Devices
FDA has approved an Obalon Therapeutics PMA for the Obalon Balloon System, a nonsurgical, reversible device for weight loss. The swallowable intragastric balloon device is indicated for temporary use to facilitate weight loss in adults with obesity who have failed to lose weight through diet and exercise. It is intended
Devices
Novocure says a long-term survival analysis of data from a Phase 3 (EF-14) trial of Optune in combination with temozolomide confirms superior progression free and overall survival in newly diagnosed glioblastoma multiforme (GBM) patients. “The long-term analysis shows survival rates were significantly higher four years from randomization
FDA Policy/General
Federal Register notice: FDA has released a draft guidance on “510(k) Third Party Review Program” that provides current thinking and proposes to harmonize with elements from the International Medical Device Regulators Forum’s regulatory assessment program called the Medical Device Single Audit Program. In addition, it describes criteria to
Devices
GE Healthcare has gained 510(k) clearance for MAGiC (Magnetic Resonance Image Compilation), which is a customized version of SyntheticMR’s SyMRI Image software marketed by GE Healthcare under a license agreement. The multi-contrast technique is intended to give clinicians more data than conventional scanning in a fraction of
Devices
FDA has released a draft guidance on “510(k) Third Party Review Program” that describes harmonization efforts, such as incorporating elements from the Medical Device Single Audit Program into the third-party review program. The document also discusses third-party reviewers’ applications for initial recognition into the program. Under the
Devices
FDA has posted a one-page Form-483 from an inspection last month at troubled blood diagnostic firm Theranos, based in Palo Alto, CA. The agency cited the firm for performing clinical investigations prior to obtaining IRB approval. Presumably, the inspection document is related to the company’s decision to
Devices
FDA has cleared a Carestream 510(k) for the OnSight 3D Extremity System, which uses cone beam computed tomography technology to capture weight-bearing and other types of extremity exams. “Our extremity imaging system can help in treating a host of orthopaedic conditions that affect the biomechanical behavior of the
Devices
The FDA Medical Device Single Audit Program (MDSAP) Regulatory Authority Council is inviting medical device manufacturers to participate in the regulatory single audit program. An online invitation says an MDSAP pilot opened 1/1/14 and is the implementation of an International Medical Device Regulators Forum MDSAP initiative. The transition
Drugs
Republican leaders of the House Energy and Commerce Committee say it’s time for FDA to stop delaying and “pursue thoughtful, Constitutionally-sound solutions that will provide certainty for the future” in terms of appropriate off-label communication. In an online blog post, the leaders note that FDA announced in
Devices
FDA says it has extended to 9/24/18 the compliance date for Unique Device Identification (UDI) label and Global Unique Device Identification Database submission requirements for certain Class 2 medical devices. An agency notice says that the affected devices include (1) collections of two or more different devices packaged
Drugs
The Clinical Decision Support Coalition is asking FDA for guidance that answers specified questions arising out of three case studies developed by the coalition on issues around a risk-based and clearly defined regulatory system for clinical decision support software that appropriately balances the need for regulatory oversight with the
Devices
An FDA safety communication alerts women to risks associated with using tests marketed as ovarian cancer screening tests. The alert says that the agency is especially concerned about delaying effective preventive treatments for women who show no symptoms but still are at increased risk for developing ovarian cancer. “Despite extensive
Devices
FDA has cleared an Invendo Medical 510(k) for the invendoscopy E200 System, which includes the invendoscope SC200, a sterile, single-use colonoscope. The device features robotic assistance for tip control and a new design to offer gastroenterologists (GIs) greater control. It is cleared to provide visualization and diagnostic/therapeutic
Devices
CDRH director Jeffrey Shuren says FDA and other international regulatory agencies are considering how to develop a harmonized premarket review system. Providing a Center update at the Alliance for a Stronger FDA in Washington, DC 9/6, Shuren said the harmonized review would be modeled after the Medical Device Single
Devices
CDRH says it has approved an updated postmarket study plan submitted by Bayer to assess safety and efficacy issues involving its controversial birth control device Essure. The study was ordered by the agency earlier this year to determine heightened risks for particular women. FDA believes that “results collected from the
Devices
BD (Becton, Dickinson) says it has submitted a PMA application to FDA for its Onclarity HPV (human papilloma virus) assay. The company says the PMA is supported by data collected during a two-year multi-center clinical trial enrolling more than 33,000 women. The submission seeks approval to use
Devices
CDRH has allowed under its de novo review the marketing of Concentric Medical’s two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and
Drugs
Scientists in New York and London say there are steps researchers can take when a trial’s primary outcome fails to achieve statistical significance. Writing in the New England Journal of Medicine, they suggest that researchers ask a set of 12 questions to help them clarify whether the new treatment
Devices
FDA says that Baxter has told it about multiple adverse event reports in 2016 associated with its Vascu-Guard peripheral vascular patch during carotid endarterectomy (CEA). An agency statement says that the report includes instances of intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and
Devices
CDRH has released a guidance on “Submission of 510(k)s for Solid State X-ray Imaging Devices” that outlines the type of data to establish the substantial equivalence of such devices to a previously cleared conventional radiographic film/screen system, fluoroscopic image intensified imaging system, or similar device. The
Devices
FDA has approved a Medtronic PMA for the Enlite sensor for use with the iPro2 Professional Continuous Glucose Monitoring system. The disposable device can be worn up to six days, and like a holter monitor for cardiovascular care it records a patient’s glucose levels 24 hours a day. “Used
Devices
FDA has issued a safety alert for lab staff and health care professionals about a software defect in Sciex mass spectrometers. The defect may cause the devices to incorrectly assign results to samples analyzed. “This is of concern because health care professionals may make inaccurate clinical diagnoses or inaccurate medical