 warning letter cites 8 “deficiencies” in Alphatec’s response to the FDA’s initial observations after it inspected the plant in February and March, the company said. “The deficiencies relate […]