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Results of a study showed that Impulse Dynamics' Optimizer device significantly improved exercise tolerance and quality of life in certain heart-failure patients. See what principal investigator (and cardiologist) William Abraham of Ohio State University said about those patients here.
The May 25 deadline for the EU's General Data Protection Regulation is rapidly approaching. See what attorneys Renzo Marchini and Robert Fett have to say about some of the considerations for medtech companies.
US FDA has set up an email inbox to accept inquiries from device-makers about facility inspections under its year-old "program alignment" audit scheme. See what former FDA investigations branch director (now consultant) Ricki Chase said about it here.
Liquid biopsy marquee player Grail Inc. has reported results of several proof-of-concept approaches to cancer screening that achieved high specificity, and a handful of smaller-scale cancer-specific tests are already available. See what Thomas Rodgers of Grail investor McKesson Ventures had to say about it here.
Company stock will make up the "vast majority" of Mike Weinstein's compensation for being Medtronic's new senior VP of strategy. CEO Omar Ishrak said Medtronic's evolving executive compensation policies are an element of the firm's efforts to improve value to shareholders. See what Ishrak said about it here.
New AdvaMed Accel Chair Martha Shadan is also a founding member of the Women's Executive Network (WEN), which aims to help women reach executive positions in the medtech industry. See what she said about her own experience of being a woman in industry here.
US FDA wants to write a new rule that would combine its Quality System Regulation and international quality systems standard ISO 13485. Commissioner Scott Gottlieb announced it in his blog; see what he wrote here.
US FDA Chief Counsel Rebecca Wood highlighted the First Amendment, as well as preemption and product safety issues, as three legal office priorities for the agency at the Food & Drug Law Institute’s annual conference in Washington, DC. See what she said here.
US FDA is seriously considering swapping its Quality System Regulation for ISO 13485. See what NSF International's Kim Trautman, who authored the QSR in the 1990s, had to say about it here.
Electrophysiologists are running into challenges in getting subcutanous ICDs covered by private insurers. See why consultant and former Aetna executive Jim Cross thinks that could change this year based on recently updated guidelines.
As the global Medical Device Single Audit Program gets off the ground, US FDA says it sees additional ways MDSAP audits could support its regulatory mission. See what FDA official Sean Boyd said about it here.
See what opthalmic industry veteran and Eyevensys CEO Patricia Zilliox said about the opportunity for her firm's technology to target eye diseases at this year's BioTrinity 2018 in London.
The medtech industry has serious concerns with a recent proposal for a shared EU health technology assessment framework. MedTech Europe's Yves Verboven describes one improvement that should be made to the plan here.
See what Global Kinetics Corporation CEO John Schellhorn told Medtech Insight about what the firm's wearable Parkinson's disease monitor brings to clinicians and patients after gaining multi-source funding for a randomized trial.
The Medical Imaging and Technology Alliance is leading an effort toward shared quality management system standards for both OEMs and third parties servicing medical equipment. See one critique of the plan from third-party servicer rep Robert Kerwin here.
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