Medtech Insight sat down with US FDA's principal deputy commissioner Amy Abernethy at the recent CES meeting in Las Vegas to talk about the agency's progress on the Technology Modernization Action Plan (TMAP), the pre-certification program for digital health products, and the FDA's plans for 2020. The FDA will hold a public meeting on 27 March to discuss the TMAP. See what FDA's Abernethy said about it here.

Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.

Manufacturers won’t need to submit 510(k)s for powered wheeled stretchers under a new order from the US FDA.

Brad Smith, the former CEO of Aspire Health, a home-based palliative-care company, was appointed director of the Center for Medicare and Medicaid Innovation (CMMI) at the US Medicare agency CMS.

No device-related warning letters were released by the US FDA the week of 14 January.

UK health technology assessment body NICE says that Medtronic’s Reveal LINQ, which transmits data remotely to doctors, is likely to be a cost-effective use of National Health Service resources.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fourth installment of a 10-part series, the experts address so-called back rooms used by manufacturers during an inspection.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this third installment of a 10-part series, the experts address the do’s and don’ts of responding to investigator requests for information and records.

Device makers initiated 243 recalls in the third quarter of 2019 – a modest 1% increase over Q2’s 200 recalls. Interestingly, the number of recalled device units skyrocketed a whopping 1013%, from 19.7 million in Q2 to 219.2 million in Q3. Check out our Q3 recalls infographic.

Quanta Dialysis has signed an agreement with B. Braun to provide support services to Quanta’s patients in the UK. The hemodialysis firm launched its compact hemodialysis device SC+ on the market at the beginning of the year.

The president of Eli Lilly USA departs for CEO post at FibroGen, a developer of medicines for anemia, fibrotic disease and cancer; a former Mallinckrodt exec is CFO of NuVasive, a maker of products for spine surgery; DBV Technologies, an investigator of treatments for food allergies, also adds a CFO; and more.

Roche and Illumina have entered a 15-year, non-exclusive partnership to expand access to next-generation sequencing- based testing in cancer care.

Medtronic said it will acquire Stimgenics, which developed a differential target multiplexed spinal cord stimulation waveform, for an undisclosed figure. See what Marshall Stanton, who heads up Medtronic's pain therapy business, said about it here.

Two-year data from a European trial showed BioVentrix’s Revivent TC system significantly reduces left-ventricular volume and improves left-ventricular function in patients with heart failure following a myocardial infarction. The company expects to complete a US pivotal trial of the device in 2021 and launch the device in the US with funding from a planned initial public offering.

Medtronic acquired Stimgenics, an Illinois company it previously helped to fund, for an undisclosed sum. The company plans to add Stimgenics’ differential target multiplexed spinal cord stimulation waveform to its Intellis spinal cord stimulation system for the treatment of chronic pain.

The rapid adoption of robotic-assisted surgery must be carefully monitored to ensure surgeons' enthusiasm for this technology does not compromise patient safety, according to a new study. See what Kyle Sheetz, a researcher at the University of Michigan who analyzed data from the Michigan Surgical Quality Collaborative, a partnership between Michigan hospitals and Blue Cross/Blue Shield of Michigan, said about it here.

French company Robocath expects its R-One robotic-assistance platform to make interventional cardiology more efficient and safer for interventionalists. See what company CEO Lucien Goffart said about “momentum in vascular robots” here.

December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.

French company Robocath believes its R-One robotic catheter intervention system will make coronary interventions more efficient for hospitals and safer for interventionalists. Robocath is sponsoring a 60-patient European trial of coronary interventions with R-One.

The final follow-up data from the CAP and CAP2 registries support left-atrial appendage closure with Watchman as an alternative to long-term anticoagulation in patients with nonvalvular atrial fibrillation.

The US FDA recently cleared Sight’s Olo analyzer to run complete blood counts on samples as small as two drops. The company is currently marketing Olo to hospital labs in the US but hopes to eventually earn a CLIA waiver so Olo can be marketed to smaller physician practices and pharmacies and used for other common blood-based diagnostics.