Devices
FDA has issued Warning Letters (see below) to all three duodenoscope manufacturers for failing to comply with a 2015 agency order to conduct postmarket surveillance studies to evaluate the effectiveness of reprocessing the devices. The order, which was part of agency actions to prevent patient infections associated with the transmission
Devices
FDA has approved a Valencia Technologies IDE to conduct a 20-site pivotal clinical trial using its eCoin device technology to treat overactive bladder. The device is intended to work by sending out electrical impulses to the tibial nerve which processes signals to the brain area that controls bladder response.
Devices
CDRH director Jeffrey Shuren says the Center’s real world evidence (RWE) initiative is a top priority and will help to obtain better and more efficient clinical evidence. For medical technology, RWE can fill gaps in the data used for premarket evaluation of devices and continued monitoring of post market
Devices
FDA commissioner Scott Gottlieb told the American Clinical Laboratory Association annual meeting 3/6 that the agency is “working hard to make sure that as inventive new tests come to us for review, we have the right tools to evaluate cutting-edge technologies. And we have the right processes in
Devices
FDA has granted Polyganics a breakthrough device designation for its Liver and Pancreas Sealant Patch, which is designed to prevent fluid leakage after hepato-pancreato-biliary procedures. Currently, there are no approved or cleared alternatives to prevent such leakages, according to the company. The device is made from Polyganics’ proprietary
Devices
FDA has announced a 4/18 public workshop on “Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing in Adults.” At the workshop, FDA will discuss appropriate clinical study designs for evaluating medical devices for diagnosing, monitoring, or treating the condition. Study design considerations include definitions
Biologics
Verax Biomedical says FDA improperly influenced members of the Blood Products Advisory Committee at an 11/30/17 meeting in violation of the Federal Advisory Committee Act (FACA), and agency actions taken to implement recommendations from that meeting should be reversed. In a 3/5 petition, Verax asks that FDA:
Devices
A CDRH Webinar gave hints to improve compliance with the custom device annual report requirements. A custom device exemption allows medical device manufacturers to market certain devices designed to treat a unique pathology or physiological condition without premarket approval. Manufacturers of custom devices are to report to FDA annually. During
Devices
FDA has cleared a Stryker’s Spine division 510(k) for its Tritanium TL Curved Posterior Lumbar Cage, a 3D-printed interbody fusion device intended for use as an aid in lumbar fixation. The hollow implant has a “unique configuration of both solid and porous structures, which are simultaneously built
Devices
FDA says it received 11, 854 medical device reports related to Bayer’s Essure contraception device in 2017, more than double the 5,019 reports received in 2016. “The nature and severity of the reports remain consistent with prior years,” an FDA Essure activity update says. “However, in 2017, 78%
Devices
The 3rd Circuit Court of Appeals has issued the first appellate decision that preemption for multi-component medical devices should be addressed on a component-by-component basis. Attorney Michelle Yeary (Dechert) says the ruling came in an appeal from a Pennsylvania federal court decision in a case involving a
Devices
FDA has expanded the approval of St. Jude Medical’s Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff to include a 15-mm valve size that is small enough to be used in newborn pediatric patients to treat heart defects. The rotatable, two-leaflet valve is designed for
Devices
FDA has granted 23andMe a de novo marketing authorization for its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (selected variants) — the first direct-to-consumer test to report on three specific breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent.
Devices
FDA has released the FDA-483 issued following a 7/17-8/18/17 inspection at Philips Medical Systems, Cleveland, OH. The eight inspection observations listed were: * failing to review, evaluate, and investigate where necessary complaints involving the possible failure of a device to meet any of its specifications; * failing
Devices
FDA has cleared a Corindus Vascular Robotics 510(k) for what the sponsor says is the first automated robotic movement designed for its CorPath GRX platform for use in percutaneous coronary and percutaneous vascular procedures. The device uses the company’s proprietary software feature called “Rotate on Retract” that allows
Devices
FDA has given 510(k) clearance to the Cardiovascular Systems’ OrbusNeich 1.0mm Sapphire II Pro coronary balloon. The company says it is the first and only 1.0mm coronary balloon available in the U.S.
Devices
A CDRH and CBER proposal on Voluntary Malfunction Summary Reporting Program for manufacturer reporting of certain device malfunction medical device reports (MDRs) has gained the backing of device industry trade group AdvaMed and drawn criticism from women’s health advocates. The proposed program is intended to streamline malfunction reporting and
Devices
FDA has cleared an Alfa Scientific Designs 510(k) for its Simple Cup multi-drug test with Driven Flow, a multi-drug of abuse urine test. The urine immunoassay identifies 13 drugs or drug metabolites and it yields results in two minutes while maintaining line integrity for at least two
Devices
FDA has approved a Medtronic PMA supplement for a new arm indication for the Guardian Sensor 3 glucose monitor that will enable patients to wear the sensor on the upper arm. The company says this is the only sensor FDA approved to control automated insulin delivery via a hybrid closed
Devices
CDRH director of Ophthalmic, and Ear, Nose, and Throat Devices Malvina Eydelman says that since passage of the 21st Century Cures Act, CDRH has received 94 requests for breakthrough devices treating a variety of conditions, and has granted 54 of them. Writing in an FDA Voice blog post, Eydelman says
Devices
FDA has cleared an Acclarent 510(k) to expand the indication for the Acclarent Aera Eustachian Tube Balloon Dilation System to include its use in patients as young as 18. The device was previously cleared only for adults aged 22 and older. In addition, the company says recent evidence shows
Drugs
FDA commissioner Scott Gottlieb says the agency is taking new steps to support and expedite development of rare disease products. Writing in an FDA Voice blog post to mark 2/28 as the 11th Rare Disease Day, Gottlieb identifies the actions as: * a new pilot for more efficient orphan designation