Synaptive Medical Inc. has introduced a free water correction feature to its Modus Plan software to restore tracts in areas surrounding brain lesions affected by edema and which interferes with automated mapping of the brain. Water from edema obscures retrieval of diffusion tensor imaging (DTI) data and tractography mapping used to evaluate white matter pathways in the brain.
Curvebeam AI Ltd. won a U.S. FDA breakthrough device designation for Ossview, its investigational software that detects osteopenia or reduced bone mass in the already fragile bones of women 70 years of age and older. Osteopenia is difficult to diagnose using conventional bone mineral density (BMD) testing because small changes in density mask major changes in bone microstructure.
Heartbeam Inc. has been awarded a patent for what it called “the first and only” 3D-vector, 12-lead ECG platform for heart attack detection, this in conjunction with a credit card-sized device inside a consumer’s wallet for personal monitoring. The company said it can record and remotely transmit a set of cardiac signals to a physician for review so that patients at high risk of cardiac arrest are not left alone deciding if an ER visit is warranted.
Applied Tissue Technologies LLC (ATT) has won U.S. FDA clearance for a negative pressure wound therapy (NPWT) system that eliminates foam as a potential impediment to complete wound healing. ATT CEO Michael Broomhead said negative pressure wound therapy is ripe for a true innovation to kick its Platform Wound Dressing (PWD) and the treatment “into its next generation.”
Boston Scientific Corp. and Abbott Laboratories continue to parry over clinical trials comparing the latter’s Amplatzer Amulet with Boston Scientific’s Watchman in sealing the heart’s left atrial appendage (LAA) to prevent ischemic stroke in patients with atrial fibrillation (Afib). In one of five presentations at the 34th Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston in mid-September, Abbott said device-related thrombosis or peri-device leak more frequently preceded strokes in patients with Watchman compared to those with Abbott’s Amplatzer Amulet device.
Baxter International Inc. has scored FDA clearance for an infusion pump used to deliver small amounts of fluid at low rates, often in pediatric, neonatal and anesthesia care settings. The Novum Iq syringe infusion pump also features Dose Iq Safety Software, a web-based, customizable drug library that incorporates titration technology to reduce dosage errors during patient treatment.
Magnus Medical Inc. received FDA clearance for a neuromodulation platform to treat major depressive disorder (MDD) in adults for whom antidepressant medication has been ineffective.
Cerevasc Inc. has treated its first U.S. patient using an investigational device intended for patients suffering from hydrocephalus, one of the most common neurological conditions worldwide. Boston-based Cerevasc’s Eshunt system is being taken through its paces during a clinical study in Buenos Aires, Argentina and is aimed at replacing a half-century-old neurosurgical procedure associated with frequent failure, infection risk and high costs.
Massachusetts Institute of Technology (MIT) engineers in collaboration with South Korean cosmetic giant Amorepacific Corp. have created a chip-free, wireless electronic “skin” for sensing and transmitting vital medical signs minus larger, clunkier chips or batteries in most smartphones. MIT postdoc Jun Min Suh explained any change to the skin’s conditions, such as an accelerated heart rate, affect the sensor’s mechanical vibrations, generating an electrical signal that automatically transmits medial data to the consumer.
Researchers at Massachusetts General Hospital (MGH) and the Massachusetts Institute of Technology (MIT) have developed a deep learning computer model that expands on the ability to identify discrete data contained in breast imaging to better predict a woman’s chances of developing breast cancer.