Devices
Anti-dental amalgam activists are rejoicing in a victory as Dentsply Sirona – the world’s largest manufacturer of dental products – has exited the amalgam market. In a 12/8 statement, Consumers for Dental Choice national counsel and World Alliance for Mercury-Free Dentistry president Charles Brown said the company had
Devices
FDA has updated its SARS-CoV-2 Viral Mutations: Impact on Covid-19 Tests Web page with information on the omicron variant. The agency says the update added new information about: * FDA recommendations for clinical laboratory staff and healthcare providers; * the Tide Laboratories DTPM Covid-19 RT-PCR test that
Devices
FDA says a 6/15-6/29 inspection at the Induction Therapies medical device operation in Louisville, KY, determined that the firm manufactures Collagen P.I.N., a microneedling product. An 11/23 Warning Letter says the device is offered for sale and distributed in the U.S. without marketing
FDA Policy/General
Former FDA commissioner Stephen Hahn has been named CEO of Flagship Pioneering’s new Harbinger Health startup. Flagship describes Harbinger as a bio-platform company pioneering the detection of early cancer with a simple blood test that combines artificial intelligence (AI) and machine learning advances with its recent discoveries about
Devices
FDA has granted RefleXion Medical a breakthrough device designation for its biology-guided radiotherapy for use in treating lung tumors. The device uses injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery, according to the company. It uses positron-emission tomography imaging data to
Devices
Congress should use the upcoming Cures 2.0 bill draft and the reauthorization of the medical device user fee program to effect meaningful change to the 510(k) clearance process, such as revamping methods used to classify risk, according to an opinion piece appearing online on Statnews.com. The piece
Devices
FDA has launched a new Web page about paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions in arteries of the legs. The page includes information about risks associated with these devices and ongoing agency efforts to work with manufacturers and investigators on additional clinical
Devices
The New Jersey Supreme Court has an opportunity to make a decision that “will have a major impact on medical device liability and, in turn, the availability of important new devices that offer technological advances over previous products.” That’s the position explained by attorney Phil Goldberg (Shook, Hardy &
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on investigator responsibilities for safety reporting for investigational drugs and medical devices “will help further ensure a consistent approach to safety and safety reporting throughout the entire medical product development process.” In its 11/29 comment letter, the
Devices
A self-employed medical sales representative will pay $100,000 to settle allegations that he assisted in causing the submission of false claims. A Justice Department statement says Matthew Thibaut, from Cyprus, who sold products through his Flex Surgical Management company, sold DyAnsys electro-acupuncture devices from 1/1/17
Devices
FDA has cleared a CoreLink 510(k) for its CentraFix Midline Spinal Fixation System. The device is a posterior thoracolumbar pedicle screw system designed for use with a medial-to-lateral approach, known as cortical bone trajectory (CBT). “This technique maximizes contact of the pedicle screw with cortical bone and
Devices
FDA has cleared a Sound Life Sciences 510(k) for its sonar software for consumer smart devices. The smartphone app produces inaudible ultrasonic sonar pulses to detect reflections caused by nearby patient respiration, according to the company. The prescription-only application can be used in home or clinical settings to
Devices
FDA has added four items to its medical device cybersecurity online post: * the availability of a threat modeling playbook that discusses best practices for understanding basic threat modeling concepts and processes and how to apply them to medical devices; * a joint FDA/University of California San Francisco-Stanford Center of
Devices
FDA says the overall benefits of titanium-based NuInvasive Precice devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. In a 12/1 online notice, the agency says the instructions for use for titanium-based Precice devices have been updated to include
Drugs
Stakeholders are contacting FDA to express opposition to or concerns about the agency’s recent reclassification of drug products as drug-led combinations whose components require additional regulatory review. The Association for Accessible Medicines (AAM), representing the generic drug industry, is calling on the agency to rescind its reclassification decision.
Devices
FDA 5/25-6/24 inspections at three Invacare manufacturing facilities identified Quality System Regulation violations in the firm’s manufacturing of a variety of Class 2 oxygen concentrators intended for patients with respiratory disorders requiring supplemental oxygen. An 11/18 Warning Letter says specific violations were: * failing to investigate
Drugs
AdvaMed says it supports FDA efforts to provide up-to-date guidance to help clinical investigators comply with IDE studies. In an 11/19 comment on an agency draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices, AdvaMed makes both general and specific comments. It says that while
Devices
Three Hyman, Phelps & McNamara attorneys say an 11/15 HHS announcement withdrawing the Trump administration’s policy preventing FDA from requiring premarket review of laboratory-developed tests (LDTs) without notice and comment rulemaking raises many questions. Writing in their firm’s FDA Law Blog, the attorneys say the “announcement
Devices
FDA has cleared a Hyperfine 510(k) for its advanced image reconstruction technology that uses deep learning to improve magnetic resonance imaging (MRI) on its Swoop MRI device. “The image quality resulting from this innovative approach elevates the diagnostic value of portable MRI,” the company says. The artificial intelligence application
Devices
A 2/23-3/30 FDA inspection at Smiths Medical ASD, Minneapolis, MN, determined that the firm is a specification developer and manufacturer for a variety of medical devices including blood warmers and infusion pumps. A just-released 10/1 Warning Letter says the inspection found that the firm’s
Devices
FDA has scheduled a 12/14 Webinar for stakeholders interested in learning about the final rule Medical Device De Novo Classification Process and associated guidance document updates. An online notice says the Webinar will: * describe the background and history of the de novo program; * describe the de novo regulations and
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