Olympus (TYO:7733) and a former senior executive in Japan have pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and to continuing to sell the devices in the United States despite those failures, the Justice Department announced. Tokyo-based Olympus and Hisao Yabe, 62, both entered guilty pleas before […]
FDA advisory panel to mull transvaginal mesh
The FDA plans to hold an advisory committee meeting in February 2019 to discuss the safety and efficacy of surgical transvaginal mesh as a treatment for pelvic organ prolapse. According to a document from the U.S. regulatory watchdog, the committee will be tasked with assessing the benefits and risks of placing mesh transvaginally in the […]
Notal Vision snags breakthrough designation for home OCT system
Ophthalmic diagnostic services company Notal Vision said it has won breakthrough device designation for its artificial-intelligence-aided macular degeneration diagnostic device. Privately-held Notal (Manassas, Va.) said its home-based optical coherence tomography (OCT) system was designed to automatically identify intra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD). The Notal Home […]
FDA tells its side of regulatory, quality story
A week after an international group of journalists published a package of stories slamming the medical device industry, the FDA has issued its own report highlighting its accomplishments dating back to 2007. The Medical Device Enforcement and Quality Report touts: Increased medtech manufacturer inspections and voluntary reporting of violative devices and adverse events; Targeted enforcement of […]
FDA issues revised draft guidances for blood glucose monitors
The FDA issued two revised draft guidances today relating to over-the-counter and prescription blood glucose monitors. The new documents, which are intended to update guidances issued in 2016, were based on feedback from stakeholders, who requested more clarification on design considerations and recommended standards, according to the U.S. regulatory agency. Get the full story at our […]
FDA clears Innovative Health to reprocess major manufacturers’ catheters
Innovative Health said it has nabbed FDA clearances to reprocess diagnostic catheters made by St. Jude Medical, Medtronic and Biosense Webster. The catheters include St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav. Innovative Health said it is the first in the industry to receive clearances to reprocess the Advisor and the Decanav, […]
FDA delays some UDI compliance dates
Under pressure from manufacturers, the FDA is pushing back Unique Device Identification (UDI) compliance deadlines for some non-sterile, class I, and unclassified devices. Devicemakers will have until September 24, 2020 before they must comply with standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements for these devices, according to the new […]
Is the medical device industry endangering people?
The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny. The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about […]
FDA releases 510(k) modernization plans
The FDA today released plans for updating its 510(k) clearance pathway, including a push to move away from using predicate devices over 10 years old and the creation of a new alternative 510(k) pathway that will allow approval based on objective safety and performance criteria. In an official posting, FDA head Dr. Scott Gottliebb and […]
FDA warns on pain drugs for implantable pumps
The FDA today warned doctors and patients about the serious complications that can occur when using the wrong painkillers with implantable drug pumps. Dosing errors, pump failure, and infection are just some of the potential problems that can crop up when using drugs that aren’t approved for use with particular devices, the regulatory agency said. […]
Report: Med device recalls down in Q3
Medical device recalls fell by 21% to 284 in the third quarter of 2018, according to a report by Stericycle Expert Solutions. Machine failure was the top cause of recalls based on units, while software led the way based on numbers of recalls, the report says. The total number of medtech recalls for Q3 was lower […]
- 1
- 2
- 3
- …
- 25
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube