A patient advocacy group recently met with US FDA officials to ask for new safety measures, if not a total ban, around LASIK eye surgery. See what the group's coleader, Paula Cofer, said about the dangers of LASIK here.

US FDA has issued a final guidance document discussing appropriate labeling for products containing heparin. The new rules reflect recent revisions to US Pharmacopeia monographs on heparin solutions.

A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.

US FDA has taken the rare step of publicly disputing a study that seemed to show elevated risks of long-term adverse events associated with silicone breast implants.

The device industry is praising passage of “The American Innovation Act” by the US House. The bill is intended to promote new business start-ups – including fledgling medtech companies – by allowing certain tax deductions for net-operating losses.

The maker of wound-dressing product Omiderm was cited for quality systems violations in the only device-related warning letter released by US FDA this week.

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.

A lawsuit over negative pressure wound-therapy devices ended in a win for plaintiff KCI Medical Services after an Ohio federal judge ordered Healthcare Essentials Inc. to pay $645m for alleged theft. See what Judge Benita Pearson wrote about the case here.

A new executive VP and head of research and development is joining the management team at Codiak Biosciences. In addition, new directors joined at Qualigen and Sectra AB.

An Ohio federal judge recently awarded $645m to Acelity subsidiary KCI Inc. The company sued Healthcare Essentials Inc. for allegedly stealing wound-therapy units for resale.

An anterior cruciate ligament (ACL) repair technology developed by MIACH Orthopedics has secured backing from investors, including the union for National Football League players, in a new round of financing. See what MIACH founder Martha Murray said about it here.

MIACH Orthopedics, has secured $22.5m from investors including the NFL Players Association to continue US clinical trials for its Bridge-Enhanced ACL Repair (BEAR) technology.

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.

A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.

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.