Researchers have developed an AI-based wearable device, called Revoice, to help individuals communicate effectively after a stroke. The system, worn around the neck, uses sensors to capture carotid pulse signals and subtle vibrations from throat muscles to reconstruct intended words and sentences in real time, potentially transforming the lives of stroke patients living with dysarthria.

The FDA’s Center for Devices and Radiological Health posted two important guidances just in the first week of the new year. The agency seems determined to sustain that pace with a new draft guidance for cuffless blood pressure monitors, apparently in response to sales of unauthorized over-the-counter devices for this indication.

Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain.

After raising more than twice as much as expected in its March IPO, Kestra Medical Technologies Inc. appears poised to repeat its success with an upsized secondary offering as well. The Kirkland, Wash.-based company initially planned to offer 5.5 million shares in its second pass at the market but increased the number of shares to 6 million two days later when it set the price at $23 per share. The projected gross proceeds of $138 million provide a nice addition to the $232 million raised nine months ago.

A jury has returned a verdict of infringement against Apple Inc., as part of a series of patent disputes with Masimo Corp., producing a damages award of $634 million which is seen in some quarters as an indicator that Masimo has the momentum against Apple.

Mode Sensors AS received U.S. FDA 510(k) clearance for its Re:Balans hydration monitoring system. The wearable patch sensor allows for the continuous monitoring of body hydration to detect fluid imbalances using thoracic bioimpedance technology to deliver automatic, accurate data to help physicians in fluid management.

Alimetry Ltd. is making waves far beyond its home market with its first-in-class wearable Gastric Alimetry device that measures gut function – an area long considered a black box in gastroenterology.

Some Apple Watch users will be able to monitor their blood oxygen levels through their iPhone, thanks to a software update the company planned to issue Aug. 14. The Cupertino, Calif.-based company pulled the feature from its watches in the U.S. in 2024, following a patent dispute with Masimo Corp., of Irvine, Calif., that threatened an import ban.

Trinity Biotech plc recently unveiled CGM+, an AI-native, wearable biosensor that goes beyond traditional continuous glucose monitors and tracks glucose levels, cardiovascular activity and body temperature at the same time. The company believes that as precision medicine becomes central to health care, especially with the collection of real-time data, CGM+ will become a critical enabler of AI-based diagnostics, behavioral coaching and chronic disease management.

A June 25 hearing in the U.S. House of Representatives highlighted some of the health care spending benefits of remote patient monitoring, but Medicare payment is seen as deficient – a problem that may be resolved by pending legislation.