Devices
FDA says the Cook Medical 11/24/20 recall of Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers is Class 1. An agency notice says the two products are catheters that have a coated shaft, a valve, a dilator, and markers that show on an x-ray.
Devices
FDA has just released the FDA-483 with five observations issued following a 1/13-1/16/20 inspection at Legacy Pharmaceutical Packaging, an Earth City, MO, medical device contract manufacturer. The observations were: * failing to adequately validate according to established procedures a process whose results cannot be fully verified
Devices
FDA has approved an Integrum PMA for Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, intended for adults who have transfemoral (above-the-knee) amputations and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The device is surgically anchored and integrated into a patient’
Devices
Attorneys Aaron Josephson and Benjamin Zegarelli (Mintz) say in an online post that 2020 was the year that Americans became familiar with lesser-known and niche FDA policies like those governing emergency use authorizations, and with the agency role in regulating laboratory-developed tests. The two use this post to
Devices
Penumbra has recalled all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) due to a risk of unexpected death or serious injury while used for removing clots in stroke patients. All users should stop using this device, and facilities should remove the
Devices
FDA has granted a de novo marketing authorization for Miach Orthopedics’ anterior cruciate ligament (ACL) implant for ACL reconstruction to treat ACL tears. The Bridge-Enhanced ACL Repair (BEAR) Implant is an alternative to traditional reconstruction and does not require the use of harvested tendons for ACL repair. The device
Devices
FDA has issued Abbott an Emergency Use Authorization (EUA) for its “virtually guided” at-home use BinaxNOW Covid-19 Ag Card rapid test for detecting Covid-19 infection. Abbott is partnering with digital health solutions provider eMed to deliver and administer 30 million BinaxNOW at-home tests in the first
Devices
EMD Serono says the FDA discussion paper “Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework” captures appropriate elements that should be considered. The company letter gives comments on sections of the FDA paper that could help to strengthen or clarify the text. The sections include “Interpretability: Make it Easy
Devices
FDA has issued an emergency use authorization (EUA) for Ellume’s Covid-19 Home Test, the first over-the-counter fully at-home diagnostic test for Covid-19. The rapid, lateral flow antigen test is designed to detect fragments of proteins of the SARS-CoV-2 virus from a nasal
Devices
FDA has granted Spark Biomedical a Breakthrough Device Designation for the Roo System: a transcutaneous electrical nerve stimulator that aids in reducing signs and symptoms of neonatal opioid withdrawal syndrome, which results from exposure to prescription or non-prescription opioids or heroin during pregnancy. The device is based on the
Devices
FDA has approved a Foldax IDE to begin a clinical study of its Tria biopolymer mitral surgical heart valve. The device is made out of a new, proprietary biopolymer – LifePolymer – and is intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong
Devices
A just-filed citizen petition is requesting that FDA not treat “daily-wear uniform scrubs” as medical devices. The petition, which was filed by the law firm Loeb & Loeb on behalf of an unnamed garment maker, is asking for enforcement discretion for the scrubs that are “intended for every
Devices
FDA has granted ReCor Medical a breakthrough device designation for Paradise Ultrasound Renal Denervation System and its use for treating patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications. The designation is based on recent positive data from the RADIANCE-HTN TRIO study, according to the company.
Devices
FDA has posted three new guidances for device makers to use under its Safety and Performance-Based Pathway. Manufacturers have the option to use FDA-identified performance criteria to demonstrate that a device is as safe and effective as its predicate. The guidance Spinal Plating Systems – Performance Criteria for Safety
Devices
FDA has authorized LabCorp’s Pixel Covid-19 Test Home Collection Kit for direct-to-consumer use without a prescription by an individual age 18 and older. An agency statement says the kit allows individuals to self-collect a nasal swab at home and send the sample to LabCorp for
Devices
Swedish researchers say that an interim analysis of data from a clinical trial in which patients with peripheral artery disease received treatment with either paclitaxel-coated or uncoated endovascular devices found no difference in all-cause mortality between the groups in the incidence of death during one to four years
Devices
FDA has granted SoniVie a breakthrough device designation for the Tivus System for renal artery denervation and its use in treating resistant hypertension, which is defined as blood pressure that remains above 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses, one
Devices
Services firm CyberMDX says that GE medical imaging devices have a cybersecurity vulnerability that potentially puts the operation of the systems and the health data contained on them at risk. MedTech Dive reports in an online post that the vulnerability also can affect certain workstations and imaging devices used in
Devices
FDA has released a final guidance on Requesting FDA Feedback on Combination Products. The document discusses ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and describes best practices for FDA and sponsors when interacting on these topics. The interactions can occur through
Devices
FDA has cleared a Zebra Medical Vision 510(k) for its artificial intelligence (AI) analytics that extract bone measurements from X-ray scans for planning orthopedic surgical procedures. The novel technology offers an alternative to CT scans and MRIs for such planning, the company says. Zebra-Med’s technology uses
Drugs
FDA is being criticized for its slow response to the need to find alternatives to physical inspections during the worsening Covid-19 pandemic. The issue is even more critical now as a number of drug submission final review actions have been put on the back burner due to the agency’
Devices
FDA has issued a safety alert to warn patients and health care providers about patient injuries from wearing face masks that contain metal parts and coatings during a Magnetic Resonance Imaging (MRI) exam. “Metal parts, like nose pieces sometimes called nose clips or wires, nanoparticles (ultrafine particles), or antimicrobial coating