At the start of 2016, Johnson & Johnson (J&J) undertook a massive restructuring aimed at turning around its medical device business. The New Brunswick, N.J., conglomerate has been gradually swapping in high-growth device businesses and ushering out low-growth ones, a disciplined, rational effort that seems to be starting to pay off.

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...

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.

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....

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.

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...