Verily Life Sciences has hit a snag in bringing a Parkinson’s disease exam tool to its research smartwatch. The Alphabet Company’s bid to add the virtual motor exam (VME III) was recently rejected by FDA. Data gathered as a result of the assessment could be used in drug development studies. Verily said the VME III provides an estimate of the MDS-UPDRS Part III Total motor score, as rated by a panel of clinicians. It guides participants wearing the Study Watch through a series of up to eight simple motor tasks. The firm said the exam takes less than 20 minutes, and can be performed in the comfort of a person’s home, without the guidance of a clinician. FDA noted in a letter that it was rejecting the request because there were concerns about the ability to interpret changes on the VME III measured by the Verily Study Watch as representing meaningful change in patients’ ability to function.
CVRx is seeking to raise at least $75 million in an IPO and has introduced a new ultrasound-guided approach to treat heart failure symptoms. The company has developed the Barostim Neo system, an implantable device designed to target the blood pressure sensors, called baroreceptors, found on the carotid artery and in the carotid sinus in the neck. CVRx has a CE mark and a nod from FDA for the device.
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Medtronic is ceasing sales of its HeartWare Ventricular Assist Device (HVAD) system and asking doctors to switch to an alternative means of durable mechanical circulatory support. The decision comes after a number of recalls, including a November 2020 recall of the HVAD’s pump implant kit because the medical device may fail to initially start, restart, or have a delay in restarting after the pump stops. Abbott Laboratories, which inherited through acquisition Thoratec’s LVAD, has indicated it has the capacity and supply to support growing demand for mechanical circulatory support devices with its HeartMate 3 device.
iRhythm Technologies’s president and CEO Mike Coyle has announced he is stepping down for personal reasons. Douglas Devine, the company’s CFO, has assumed the role of interim CEO while a search for a permanent CEO is conducted. Coyle had just taken the position in January after Kevin King retired. iRhythm markets the wearable Zio XT technology for monitoring heart rate.
LivaNova has completed the initial close of divesting its heart valve business to Gyrus Capital, an investment firm, for $73 million. The portfolio includes Perceval, a sutureless aortic valve, and Memo 4D, a semi-rigid mitral annuloplasty ring. About 850 employees will shift to CORCYM, an independent company recently launched and owned by entities funded and controlled by Gyrus to manage the global heart valve business.
Abiomed is acquiring preCARDIA, a company that has developed a catheter-based system designed to rapidly treat ADHF-related volume overload by reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function. The system includes a superior vena cava (SVC) balloon that delivers programmed intermittent occlusion of the SVC.