EnsoData announced today that it received FDA 510(k) clearance for technology that enables AI-powered sleep diagnosis using pulse oximetry devices. Powered by the company’s EnsoSleep PPG scoring, widely available, wearable, FDA-cleared pulse oximetry technology can be used for sleep diagnosis, according to EnsoData. The company says it enables a high-quality, accessible and cost-effective approach to […]
Diagnostics
FDA clears wearable EP monitoring patch from X-trodes
X-trodes announced today that it received FDA 510(k) clearance for a new wireless wearable technology for electrophysiological (EP) monitoring. The Herzliya, Israel-based company calls its solution “Smart Skin,” although it plans to market it in the U.S. as the X-trodes System M. Smart Skin features a customizable, dry-printed, multi-modal electrode patches. It monitors a wide […]
BioSig reduces workforce again, will ‘substantially’ cut operations
BioSig Technologies (Nasdaq:BSGM) announced today that it terminated “a significant number of its employees.” Shares of BSGM were up 3.1% to 64¢ apiece in mid-morning trading today following the announcement. With this latest workforce reduction, the company says it expects to “substantially reduce business operations.” Today’s announcement marks the company’s second significant headcount cut in […]
Sparrow BioAcoustics launches software that turns a smartphone into a stethoscope
Sparrow BioAcoustics announced that it launched its Stethophone software that enables using a smartphone as a stethoscope. The software turns smartphones into medical-grade stethoscopes. It allows users to capture, analyze and share critical heart health data with medical personnel from any location. Sparrow won FDA clearance for the downloadable application in June 2023. That clearance […]
FDA clears first over-the-counter fingertip pulse oximeter from Masimo
Masimo announced today that it received FDA clearance for its MightySat Medical over-the-counter fingertip pulse oximeter. The company says that the regulatory nod makes MightySat Medical the first and only FDA-cleared medical fingertip pulse oximeter available over the counter (OTC), direct to consumers without a prescription. Irvine, California-based Masimo powers its OTC pulse oximeter with […]
Butterfly Network rolls out next-gen ultrasound-on-chip tech in the U.S.
Butterfly Network (NYSE:BFLY) announced today that it launched its iQ3 third-generation handheld point-of-care ultrasound system. The Butterfly iQ3 point-of-care ultrasound (POCUS) system is a semiconductor-based, single-probe, whole-body ultrasound offering. iQ3 features a brand-new ergonomic design and provides double the data processing speed compared to previous generations. The FDA cleared the iQ3 system last month. Burlington, […]
Study says Masimo pulse oximetry is accurate for different skin colors
Masimo today announced findings from a study evaluating its pulse oximetry technology across a variety of skin pigmentations. Dr. Vikrant Sharma, Dr. Steven Barker, Dr. William C. Wilson and colleagues at Masimo performed a focused analysis of previously published data evaluating the impact of low perfusion on the performance of Masimo SET pulse oximetry across […]
FDA clears new cervical cytology AI tech from Hologic
Hologic announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm. Clearance makes Genius the first and only FDA-cleared digital cytology system combining deep learning-based AI with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells, according to a news release. Hologic’s clearance […]
BD, Techcyte collab on AI-based cervical cytology
BD announced today that it partnered with Techcyte on AI-based guidance for cytologists and pathologists. The strategic collaboration aims to offer an AI algorithm to guide cytologists and pathologists to efficiently and effectively identify evidence of cervical cancer and precancer using whole-slide imaging. Franklin Lakes, New Jersey-based BD said in a news release that the agreement […]
BioSig announces layoffs as part of cost-cutting effort
BioSig Technologies (Nasdaq:BSGM) announced today that it enacted a workforce reduction in an effort to reduce cash burn. Westport, Connecticut-based BioSig did not disclose the number of employees affected by the reduction. As of the company’s last annual report on March 30, 2023, it had 47 full-time employees. Shares of BSGM fell 4.3% to 21¢ […]
The top IVD and diabetes tech stories of 2023
Over the course of 2023, the medtech industry produced another impressive year of innovation, with news coming from a variety of spaces. Chiefly among those were diabetes technologies and in vitro diagnostics (IVDs). We saw regulatory nods, product launches, funds raised and mergers fall apart. Looking at those two spaces in particular, here are five […]