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Category: Medical


Design &Planning, Industry Focus Areas, Medical, Process

FDA focuses on digital health and diagnostics in 2018

February 2, 2018

Via: Mass Device

US FDA Commissioner Scott Gottlieb provided some key digital health initiatives along with his vision on how he wants the agency to work with the sector in the coming years. A published list of the commissioner’s priorities titled “Healthy Innovation, […]


Industry Focus Areas, Medical

Honda wins CE Mark for Walking Assist Device

January 19, 2018

Via: Mass Device

Honda (NYSE:HMC) said yesterday it won CE Mark approval in the European Union for its Honda Walking Assist Device designed for walking rehabilitation. The walking assist device uses cooperative control technology, based on Honda’s cumulative study of human walking, the […]


Industry Focus Areas, Logistics, Medical, Process, Production

Modern EBR: The Future of Batch Execution

January 16, 2018

Via: Industry Week

Phone books may be a thing of the past, but the transition from paper to digital systems is still rolling out across many industries. Exhaustive paper documentation became the status quo in the pharmaceutical industry to satisfy regulatory documentation requirements. […]


Industry Focus Areas, Medical

Study: Implantable robot helps spur tissue regeneration

January 11, 2018

Via: Mass Device

An implantable, programmable robot induced cell growth and lengthened part of the esophagus in an animal model by more than 75%, according to researchers from Boston Children’s Hospital. The team reported in Science Robotics today that the robot triggered tissue […]


Industry Focus Areas, Medical

FDA clears Xcision Medical’s GammaPod breast cancer device

December 22, 2017

Via: Mass Device

The FDA said today that it granted 510(k) clearance to the GammaPod stereotactic radiotherapy device made by Xcision Medical Systems to treat breast cancer. The federal safety watchdog said the GammaPod is designed to treat a portion of the breast […]


Industry Focus Areas, Medical

FDA suggests controls on interoperable devices

December 12, 2017

Via: Mass Device

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between […]


Industry Focus Areas, Medical

Medicrea wins FDA nod for IB3D interbody devices

November 22, 2017

Via: Mass Device

Medicrea (EPA:ALMED) said today it won FDA clearance for its IB3D portfolio of 3D-printed titanium interbody devices featuring its AdapTEK technology. The company’s AdapTEK technology is intended to allow surgeons to create interbody devices customized to individual specifications through in-house […]


Industry Focus Areas, Medical, Regulations

TransEnterix escapes shareholders lawsuit

October 10, 2017

Via: Mass Device

TransEnterix (NYSE:TRXC) last week won the dismissal of a shareholders lawsuit brought over the collapse of its SurgiBot program, with a federal judge ruling that the company and its management and investors didn’t mislead shareholders about the robot-assisted surgery platform’s […]


Industry Focus Areas, Medical

J&J touts perioperative efficiency CareAdvantage study data

October 5, 2017

Via: Mass Device

Johnson & Johnson (NYSE:JNJ) this week reported results from a real-world evidence study of its CareAdvantage program, touting improved tray set up time and reduced surgical tray numbers with an estimated $262,000 saved annually. The data was presented at the […]


Industry Focus Areas, Medical

Thync touts first effective use of bioelectronics to treat psoriasis

October 4, 2017

Via: Mass Device

Bioelectronics company Thync touted positive results today from the pilot study of its neuromodulation technology as a treatment for plaque psoriasis. The study showed that people using Thync’s technology experienced reduced redness, scaling and itchiness of their plaque psoriasis after […]