Devices
FDA has cleared a Bio-Rad Laboratories 510(k) for “enhanced capability” with its IH-Com data management software to manage patient results with the company’s IH-1000 automated blood typing instrument. IH-Com is a data management tool that “combines all current and prior results associated with a
Devices
A New Jersey federal judge has dismissed a state product liability suit against Boston Scientific, Guidant, and two related medical device companies because the state law claims are preempted by federal law. Attorney Elizabeth Boggia (Weil Gotshal & Manges) writes in an online blog post that the plaintiff filed suit
Drugs
Attorney James Beck (Reed Smith) says that based on FDA commissioner Scott Gottlieb’s previous agency and non-agency statements, he doubts “that FDA’s absolutist ban on truthful industry speech about off-label uses will continue much longer in its current form.” Writing in an online blog post, Beck
Devices
FDA has granted a de novo clearance for Sciex Diagnostics’ LC MS-based Vitamin D 200M Assay for use on the company’s Topaz System. “The CDC has established a Vitamin D Standardization-Certification Program (VDSCP) and the SCIEX Topaz Vitamin D 200M Assay Kit has successfully met the rigorous
Devices
FDA has released the FDA-483 issued at the completion of an 11/29-12/16/16 agency inspection at Repro-Med Systems, Chester, NY. Inspection observations were: * failing to report in writing to FDA a correction or removal conducted to reduce a health risk posed by a medical device;
Devices
FDA says the Abbott-Thoratec 3/29 recall of its HeartMate II LVAS pocket system controller is Class 1. The device was recalled due to risk of patient injury and/or death during backup controller exchange, an agency notice says. The controller is a power supply that connects to an
Devices
Respironics has begun a Class 1 recall of its V60 Non-invasive Ventilator because the pins within the internal cable that connects the ventilator's motor to the control board may become loose over time due to low frequency vibration, an FDA notice says. The loose pins may prevent
Devices
FDA has cleared a Soterix Medical 510(k) for its IontoDC device, which uses a direct current to introduce ions of soluble salts or other drugs into the body. “Iontophoresis is used for hyperhidrosis treatment, delivery of local anesthetic before emergent skin puncture or dermatological procedure to reduce pain, administration
Devices
FDA has classified as Class 1 an Abbott recall of specific lots of three catheters — NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. A recall notice says that affected products could cause difficulty when the protective balloon sheath is removed,
Devices
FDA has cleared an XpandOrtho 510(k) for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses “multiple miniaturized sensors and actuators to perform multiplanar balancing of the knee joint during a full range of motion,” the company says. “The device
Drugs
Attorney Stephen Wood (Chuhak & Tecson) says a stay of discovery should be mandatory to weed out frivolous False Claims Act cases before defendants have to bear the cost of discovery. Writing in a Washington Legal Foundation Legal Backgrounder, Wood says that the small percentage of whistleblower cases that succeed
Devices
FDA has cleared a Myoscience 510(k) for its iovera device for relieving pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The device uses iovera’s technology and non-systemic treatment for blocking pain signals from peripheral nerves. It uses the “body’s natural
Devices
AdvaMed says that the bipartisan Medical Product Review Harmonization Act of 2017 (H.R. 2474), sponsored by Reps. Mimi Walters (R-CA) and Ami Bera (D-CA), would establish an alternate review approach for a subset of moderate-risk Class 2 medical devices, making FDA review of these devices more
Drugs
In a 5/15 letter to Sen. Patty Murray (D-WA), ranking Democrat on the Senate HELP Committee, HHS secretary Tom Price says the administration’s budget blueprint calls for increasing and restructuring the medical product user fee programs at FDA to be 100% user fee supported programs, with no
Devices
FDA and the Centers for Disease Control (CDC) say that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the U.S. An agency news release says the CDC recommends that parents of children younger than age 6 and currently pregnant women
Devices
A comment letter signed by former FDA principal deputy commissioner Joshua Sharfstein (now a professor at Johns Hopkins University) and five other medical school professors or researchers says that drug testing assays that are Class 2 medical devices and used for employment or insurance purposes should not be permitted to
Devices
FDA has cleared a BrainCool AB 510(k) for the IQool System, intended for use for temperature reduction in adult patients when clinically indicated. The device is a “next-generation precision surface cooling system intended for temperature management with a focus on three independent anatomical zones: head/neck, thigh and
Devices
FDA has cleared an Exactech 510(k) to market the ExactechGPS Shoulder Application that combines preoperative planning with computer-assisted shoulder arthroplasty surgery. The device is designed to help surgeons understand their patient’s anatomy prior to surgery, according to the company. “In addition, ExactechGPS provides a real-time view
Devices
Abbott has begun a recall of specific lots of three catheters — NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. A recall notice says that affected products could cause difficulty when the protective balloon sheath is removed, which in turn could
Devices
A 3/28-4/7 FDA inspection at Oxford Performance Materials, South Windsor, CT, found Quality System Regulation violations in the firm’s manufacturing of Osteofab 3D-printed cranial and maxillofacial implants, according to a 5/1 Warning Letter from the agency’s New England District Office. Specific violations documented
Devices
A 1/3-1/12 FDA inspection at Vidco, Inc., Beaverton, OR, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of patient monitoring devices including the NetViewer MDP2040-0100 device, according to a 5/5 Warning Letter from the agency’s Seattle District Office.
Drugs
Enforcement officials are closely scrutinizing drug and medical company speaker programs for False Claims Act violations. Attorney Matthew Curley (Bass, Berry & Sims) writes in an online blog post that drug and device manufacturers accounted for nearly half of the enforcement recoveries from the healthcare industry last year. Curley says