The U.S. FDA has posted its guidance agenda for this still-young fiscal year (FY), a list that covers topics such as Clinical Laboratory Improvements Amendments (CLIA) waivers. However, the agency appears to be concerned about a lack of compliance with Section 522 postmarket surveillance studies, as indicated by the inclusion of the related guidance in the high priority list for do-overs in fiscal 2020.

PERTH, Australia – Following stunning interim clinical results for its Celgro nerve regeneration treatment in quadriplegic patients, regenerative medicine company Orthocell Ltd. will focus all its efforts on gaining quick U.S. FDA approval based on the early results.

Think Surgical Inc., of Fremont, Calif., won good news from the U.S. FDA, which cleared the company's Tsolution One total knee application for use in total knee arthroplasty (TKA). The Tsolution One total knee application includes computed tomography-based 3D presurgical planning software, providing surgeons the ability to design and prepare the patient's knee joint replacement plan. During surgery, the physician puts the patient's pre-planned procedure using the robot into effect, with the goal of precisely placing the knee implants.

As the U.K. pursues its divorce from the EU, smaller U.S. drug and device companies could be caught disproportionately in the collateral damage. Many of them already struggle with the cost of duplicative regulatory requirements involved in marketing their products in the EU, but those costs could increase under Brexit, according to a report released last week by the U.S. International Trade Commission on trade-related barriers impacting U.S. small- and medium-sized enterprises (SMEs) that export to the U.K.

The U.S. FDA has given Pq Bypass Inc. the greenlight to conduct a pivotal trial aimed at assessing its Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. The TORUS-2 study is the Milpitas, Calif.-based startup's second IDE approval in less than two years and the first pivotal IDE for an SFA stent graft since W.L. Gore & Associates Inc.'s Viabahn device, which notched an initial PMA approval in 2005.

The U.S. FDA has posted a draft guidance that will overwrite a 2014 draft guidance dealing with MRI compatibility for medical devices, but at least one observer is concerned that the agency posted draft as standards-setting organizations are rewriting their own related device performance standards, a fact that could draw out the time to completion of the draft.

The device industry is quite familiar with whistleblower lawsuits, but Cisco Systems Inc., of San Jose, Calif., was recently forced to pay more than $8 million in connection with a qui tam lawsuit over cybersecurity lapses for video surveillance equipment sold to state and federal government agencies. The case suggests device makers will have to be up to speed on cybersecurity if they wish to avoid suffering a similar fate, particularly given a recent warning the FDA posted regarding a widespread cybersecurity vulnerability.

Medicare coverage of digital health is evolving, but there are those who have argued that the U.S. Centers for Medicare and Medicaid Services (CMS) is moving too slowly to capitalize on significant opportunities. The Advanced Medical Technology Association (Advamed) said in comments to the docket for the draft physician fee schedule that an advisory panel should be regularly convened in order to exploit the potential for digital health to "transform the delivery of care and improve patient care outcomes."

The FDA has reissued a 2017 draft guidance for clinical decision support (CDS) applications as part of a reexamination of software regulations, and one difference between the 2017 draft and the latest iteration that is sure to cheer developers is that the agency now provides much more clarity as to the types of functions that will and will not fall under regulatory scrutiny going forward.