Royal Philips (NYSE:PHG) this week announced that it acquired Boston-based patient navigation platform Medumo for an undisclosed amount, CNBC reported. Medumo makes a smartphone app that helps hospitals, surgical centers and care teams guide patients with customizable, timely resources and information available through a number of channels, according to the company. Doctors can send out […]
Report: Literal killer app prompted Medtronic MiniMed recall
Two years ago, researchers discovered vulnerabilities in Medtronic’s MiniMed and MiniMed Paradigm insulin pump lines that could allow hackers to remotely withhold insulin or trigger a potentially lethal overdose. But after months of negotiations with Medtronic and regulators with no fix forthcoming, the researchers decided to build a smartphone app that could show how the […]
How Eva Mozes Kor taught patient protection in clinical trials
Sandra Maddock, CEO of IMARC Research My motivations for going to professional conferences usually revolve around staying abreast of new information relevant to my field, networking with others, and earning CEUs. I’ve never gone to a professional conference expecting to be emotionally moved in a giant way, but that’s exactly what happened at an ACRP […]
Australia eyes ban on textured breast implants
Australia’s TGA said last week that it concluded breast implants do not need to be removed as breast implant-associated anapestic large cell lymphoma (BIA-ALCL) is rare. The regulatory body said in April that is was considering implementing a ban on textured breast implants and was seeking new data from suppliers of the implants to decide […]
Teva wins FDA approval for AirDuo Digihaler for asthma
Teva (NYSE:TEVA) yesterday said that it received FDA approval for its AirDuo Digihaler Inhalation Powder. The Israel-based company’s AirDuo Digihaler is a combination therapy digital inhaler with built-in sensors that can connect to a smartphone application, indicated to treat asthma in people 12 years and older.. It delivers a multi-dose dry powder of 113mcg of fluticasone […]
Varex Imaging closes Santa Clara facility
Varex Imaging (NSDQ:VREX) last week announced that it is closing its Santa Clara, Calif. facility. The closure of the company’s Santa Clara facility is part of an ongoing integration of business acquired from PerkinElmer in May 2017. The Salt Lake City-based company expects operations at the Santa Clara facility to completely stop by the end of […]
How human factors validation investigators identify user groups and populations
By Ella Engels, Emergo Group Imagine you are preparing for a human factors (HF) validation study to bring your medical device to market, and the market research recruiters inform you that it will be very challenging, if not unfeasible, to recruit the required 15 participants per user group. What do you do? Get the full […]
FDA clears RaySearch’s RayStation 8B
RaySearch yesterday announced it received FDA 510(k) clearance for its RayStation 8B treatment planning system. The RayStation 8B is a machine learning treatment planning system for the radiation oncology market. The system uses deep neural networks and is designed for automated treatment planning and automated organ segmentation to improve efficiency and consistency. The framework of […]
Nemaura bids for de novo clearance from FDA for SugarBEAT glucose monitor
Nemaura Medical (NSDQ:NMRD) this week said it submitted a De Novo medical device applications to the FDA for its SugarBEAT non-invasive glucose monitor. The Loughborough, England-based company recently successfully completed clinical studies and two summative human factors usability studies needed to support De Novo submission. Get the full story on our sister site, Drug Delivery Business.
European Commission publishes guidance on responsible person requirements under MDR, IVDR
By Stewart Eisenhart, Emergo Group European regulators have published new guidance documents addressing persons responsible for managing compliance with the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Procyrion raises $30m Series D for Aortix heart pump
Procyrion said this week that it closed a $30 million Series D round for its Aortix percutaneous blood pump. The Aortix blood pump is designed to treat patients with heart failure and worsening kidney function. The pump is thinner than a pencil and can be placed in less than 10 minutes during a cath-lab procedure. […]