Devices
Stryker has ended patient enrollment early in its DAWN clinical study comparing mechanical thrombectomy with the Trevo Retriever plus medical therapy against medical therapy alone. An independent data safety monitoring board recommended stopping enrollment based on a pre-planned interim review of data from the first 200 patients, “which concluded
Drugs
Epstein Becker Green is asking FDA to establish a reasonable review timeline for assessing appeals of letter of designation decisions from the FDA Office of Combined Products. The firm’s 3/3 petition says that letter of designation decisions may be appealed to the associate commissioner of special medical programs,
Devices
FDA has issued a safety alert to warn of potentially contaminated SPS-1 Static Preservation Solution distributed by Organ Recovery Systems, Inc. The clear to light yellow, sterile solution is intended for the flushing and cold storage of kidney, liver, and pancreas at the time of organ removal from a
Devices
FDA has approved a Zoll Medical Corp. PMA for the Hospital Wearable Defibrillator (HWD). The device is designed to continuously protect patients at risk of ventricular tachycardia or ventricular fibrillation (VT/VF) during their stay in the hospital. “For a patient experiencing VT/VF, each minute that defibrillation is delayed
Devices
FDA has issued a safety communication to alert healthcare providers and others about its concerns with transvascular autonomic modulation, an experimental procedure using balloon angioplasty devices to treat autonomic dysfunction. The communication says the procedure may put patients at risk because it is being promoted as treatment for a variety
Devices
Physio-Control Inc. has begun a Class 1 recall of its Lifepak 1000 Defibrillators due to an electrical issue that may cause the device to shut down unexpectedly. The recall covers 50,000 devices made from 6/2016 to 12/2016. The devices are used to deliver lifesaving electrical shocks
Devices
Attorney Michelle Yeary (Reed Smith) says that federal courts in Ohio and California both found that all claims brought against Medtronic’s PMA-approved pain pump device were completely preempted, although they reached their conclusions through different means. Writing in an online blog post, she compares the two decisions: * Manufacturing
Devices
FDA has accepted a Keryx Biopharmaceuticals supplemental NDA for Auryxia (ferric citrate) tablets, which seeks an expanded indication to include the treatment of iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease (NDD-CKD). Auryxia is currently approved for use in the U.S. for the control
Devices
FDA has cleared an Intellijoint Surgical 510(k) for the intellijoint Hip Anterior, a 3D mini-optical navigation solution that provides quantifiable, intraoperative measurements for cup position, leg length, and offset to orthopedic surgeons performing direct anterior approach total hip arthroplasty. The device’s use could eliminate fluoroscopy verification for
Devices
FDA has cleared a Beckman Coulter Diagnostics 510(k) for its new DxC 700 AU chemistry analyzer. The new device combines the capabilities of two Beckman Coulter products – the “simple intuitive design of the DxC analyzer and the robust throughput and workhorse capabilities of the AU analyzer – into one standardized
Devices
Information prepared by FDA for the 3/6 MDUFA 3 quarterly performance meeting shows that the percentage of PMA originals and panel track supplements with major deficiency letters in the first FDA review cycle was 81%, as high as it was in 2010 and 2007. The meeting agenda covered guidances
Drugs
Consumer advocacy group Public Citizen is urging Congress to reject three “right to try” bills (S 204, HR 878 and HR 1020) because they would “put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely
Devices
A 2.3% medical device tax in the Affordable Care Act (ACA), which was suspended for tax years 2016 and 2017, cost the U.S. economy 28,000 jobs, according to a new AdvaMed-backed report entitled “Employment Effects of the Medical Device Tax.” Absent a repeal of the ACA
Devices
FDA has cleared a Neocis Inc. 510(k) for Yomi, a robotic guidance system for dental implant procedures. The computerized navigational system is intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery, according to the company. It provides software
Devices
A Pennsylvania federal court last year allowed a strict-liability medical device manufacturing defect claim to proceed, based on a misconstruction of prior decisions and the state’s product liability law generally, according to a Washington Legal Foundation Counsel’s Advisory by attorney Michelle Yeary (Dechert). She writes that the
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA may finally give medical device manufacturers relief on reporting requirements for Class 1 and 2 devices that Congress called for 10 years ago. Writing in his firm’s FDA Law Blog, Shapiro says that the FDA Amendments Act of 2007 directed
Drugs
President Trump took aim at speeding up FDA’s approval process during his 2/28 address to Congress. Noting that it was Rare Disease day, Trump illustrated the need for getting therapies to patients sooner by profiling rare disease survivor Megan Crowley, who was sitting in the Capitol gallery. “Megan
Devices
FDA has approved a CeloNova BioSciences PMA for its first-in-class Cobra PzF NanoCoated Coronary Stent System, indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with reference vessel diameter of
Devices
In a letter to healthcare providers, CDRH says it is aware of marketing materials and recently published literature that imply a new intended use for some neurovascular guide catheters for neurovascular thrombosis removal in patients with acute ischemic stroke. The letter says that FDA has not cleared neurovascular guide catheters
Devices
AdvaMed is telling the HHS Inspector General that existing federal anti-kickback law safe harbors retain beneficial value-based solutions but some changes are needed. In a 2/27 letter, the trade association lists problems that it says manufacturers and others currently face in seeking to engage in value-based
Devices
FDA has approved an Intersect ENT PMA for its Propel Contour steroid releasing sinus implant. The device features an hourglass design for treating patients with chronic sinusitis in the frontal (behind the forehead) and maxillary (behind the cheeks) sinuses. It also has a low-profile flexible delivery system to make
Devices
FDA has granted a de novo petition request to allow marketing of Accelerate Diagnostics’ Pheno system and PhenoTest BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. The blood culture kit is indicated for susceptibility testing of specific pathogenic bacteria commonly associated with