Devices
FDA has granted Pear Therapeutics a breakthrough device designation for its reSET-A PDT (Prescription Digital Therapeutic) product candidate designed for treating alcohol use disorder. PDTs are designed to collect real world data for use by prescribing clinicians and for population health management by payors and health systems, according to
Drugs
The Sedgwick Recall Index for the third quarter of 2021 says both medical device and pharmaceutical recalls “surged.” The index says medical device recalls rose 35.8% from 173 in the previous quarter to 235. And drug recalls surged by 45.8% from 59 last quarter to 86. Software issues
Devices
Two medical device technical experts at Hyman, Phelps & McNamara say an 11/4 FDA draft guidance describes the recommended documentation that a sponsor should include in premarket submissions for medical device software functions. Writing in their firm’s FDA Law Blog, the two say the draft, when finalized, will
Devices
FDA has granted Theradaptive a breakthrough medical device designation for its Osteo-Adapt SP Spinal Fusion implant indicated for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. The company says the implant is designed to permit precise tissue regeneration for a variety of tissue types
Drugs
FDA appears to be making progress in the backlog of inspectional work needed to render review decisions on outstanding medical product applications that were delayed due to the Covid-19 pandemic. In May, the agency released its “Resiliency Roadmap for FDA Inspectional Oversight” report (see earlier story) that said 68
Devices
FDA has issued two final orders reclassifying certain Hepatitis C virus (HCV) diagnostic tests from Class 3 to Class 2, which will allow the tests to use the agency’s 510(k) pathway rather than the PMA process. The two types of HCV diagnostic tests being reclassified are nucleic acid-
Devices
CDRH says a recent article published in the Journal of Clinical Pharmacy and Therapeutics entitled Assessing Dosing Errors in Legacy and Low Dose Tip ENFit Syringes sheds some light on an agency safety alert about the risk of medication overdose from the moat area of ENFit LDT syringes. Last month,
Devices
FDA has cleared a Lunit 510(k) for its Insight MMG, an artificial intelligence (AI) application for breast cancer detection. The AI software for breast cancer joins the the company’s AI solutions for chest x-ray and mammography. Insight MMG is a radiology product which analyzes mammography images with
Devices
FDA is reminding healthcare providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation. An agency letter to providers says the overall risk of cardiac perforation associated with leadless pacemaker implantation appears similar to the risk associated with traditional transvenous pacing systems. “However,” the letter
Devices
FDA has qualified the MED Institute’s medical device development tool (MDDT) for virtual MRI safety evaluations to determine if MRI imaging is safe for patients with implanted medical devices. The institute says its MDDT uses computational modeling and simulation to predict RF-induced heating of passive medical devices during
Devices
FDA has cleared a MIM Software 510(k) for its MIM SurePlan MRT, a software package for molecular radiotherapy. The software features artificial intelligence segmentation models, which simplify the contouring process for dosimetry, the company says, adding that it provides quicker and enhanced results compared to manual and atlas-based
Devices
FDA has cleared an Avinger 510(k) for a new clinical indication for the Pantheris image-guided atherectomy system — treating in-stent restenosis in the lower extremity arteries. Clearance was based on data generated from the INSIGHT trial, a prospective, global, single arm, multi-center study, according to the company.
Devices
Cook Group says the FDA non-in vitro diagnostic electronic submission template and resource (eSTAR) is easy to use and intuitive, while also driving standardization. In an 11/12 comment letter on an agency draft guidance on the electronic submission template for medical device 510(k) submissions, Cook says additional
Devices
FDA has granted Blackrock Neurotech a breakthrough device designation for its MoveAgain Brain Computer Interface System. The device is intended to provide immobile patients the ability to control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by thinking. It comprises an array implanted in the brain, which
Devices
FDA has authorized the de novo marketing of AppliedVR’s EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain. EaseVRx uses cognitive
Devices
FDA has granted Medtronic 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures. The device provides a telehealth option for direct visualization and monitoring of the small bowel to help detect lesions not detected by upper and lower endoscopy that may signal Crohn’s disease,
Devices
FDA has published a revised guidance entitled Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency. The agency says that policy set forth in this guidance will help address public health concerns regarding the availability of such transport media devices and therefore help expand the
Devices
HHS 11/15 withdrew a Trump Administration policy that directed FDA not to enforce premarket review requirements for laboratory developed tests (LDTs). FDA says the move is intended to help ensure that COVID-19 tests are accurate and reliable. The highly critical 8/20/2020 policy was part of the
Devices
Baxter Healthcare has recalled its PrisMax System Version 2, a high permeability hemodialysis device, due to a software design error. If a device operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the “Same Patient” button, the system
Devices
FDA recently inspected Philips Respironics and issued a 29-page Form FDA-483 based on a Class 1 recall follow-up involving its continuous and non-continuous ventilators. The inspection was initiated to assess compliance with regulatory requirements and to investigate concerns about the devices’ polyester-based polyurethane sound abatement
Biologics
FDA has authorized Inovio to proceed with the INNOVATE Phase 3 segment for its INO-4800 Covid-19 vaccine candidate. In authorizing the trial, FDA lifted a partial clinical hold after reviewing additional non-clinical, clinical, and device information submitted by the company. Inovio says the vaccine candidate is composed
Devices
FDA says the 10/1 Eluume Covid-19 Home Test recall is Class 1. The company recalled 2,212,335 units in the U.S. manufactured between 2/24 and 8/11 and distributed between 4/13 and 8/26. The company says it recalled certain lots of the test