medical device guru

Surgery and Surgical Robotics

FDA Warns Against Using Surgical Robots in Cancer Surgeries

The Food and Drug Administration on Thursday warned against the use of robotically assisted devices for mastectomies and other cancer surgeries, asserting the products may pose safety risks and result in poor outcomes for patients. The agency said it decided to issue...

March 4, 2019

Surgery and Surgical Robotics

Axilum Wins 510(k) Clearance for Robotic TMS System

Axilum Robotics, which specializes in the development of medical robots, announced that two weeks after the CE mark, it has received 510(k) clearance from the U.S. Food and Drug Administration to market the TMS-Cobot TS MV for the spatial positioning and...

February 27, 2019

Surgery and Surgical Robotics

Intuitive Surgical Gains FDA Clearance for Lung Cancer Biopsy Robot

Intuitive Surgical Inc. said last week that the U.S. Food and Drug Administration has cleared its Ion system. The robotic endoluminal system is designed to enable doctors to conduct minimally invasive biopsies deep within the lung. Ion includes an articulating...

February 25, 2019

Cardiovascular / Cardiology

Massive Medtronic Pacemaker Recall is Class I Says FDA

The FDA has slapped the most serious designation on a recall of approximately 156,957 Medtronic dual-chamber pacemakers. The Fridley, Minn.-based company issued a recall in January on pacemakers with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron due to a software error that can...

February 18, 2019

Surgery and Surgical Robotics

J&J Acquires Robotic-Surgery Firm Auris for $3.4 Billion

Focused on creating the next frontier of surgery, Johnson & Johnson, today announced that Ethicon, Inc., entered into a definitive agreement to acquire Auris Health, Inc. for approximately $3.4 billion in cash. Additional contingent payments of up to $2.35 billion,...

February 13, 2019

Orthopedics and Spine

Smith & Nephew Discussing $3B NuVasive Acquisition

Smith & Nephew is in discussions to pick up spine-focused medtech developer NuVasive Inc. in a deal that could be worth more than $3 billion, according to a report from the Financial Times released late last week. The companies have not officially commented on the...

February 11, 2019

Biologics, Wound Care, Infection Prevention

Fish-Skin Wound Care Company Gets Swiss Approval, Makes Acquisition

Kerecis, the company pioneering the use of fish skin in tissue regeneration, today received a notice from Swiss healthcare authorities that the company’s lead product, Kerecis Omega3 Wound, will be reimbursed in Switzerland. The company will also acquire the Swiss life-science...

February 11, 2019

Orthopedics and Spine

Sirakoss Wins CE Mark for Osteo3 Bone Graft Substitute

SIRAKOSS Ltd, a developer of nanosynthetic bone graft substitutes, announced today it has been granted CE Mark clearance in the European Union (EU) for Osteo3, a novel nanosynthetic bone graft substitute designed to improve patient healing, offering surgeons a more...

February 4, 2019

Orthopedics and Spine

Stryker Installed an Impressive 54 Mako Robots in Q4 2018

Stryker made the market wait for more than a year after FDA approval for the full commercial launch of its Mako total knee product, prompting us to wonder, at the time, if the robot would be worth the wait. It’s safe...

January 31, 2019