Devices
FDA has sent Palm Harbor, FL-based Oscor Inc. a Warning Letter after an inspection cited GMP deficiencies involving the manufacturing of introducer catheters (Adelante Magnum) and a neuromodulator for obesity (Maestro Rechargeable System). According to the letter, Oscor failed to develop, conduct, control, and monitor production processes to ensure
Devices
CDRH says that it will take into consideration an assessment of patients’ tolerance for risk when deciding whether to take a regulatory action that could remove a medically necessary medical device from the market. This was explained during a 7/11 webinar (see transcript) on a draft guidance on Factors
Drugs
Despite a push by the White House to advance personalized medicine, this “new era of medicine” is many years away if it is ever to be truly realized, according to an article in the 7/19 MIT Technology Review. Research editor Mike Orcutt says the reasons for such pessimism are
Devices
Allergan has filed a de novo application for the Oculeve Intranasal Tear Neurostimulator device, a handheld stimulator for temporarily increasing tear production in patients with dry eye disease due to decreased tear production. The company recently announced that two pivotal trials involving the device each met their effectiveness endpoints. The
Devices
FDA has approved a Medtronic PMA for the Prestige LP Cervical Disc for treating cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the neck’s C3-C7 segments. The device is designed to allow motion in the neck at the operated levels, unlike fusion
Devices
The European Union (EU) has proposed to include a medical device annex as part of ongoing negotiations under the Transatlantic Trade Investment Partnership between the U.S and the EU. The annex would encourage more harmonization on regulatory standards between CDRH and its EU counterpart. According to an EU proposal,
Devices
FDA has approved an Abbott Medical Optics PMA for what the agency describes as the “first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.” Traditional monofocal IOLs have been limited
Devices
FDA has cleared a Medifirst Solutions 510(k) for its Time Machine TTML-8102000 Laser Thermal Therapeutic Device. The Infrared Laser at 810/830nm wavelength is indicated for temporary relief of minor muscle and joint pain, muscle spasm, temporary increase in local blood circulation and temporary relaxation of muscles by
Drugs
FDA has issued a draft guidance, Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, as a “how-to” supplement to an earlier final guidance that defined in vitro companion diagnostic (IVD) devices and set an expectation that companion diagnostics and corresponding therapeutic products should
Devices
FDA has approved a Novocure PMA supplement for its second generation Optune system for treating adult patients with histologically-confirmed glioblastoma multiforme. The device features new smaller, lighter Tumor Treating Fields (TTFields) that are less than half the weight and half the size of the generator in the first Optune
Devices
FDA has cleared a Tandem Diabetes Care 510(k) for the Tandem Device Updater, an Apple (Mac) and PC-compatible tool for remote updates to its Tandem insulin pump software. “The first use of the Tandem Device Updater will be for deployment of the latest t:slim Insulin Pump software
Devices
FDA has denied a 1/7 petition from Biorex Labs seeking exemption from the premarket notification requirements for its copper reduction tablet test that measures glucose in urine. The denial letter says that such tests are used in diagnosing and treating carbohydrate metabolism disorders and says that such tests require
Devices
EP Vantage says in an online post that FDA approved 19 first-time PMAs and HDEs in the first half of 2016, down slightly from the 26 approved in the comparable period in 2015. “Perhaps the large companies have been too preoccupied with integrating their acquisitions to have put the
Devices
FDA has approved a Medtronic PMA supplement for the IN.PACT Admiral drug-coated balloon (DCB) in longer (150 mm lengths), which will be available in four, five, and six mm diameters, for treating long lesions in patients with peripheral artery disease. “The long lesion (10-18 cm) sub-group
Devices
Writing in a Journal of the American Medical Association column, FDA commissioner Robert Califf and CDRH director Jeffrey Shuren say that a “national evaluation system that engages all stakeholders could enable FDA to focus efforts on facilitating the development and interpretation of more informative data essential for policy-making and
Devices
Alere Inc. says it will be initiating a voluntary withdrawal of its controversial INRatio and INRatio 2 PT/INR Monitoring Systems due to concerns about inaccurate test results. Last year, Public Citizen reported that the blood testing devices, used in a trial of Bayer’s Xarelto overseen by a steering
Devices
A Congressional Budget Office (CBO) cost estimate says that implementation of S. 1622, the FDA Device Accountability Act of 2016, would cost $7 million over the 2017-2021 period, subject to the availability of appropriated funds. The bill would require the agency to train certain employees to determine the least
Drugs
Senate HELP Committee chairman Lamar Alexander (R-TN) says that Senate should finish its work on the 21st Century Cures legislation in September. “Rarely do we have such an opportunity,” Alexander says in a statement. “It includes support for the president’s precision medicine initiative and the vice president’s
Devices
Prisym ID says that too many medical device companies are not aware of or fail to follow FDA regulations on labeling of their products. “The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach
Devices
FDA has approved the Roche cobas HPV test as the first test for human papilloma virus that can be used with cervical cells obtained for a Pap test and collected in SurePath preservative fluid. An agency statement says that the Roche test is the first to be approved for use
Devices
FDA has approved Abbott Vascular’s Absorb GT1 bioresorbable vascular scaffold system, which releases the drug everolimus to limit the growth of scar tissue and is gradually absorbed by the body in about three years. It is the first fully absorbable stent to treat coronary artery disease. An FDA news
Drugs
FDA says it is supporting President Obama’s Precision Medicine Initiative through release of two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup. An agency statement (contains links to both