Nyxoah sleep apnea neuro-stim therapy gains CE Mark

Nyxoah said it has won the CE Mark for its novel hypoglossal nerve stimulation therapy for treating obstructive sleep apnea (OSA). The Genio system is a battery-free, leadless and minimally invasive neurostimulator designed to deliver bilateral hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea patients who have failed conventional continuous positive airway pressure (CPAP) […]

OptiScan raises $20m for bedside glucose monitoring system

OptiScan Biomedical said today that it closed a $20 million Series E round to support the commercialization of its continuous monitoring system, the OptiScanner 5000, in the U.S. The company’s device is an automated bedside blood glucose monitor designed for use in the intensive care unit. The system can measure glucose values from a micro-sample of […]

Ex-NuVasive CEO Lucier to head new M&A firm

Ex-NuVasive CEO Gregory Lucier will lead new M&A-focused company Corza Health. Recently departed NuVasive (NSDQ:NUVA) CEO Gregory Lucier will lead a new company formed to acquire medtech and life sciences firms and assets. Lucier, 54, is partnering with Chicago-based private equity firm GTCR to form the new company, Corza Health, in San Diego. GTCR holds stakes in Regatta Medical, […]

Boston VC shop Flagship Pioneering raises $824m with 8th fund

Life-sciences focused venture capital group Flagship Pioneering said today that it raised $824 million for its new Special Opportunities Fund II, which aims to support companies created by its Flagship Labs unit. The funds join an existing capital pool of more than $700 million Flagship said it raised between late 2017 and 2018 to finance […]

Syneron Candela, InMode settle patent suits

Syneron Candela (NSDQ:ELOS) said today it inked a settlement deal with InMode Aesthetic Solutions to end a patent dispute between the companies. Through the settlement deal, Wayland, Mass.-based Syneron Candela said that it offered InMode a sublicense to continue to market its bi-polar fractional radiofrequency product line. The companies did not release terms of the settlement […]

Siemens wins FDA nod for Mobilett Elara Max mobile X-ray

Siemens (NYSE:SI) Healthineers said today that it won FDA 510(k) clearance for its Mobilett Elara Max mobile X-ray system. The Erlangen, Germany-based company touted that the newly cleared system features improved IT security and secure system integration to allow access of patient data at any time. Siemens Healthineers also said that the system features antibacterial coating and […]

Brainlab acquires Medineering’s robotics platform

Brainlab said today that it acquired Medineering and its line of robot-assisted surgery devices for an undisclosed amount. Brainlab, which earlier this month dealt its orthopedic joint reconstruction assets to Smith & Nephew (NYSE:SNN), is already an investor and markets the Medineering robot-assisted surgical arm under the Cirq brand. The Munich-based company said it plans […]

FDA warns Integra’s TEI Biosciences over quality, validation issues

The FDA recently revealed a warning letter it sent to Integra LifeSciences‘ (NSDQ:IART) TEI Biosciences over four noted violations it found during an inspection of TEI’s Boston-based facilities. The federal watchdog said that it inspected the company’s facilities where it produces collagen-based medical devices, including its Xenform soft tissue repair matrix, from last October to […]

Nevro taps ex-Thoratec CEO Grossman | Personnel Moves, March 20, 2019

Nevro Corp. (NYSE:NVRO) said yesterday that it named former Thoratec CEO Keith Grossman to replace president & CEO Rami Elghandour after striking a deal with one of its investors, Broadfin Capital. Grossman re-joined Thoratec after taking over at Conceptus in December 2011 and leading it to a $1.1 billion sale to Bayer in June 2013 (he’d […]

Sage wins historic FDA nod for postpartum depression therapy

Sage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression. The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June. Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth […]