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Category: Medical


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 […]


Industry Focus Areas, Medical

Siemens Healthineers lands CE Mark for Atellica advanced diagnostics system

September 25, 2017

Via: Mass Device

Siemens Healthineers (NYSE:SI) said today that its Atellica Solution won CE Mark and that the advanced diagnostic system is now available in Europe, the U.S., South America and Asia. The system consists of scalable immunoassay and chemistry analyzers, the company […]


Industry Focus Areas, Medical

Boston Scientific launches MRI-safe Resonate devices with HeartLogic diagnostic in U.S.

September 25, 2017

Via: Mass Device

Boston Scientific (NYSE:BSX) launched today its Resonate implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems with the HeartLogic heart failure diagnostic tool. The devices are approved by the FDA for conditional use in an MRI environment, the company reported. […]


Industry Focus Areas, Medical, Regulations

Following regulatory win, GSK & Innoviva tout data for once-daily triple-med inhaler

September 20, 2017

Via: Mass Device

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) notched a win this week after the FDA approved its once-daily, triple combination therapy for the treatment of chronic obstructive pulmonary disease. Last week, an EU agency recommended the inhaler’s approval. Now, the companies are […]


Industry Focus Areas, Medical

Medtronic wins FDA nod for Intellis SCS, launches in US

September 18, 2017

Via: Mass Device

Medtronic (NYSE:MDT) said today it won FDA approval for its Intellis implantable spinal cord stimulation system and launched it in the US. The Fridley, Minn.-based company touted the newly revised system as the world’s smallest, and said that the new […]


Industry Focus Areas, Medical

Medtronic, Mazor Robotics close $40m round

September 15, 2017

Via: Mass Device

Mazor Robotics (NSDQ:MZOR) said today that closed the third, $40 million tranche of a deal with Medtronic (NYSE:MDT), which is due to take on exclusive global distribution rights for the Mazor X robot-assisted surgery device. It’s the third investment in […]