medical device guru

Orthopedics and Spine

IlluminOss Medical Receives FDA Clearance for Use in Femur and Tibia Fractures as a Supplement to Approved Hardware

IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced an expanded U.S. Food and Drug Administration (FDA 510k) clearance for its Photodynamic Bone Stabilization System. The new clearance allows IlluminOss to be used in femur and...

October 29, 2020

Surgery and Surgical Robotics

Medical Microinstruments Announces CE Mark for Robotic Microsurgery with the World’s Smallest Wristed Surgical Instruments

MMI SpA, an Italian company dedicated to improving clinical outcomes for patients undergoing microsurgery, announced today the CE Mark, launch and first human use of its Symani® Surgical System in Europe for open microsurgical procedures. The first four robotic surgeries were successfully...

October 28, 2020

Imaging Visualization & Navigation

Siemens X-Ray System Gains FDA Clearance

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the YSIO X.pree, a ceiling-mounted radiography system with the MyExam Companion intelligent user interface. In addition to this easy-to-use interface that guides the radiologic technologist through the exam...

October 27, 2020

Cardiovascular / Cardiology

Bristol Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash

Bristol Myers Squibb (NYSE: BMY) and MyoKardia, Inc. (Nasdaq: MYOK) today announced a definitive merger agreement under which Bristol Myers Squibb will acquire MyoKardia for $13.1 billion, or $225.00 per share in cash. The transaction was unanimously approved by both the...

October 21, 2020

Imaging Visualization & Navigation

Ezra Receives FDA Clearance for Prostate Cancer Artificial Intelligence

Ezra, the New York-based startup transforming early cancer screening using MRI, announced today that it has received FDA 510(k) clearance for its Artificial Intelligence designed to assist radiologists in analyzing and segmenting prostate MRI. Use of the innovative AI technology can...

October 20, 2020

Cardiovascular / Cardiology

Livmor wins FDA clearance for continuous heart monitoring wearable

LIVMOR, Inc., a leading digital health solutions company, announced today that the Company received FDA 510(k) clearance for the LIVMOR Halo™ AF Detection System, a physician-prescribed wearable solution that provides continuous monitoring of pulse rhythms for the detection of atrial fibrillation...

October 16, 2020

Orthopedics and Spine

Conformis Announces 510(k) Clearance for Cordera Hip System

Conformis, Inc. today announced 510(k) clearance by the U.S. Food and Drug Administration of the Company’s new Cordera Hip System. The first product in the Conformis hip product line, the Conformis Hip System, was launched commercially in November 2019 and...

October 15, 2020

Surgery and Surgical Robotics

CrossBay Medical Receives FDA Clearance for CrossGlide ETS Plus

CrossBay Medical, Inc., a health technology company focused on improving the delivery of women’s healthcare, announced it has received clearance from the Food and Drug Administration (FDA) to market its CrossGlide ETS Plus. Similar to the CrossGlide ETS, Endometrial Tissue Sampler...

October 14, 2020

Orthopedics and Spine

CartiHeal Receives FDA “Breakthrough Device Designation” for the novel Agili-C Implant

CartiHeal, developer of Agili-C, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, announced today that FDA has granted Breakthrough Device Designation for the Agili-C implant. FDA’s Breakthrough Device Program is reserved for certain medical...

October 12, 2020