Devices
CDRH says that in 2023 it gave marketing authorization to 124 novel devices, excluding emergency use authorizations, the highest on record in the Center’s history. “CDRH continues to see high numbers of novel devices coming to market,” the Center’s 2023 annual report says, “with an almost five-fold
Devices
CDRH Office of In Vitro Diagnostics (OIVD) director Timothy Stenzel has retired and a national search is underway to fill the vacant position. Stenzel joined FDA 7/2018 after long careers in both academics and industry, which included oversight of test development for both Clinical Laboratory Improvement Amendment labs and
Devices
Percussionaire has recalled its Distal Phasitron, part: S20020, for use with the Percussionaire VDR-4 ventilator control driver due to the potential for the breathing circuit reservoir bag to be assembled at the wrong attachment point, which could result in less than optimal therapy. An FDA recall notice attributes the
Devices
FDA says the Megadyne Medical Products 12/8/2023 recall (correction) of four Mega Soft patient return electrode models is Class 1. An agency notice says the recall was to update the instructions for use and product labeling to restrict the use of the device to patients aged 12 and
Devices
At the request of Sens. Dick Durbin (R-IL) and Richard Blumenthal (D-CT), the Government Accountability Office (GAO) will look into FDA’s role and actions in oversight of medical device recalls, and especially the Philips Respironics recall of breathing machines. The Pittsburgh Post-Gazette, which worked with ProPublica
Devices
Medtronic says it supports FDA efforts to further enhance industry standards for pulse oximeters and to reduce potential health disparities related to using the devices by considering skin pigmentation, race, and ethnicity. Commenting on an agency discussion paper on the topic, Medtronic says that while there is still work to
FDA Policy/General
Speaking at the Consumer Technology Association’s “Ask A Commissioner” program at last week’s Consumer Electronics Show in Las Vegas, FDA commissioner Robert Califf said the agency can’t be solely responsible for effectively regulating products with adaptive algorithms that can learn and change. “If you have an algorithm
Devices
A 6/27-6/30/2023 FDA inspection at Dr. Joel Kaplan Inc. in San Diego, CA, determined there were multiple violations in the firm’s manufacturing and distribution of several male and female sexual health enhancement devices. A 1/8 Warning Letter discusses information from the devices’ product inserts
Drugs
Many doctors are not familiar with how FDA regulates new drugs and medical devices, according to the results of a survey conducted by researchers at the University of California San Francisco (UCSF). The researchers say that doctors may be under the impression that the data supporting drug and medical device
Devices
FDA is alerting patients and healthcare providers about Exactech’s Equinoxe Shoulder System joint replacement devices and possible health risks. The devices were manufactured between 2004 and 2021 and were packaged in defective bags. “The defective bags used to package the Equinoxe Shoulder System devices were missing one of the
Devices
ROi CPS has recalled its Regard Operative Lap P&S Surgical Kit due to the possibility it may not be sterile. The surgical kits were built with a recalled item from a separate Class I recall from Nurse Assist. “Nurse Assist, LLC recalled their 0.9% sodium chloride irrigation
Devices
FDA has granted Darmiyan a de novo marketing authorization for its clinical test BrainSee. The software platform combines standard clinical brain MRI and cognitive assessments to generate an objective score that predicts the likelihood of progression from amnestic mild cognitive (aMCI) impairment to Alzheimer's dementia within five years.
Drugs
The Washington Legal Foundation (WLF) says an FDA draft guidance on communications from firms to healthcare providers about scientific information on unapproved uses (SIUU) of approved/cleared medical products “threatens to undermine public health” and also “disregards the Constitution.” The WLF comment letter says the draft would chill truthful, non-
Devices
FDA has cleared a Zeta Surgical 510(k) for its Zeta Cranial Navigation System. The mixed reality surgical navigation system is intended to provide neurosurgeons “GPS-like” guidance with millimetric accuracy in real time, according to the company. “Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple
Devices
A 5/15-5/19/23 FDA inspection at Neitz Instruments Company in Ichibancho, Japan, found Medical Device Reporting (MDR) issues in the firm’s manufacturing of the Neitz Halogen Ophthalmoscope BXa. A just-released 8/25/23 Warning Letter says Neitz failed to develop, maintain, and implement written Medical
Devices
FDA says healthcare professionals and facilities should be aware of the potential for exposure to certain chemicals that may be released when the General Electric HealthCare EVair or EVair03 compressors are used with certain ventilators. An agency notice says the compressors are optional accessories for ventilators and are used when
Devices
A 7/24-7/27/2023 FDA inspection at Deymed Diagnostic in Nachod CZ, Czechia, found Quality System Regulation violations in the firm’s production of a variety of Class 2 non-sterile products. A just-released 11/7/2023 Warning Letter said the violations were: * failing to establish and
Devices
FDA has approved Bausch + Lomb’s Teneo Excimer Laser Platform for laser-assisted in situ keratomileusis (LASIK) vision correction surgery for myopia and myopic astigmatism (nearsightedness and nearsightedness with astigmatism). The device features an advanced eye-tracker that operates at more than three times the speed of the laser’s
Devices
FDA has approved a Medtronic PMA for its Percept RC Deep Brain Stimulation (DBS) system. The implanted device transmits electrical signals via slender wires to specific brain targets affected by debilitating neurological disorders like Parkinson’s disease, the company says. Medtronic says Percept RC is the smallest and thinnest dual
Devices
FDA says it now considers vaporized hydrogen peroxide (VHP) to be an established sterilization method for medical devices. The agency has revised its final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to reflect VHP’s recognition for sterilization. The
Devices
Megadyne Medical Product, Inc. is recalling its Mega Soft Universal Patient Return Electrodes to update its Instructions for Use and product labeling to restrict use of the device to patients 12 years and older. A recall notice says the company has received 99 reports of patient burn injuries, including third-
Devices
Endotronix has submitted a PMA for the Cordella Pulmonary Artery (PA) Sensor System, a heart failure patient management platform that is intended to deliver proactive PA pressure data and other important health data for comprehensive heart failure management at home. The transmitted daily health information permits managing clinicians to achieve