Communications Pilot to Enhance the Medical Device Recall Program
Friday, November 22, 2024
Today, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is announcing a communications pilot to enhance the medical device recall program. This pilot is intended to improve the timeliness of communications about corrective actions being taken by compan... .. read more..
FDA Issues Final Guidance on 510(k) Third Party Review Program
Thursday, November 21, 2024
Recently, the U.S. Food and Drug Administration (FDA) issued this final guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. This guidance supersedes the previous “510(k) Third Party Review Program” guidance, clarifying how the FDA will... .. read more..
Brain Science Can Help Manufacturers Understand Standards
Wednesday, November 20, 2024
Even after the U.S. FDA’s adoption of ISO 13485 into its Quality Management System Regulation (QMSR), misconceptions about it and other standards documents remain. The Association for the Advancement of Medical Instrumentation (AAMI) seeks to remedy misconceptions about documents like ISO 1... .. read more..
Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Ba...
Tuesday, November 19, 2024
Smiths Medical is updating use instructions for CADD-Solis Li-ion Rechargeable Battery Packs due to a potential issue where battery pack damage may lead to a short within the battery that melts the pack casing and stops the battery from being able to charge. Read More The U.S. Food and Drug Admin... .. read more..
FDA clears the way for additional bivalent boosters for certain vulnerable in...
Tuesday, April 18, 2023
The U.S. Food and Drug Administration amended the terms of its emergency use authorizations for the Pfizer and Moderna bivalent vaccines on Tuesday, allowing people ages 65 and older and certain people with weakened immunity to get additional doses before this fall's vaccination campaigns. .. read more..
Home, Suite, Home
Tuesday, September 24, 2019
In this cover story, 24x7 correspondent Chris Hayhurst explores the evolving—and thriving—home healthcare sector and reveals what it means for HTM professionals. Read on to learn more. .. read more..
The HTM Industry Mourns the Loss of ‘Maverick’ Bill Hyman
Tuesday, September 24, 2019
William A. “Bill” Hyman, ScD, an esteemed clinical engineering professional and frequent 24x7 contributor, passed away this summer. In a statement, the American College of Clinical Engineering called Hyman a “dedicated professional— always generous and willing to share his extensive knowledge.” .. read more..
AAMI Seeks Nominations for Awards Programs
Tuesday, September 24, 2019
Do you know a health technology innovator, safety advocate, or revolutionary? How about a standards leader or humanitarian? You can make sure that health technology’s finest are recognized for their achievements by nominating them for an AAMI or AAMI Foundation award. .. read more..
Patient Monitoring in the NICU
Thursday, September 19, 2019
Monitoring devices for preterm infants haven’t changed much since the ’60s. But they’re about to—and should, asserts one healthcare company executive. Here’s what you need to know about monitoring devices in the NICU—and how they are advancing. .. read more..
FDA Takes Steps to Modernize 510(k) Medical Device Program
Thursday, September 19, 2019
The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific t... .. read more..
Pediatric Medical Device Competition Finalists Named
Wednesday, September 18, 2019
Organizers of the $150,000 “Make Your Medical Device Pitch for Kids!” competition have announced the 12 finalists who are advancing to the live pitch component of the competition scheduled for September 22 during the 7th Annual Pediatric Device Innovation Symposium hosted by Children’s National H... .. read more..
AAMI to Offer CBET Study Course
Wednesday, September 18, 2019
For the first time, AAMI will offer an online review course to help biomedical equipment technicians (BMETs) prepare for the exam to become certified biomedical equipment technicians (CBETs). The four-week online CBET Study Course will cover all six areas of the CBET exam. .. read more..
AAMI Partners with Other Industries to Promote Job Openings
Tuesday, September 17, 2019
On the heels of the latest jobs report, AAMI is partnering with three other U.S. industries—the professional landscape sector, the foodservice distribution industry, and the grocery sector—to encourage job seekers to explore the many career opportunities in their respective fields. .. read more..
Market Watch: Medical Wearable Technologies
Monday, September 16, 2019
In their work at the Advanced Self-Powered Systems of Integrated Sensors and Technologies Center at North Carolina State University, the authors of this article examined current trends in the medical wearable technology market. They reveal them here. .. read more..
Looking to Optimize Your Medical Equipment Spend?
Friday, September 13, 2019
On Monday, September 30, at 2 p.m. CST, 24x7 Magazine will host a webinar you don’t want to miss. Titled, “Optimize Your Medical Equipment Spend with Real-World Data,” the webinar will be presented by Michael Garel, Director of Big Data Strategy at Accruent, and offer participants tangible advice. .. read more..
Leading the Charge
Thursday, September 12, 2019
In this roundtable, three medical equipment battery experts discuss what’s propelling growth in this sector and reveal what pitfalls to avoid when purchasing medical batteries. .. read more..
Surgical Robots: Healthcare’s Next Frontier?
Thursday, September 12, 2019
The history of surgical robots, although a brief one, cannot be overlooked. From “promise” and “potential” to real-time implementation, the journey of surgical robots has been swift. But is robotics healthcare technology’s next frontier? One writer investigates here. .. read more..
RSTI Expands MRI Course Portfolio
Tuesday, September 10, 2019
Solon, Ohio-based RSTI announces that it is expanding its portfolio to include a “Principles of Servicing MRI” training course in November. The course will be divided into two, week-long phases. .. read more..
FDA Clears Netech Defibrillator/Pacemaker Analyzer
Monday, September 9, 2019
Farmingdale, N.Y.-based biomedical test-instrument manufacturer Netech announces the launch of its new defibrillator/pacemaker analyzer, the Delta 3300, which recently garnered U.S. FDA clearance. .. read more..
Viewpoint: AI Implications for Healthcare
Sunday, September 8, 2019
Advancements in computing, communications, and robotics technologies are converging to drive the emergence of artificial intelligence in medicine. Here, Verathon’s Sven Powilleit delves into how AI is transforming healthcare. Don’t miss out. .. read more..