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
Devices
FDA has cleared Accelerate Diagnostics’ PhenoTest BC Kit performed on the Pheno System, the first test to identify organisms that cause bloodstream infections and provide information about antibiotic sensitivity. An agency news release says that the test also reduces the amount of time needed to provide the information, which can
Devices
FDA has cleared a Seventh Sense Biosystems 510(k) for TAP, a new blood collection device. TAP is the world’s first push-button blood collection device that eliminates needle inserts to draw blood, according to the company. The small device is positioned on a patient’s upper arm and
Devices
Decision makers in medical device firms over- or under-react to market feedback through user-generated reports on adverse events related to their products and making product recall decisions, according to a detailed “big data” analysis reported in Production and Operations Management. The study authors say that the characteristics of
Devices
The FDA Circulatory System Devices Panel will consider 2/23 a Claret Medical De Novo 510(k) application for its Sentinel cerebral protection system for use in patients undergoing transcatheter aortic valve replacement (TAVR). The company is asking that the device be indicated for use as a cerebral protection device
Devices
Cybersecurity firm TrapX says it has found malware on medical devices at major healthcare providers across the globe. The company says the infected devices “create a backdoor security breech that puts tens of thousands of patient records at risk.” Company president Greg Enriquez tells a San Mateo, CA, television station
Devices
Molecular diagnostic company Immunexpress has received 510(k) clearance for the use of SeptiCyte LAB as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of intensive care unit admission. “It is the first RNA-based clinical diagnostic
Devices
Responding to an FDA notice of proposed medical device guidance development for Fiscal Year 2017, AdvaMed has submitted its priorities for the items on the agency’s lists, marking them either “high,” “medium,” or “low” priority to its member companies. The association also recommends that the agency finalize all of
Devices
InRange Systems says FDA should detain the Life Integrating Technologies and Experiences Lumma remote medication management system which has not been cleared or approved by the agency and is misbranded. The InRange petition says the Lumma device does not (1) conform to the general controls of the Federal Food, Drug,
Drugs
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says that the FDA “intended use” regulation is a root cause of the agency’s 1st Amendment problems. Writing in his firm’s FDA Law Blog, Shapiro says the issues created by an FDA 1/9 final rule that created a new “totality
Drugs
Four Dechert attorneys say that life sciences companies continued to be popular targets of securities fraud class action lawsuits in 2016. In a white paper, the four report that in 2016, plaintiffs filed a total of 67 class action securities suits against life sciences companies, an increase of more than
Drugs
Alliance for a Stronger FDA has completed its annual agency budget analysis and has determined FDA needs $2.8 billion or 3% ($78 million) more in FY 2018 than the amount appropriated in FY 2016 and available to the agency under the FY 2017 continuing resolution. The 3% increase is
Devices
FDA has cleared a Medtronic 510(k) of its Signia Stapling System. The device includes “Adaptive Firing” technology that measures the firing force and adjusts the stapler’s speed based on tissue variability measurements, allowing for consistent staple lines, according to the company. “Adaptive Firing technology can detect the variability
Devices
FDA has approved an expanded indication for Medtronic’s Freezor Xtra Cryoablation Catheter — treating patients with atrioventricular nodal re-entrant tachycardia (AVNRT),a life-threatening abnormal heart rhythm. The flexible, single-use device is used to freeze cardiac tissue and block unnecessary electrical signals within the heart. The expanded indication
Devices
FDA has approved a Hologic PMA for its hepatitis C virus (HCV) assay for quantitation of HCV viral load and confirming active HCV infection on the fully automated Panther system. The test uses real-time transcription-mediated amplification (TMA), “which provides highly sensitive and specific performance for diagnostic use, as
Devices
The Advanced Medical Technology Association (AdvaMed) says bipartisan legislation introduced 2/16 “will help modernize FDA’s inspections process through a risk-based approach that will focus the agency’s limited resources on facilities that have the most potential to impact public health, improving overall patient safety.” The bill, S.
Devices
FDA has cleared a FlowAid Medical Technologies 510(k) for its FA100 SCCD (Sequential Continuous Contraction Device) and its use for increasing local blood circulation, post-surgical stimulation of calf muscles to prevent venous thrombosis, and preventing disuse atrophy and edema reduction. The small, lightweight, portable, and handheld four-channel
Drugs
Yale Law School professor Gregory Curfman and student Deborah Mazer say that while there are positive elements in the recently-approved 21st Century Cures Act, subtle changes to the approval procedures for new drugs and medical devices included in the law “could weaken FDA’s regulatory oversight as could a
Drugs
FDA has exempted Evoke Pharma from having to perform a human factors validation study requirement prior to submitting an NDA on its late stage product Gimoti (metoclopramide nasal spray) for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Last year, FDA released a
Devices
FDA has approved a Biotronik PMA for PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System and its use to improve coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries. The ultra-thin, 60 µm strut thickness of the stent “allows for optimal deliverability under
Drugs
FDA Warning Letters issued in fiscal year (FY) 2016 fell by 15% compared with such letters issued in FY 2015, according to just-released enforcement statistics. Overall, there were 14,590 Warning Lettters issued in FY 2016, down about 2,600 from the 17,232 letters issued in 2015. The
Devices
FDA has cleared a Spinal Simplicity 510(k) for the Minuteman G3-R spinal implant, which is intended to be implanted using a lateral approach. The sterile packed, posterior, non-pedicle supplemental fusion and fixation device is cleared for use in the non-cervical spine (T1-S1), the company says.