Devices
A 7/25-8/12/22 FDA inspection at iRhythm Technologies in Cypress, CA, determined that the company manufactures the ZIO AT system, which it says is an unapproved medical device. A 5/25 Warning Letter says the system is intended to continuously record and report patient symptomatic and asymptomatic
Devices
FDA has granted a de novo marketing authorization for Cue Health’s Cue Covid-19 Molecular Test, the first at-home Covid test granted a traditional marketing authorization outside of the agency’s emergency use authorities. The molecular nucleic acid amplification test (NAAT) is intended to detect genetic material from
Devices
Abiomed has recalled (Class 1) its Impella 5.5 with SmartAssist System after receiving complaints about purge fluid leaking from the device’s purge sidearm. “If a purge leak occurs the system will experience low purge pressures, prompting alarms and requiring evaluation,” a recall notice says. “If the leak issue
Devices
FDA has sent a “Dear Doctor” letter about “supply constraints” involving non-sterile, single-use pneumatic tourniquet cuffs in the U.S. The devices are mainly used in elective limb surgeries and in emergency and trauma settings. During the supply issue, the agency is recommending that health care providers use
Devices
Draeger Medical has recalled (Class 1) its ventilator set, tubing and support (with harness) because glued connections on the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. A recall notice says that FDA has determined that the faulty parts are the
Devices
FDA has posted a final guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The document includes minor procedural updates and clarifications related to scheduling pre-submission meetings for investigational medical devices. Under the Medical Device User Fee Amendments of 2022, new performance goals
Devices
CDRH is soliciting public comment on increasing patient access to at-home use medical technologies. The request for comment says access to medical devices outside a clinical care setting “may help bridge the gap by bringing healthcare directly to patients wherever they are….” The Center says it particularly wants public
Devices
FDA has cleared an Ezra 510(k) for its artificial intelligence-enabled Ezra Flash and its use in enhancing MR image quality and decreasing the time needed to complete a high quality scan. The company says it will use this technology to launch the “world’s first 30-minute full
Drugs
FDA commissioner Robert Califf says artificial intelligence (AI), like many of the great innovations for humankind, can be used for tremendous good or tremendous harm. In a wide-ranging Medscape interview, Califf says it’s always good to have in the back of one’s mind that harm can be
Devices
CDRH is announcing a 9/6 Patient Engagement Advisory Committee meeting to discuss and make recommendations on “Advancing Health Equity in Medical Devices.” Panel members are scheduled to discuss using technology, including digital health technology, to help bridge gaps in health equity by extending access and bringing healthcare to patients
Devices
The Center for Science in the Public Interest and 15 other public interest organizations are asking FDA to regulate laboratory-developed tests (LDTs). A 5/30 letter says the agency has the authority to regulate LDTs but has chosen not to use it because early tests were fairly simple and
Devices
FDA has cleared a Think Surgical 510(k) for its TMINI Miniature Robotic System for performing total knee replacement surgeries. The device includes a wireless robotic handpiece to assist surgeons. “Following a CT-based three-dimensional surgical plan, the TMINI robotic handpiece automatically compensates for surgeon hand movement to locate
Devices
iRhythm Technologies says it received a 5/25-dated Warning Letter that cites violations from an 8/22 agency inspection. “The Warning Letter alleges non-conformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements,
Devices
Germany-based Berlin Heart has recalled (Class 1) its Excor Pediatric Ventricular Assist Device Blood Pumps due to the potential for therapy disruption. “There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device,” a recall notice says. The recall
Devices
Neuralink, the neurotechnology company owned by Elon Musk, says it has gained FDA approval for a human clinical trial of its brain implant technology. The agency has not commented publicly on the reported approval or specified what it includes, according to a UPI report. In March, Reuters reported it had
Devices
FDA has published a guidance, Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures, with recommendations it says may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems. The document says tissue containment
Drugs
Drug recalls surged by 53.2% from 94 in the fourth quarter of 2022 to 144 in the first quarter of 2023, according to the Sedgwick first quarter recall index. The report says current good manufacturing practice deviations dominated the recall activity, accounting for 70 events and 33.2 million
Devices
Integra LifeSciences says it is recalling all products manufactured at its Boston, MA facility due to inadequate endotoxin testing. An internal investigation found deviations with endotoxin testing that may have resulted in the release of products with higher levels of endotoxins than permitted by the product specifications, the company says
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) say they commend FDA for publishing a framework to guide the use of digital health technology (DHT)-derived data in regulatory decision-making for drug and biological products. The associations’ joint letter recommends that the agency consider
Devices
FDA has published a question-and-answer guidance, Use of Whole Slide Imaging in Nonclinical Toxicology Studies, with information for sponsors and nonclinical laboratories on the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice(GLP)-compliant nonclinical
Devices
SD Biosensor has recalled (Class 1) its Pilot Covid-19 At-Home Test due to microbial contamination. “The liquid buffer component in the affected test kit lots was determined to have bacterial contamination,” an FDA recall notice says. “Users may notice a slight odor when the buffer is brought close
Drugs
University of Florida law professor Lars Noah wants FDA to take administrative action to define when client-seeking ads by personal injury lawyers related to FDA-regulated therapeutic products would qualify as potentially misleading lawyer advertising related to drugs and devices. In a 5/19 petition, Noah attaches an article