Attorney and industry advocate Bradley Merrill Thompson argues in a recent Medtech Insight article that US FDA is pursuing expanded authorities for collecting and acting on post-market device data without congressional authorization. Read one of Thompson's recommendations here.

US FDA used its de novo review pathway to approve Brainsway Ltd.’s Brainsway Deep Transcranial Magnetic Stimulation System to treat obsessive compulsive disorder.

The 8th Circuit Court of Appeals has sent a Medtronic transfer pricing tax dispute back to US Tax Court after finding that the tax court verdict hadn’t addressed several relevant factors. IRS initially asked for $1.4bn in back taxes in the case.

The US FDA is floating eight categories of device accessories for low-risk, class I designation as part of its shift to addressing classification of accessories separately from "parent" devices. It also clarifies its approach to orthopedic instruments.

New US FDA draft guidance attempts to clarify when and why the agency might deny device manufacturers an export certificate, as well as the review process to appeal such denials.

The agency has responded to a draft diagnostics reform bill in Congress with proposed reforms that diverge some ways from the proposed legislation, but stick with the underlying goal of completely remaking how lab tests, including test kits and lab-developed tests, are regulated. The agency has put forward a proposal to establish a pre-certification process for test developers, divide most tests into high- or low-risk categories (but exempt many from pre-market review) and remove the concept of substantial equivalence.

A record 360 recall events were initiated by device-makers in the second quarter of 2018, beating the previous high of 343 product recalls recorded in Q1. On a somewhat brighter note, the number of device units recalled in Q2 fell a whopping 80% from the prior quarter. Check out our Q2 recalls infographic.

A letter from DITTA Chair Patrick Hope to a US FDA point person for MDSAP highlights concerns some device-makers have about the flourishing Medical Device Single Audit Program, including inconsistent auditing approaches from facility to facility, and long-delayed audit results and MDSAP certificates.

Device-makers have given a collective shrug to US FDA's Premarket Approval Critical-to-Quality (PMA CtQ) pilot program, a Case for Quality initiative that aims to identify "critical-to-quality" attributes for an array of products and ensure that quality is built into devices at their earliest stages. Since the pilot began in September 2017, no firms have enrolled. FDA's Bleta Vuniqi surmises that the empty pilot might be a victim of a glut of FDA pilot programs. Meanwhile, the agency has been talking internally about ways that the fledgling PMA CtQ pilot could be absorbed by FDA's burgeoning CMMI maturity model pilot.

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, for the two weeks between Aug. 6-19, 2018.

The 8th Circuit Court of Appeals has sent a Medtronic transfer pricing tax dispute back to US Tax Court after finding that the tax court verdict hadn’t addressed several relevant factors. IRS initially asked for $1.4bn in back taxes in the case.

US FDA's Neurological Device Panel is set to meet Sept. 27 to weigh the merits of a PMA submitted for the WEB embolization device for treating aneurysms.

Device manufacturer Maquet has agreed to settle a lawsuit brought after a patient died when one of the company’s blood oxygenation devices broke.

The potential to use a simple blood test to guide physicians in monitoring cancer therapies, detect early cancers, serve as a companion diagnostic to guide targeted therapeutics and predict the likely course or outcomes of disease in patients has spurred a lot of interest and innovation. Here's a look at emerging companies hoping to make an impact, including insights from interviews conducted with C-Level visitors at the recent Liquid Biopsy Conference in San Francisco. This is the second of a two-part series focusing on the global liquid biopsy market.

Endomag is making plans to shake up the US breast cancer market with its Sentimag and Magtrace combination breast cancer system, which recently earned US FDA approval. The company recently raised $10m to scale its commercial operations.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, two Health Canada approvals, and more.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Aug. 13 through 19, including trial announcements from Smith & Nephew, Creavo Medical, Elixir Medical, Abbott, and Medtronic.

Kevin Brown, physicist and global VP of scientific research for device-maker Elekta, says his company has rejected some product ideas because they ultimately wouldn't be profitable. See what he said here.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Aug. 6 through 12, including trial announcements from Hancock Jaffe, Medtronic, and LivaNova.

PRELUDE feasibility study of LivaNova's Caisson transseptal transcatheter mitral valve replacement (TMVR) system is complete and the company the INTERLUDE CE Mark trial has begun, the company announced. The company is now working with the US FDA to finalize the protocol for the ENSEMBLE US pivotal trial.

Hindsight 20/20 is a Q&A feature where veterans of the medtech industry share career highlights, specific achievements and hurdles they have faced. In this installment, Kevin Brown, global VP of scientific research at radiation therapy specialist Elekta, discusses the challenges of translating scientific ideas into breakthrough technologies that bring value to clinicians and patients. He also addresses his guiding principles for picking winning ideas and his journey bringing to market the world's first integrated high-field MRI and radiotherapy system.