German medtech companies are keeping up the pressure for practical changes to be made to the EU Medical Device Regulation to limit its potentially damaging effects on product innovation and patient care, and drawing on recent support from German state economy ministers.

The trade association, NHS Providers, has warned of shortages and stockpiles of medical devices in the UK, as well as problems with public health and disease control, if contingency planning for a “no-deal” Brexit is not coordinated at national level.

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.

US FDA will face high hurdles as it works to write a new rule that would merge the agency's Quality System Regulation with international quality systems standard ISO 13485. That's according to Kim Trautman, a longtime industry insider who wrote the QSR in the early to mid-1990s. "It’s a clear heavy lift from a regulatory policy perspective" that could take as long as five years to complete, she says. In the meantime, Trautman offers some insight into what device-makers might see in a new hybrid quality systems regulation from FDA. She addresses everything from corrective and preventive action (CAPA) to labeling, and complaint handling to risk management – and more.

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.

Medtronic may not have hit the headlines with any M&A deals this year so far, but the medtech giant has turned in an impressive set of first-fiscal quarter results driven by strong product sales. Organic growth, according to CEO Omar Ishrak, is currently the company's main goal, but it won't dismiss any tuck-in acquisitions that complement this organic growth and the firm will act promptly when the right opportunity comes knocking.

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.

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.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, a new microstent for glaucoma was approved by US FDA.

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.