Arkray is recalling its Spotchem II test strips over inaccurate blood sugar readings in what the FDA has labeled a Class I recall. The FDA labels recalls as Class I when there is a reasonable probability that product use could cause serious adverse health consequences or death. The recall includes both the Spotchem II Basic […]
Food & Drug Administration (FDA)
Velano Vascular wins FDA nod for new blood draw device
Velano Vascular said today that it won 510(k) clearance from the FDA for a new iteration of its needle-free blood draw device. San Francisco-based Velano, which raised a $5 million Series A round in February 2015, won its 1st FDA nod for the device last year. The new clearance covers a pair of modifications to the device aimed […]
Sanders joins Markey, puts hold on FDA chief nominee Califf
U.S. Democratic presidential candidate Bernie Sanders placed a hold on Barack Obama’s FDA nominee Robert Califf, stating Califf is too close to the pharma industry to be an impartial regulator. Sanders has stated he would oppose the nomination of Califf over his ties to the pharmaceutical industry since shortly after President Obama nominated him in […]
Markey puts hold on Califf’s nomination for FDA chief
(Reuters) — Sen. Edward Markey (D-Mass.) yesterday put a hold on President Barack Obama’s nominee to head the FDA until the agency agrees to reform its process for approving opioid painkillers. Markey wants opioid-approval matters to be reviewed by an FDA advisory committee and believes the committee should consider the risk of addiction and abuse during the approval […]
Commonwealth Informatics inks data deal with FDA
Commonwealth Informatics said today it inked a 2-year research collaboration agreement with the FDA to improve Commonwealth’s Clinical Data Analytics platform. The CCDA is clinical data analytics platform designed to be used by healthcare and medical product researchers looking to analyze multiple data sources. The collaborative deal will allow Commonwealth to improve the software, the […]
FDA clears next-gen Pelvalon incontinence device
Pelvalon said yesterday it won FDA 510(k) for its next-generation Eclipse incontinence device designed for women suffering loss of bowel control. Sunnyvale, Calif.-based Pelvalon’s Eclipse is designed to be vaginally inserted, with a balloon that is inflated to put pressure on the rectal wall and prevent involuntary bowel movements. The new version includes a trial insert […]
FDA proposes to require PMAs for cranial electrotherapy stimulators for depression
The FDA is proposing to require manufacturers of cranial electrotherapy stimulators to submit pre-market approval applications if their devices are intended to treat depression. The federal safety watchdog said it’s also proposing to down-classify CES devices aimed at treating insomnia and anxiety from Class III, which would also require PMA applications, to Class II subject to […]
Medtech approvals: FDA releases November 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015: Summary of PMA Originals & Supplements Approved Originals: 3 Supplements: 69 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 30 Total On Hold: 27 Summary of PMA Supplements Under Review Total Under Review: 583 […]
Centinel Spine wins FDA 510(k) for Altos cervical spine implant
Centinel Spine said today it won FDA 510(k) clearance for its Altos posterior cervical thoracic stabilization system with indications for use in lateral masses of the cervical spine or pedicles of the cervical-thoracic spine. The West Chester, Penn.-based company said the 1st surgical implantation of the system was performed earlier this month at Las Vegas’ Western […]
FDA to offer webinar on new final guidance on sterility
The FDA said yesterday it will host a webinar covering newly released guidance concerning sterilization. The federal watchdog yesterday issued a final guidance on sterilization, outlining adequate sterilization methods for sterile-labeled 510(k) devices and the appropriate documentation necessary for the premarket review of novel sterilization processes. The Agency said its final guidance also included details […]
Delcath inks FDA deal for design of Phase III trial
Delcath (NSDQ:DCTH) said yesterday the company reached a special protocol assessment agreement with the FDA for the design of a Phase III trial of its Delcath Hepatic Delivery System and Melphalan Hydrochloride. The system is designed to treat patients with hepatic dominant ocular melanoma, the New York City-based company said. The company said the agreement acted as a […]