Devices & Diagnostics Letter

Premarket submissions for internet-connected medical devices should include cybersecurity risks considered during the product design, established cybersecurity controls and a traceability matrix linking the controls to the risks they mitigate, according to a Friday draft guidance.

Industry’s case against significant reforms to the FDA’s policy on when devicemakers must submit a new 510(k), made during a Thursday public meeting, drew pushback from consumer groups that argued current controls don’t ensure patient safety.

Hologic and Quest Diagnostics have struck a five-year deal for Quest to offer a broader range of women’s health testing based on Hologic’s APTIMA products.

The Supreme Court Thursday dismissed Myriad Genetics’ patent-eligibility claims on the BRCA1 and BRCA2 genes commonly associated with breast and ovarian cancers, while upholding the company’s patents on the diagnostic technology it created from those genes.

The FDA is seeking industry input on a voluntary program aimed at getting devicemakers to engage with the agency early in the clinical trial design process.

A journal article critical of a cardiac biomarker is libelous and represents a conflict of interest, a lawsuit filed by the manufacturer of an assay for the biomarker charges.

As the Supreme Court decides whether to take up Medtronic’s appeal in a patent dispute with Edwards LifeSciences, the Public Patent Foundation has filed an amicus brief urging against the use of injunctions in any patent infringement cases.

St. Jude Medical has struck a $40 million deal with Spinal Modulation, allowing it to distribute the Menlo Park, Calif., start-up’s neuromodulation device for chronic pain in markets where it is approved.

While the numbers are not high, hospitalized children are at risk for medical device-related adverse events, a recent study co-authored by an FDA scientist found.

Postmarket studies of patients with metal-on-metal hips should continue for several years and examine certain bodily systems to catch all potential late effects, a small study published last week by the Public Library of Science suggests.

ConvaTec failed to document its adverse event decision for a complaint about a patient exposed to fecal matter on a skin grafting after a “balloon came out, half inflated,” an FDA warning letter says.

An industry effort to protect user fees from sequestration got a major boost Thursday as House leaders promised to take up the issue in future budget negotiations with the Senate.