Public genetic databases could have a discrepancy in identifying BRCA1 and BRCA2 variant classifications, which can introduce uncertainty and diminish patient care, according to a study by Myriad Genetics Inc. and researchers from Gradishar from the Feinberg School of Medicine at Northwestern University. The study was published in this month's edition of the journal The Oncologist and results from it show that the Clinvar public database provided discrepant variant classifications more than 26 percent of the time. The Salt Lake City-based company's study evaluated 4,250 BRCA1 and BRCA2 variants. Clinvar is a freely accessible public...

The FDA issued an April 12 warning letter to Abbott Laboratories regarding known manufacturing and quality control issues that include a long-nagging cybersecurity one. The problems stem from a February inspection of a Sylmar, Calif., facility that was gained via the acquisition of St. Jude Medical, which closed in early January. Abbott Park, Ill.-based Abbott shed more than $1 billion in market cap on the news, with Wall Street analysts worried less about the rectification of these ongoing issues – and more about the potential delays this news could portend for anticipated product approvals, which...

Digital slides of patient tissue for pathologists' analysis are ready for the U.S. market. The FDA has issued its first clearance for a whole slide imaging system to enable the review and interpretation of digital surgical pathology slides prepared from biopsied tissue – for Royal Philips' Intellisite Pathology Solution. The agency's decision on the Amsterdam-based company's product was based on one of the largest studies ever done of about 2,000 surgical pathology cases to compare digital pathology to optical microscopes. The FDA clearance includes special controls to ensure the system's precision, reliability and clinical relevance....

The FDA has issued an emergency use authorization (EUA) for Nanobiosym Diagnostics Inc.'s Gene-Radar Zika virus test. The Cambridge, Mass.-based company's diagnostic is authorized for the qualitative detection of RNA from Zika virus in human serum from individuals meeting Centers for Disease Control and Prevention (CDC) and/or epidemiological criteria by U.S. laboratories. Gene-Radar's EUA comes prior to the summer months where conditions are favorable for mosquitoes that can transmit the Zika virus. There are an estimated 4,800 people infected with Zika in the U.S., with an additional roughly 35,000 in the U.S. territories – primarily...

Alung Technologies Inc. has closed on its $36 million series C financing round that will go toward funding a pivotal trial for the private company's respiratory dialysis technology. The round was led by Royal Philips NV and UPMC, through its innovation and commercialization arm UPMC Enterprises. Other investors include Danvers, Mass.-based Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures and Riverfront Ventures. Raymond James & Associates Inc. acted as lead placement agent for the transaction. The Pittsburgh-based company is seeking FDA approval for the Hemolung Respiratory Assist System (RAS), a minimally invasive...

Neural Analytics Inc. raised $10 million to back the commercialization of its portable ultrasound Lucid System that's intended to better enable first responders and health care providers to measure, diagnose and track brain disorders including stroke and traumatic brain injury. The system received FDA clearance last October and a CE mark this January. Part of this financing for the Los Angeles-based start up will also go to back the use of the Lucid system in early diagnostics of brain conditions. In the future, Neural Analytics plans upgrades to its technology to include robotics that obviate...

Technology to enable paralyzed patients to move, and even to feel, their limbs is advancing apace. The latest progress comes from Case Western Reserve University researchers who have worked for months with a man with quadriplegia to enable him to raise a mug to his own lips to sip through a straw. He made the movement simply through his thoughts due to temporarily implanted, linked brain-recording and muscle-stimulating systems. It took four months of practice with a virtual arm on a computer screen and 45 weeks of physical training for his arm and shoulder to...

With the off-label/intended use controversy still simmering, a bill has debuted in the U.S. House of Representatives that would restrict the federal government's ability to pursue charges against manufacturers of drugs and devices based merely on "actual or constructive knowledge" on the part of the manufacturer that the drug, device or biologic will be used outside the FDA-approved labeling. Should the bill pass into law, it would close the book on one of the most hotly contested areas of commercial speech law in recent memory, but there are skeptics about the need for such legislation....

PARIS – It's almost official. After eight years of hard-fought negotiating, the European Parliament repealed the 30-page Medical Device Directives governing the Conformité Européen certification, or CE Mark, and adopted the 600 pages of the Medical Device Regulation (MDR) and In vitro Diagnostic Medical Devices (IVDR). No one in Europe is celebrating. Though April 5, 2017 was called "an historic day for our industry" by the German Medical Association BVMed, based in Berlin, before it carefully described a potential train wreck the new legislation has put in motion. (See Medical Device Daily, Feb. 27, 2017.)...

LONDON – Members of parliament scrutinizing the Brexit process have called for a standalone agreement to be made to protect the rights of EU27 nationals living in the U.K. and British citizens in mainland Europe as soon as negotiations on the terms of the U.K.'s exit from the EU begin. An agreement on reciprocal rights should be reached as a matter of priority and be a separate deal that is not dependent on any other exit arrangements or trade deals, MPs on the parliamentary committee on Exiting the European Union said in a report published...