Philips is recalling some of its ventilators and sleep apnea machines because the foam used to dampen the machines’ sound can degrade and emit small particles that irritate airways. Gases released by the degrading foam may also be toxic or carry cancer risks. The recall is expected to impact between 3 million and 4 million devices.
Neovasc is pausing its Tiara transfemoral (TF) mitral valve replacement program and cutting its headcount by 40%. The company said it would instead focus on its core Reducer and Tiara TA (transatrial) valve. Neovasc said a decision on the potential European approval of the Tiara TA is expected during the second half of 2022.
Hologic has closed on its Mobidiag Oy acquisition, a deal valued at $808 million. The company has announced four acquisitions this year, taking advantage of more cash on hand than usual due to strong COVID-19 testing sales.
And in case you missed our last Medtech in a Minute report...
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.