Venture capital firms invested more than $2.9 billion in medical device companies in 2018 — a slight increase from the $2.8 billion raised in 2017, according to the MoneyTree report from PricewaterhouseCoopers (PwC) and CB Insights. Both the first and second quarters of 2018 saw an increase in investments, totaling nearly $778 million and $786 million respectively. The third […]
A record year for device innovation
Emily Zetzer, clinical research associate, IMARC Recently FDA Commissioner Scott Gottlieb released a statement on a record year for device innovation. This press release highlights the FDA’s efforts for advancement of medical devices that serve previously unmet medical need, improve quality of life, and in some cases save lives. The FDA’s efforts to continue the […]
How the Belmont Report clarified informed consent
Sandra Maddock, President & CEO, IMARC Research Imagine being enrolled in a clinical trial without fully understanding the scope or the risks. The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection. […]
FDA green-lights Siemens Healthineers Magentom Lumina 3T MRI
Siemens Healthineers has received FDA clearance for its Magnetom Lumina 3 Tesla MRI scanner. The scanner features BioMatrix patient personalization that helps improve productivity and ensure consistent quality, according to the company. It has a wide, 70 cm bore and GO technologies that are powered by artificial intelligence to speed up MRI workflow. Magnetom Lumina […]
Accuron spins out urology business to Temasek
Accuron Technologies announced that it is spending out its medtech business into an integrated urology business owned by Temasek. The company expects the process to be completed by March this year. “Accuron MedTech has been managed as an independent division of Accuron Technologies for some time now. The spin out will enable Accuron MedTech to […]
Senseonics wins MRI-safe FDA nod for Eversense CGM
Senseonics announced that it has received notice from the FDA that its Eversense sensor no longer has to be removed for MRI scanning. “Based on our testing, we have demonstrated hat it is safe for patients to leave the Eversense Sensor in place, even when they need to have an MRI,” Tim Goodnow, president and […]
FDA final guidance on safety and performance 510(k) medical device registration
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device oversight division has rolled out final guidance on an expanded 510(k) registration route retooled to focus on device safety and performance issues, and is seeking industry comment on proposed changes to its predicate device policy. Get the full story here at the […]
FDA sets date for advisory panel meeting on breast implants
The FDA announced today that it tentatively plans to hold a meeting of the General and Plastic Surgery Devices Panel, March 25-26. The meeting will take place at the FDA’s headquarters in Silver Spring, Md. The meeting will discuss a range of topics concerning benefit-risk profiles of breast implants, according to the FDA. Breast implants are […]
Johnson & Johnson plans €36M expansion in Ireland
Johnson & Johnson’s DePuy Synthes is investing €36 million in expanding research and development capabilities at its Ireland Innovation Center. As part of the expansion, DePuy Synthes will establish a 3D-printing Development and Launch Center and implement the Johnson & Johnson 3D Bioprinting Laboratory. Get the full story on our sister site, Medical Design & […]
Boston Scientific closes Millipede buyout
Boston Scientific (NYSE:BSX) announced that it has completed its acquisition of Iris transcatheter annuloplasty ring developer Millipede (Santa Rosa, Calif.). The company announced the acquisition plan in December last year. The deal was worth approximately $325 million with the opportunity for an additional $125 million based on commercial milestone. The company said in December that […]
How diary studies can support medical device human factors engineering and usability
By Erin Davis and Benjamin Basseches, Emergo Group Some people might assume that diaries are only used to record the day-to-day trials and musings of teenagers. But – surprise! – diaries (specifically, diary studies) are actually a valuable method to add to your ethnographic research toolkit. Generally speaking, a diary study is a qualitative research […]
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