Posts by rw-admin
Stryker announces definitive agreement to acquire Mobius Imaging & Cardan Robotics
Stryker (NYSE: SYK) announced today a definitive agreement to acquire Mobius Imaging, LLC, a leader in point-of-care imaging technology, and its sister company, GYS Tech, LLC (DBA Cardan Robotics), in an all cash transaction of approximately $370 million upfront and up to $130 million of contingent payments associated with development and commercial milestones. The acquisition…
Read MorePacemaker-Like Implant Cleared in Europe to Lower Blood Pressure
Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, announced today that it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy™ (CNT) for treatment of hypertension while also providing standard pacemaker functions. Additionally,…
Read MoreFirst-ever: FDA Clears Biobeat’s Wearable Watch and Patch for Non-invasive Cuffless Blood Pressure Monitoring
Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced today that the U.S. Food and Drug Administration (FDA) has granted a 510K clearance for its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. Biobeat’s products enable cloud-based healthcare…
Read MoreMedtronic’s Ishrak Set to Retire, Leadership Succession Announced
Medtronic announced that Omar Ishrak, Medtronic’s Chairman and Chief Executive Officer (CEO), has announced his intention to retire as CEO on April 26, 2020, following the end of the company’s current fiscal year. As a result, the Medtronic Board of Directors announced key leadership appointments as part of its multi-year, leadership succession planning process, which…
Read MoreFDA 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 U.S. for patients undergoing cataract surgery. It’s designed to provide a combination of improved near,…
Read MoreOneDraw 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 draw, collect, and stabilize blood to measure hemoglobin A1c (HbA1c) levels to help manage glucose…
Read MoreLumendi 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 within the digestive tract during endoscopic procedures. The DiLumen Ik™ is also designed to deliver a…
Read MoreMiracor’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 the heart affected by the myocardial infarction. Miracor, which received a CE mark for its…
Read MoreExo 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 and has raised nearly $50M to date. Intel Capital led the Series B. Other investors…
Read MoreFDA 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 for Devices and Radiological Health (CDRH) approved the Company’s submission after a thorough review of…
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