FDA Commissioner Scott Gottlieb envisions a day when only 10% of new diagnostics will have to undergo pre-market review by the US agency to reach market. See what he said about it here.

Many legal threats faced by device and diagnostics companies come from federal law and regulations, but a growing class of strict state privacy laws protecting consumer data could open the door to new risks. See what attorney Kevin Coy said about it here.

A group of patient advocates including one former US FDA official met with agency staff on Sept. 13 to raise awareness about adverse events tied to LASIK surgery. The group said the vision-correcting procedure is too risky to be offered as elective surgery.

US FDA Commissioner Scott Gottlieb and the agency’s new diagnostics office chief Tim Stenzel want to use a combination of pre-certification, assistance from third-party reviewers and review exemptions to help quickly clear the tsunami of molecular-based diagnostic tests expected to be submitted to FDA for review in the next several years.

The UK's MHRA is promising a consultation process to seek feedback on how medtech would be impacted by a no-deal Brexit; industry is currently left with many unanswered questions and a lack of informed, expert speculation.

Canada has proposed 15 new additions and other changes to its list of recognized medtech standards. By demonstrating conformity with the recognized standards, device-makers can satisfy the safety and effectiveness requirements of the Canadian medical device regulations.

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

US FDA has released a six-violation warning letter sent to a Zimmer Biomet facility in Warsaw, Ind. The company had already acknowledged that the letter was a possibility.

US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties – and it looks like SMEs will be hardest hit.

XACT Robotics has secured a CE mark for its XACT image-guided robotic needle steering system for CT-guided percutaneous procedures in the abdomen. The company is hoping to formally launch XACT by 2019 while expanding the system to additional clinical indications, including spine, and lung procedures.

Prominent medtech inventor and entrepreneur Mir Imran is laser-focused on robotic pill technologies. Check out what Imran said about a "smart" pill being developed by Rani Therapeutics that can deliver biologics orally.

In this edition of the Device Week podcast, Medtech Insight’s Reed Miller talks about the latest good news for LivaNova and Catherine Longworth provides an update on Creavo Medical, a UK-based company using an old technology for a new kind of cardiac test that could save hospitals money.

Just weeks after inking a billion-dollar acquisition of K2M, Stryker has announced a $190m deal to acquire photonics firm Invuity. Under the terms of the agreement, a subsidiary of Stryker will purchase all outstanding shares of Invuity for $7.40 per share in cash.

A roundup of new exits and entries, with execs in clinical moving from Carl Zeiss Meditech to Topcon Medical Systems, in acute care from KCI to TransEnterix, and in operations, moving from Synaptic Medical to Second Sight Medical Products.

Results Recap is a new regular feature in Medtech Insight providing a summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition includes trial announcements from NeuroMetrix, Vertos, LivaNova, and Boston Scientific.

A new guidance from the UK's National Institute for Health and Care Excellence (NICE) concludes that sutureless aortic valve replacement is an alternative to conventional surgical aortic valve replacement. The NICE guidance came as LivaNova announced completed enrollment in the 900-patient, randomized PERSIST-AVR trial of its Perceval sutureless aortic valv.

The US Centers for Disease Control and Prevention's new clinical recommendations for health-care providers treating children with concussions or mild traumatic brain injury (mTBI) advise physicians against using advanced imaging for diagnosis. See what the CDC's Deb Houry said about the guidelines here.

Aselsan, Turkey's leading defense company, is increasing its focus on medical technology to support localization of medical devices. The company has started projects to develop and produce mobile X-ray and MRI systems, as well as defibrillators.

The US Centers for Disease Control and Prevention (CDC) has issued a guidance on diagnosing and treating pediatric mild traumatic brain injury, that advises health care providers to avoid use of computed tomography, MRI, single photo-emission CTs, and skull radiographs in diagnosing kids 18 years and younger.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, five approvals were added from Europe, Israel and Japan.