Devices
FDA has granted InspectIR an emergency use authorization for the first Covid-19 diagnostic test that detects Covid-19 chemical compounds in breath samples. “The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites,
FDA Policy/General
A California state appeals court has upheld almost all of a massive $344 million civil penalty judgment against Johnson & Johnson’s Ethicon unit awarded in a bench trial for circulating misleading instructions about its transvaginal pelvic mesh products. Legal Newsline reports the appeals court only struck $42 million in
Drugs
FDA has published a new draft guidance, Diversity Plans to Improve Enrollment of Participants from Under-represented Racial and Ethnic Populations in Clinical Trials, that expands on an earlier guidance intended to help the industry improve clinical trial diversity. The document says individuals from several named populations are frequently under-
Devices
FDA has granted a Safer Technologies Program (STeP) designation to Pear Therapeutics for its Pear-010 product candidate intended to treat acute and chronic pain. The company says the product is intended to provide a neurobehavioral intervention (virtual reality delivered pain reduction) to patients age 18 and older with acute
Devices
FDA has approved a Boston Scientific PMA for its latest image guided programming software, Vercise Neural Navigator with StimViewXT. The device is intended to provide clinicians in real-time the ability to visualize both lead placement and “stimulation modeling of the brain anatomy of their patients living with Parkinson’s
Devices
FDA has announced a 7/12-13 CDRH Patient Engagement Advisory Committee meeting that will discuss and make recommendations on augmented reality (AR) and virtual reality (VR) medical devices. “From diagnostics to clinical decision making, to surgical support, and to directly treating patients, AR/VR devices are used across multiple
Devices
FDA has issued two guidances with performance criteria for products in support of the 510(k) Safety and Performance Based Pathway. The first guidance, Denture Based Resins — Performance Criteria for Safety and Performance Based Pathway, gives submitters an option to use the performance criteria proposed in the document to support
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says a 12/2021 FDA Warning Letter to Medtronic “provides an important reminder from FDA as to the correct estimation of risk associated with [medical device] malfunctions.” Writing in his firm’s FDA Law Blog, Shapiro says that among other issues, the letter
Devices
FDA’s latest cybersecurity draft guidance underscores the total product lifecycle nature of cybersecurity considerations for medical devices, including premarket device submissions and deployment mitigations for older legacy devices that were not built with security in mind. That’s the assessment of CDRH Office of Strategic Partnerships and Technology Innovation
Devices
The Medical Imaging and Technology Alliance (MITA) says an FDA draft guidance on notifying the agency in advance of a public health emergency about the permanent discontinuance or interruption in manufacturing a device under Section 506J of the Federal Food, Drug, and Cosmetic Act should be “significantly narrower in scope.
Devices
FDA has cleared a Google 510(k) for its Fitbit and the company’s new PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib). The algorithm is intended to power a new Irregular Heart Rhythm Notifications feature on Fitbit, Google says in a blog post. Often, AFib is difficult to detect
Devices
FDA says healthcare providers may not be fully aware that the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO) is to triage suspected findings of LVO based on the analysis of brain radiological exams. CDRH is working with LVO CADt device
Devices
FDA says Medtronic has recalled certain MiniMed 630G insulin pumps with SmartGuard due to a labeling design error. The pumps are intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for managing Type 1 diabetes mellitus in patients 16
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are ratcheting up pressure on FDA to issue its promised final rule allowing over-the-counter (OTC) hearing aids. The two lawmakers have just introduced their Delivering Over-the-Counter Hearing Aids Now Act to push the agency to finalize
Devices
FDA has published a draft guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, that replaces a 2018 draft guidance on content of premarket submissions for management of cybersecurity in medical devices. FDA says the new version is intended to “further emphasize the importance of ensuring
Devices
FDA has published a draft guidance, Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers, to provide information to sponsors and nonclinical laboratories about using and managing whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical
Devices
Medtronic says long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial showed that patients who were prescribed anti-hypertensive medications and treated with the Medtronic Symplicity Spyral Renal Denervation System continued to show durable, clinically significant blood pressure reductions through three years. The company
Drugs
FDA is participating with the University of California San Francisco and Quantum Leap Healthcare Collaborative in an electronic health record (EHR) integration project that aims to streamline health data for clinical research trials. An EHR Intelligence story says that OneSource is an electronic data capture system based on open-source
Devices
FDA has approved a GE Healthcare PMA for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS2Anesthesia Delivery System. The company says it is the only manufacturer in the U.S. approved to offer general anesthesia delivery with the automatic software. The Et Control software
Devices
FDA says that given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete the transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or
Devices
FDA has approved Abbott’s Aveir VR single-chamber leadless pacemaker for treating patients with slow heart rhythms. The device is implanted directly inside the heart’s right ventricle and the leadless pacemaker does not require an incision in the chest or cardiac leads to deliver therapy, according to the
Devices
Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) have introduced the Protecting and Transforming Cyber Health Care (PATCH) Act that would implement critical cybersecurity requirements for device manufacturers applying for premarket approval through FDA. The bipartisan PATCH Act would “ensure that innovative medical technologies are better protected from