medical device guru

Surgery and Surgical Robotics

FDA Approves Alcon’s AcrySof IQ PanOptix trifocal IOL

Alcon won FDA approval for its AcrySof IQ PanOptix trifocal intraocular lens and is preparing an initial commercial launch for the device. The Fort Worth, Texas-based company’s AcrySof IQ PanOptix device is the first and only trifocal device in the...

August 27, 2019

Diagnostics & Healthcare News

OneDraw A1C Needle-Free Test System FDA Cleared

Drawbridge Health, out of Menlo Park, California, won FDA clearance for its OneDraw A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test. Designed for use by clinicians, the disposable product is used to...

August 27, 2019

Surgery and Surgical Robotics

Lumendi Gets FDA Clearance for Endolumenal Interventional Knife

Westport, Connecticut-based medical device innovator Lumendi, LLC (http://www.lumendi.com) has announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DiLumen Ik™ Endolumenal Interventional Knife, a sterile, single-use, disposable monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue...

August 26, 2019

Cardiovascular / Cardiology

Miracor’s Heart Attack Device Secures FDA Breakthrough Status

The concept of pressure-controlled intermittent coronary sinus occlusion, abbreviated to PICSO, has been around since the 1980s. PICSO entails placing a device in the coronary sinus to intermittently obstruct blood flow. Through the interference, PICSO may increase blood flow to parts of...

August 23, 2019

Imaging Visualization & Navigation

Exo Imaging Emerges from Stealth to Announce All-In-One Handheld Ultrasound Platform, Funding

Exo Imaging, Inc., a company pioneering a high-performance ultrasound platform based on patented Piezoelectric Micromachined Ultrasonic Transducers (pMUT) technology and artificial intelligence (AI) for imaging and therapeutic applications, announced a $35M Series B financing round.  The company was founded in 2015...

August 21, 2019

Cardiovascular / Cardiology

FDA Approves CVRx’s Neuromodulation Device for Heart Failure

CVRx, Inc., a private medical device company, announced today that it has received Premarket Approval (PMA) from the United States Food and Drug Administration (FDA) to market its BAROSTIM NEO device for heart failure in the United States. The FDA’s Center...

August 19, 2019

Cardiovascular / Cardiology

FDA Grants Breakthrough Device Designation to Ascyrus Medical Dissection Stent

Ascyrus Medical announced yesterday that it has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. This designation serves as validation of the clinical importance of the AMDS...

August 15, 2019

Imaging Visualization & Navigation

FDA Clears Ninepoint’s OCT Imaging System for Use in Bile Ducts

NinePoint Medical, Inc., a transformative medical device company pioneering the use of a real-time optical imaging platform for gastrointestinal applications, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the NvisionVLE® Imaging System for use...

August 14, 2019

Surgery and Surgical Robotics

Misonix Announces CE Mark Approval for Nexus Ultrasonic Platform

Misonix, Inc, a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today that it has received  Conformité Européene (CE) Mark approval for Nexus. The CE marking confirms that Nexus meets the requirements of the European Medical Devices...

August 13, 2019